Lyphochek Immunoassay 370 Data Sheet

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Transcript of Lyphochek Immunoassay 370 Data Sheet

Page 1: Lyphochek Immunoassay 370 Data Sheet

Lyphochek® Immunoassay Plus ControlLevels 1, 2 and 3

370 Trilevel 12 x 5 mL371 Level 1 12 x 5 mL372 Level 2 12 x 5 mL373 Level 3 12 x 5 mL370X Trilevel MiniPak 3 x 5 mL

ENGLISH

INTENDED USE

Lyphochek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

SUMMARY AND PRINCIPLE

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the clinical range.

REAGENT

This product is prepared from human serum with added constituents of human and animal origin, chemicals, and therapeutic drugs. Level 1 also contains stabilizers. The control is provided in lyophilized form for increased stability.

STORAGE AND STABILITY

This product will be stable until the expiration date when stored unopened at 2 to 8°C. Once the control is reconstituted all analytes will be stable for 7 days when stored tightly capped at 2 to 8°C with the following exceptions: (1) Folate and PSA will be stable for 3 days, (2) C-Peptide will be stable for 1 day, (3) ACTH, Calcitonin, Gastrin and Free PSA should be assayed immediately after reconstitution.After reconstituting and freezing the control, all analytes will be stable for 20 days when stored tightly capped at –10 to –20°C with the following exceptions: no frozen stability claim is supplied for ACTH, Aldosterone, Androstenedione, Calcitonin and C-Peptide. Once thawed, do not refreeze the control; discard remaining material.This product is shipped under ambient conditions.

RECONSTITUTION INSTRUCTION

Using a volumetric pipet, reconstitute each vial with 5.0 mL of distilled or deionized water. Replace the stopper and allow the control to stand for 15 minutes. Before sampling, allow the control to reach room temperature (18 to 25°C) and swirl gently to ensure homogeneity. After each use, promptly replace the stopper and return to 2 to 8°C storage.

PROCEDURE

This product should be treated the same as patient specimens and run in accordance with the instructions accompanying the instrument, kit, or reagent being used. Dispose of any discarded materials in accordance with the requirements of your local waste management authorities. In the event of damage to packaging, contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories Technical Services.

LIMITATIONS

1. This product should not be used past the expiration date. 2. If there is evidence of microbial contamination or excessive turbidity in the reconstituted product, discard the vial. 3. This product is not intended for use as a standard.

ASSIGNMENT OF VALUES

The mean values printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control. Individual laboratory means should fall within the corresponding acceptable range; however, laboratory means may vary from the listed values during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as guides.Refer to www.qcnet.com for insert update information.

SPECIFIC PERFORMANCE CHARACTERISTICS

This product is a freeze-dried product manufactured under rigid quality control standards. To obtain consistent vial-to-vial assay values, the control requires proper storage and handling as described. See important product information listed in footnote.

DEUTSCH

VORGESEHENER VERWENDUNGSZWECK

Die Lyphochek Immunoassay Plus Control ist ein Qualitätskontrollserum für die quantitative Bestimmung der in dieser Packungsbeilage angegebenen Analyte, mit Zielwertangaben.

EINLEITUNG UND ZUSAMMENFASSUNG

Die Verwendung entsprechender Kontrollmaterialien dient der objektiven Beurteilung der Qualität von im Labor durchgeführten Untersuchungen und ist ein unerlässlicher Bestandteil der guten Laborpraxis. Die drei Level dieser Kontrolle ermöglichen eine umfassende Qualitätssicherung über den gesamten klinisch relevanten Bereich.

REAGENZ

Dieses Produkt wurde aus Humanserum hergestellt und enthält Zusätze menschlichen und tierischen Ursprungs, Chemikalien und Medikamente. Level 1 enthält außerdem Stabilisatoren. Die Kontrolle wurde zur Verbesserung der Stabilität lyophilisiert.

LAGERUNG UND HALTBARKEIT

Dieses Produkt ist bis zum angegebenen Haltbarkeitsdatum stabil, wenn es ungeöffnet bei 2-8°C gelagert wird. Nach Rekonstitution der Kontrolle sind alle Analyte 7 Tage stabil, sofern die Kontrolle dicht verschlossen bei 2-8°C aufbewahrt wird. Ausnahmen: (1) Folat und PSA sind nach der Rekonstitution 3 Tage stabil. (2) C-Peptid ist nach der Rekonstitution 1 Tag stabil. (3) ACTH, Calcitonin, Gastrin und freies PSA müssen sofort nach der Rekonstitution bestimmt werden.Wenn das Kontrollmaterial nach Rekonstitution eingefroren wird, sind alle Analyte 20 Tage stabil, sofern die Kontrolle dicht verschlossen bei –10 bis –20°C gelagert wird. Ausnahmen: Für ACTH, Aldosteron, Androstendion, Calcitonin und C-Peptid können keine Angaben hinsichtlich der Stabilität nach Einfrieren gemacht werden. Die Kontrolle nach dem Auftauen nicht erneut einfrieren; restliches Material verwerfen.Dieses Produkt wird unter Umgebungsbedingungen versandt.

ANLEITUNG ZUR REKONSTITUTION

In jedes Fläschchen mit einer Vollpipette genau 5,0 ml destilliertes oder deionisiertes Wasser pipettieren. Mit dem Stopfen verschließen und die Kontrolle 15 Minuten stehen lassen. Die Kontrolle vor Entnahme einer Probe Raumtemperatur (18 bis 25°C) erreichen lassen und vorsichtig durchmischen, um die Homogenität sicherzustellen. Nach jedem Gebrauch sofort wieder mit dem Stopfen verschließen und bei 2 bis 8°C aufbewahren.

HANDHABUNG

Das Produkt ist genau wie eine Patientenprobe zu behandeln und in Übereinstimmung mit den Vorschriften des Geräte-, Kit- oder Reagenzherstellers anzuwenden.Die Entsorgung aller Abfälle ist nach den geltenden örtlichen Bestimmungen vorzunehmen. Falls die Verpackung beschädigt ist, nehmen Sie bitte Kontakt zur Bio-Rad-Niederlassung auf.

EINSCHRÄNKUNGEN

1. Dieses Produkt nach Ablauf des Haltbarkeitsdatums nicht mehr verwenden. 2. Bei Anzeichen einer mikrobiellen Kontamination oder einer starken Trübung des rekonstituierten Produkts ist das Fläschchen zu verwerfen. 3. Dieses Produkt ist nicht zur Verwendung als Standard geeignet.

WERTEERMITTLUNG

Die in dieser Packungsbeilage angegebenen Mittelwerte stammen aus Vielfachbestimmungen und gelten speziell für diese Produktcharge. Die angegebenen Tests wurden vom Reagenzhersteller und/oder von unabhängigen Laboratorien mit vom Hersteller unterstützten Reagenzien durchgeführt; dazu wurde eine repräsentative Stichprobe von Fläschchen dieser Produktcharge eingesetzt. Die einzelnen Werte sollten im entsprechenden Akzeptanzbereich liegen; die tatsächlich erzielten Werte können jedoch während der Lebensdauer dieser Kontrolle von den angegebenen Zielwerten abweichen. Abweichungen im Laufe der Zeit und zwischen verschiedenen Laboratorien sind möglicherweise auf unterschiedliche Labortechniken, Geräte und Reagenzien oder auf Modifikationen der Testmethoden durch den Hersteller zurückzuführen. Jedem Labor wird empfohlen, eigene Mittelwerte und Akzeptanzbereiche zu ermitteln und die hier aufgeführten Werte als Richtwerte zu betrachten.Aktualisierte Zielwerttabellen finden Sie im Internet unter www.qcnet.com.

SPEZIFISCHE EIGENSCHAFTEN

Dieses gefriergetrocknete Produkt wurde nach strengen Qualitätsstandards hergestellt. Um reproduzierbare Ergebnisse von Fläschchen zu Fläschchen sicherzustellen, muss die Kontrolle sachgerecht gelagert und wie angegeben gehandhabt werden. Wichtige Produktinformationen in der Fußnote beachten.

FRANÇAIS

UTILISATION

Lyphochek Immunoassay Plus Control est un sérum titré de contrôle de la qualité permettant de surveiller la précision des tests réalisés en laboratoire pour les analytes dont la liste figure sur cette notice.

INTRODUCTION ET PRINCIPE

L’utilisation de produits de contrôle de la qualité est indiquée pour évaluer de façon objective la précision des méthodes et des techniques utilisées, et fait partie intégrante des bonnes pratiques de laboratoire. Trois concentrations sont disponibles afin de permettre un contrôle de la qualité sur l’ensemble de la plage de valeurs cliniques.

RÉACTIF

Ce produit est préparé à partir de sérum humain auquel ont été ajoutés des constituants d’origine humaine et animale, des produits chimiques et des médicaments thérapeutiques. Le niveau 1 contient également des stabilisants. Le contrôle est fourni sous forme lyophilisée pour assurer une meilleure stabilité.

CONSERVATION ET STABILITÉ

Ce produit restera stable jusqu’à la date de péremption en flacon non ouvert et conservé entre 2 et 8°C. Une fois le contrôle reconstitué, tous les analytes resteront stables pendant 7 jours en flacon convenablement fermé et conservé entre 2 et 8°C. Exceptions : (1) Le folate et l’antigène prostatique spécifique (PSA) seront stables pendant 3 jours après reconstitution. (2) Le peptide-C est stable pendant un jour après reconstitution. (3) L’ACTH, la calcitonine, la gastrine et le PSA libre doivent être titrés immédiatement après reconstitution.Une fois le contrôle reconstitué et congelé, tous les analytes resteront stables pendant 20 jours en flacon convenablement fermé et conservé entre –10 et –20°C. Exceptions : Aucune garantie de stabilité de congélation n’est fournie pour l’ACTH, l’aldostérone, l’androstènedione, la calcitonine et le peptide C. Une fois le contrôle décongelé, ne pas le recongeler, et éliminer le produit restant.Ce produit est expédié sous conditions ambiantes.

INSTRUCTIONS POUR LA RECONSTITUTION

A l’aide d’une pipette volumétrique, reconstituer chaque flacon avec 5,0 ml d’eau distillée ou désionisée. Replacer le bouchon et laisser le produit reposer pendant 15 minutes. Avant utilisation, amener le contrôle à la température ambiante (entre 18 et 25°C) et homogénéiser en imprimant un léger mouvement de rotation au flacon. Après chaque utilisation, remettre rapidement le bouchon et conserver entre 2 et 8°C.

MODE OPÉRATOIRE

Ce produit doit être traité comme les échantillons de patients, en respectant les instructions accompagnant l’appareil, le kit ou le réactif utilisés.Tout déchet doit être éliminé conformément aux réglementations en vigueur dans le laboratoire pour le traitement des déchets. Si le conditionnement est endommagé, contacter votre service technique Bio-Rad local.

LIMITES

1. Ne pas utiliser ce produit après la date de péremption. 2. En cas de contamination microbienne ou de trouble excessif du produit reconstitué, éliminer le flacon. 3. Ce produit n’est pas conçu pour être utilisé comme étalon.

DÉTERMINATION DES VALEURS

Les valeurs moyennes indiquées sur cette notice ont été déterminées à partir d’analyses répétées et concernent spécifiquement ce numéro de lot du produit. Les essais indiqués ont été réalisés par le fabricant du réactif et/ou par des laboratoires indépendants à l’aide de réactifs acceptés par le fabricant et sur un échantillonnage représentatif de ce lot de contrôle. Les moyennes obtenues par un laboratoire donné doivent se trouver sur la plage de valeurs acceptables correspondante ; cependant, les moyennes obtenues par le laboratoire peuvent varier par rapport aux valeurs indiquées pendant la durée de vie de ce contrôle. Les variations dans le temps et entre laboratoires peuvent être dues à des différences de méthodes, d’appareils et de réactifs employés par chaque laboratoire ou à des modifications de la méthode d’analyse employée par le fabricant. Il est recommandé à chaque laboratoire d’établir ses propres moyennes et plages de valeurs acceptables et de n’utiliser les valeurs fournies qu’à titre indicatif.Consulter le site www.qcnet.com pour obtenir une mise à jour de la notice.

CARACTÉRISTIQUES

Ce produit lyophilisé est fabriqué selon des normes rigoureuses de contrôle de la qualité. Pour obtenir des résultats reproductibles d’un flacon à l’autre, le contrôle doit être convenablement conservé et manipulé, tel que décrit dans cette notice. Consulter les notes de bas de page pour d’importantes informations sur le produit.

0197 EXP 2012-05-31Level 1 40231Level 2 40232Level 3 40233

40230

Printed // Gedruckt // Imprimé // Stampato // Impreso // Impresso // Tryckt // Trykt 2009-10 • 1536

For In Vitro Diagnostic UseIn Vitro Diagnosticum

Usage In Vitro Per Uso Diagnostico In VitroPara Uso Diagnóstico In Vitro

Utilizar Apenas Em Diagnóstico In VitroFör in-vitro diagnostiskt bruk Til in Vitro diagnosticering

European ConformityCE-Konformitätskennzeichnung

Conformité aux normes européennes Conformità europea

Conformidad europeaConformidade com as normas europeias

Europeisk överensstämmelseEuropæisk overensstemmelse

Temperature LimitTemperaturlimit

Limite de température Limite di temperatura Límite de temperatura Limite de temperatura

TemperaturgränserTemperaturgrænse

Consult Instructions for UseGebrauchsanweisung beachten

Consulter la notice d’emploiConsultare le istruzioni per l’uso

Consulte las instrucciones de usoConsulte as instruções de utilização

Läs bruksanvisningenBenyt brugsanvisninger

Lot NumberChargen-Nr.

Numéro de lot Numero di lottoNúmero de lote Número de lote Satsnummer

Batchnummer

EXPUse by (YYYY-MM-DD)

Verwendbar bis (JJJJ-MM-TT)Date de péremption (AAAA-MM-JJ)Data di scadenza (AAAA-MM-GG)

Usar hasta el (AAAA-MM-GG)Utilizar até (AAAA-MM-DD)

Använd före (ÅÅÅÅ-MM-DD)Anvend før (ÅÅÅÅ-MM-DD)

Manufactured byHergestellt vonFabriqué parFabbricato daFabricado porFabricado por

TillverkareFremstillet af

Authorized RepresentativeBevollmächtigter

Représentant agrééRappresentante autorizzatoRepresentante autorizadoRepresentante autorizadoAuktoriserad representantAutoriseret repræsentant

Catalog NumberKatalognummer

Numéro de catalogueNumero di catalogoNúmero de catálogoNúmero de catálogo

KatalognummerKatalognr.

CautionVosicht

AttentionAttenzionePrecaución

CuidadoFörsiktighet

Forsigtig

Reconstitute WithRekonstitutieren mitÀ reconstituer avec

Ricostituito conReconstituir conReconstituir com

Spä ut medRekonstitueret med

5.0 mL H2O

Page 2: Lyphochek Immunoassay 370 Data Sheet

ITALIANO

USO PREVISTO

Il Lyphochek Immunoassay Plus Control è un siero di controllo di qualità, dosato, formulato per monitorare la precisione delle procedure di analisi di laboratorio per gli analiti elencati nel presente inserto.

SOMMARIO E PRINCIPIO

L’uso di materiali per il controllo di qualità è indicato come valutazione oggettiva della precisione dei metodi e delle tecniche in uso, e costituisce parte integrante delle buone pratiche di laboratorio. Per permettere di controllare le prestazioni nell’ambito di tutto l’intervallo clinico sono disponibili tre livelli di controllo.

REATTIVO

Questo prodotto è stato preparato da siero umano con aggiunta di componenti di origine umana e animale, sostanze chimiche e farmaci. Il Livello 1 contiene anche stabilizzanti. Questo controllo è fornito in forma liofila per aumentarne la stabilità.

CONSERVAZIONE E STABILITÀ

Questo prodotto è stabile fino alla data di scadenza quando viene conservato, non aperto, a 2-8°C. Una volta ricostituito il controllo, tutti gli analiti sono stabili per 7 giorni quando il controllo è conservato ben chiuso a 2-8°C, con le seguenti eccezioni: (1) Folati e PSA sono stabili per 3 giorni dopo la ricostituzione. (2) C-Peptide è stabile per 1 giorno dopo la ricostituzione. (3) ACTH, Calcitonina, Gastrina e PSA libero vanno dosati immediatamente dopo la ricostituzione.Una volta ricostituito e congelato, tutti gli analiti sono stabili per 20 giorni quando il controllo viene conservato ben chiuso a –10 / –20°C con le seguenti eccezioni: non vengono fornite dichiarazioni di stabilità per ACTH, Aldosterone, Androstenedione, Calcitonina e C-peptide. Una volta scongelato, non ricongelare il controllo e gettare quanto rimasto.Il prodotto viene spedito in normali condizioni ambientali.

ISTRUZIONI PER LA RICOSTITUZIONE

Con una pipetta volumetrica, ricostituire ogni flacone con 5,0 ml di acqua distillata o deionizzata. Chiudere e lasciare riposare il controllo per 15 minuti. Prima dell’uso, lasciare riposare il controllo a temperatura ambiente (18-25°C) e agitarlo delicatamente per garantire l’omogeneità del contenuto. Dopo ogni uso, chiudere immediatamente con il tappo e conservare il prodotto a 2-8°C.

PROCEDURA

Questo prodotto deve essere trattato allo stesso modo dei campioni in esame ed usato secondo le istruzioni che accompagnano lo strumento, il kit o il reattivo in uso.Eliminare eventuali materiali residui nel rispetto delle norme locali sullo smaltimento dei rifiuti. Nel caso di danni alla confezione, contattare gli uffici Bio-Rad o l’agente di zona.

LIMITI

1. Questo prodotto non deve essere usato dopo la data di scadenza. 2. In caso di evidente contaminazione microbica o di una eccessiva torbidezza nel prodotto ricostituito, eliminare il flacone. 3. Questo prodotto non è concepito per l’uso come standard di riferimento.

ASSEGNAZIONE DEI VALORI

I valori medi riportati in questo inserto sono il risultato di analisi in replicato e sono specifici per questo lotto di prodotto. Le analisi sono state effettuate dai produttori dei reattivi e/o da laboratori indipendenti utilizzando reattivi forniti dal produttore ed una campionatura rappresentativa di questo lotto di controllo. Le medie di ciascun laboratorio dovrebbero rientrare nel corrispondente intervallo di accettabilità; tuttavia i valori medi del laboratorio possono variare rispetto a quelli dichiarati per il periodo di validità del presente controllo. Le variazioni nel tempo e tra laboratori possono essere causate da differenze nelle metodologie, strumentazioni o reattivi di ogni laboratorio o da modifiche metodologiche dei produttori dei reattivi. Ogni laboratorio dovrebbe stabilire le proprie medie e i relativi intervalli di accettabilità ed utilizzare i valori pubblicati sull’inserto solo come guida.Consultare il sito www.qcnet.it per informazioni sull’aggiornamento dell’inserto.

CARATTERISTICHE

Questo è un prodotto liofilo stabilizzato preparato sotto un rigido controllo standard di qualità. Per ottenere una consistente uniformità di risultati da flacone a flacone, si raccomanda una corretta conservazione e un corretto uso, come descritto. Vedere importanti informazioni sul prodotto indicate nella sezione delle note a piè pagina.

ESPAÑOL

USO INTENCIONADO

Lyphochek Immunoassay Plus Control tiene un uso intencionado como suero valorado para el control de la calidad y con el fin de supervisar la precisión de los procedimientos de análisis del laboratorio y para los analitos que se enumeran en este prospecto.

INTRODUCCIÓN Y PRINCIPIO

El uso de materiales para el control de la calidad está indicado para la evaluación objetiva de la precisión de los métodos y las técnicas en uso, y forma parte integral de las buenas prácticas del laboratorio. Existen tres niveles de control para permitir supervisar el funcionamiento dentro del rango clínico.

REACTIVOS

Este producto está preparado a partir de suero humano al que se añaden constituyentes de origen humano y animal, productos quimicos y drogas terapéuticas. El nivel 1 contiene también estabilizadores. El control se suministra liofilizado para una mayor estabilidad.

CONSERVACIÓN Y ESTABILIDAD

Este producto permanecerá estable hasta la fecha de caducidad, siempre que esté almacenado sin abrir a una temperatura entre 2 y 8°C. Una vez reconstituido el control, si se almacena bien tapado entre 2 y 8°C, todos los analitos permanecerán estables durante 7 días, con las siguientes excepciones: (1) Folato y PSA permanecerán estables durante 3 días después de la reconstitución. (2) Peptida-C permanece estable durante 1 día después de la reconstitución. (3) ACTH (hormona adrenocorticotrópica), Calcitonina, Gastrina y PSA Libre deben ser valorados inmediatamente después de la reconstitución.Una vez reconstituido y congelado el control, si se almacena bien tapado entre –10 y –20°C, todos los analitos permanecerán estables durante 20 días, con las siguientes excepciones: ACTH, Aldosterona, Androstenodiona, Calcitonina y Péptido C, cuya estabilidad en congelación no se garantiza. No vuelva a congelar el control una vez descongelado. Deseche el material sobrante.Este producto se transporta a temperatura ambiente.

INSTRUCCIONES PARA LA RECONSTITUCIÓN

Utilizando una pipeta volumétrica, reconstituya cada vial con 5,0 ml de agua destilada o desionizada. Vuelva a taparlo y deje reposar el control durante unos 15 minutos. Antes del muestreo, deje que el control alcance la temperatura ambiente (entre 18 y 25°C) y gírelo en círculos con suavidad para garantizar su homogeneidad. Tras cada uso, tápelo inmediatamente y consérvelo de nuevo entre 2 y 8°C.

PROCEDIMIENTO

Este producto debe tratarse de la misma forma que las muestras de pacientes y debe ser ensayado conforme a las instrucciones incluidas con el instrumento, kit o reactivos utilizados.Elimine todo material desechable de acuerdo con las normativas locales vigentes sobre la gestión de residuos. En el caso de que el envoltorio haya sufrido daños, póngase en contacto con la oficina de ventas o con el Servicio técnico local de Bio-Rad.

LIMITACIONES

1. Este producto no debe utilizarse después de la fecha de caducidad. 2. Si hubiese indicios de contaminación microbiana o exceso de turbidez en el producto reconstituido, deseche el vial. 3. Este producto no está previsto para ser utilizado como estándar.

ASIGNACIÓN DE VALORES

Los valores medios que figuran en este prospecto se obtuvieron a partir de la replicación de análisis y son específicos de este lote del producto. Las pruebas fueron realizadas por el fabricante del reactivo o por laboratorios independientes que utilizaron reactivos admitidos por el fabricante y una muestra representativa de este lote de control. Las medias de cada laboratorio deben estar comprendidas en el correspondiente rango aceptable, pero pueden apartarse de los valores indicados mientras dure este control. Las variaciones a lo largo del tiempo y entre laboratorios pueden deberse a diferencias en las técnicas del laboratorio, su instrumental y sus reactivos, o a modificaciones introducidas en el método de medida del fabricante. Se recomienda que cada laboratorio establezca sus propias medias y rangos aceptables y utilicen los que aquí se proporcionan sólo como orientación.Puede consultar las actualizaciones de prospectos en la página web www.qcnet.com.

CARACTERÍSTICAS ESPECÍFICAS DE FUNCIONAMIENTO

Éste es un producto liofilizado que ha sido fabricado según las más estrictas normas de control de la calidad. Para obtener valores de ensayo coherentes entre viales, será necesario almacenar y manipular el control según se indica. Consulte información importante sobre el producto en la nota al pie de página.

PORTUGUÊS

UTILIZAÇÃO

O Lyphochek Immunoassay Plus Control destina-se a ser utilizado como soro de controlo da qualidade ensaiado para controlar a precisão dos procedimentos laboratoriais de análise para os analitos listados neste folheto informativo.

SUMÁRIO E PRINCÍPIO

A utilização de materiais de controlo da qualidade é indicada como uma avaliação objectiva da precisão de métodos e técnicas aplicados e é parte integrante das boas práticas laboratoriais. Encontram-se disponíveis três níveis de controlo para permitir aferir o desempenho dentro dos limites clínicos.

REAGENTE

Este produto é preparado a partir de soro humano acrescido de constituintes de origem humana e animal, químicos e fármacos terapêuticos. O nível 1 também contém estabilizadores. O controlo é fornecido sob forma liofilizada para maior estabilidade.

ARMAZENAMENTO E ESTABILIDADE

Este produto permanecerá estável até ao fim do prazo de validade desde que seja armazenado por abrir a uma temperatura de 2 a 8°C. Depois de o controlo ter sido reconstituído, todos os analitos permanecerão estáveis durante 7 dias desde que o produto seja armazenado com a tampa firmemente apertada a uma temperatura de 2 a 8°C, com as seguintes excepções: (1) O Folato e o PSA permanecem estáveis durante 3 dias após a reconstituição. (2) O Peptídeo C permanecerá estável durante 1 dia após a reconstituição. (3) A ACTH, a Calcitonina, a Gastrina e o PSA Livre devem ser ensaiados imediatamente após a reconstituição.Depois de reconstituir e congelar o controlo, todos os analitos permanecerão estáveis durante 20 dias desde que sejam armazenados com a tampa firmemente apertada a uma temperatura de –10 a –20°C, com as seguintes excepções: não se proporciona qualquer afirmação de estabilidade congelada para a ACTH, a Aldosterona, a Androstenediona, a Calcitonina e o Peptídeo C. Depois de ter descongelado, o controlo não deve voltar a ser congelado; descarte qualquer material restante.Este produto é enviado em condições de temperatura ambiente.

INSTRUÇÕES DE RECONSTITUIÇÃO

Utilizando uma pipeta volumétrica, reconstitua cada frasco com 5,0 ml de água destilada ou desionizada. Reponha a tampa e deixe o controlo repousar durante 15 minutos. Antes de efectuar a recolha da amostra, permita que o controlo atinja a temperatura ambiente (18 a 25°C) e agite suavemente o frasco para assegurar a homogeneidade. Após cada utilização, reponha imediatamente a tampa e volte a armazenar a uma temperatura de 2 a 8°C.

PROCEDIMENTO

Este produto deve ser tratado da mesma forma que as amostras de pacientes e utilizado de acordo com as instruções que acompanham o instrumento, dispositivo ou reagente que está a ser utilizado.Elimine todos os materiais descartados de acordo com as disposições locais em vigor para a eliminação de resíduos biológicos. Na eventualidade de observar danos na embalagem, contacte a Bio-Rad Laboratories.

LIMITAÇÕES

1. Este produto não deve ser utilizado após o fim do prazo de validade. 2. Caso se verifique uma contaminação microbiana ou turvação excessiva no produto reconstituído, descarte o frasco. 3. Este produto não deve ser utilizado como um calibrador.

VALORIZAÇÕES

Os valores médios impressos neste folheto derivam de análises repetidas e são específicos para este lote do produto. Os testes listados foram executados pelo fabricante do reagente e/ou por laboratórios independentes que utilizam os reagentes de acordo com as especificações do fabricante e uma amostra significativa deste lote de controlo. As médias laboratoriais individuais devem estar dentro dos limites correspondentes aceitáveis; no entanto, as médias laboratoriais podem variar dos valores listados durante o tempo de duração deste controlo. Variações ao longo do tempo e entre laboratórios podem dever-se a diferenças de técnicas, instrumentos ou reagentes, ou a modificações nas técnicas de teste pelo fabricante. Recomenda-se que cada laboratório estabeleça as suas próprias médias e limites aceitáveis e utilize as que são fornecidas apenas como guias.Consulte o site www.qcnet.com para obter informações sobre actualizações de folhetos informativos.

CARACTERÍSTICAS ESPECÍFICAS DE DESEMPENHO

Este produto é liofilizado e fabricado de acordo com os mais rígidos padrões de controlo da qualidade. Para obter valorizações consistentes de frasco para frasco, o controlo deve ser manuseado e armazenado de acordo com o descrito. Consulte informação importante sobre o produto na nota de rodapé.

SVENSKA

AVSEDD ANVÄNDNING

Lyphochek Immunoassay Plus Control är ett analyserat kvalitetskontrollserum avsett för kontroll av precisionen i testförfaranden på laboratorium, för de analyter som anges i denna bipacksedel.

SAMMANFATTNING OCH PRINCIP

Användning av kvalitetskontrollmaterial är indicerad för objektiv utvärdering av precisionen i använda metoder och tekniker och ingår i god laboratoriepraxis. Tre kontrollnivåer finns tillgängliga, för kontroll av prestandan inom det kliniska mätområdet.

REAGENS

Denna produkt är framställd av humanserum med tillsatser av humant och animaliskt ursprung, kemikalier samt läkemedel. Nivå 1 innehåller även stabiliseringsmedel. Kontrollen tillhandahålles i frystorkad form för ökad hållbarhet.

FÖRVARING OCH HÅLLBARHET

Denna produkt är hållbar fram till utgångsdatum vid förvaring i oöppnad förpackning vid 2 – 8°C. Efter att kontrollen har rekonstituerats och vid förvaring i tätt försluten flaska vid 2 – 8°C är alla analyter hållbara i 7 dagar, med följande undantag: (1) Folat och PSA är hållbara i 3 dagar efter rekonstituering. (2) C-peptid är hållbar i 1 dag efter rekonstituering. (3) ACTH, kalcitonin, gastrin och fritt PSA skall analyseras omedelbart efter rekonstituering.Efter att kontrollen har rekonstituerats och frusits och vid förvaring i tätt försluten flaska vid –10 till –20°C är alla analyter hållbara i 20 dagar, med följande undantag: inga utfästelser kan göras beträffande hållbarheten i fruset tillstånd av ACTH, aldosteron, androstenedion, kalcitonin eller C-peptid. När flaskan väl har tinats får kontrollen ej åter frysas utan resterande material skall kasseras.Denna produkt transporteras vid omgivningstemperatur.

ANVISNINGAR FÖR REKONSTITUERING

Använd en volumetrisk pipett och rekonstituera varje flaska med 5,0 mL destillerat eller avjoniserat vatten. Sätt på proppen igen och låt kontrollen stå i 15 minuter. Låt kontrollen uppnå rumstemperatur (18–25°C) innan den används och snurra sedan försiktigt för hand så att den blandas ordentligt Efter varje användning skall flaskan omedelbart förslutas med propp och sättas tillbaka i kylförvaring vid 2-8°C.

FÖRFARANDE

Denna produkt skall behandlas på samma sätt som patientprover och användas enligt anvisningarna för de instrument, kit och reagenser som används.Kasserat material skall hanteras enligt de avfallsbestämmelser som utfärdats av lokala myndigheter. Om förpackningen är skadad kontaktas närmaste Bio-Rad Laboratories försäljningsavdelning eller teknisk serviceavdelning.

BEGRÄNSNINGAR

1. Denna produkt skall inte användas efter utgångsdatum. 2. Vid tecken på mikrobiell kontaminering eller om den rekonstituerade vätskan är mycket grumlig skall flaskan kasseras. 3. Denna produkt är inte avsedd att användas som en standard.

TILLDELNING AV VÄRDEN

Medelvärdena som anges i denna bipacksedel är härledda via replikatanalyser och är specifika för denna batch. De angivna testerna har utförts av reagenstillverkaren och/eller på oberoende laboratorier med användning av tillverkarens reagenser och ett representativt prov från denna kontrollbatch. Medelvärdena på det enskilda laboratoriet bör ligga inom motsvarande acceptabla område; laboratoriets medelvärden kan dock skilja sig från de angivna värdena under kontrollens livstid. Variationer över tiden och från laboratorium till laboratorium kan bero på skillnader i laboratorieteknik, instrument och reagenser, eller på modifikationer i tillverkarens testmetoder. Det rekommenderas att varje laboratorium fastställer sina egna medelvärden och acceptabla områden och endast betraktar de häri angivna värdena som vägledande.Besök www.qcnet.com för aktuell bipacksedelsinformation.

SPECIFIKA PRODUKTEGENSKAPER

Denna produkt är en frystorkad produkt som framställs enligt strikta kvalitetskontrollstandarder. För reproducerbara analysresultat från flaska till flaska skall kontrollen förvaras och hanteras korrekt, enligt anvisningarna. Se viktig produktinformation i fotnoten.

Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

Page 3: Lyphochek Immunoassay 370 Data Sheet

DANSK

TILSIGTET ANVENDELSE

Lyphochek Immunoassay Plus Control er beregnet til anvendelse som en analyseret kvalitetskontrolserum med henblik på overvågning af præcisionen af laboratoriets analysemetoder for de analytter, der er angivet i indlægssedlen.

RESUMÉ OG PRINCIP

Anvendelsen af kvalitetskontrolmateriale er tilsigtet som en objektiv vurdering af de anvendte metoders og teknikkers præcision og er en integreret del af god laboratoriepraksis. Der findes tre kontrolniveauer tilgængelige til overvågning af præstationen inden for det kliniske område.

REAGENS

Dette produkt er fremstillet af human serum tilsat bestanddele af human og animalsk oprindelse, kemikalier og terapeutiske medikamenter. Niveau 1 indeholder også stabilisatorer. Denne kontrol leveres i frysetørret form for forøget stabilitet.

OPBEVARING OG STABILITET

Dette produkt er holdbart til udløbsdatoen ved opbevaring uåbnet ved 2-8°C. Efter rekonstituering er alle analytter holdbare i 7 dage ved opbevaring med tæt lukket låg ved 2-8°C, med følgende undtagelser: (1) Folat og PSA vil være holdbare i 3 dage efter rekonstituering. (2) C-peptid er holdbart i 1 dag efter rekonstituering. (3) ACTH, calcitonin, gastrin og frit PSA bør analyseres umiddelbart efter rekonstituering.Efter rekonstituering og frysning vil alle analytter være holdbare i 20 dage ved opbevaring med tæt lukket låg ved –10 till –20°C, med følgende undtagelser: Der er intet fastsat om stabilitet efter frysning af ACTH, aldosteron, androstenedion, calcitonin og C-peptid. Optøet kontrolmaterialet må ikke fryses igen; resten af materialet kasseres.Dette produkt forsendes i ukølet tilstand.

VEJLEDNING I REKONSTITUERING

Hver ampul rekonstitueres med 5,0 ml destilleret eller deioniseret vand ved hjælp af en volumetrisk pipette. Sæt omgående låget på igen, og lad kontrolmaterialet stå i 15 minutter. Inden analysering skal kontrolmaterialet have stuetemperatur (18-25°C) og blandes forsigtigt for at sikre homogenitet. Efter hver brug lukkes glasset straks igen og anbringes ved 2-8°C.

FREMGANGSMÅDE

Dette produkt skal behandles som patientprøver og anvendes iht. de vejledninger, der følger med det anvendte instrument, reagenskit eller reagens.Kasseret materiale skal bortskaffes iht. gældende affaldsregulativer. Hvis emballagen er beskadiget, kontaktes den lokale Bio-Rad Laboratories forhandler eller teknisk service hos Bio-Rad Laboratories.

BEGRÆNSNINGER

1. Dette produkt bør ikke anvendes efter udløbsdatoen. 2. Hvis der er tegn på mikrobiel kontaminering i det rekonstituerede kontrolmateriale, eller det er meget uklart, skal ampullen kasseres. 3. Dette produkt er ikke beregnet til anvendelse som standard.

FASTSÆTTELSE AF VÆRDIER

De middelværdier, der er trykt i denne indlægsseddel, er udledt af gentagne analyser og er specifikke for dette produktlot. De angivne analyser er udført af reagensproducenten og/eller uafhængige laboratorier vha. producentens reagenser og et repræsentativt udvalg af dette lot af kontrolmateriale. Individuelle laboratoriemiddelværdier bør ligge inden for det i indlægssedlen angivne referenceområde, men kan dog variere i forhold til de angivne værdier i løbet af kontrolmaterialets levetid. Variationer over tid og imellem laboratorier kan skyldes forskellige laboratorieteknikker, instrumenter og reagenser, eller modifikationer i testmetoder fra producentens side. Det anbefales at laboratorier etablerer deres egne middelværdier og referenceområder og kun betragter de medfølgende værdier som vejledende.Der henvises til www.qcnet.com vedr. opdateringer af indlægssedlen.

SPECIFIKKE YDELSESEGENSKABER

Dette produkt er et frysetørret produkt, der er produceret under strenge kvalitetskontrolkrav. Kontrolmaterialet skal opbevares korrekt og håndteres som anvist for at give pålidelige resultater. Se vigtige oplysninger om produktet i fodnoten.

TÜRKÇE

KULLANIM AMACI

Lyphochek Immunoassay Plus Control, laboratuvar test prosedürlerinin bu prospektüste listelenen analitler için kesinliğinin takip edilmesi amacıyla değerleri bilinen bir kalite kontrol serumu olarak kullanılması içindir.

ÖZET VE PRENSİP

Kalite kontrol materyallerinin kullanılması, çalışılan yöntemlerin ve tekniklerin kesinliği ile ilgili objektif bir değerlendirme yapılması içindir ve iyi laboratuvar uygulamalarının ayrılmaz bir parçasıdır. Klinik aralıkta performansın takip edilmesi için üç seviye kontrol mevcuttur.

REAKTİF

Bu ürün, insan ve hayvan kaynaklı bileşenler, kimyasallar ve terapötik ilaçların eklendiği insan serumundan hazırlanmaktadır. Seviye 1 stabilizatör de içermektedir. Kontrol stabilitenin arttırılması amacıyla liyofilize formda sağlanmaktadır.

SAKLAMA VE STABİLİTE

Bu ürün açılmadan 2 ila 8°C arasında saklandığında son kullanma tarihine kadar stabildir. Kontrol hazırlandıktan sonra, sıkıca kapatılıp 2 ila 8°C arasında saklandığında aşağıdaki istisnalar dışında tüm analitler 7 gün stabildir: (1) Folat ve PSA 3 gün stabildir, (2) C-Peptid 1 gün stabildir, (3) ACTH, Kalsitonin, Gastrin ve Serbest PSA hazırlandıktan sonra hemen test edilmelidir.Kontrol hazırlandıktan ve dondurulduktan sonra, sıkıca kapatılıp -10 ila -20°C arasında saklandığında aşağıdaki istisnalar dışında tüm analitler 20 gün stabildir: ACTH, Aldosteron, Androstenedion, Kalsitonin ve C-Peptid için herhangi bir donmuş halde stabilite önerisinde bulunulmamıştır. Kontrolü çözdürdükten sonra tekrar dondurmayın; kalanı atın.Bu ürün ortam koşulları altında sevk edilir.

HAZIRLAMA TALİMATLARI

Hacimsel bir pipet kullanarak 5,0 mL distile veya deiyonize su ile her flakonun içindekileri sulandırın. Kapağını yerine takın ve kontrolü 15 dakika bekletin. Numune almadan önce kontrolün oda sıcaklığına (18 ila 25°C) gelmesini bekleyin ve homojen hale gelmesini sağlamak için yavaşça karıştırın. Her kullanımdan sonra kapağı derhal yerine takın ve 2 ila 8°C arasında saklayın.

PROSEDÜR

Bu ürün hasta örnekleri ile aynı muameleye tabi tutulmalıdır ve kullanılmakta olan cihaz, kit veya reaktif ile birlikte verilen talimatlara uygun olarak çalışılmalıdır. Herhangi bir atık malzemeyi yerel atık yönetimi yetkililerinin gereklerine uygun olarak atın. Ambalajda hasar olması durumunda, Bio-Rad Laboratories Satış Ofisi veya Bio-Rad Laboratories Teknik Servisi ile irtibata geçin.

SINIRLAMALAR

1. Bu ürün son kullanma tarihinden sonra kullanılmamalıdır. 2. Sulandırılan üründe mikrobiyal kontaminasyona veya aşırı türbiditeye dair bir gösterge varsa, flakonu atın. 3. Bu ürünün bir standart olarak kullanılması amaçlanmamıştır.

DEĞERLERİN TAYİN EDİLMESİ

Bu prospektüste yazılı olan ortalama değerler tekrar tekrar yapılan analizlerden elde edilmiştir ve ürünün bu lotuna özgüdür. Listelenen testler, üreticinin sağladığı reaktifler ve kontrolün bu lotunun temsili bir numunesi kullanılarak reaktif üreticisi ve/veya bağımsız laboratuvarlar tarafından gerçekleştirilmiştir. Ayrı ayrı laboratuvar ortalamaları karşılık gelen kabul edilebilir aralık içerisinde olmalıdır; bununla birlikte laboratuvar ortalamaları bu kontrolün ömrü süresince listelenen değerlerden farklı olabilir. Zaman içerisindeki ve laboratuvarlar arasındaki değişiklikler laboratuvar tekniği, cihaz ve reaktiflerdeki farklılıklar veya üreticinin test yöntemindeki modifikasyonları neden olabilir. Her laboratuvarın kendi ortalamalarını ve kabul edilebilir aralıklarını belirlemeleri ve verilen bu değerleri sadece kılavuz olarak kullanmaları önerilir.Güncel prospektüs bilgileri için www.qcnet.com adresine bakın.

SPESİFİK PERFORMANS ÖZELLİKLERİ

Bu ürün, sıkı kalite kontrol standartları altında üretilmiş dondurularak kurutulmuş bir üründür. Flakondan flakona tutarlı test değerleri elde etmek için kontrolün belirtilen şekillerde saklanması ve kullanılması gerekmektedir. Dipnotta listelenen önemli ürün bilgisine bakın.

DİPNOTLAR

Kontrolün bu lotu için: İntakt PTH:

Beklenen değerler veya stabilite için herhangi bir öneride bulunulmamıştır. (1) Sadece endojen seviyeleri gösterir. (2) Beklenen değer veya stabilite için herhangi bir öneride bulunulmamıştır. (3) Değerler verilmemiştir. (4) Seviye 3‘ü, üreticinin Östradiol değerleri >250 pg/mL (917,5 pmol/L) olan hasta örnekleri için verdiği önerilere göre seyreltin. § Bu test ile ilgili ortalama değerlerin ve kabul edilebilir aralıkların belirlenmesi için gereken veriler tayine sınırlı sayıda katılımdan dolayı sağlanamamıştır. Merkeziniz bu test ile ilgili Değer Tayini Programına katılmayı düşünüyorsa, lütfen yerel Bio-Rad Satış veya Teknik Servis Grubu ile irtibata geçin. SADECE ULUSLARARASI KULLANIM - Aşağıdaki bölüm Birleşik Devletlerde diagnostik kullanım için mevcut olmayan yöntemlere dair veriler içermektedir.

Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

Page 4: Lyphochek Immunoassay 370 Data Sheet

WARNING // Warnung // Attention // Avvertenze // Precaución // Aviso // Varning // Advarsel // Uyari

ENGLISHBiological source material. Treat as potentially infectious.

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source materials for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.Material Safety Data Sheet (MSDS) available for professional users on www.bio-rad.com.

DEUTSCHMaterial biologischer Herkunft. Als potenziell infektiös

zu behandeln.

Jede zur Herstellung dieser Kontrolle verwendete Einheit von menschlichen Spendern wurde mit von der amerikanischen Arzneimittelbehörde FDA (Food and Drug Administration) zugelassenen Methoden getestet und als nicht-reaktiv bezüglich Hepatitis-B-Oberflächen-Antigen (HBsAg), Antikörper gegen Hepatitis C (HCV) und Antikörper gegen HIV-1/HIV-2 befunden. Das Produkt enthält möglicherweise auch andere Bestandteile menschlichen Ursprungs, für die keine zugelassenen Tests existieren. In Übereinstimmung mit der guten Laborpraxis sollten alle Materialien menschlichen Ursprungs als potenziell infektiös betrachtet und mit der gleichen Sorgfalt wie Patientenproben behandelt werden.Sicherheitsdatenblätter (MSDS) stehen Ihnen im Internet unter www.bio-rad.com zur Verfügung.

FRANÇAISProduit d’origine biologique. A considérer comme

potentiellement infectieux.

Chaque unité de produit provenant d’un donneur humain et utiliséeutilisé dans la préparation de ce contrôle a été analysée à l’aide de méthodes approuvées par la FDA et a présenté des résultats négatifs pour l’antigène de surface de l’hépatite B (AgHBs), et les anticorps de l’hépatite C (VHC) et du VIH-1/VIH-2. Il est possible que ce produit contienne d’autres substances d’origine humaine pour lesquelles il n’existe pas de test agréé. Conformément aux bonnes pratiques de laboratoire, toute substance d’origine

humaine doit être considérée comme potentiellement infectieuse et manipulée avec les mêmes précautions que les échantillons provenant de patients.Une fiche de sécurité est à disposition des utilisateurs professionnels sur le site www.bio-rad.com.

ITALIANOMateriale di origine biologica. Trattare come

potenzialmente infettivo.

Ciascuna unità donatore utilizzata per preparare questo controllo, è stata testata mediante metodi approvati dalla FDA ed è risultata non reattiva per l’antigene di superficie dell’epatite B (HBsAg), l’anticorpo contro l’epatite C (HCV) e l’anticorpo contro l’HIV-1/HIV-2. Questo prodotto può anche contenere altro materiale di origine umana per il quale non esistono procedure di dosaggio raccomandate. Secondo le buone pratiche di laboratorio, tutti i materiali di origine umana devono essere considerati potenzialmente infettivi, perciò si raccomanda di trattare questo prodotto con le medesime precauzioni adottate per i campioni dei pazienti.Scheda informativa sulla sicurezza del materiale (MSDS) ad uso professionale disponibile al sito www.bio-rad.it.

ESPAÑOLMaterial de origen biológico. Manipular como

potencialmente infeccioso.

Todas las unidades de donantes humanos utilizadas en la fabricación de este control se han analizado según métodos de análisis aceptados por la FDA (agencia estadounidense para alimentos y fármacos) y se ha determinado que no reaccionan contra el antígeno superficial de la hepatitis B (HBsAg), el anticuerpo de la hepatitis C (VHC) y el anticuerpo del VIH-1/VIH-2. Este producto puede contener asimismo material de origen humano para el que no existen análisis homologados. De acuerdo con las prácticas de laboratorio correctas, todo material de origen humano se debe considerar potencialmente infeccioso y manipular con las mismas precauciones que las muestras de pacientes.La ficha de datos de seguridad (MSDS) está disponible para los usuarios profesionales en www.bio-rad.com.

PORTUGUÊSMaterial de origem biológica. Tratar como

potencialmente infeccioso.

Cada dádiva humana utilizada no fabrico deste controlo foi testada pelos métodos aprovados pela FDA (Administração dos Alimentos e Fármacos dos Estados Unidos), tendo sido considerada não reactiva em antigénios de superfície da hepatite B (HBsAg), anticorpo da hepatite C (VHC) e anticorpos VIH-1/VIH-2. Este produto também poderá conter outros materiais de origem humana para os quais não existem testes aprovados. De acordo com as boas práticas laboratoriais, todo o material de origem humana deve ser considerado potencialmente infeccioso, pelo que deverá ser manuseado com as mesmas precauções utilizadas com as amostras dos pacientes.Existem fichas de dados de segurança (MSDS) disponíveis para os utilizadores profissionais em www.bio-rad.com.

SVENSKAMaterial av biologiskt ursprung. Skall behandlas som

potentiellt infektiöst.

Varje enhet från humana donatorer till denna kontroll har testats enligt FDA-godkända metoder och har visat sig icke-reaktiv för hepatit B ytantigen (HBsAg), antikroppar mot hepatit C (HCV) och antikroppar mot HIV-1/HIV-2. Denna produkt kan även innehålla annat material av humant ursprung, för vilket godkända tester saknas. Enligt god laboratoriepraxis bör alla material av humant ursprung betraktas som potentiellt infektiösa och hanteras enligt samma försiktighetsregler som patientprover.Säkerhetsdatablad för laboratoriepersonal finns på www.bio-rad.com.

DANSKBiologisk kildemateriale. Bør behandles som

potentiel smittekilde.

Hver human donorenhed, der er anvendt ved fremstilling af dette produkt, er blevet testet med metoder, der er godkendte af FDA, og er fundet ikke-reaktiv over for hepatitis B overfladeantigen (HBsAg), antistof mod hepatitis C (HCV) og antistof mod HIV-1/HIV-2. Dette produkt kan også indeholde andet humant kildemateriale, for hvilket der ikke findes godkendte tests. I overensstemmelse med god laboratoriepraksis bør alle materialer af human oprindelse betragtes som potentiel smittekilde og håndteres efter samme forholdsregler som patientprøver.Professionelle brugere kan få sikkerhedsdatabladet (MSDS) via webstedet www.bio-rad.com.

TÜRKÇEBiyolojik kaynaklı madde. Potansiyel bulaşıcı olarak

muamele edin.

Bu kontrolün üretiminde kullanılan her bir insan donör birimi FDA tarafından kabul edilen yöntemlerle test edilmiştir ve Hepatit B Yüzey Antijeni (HBsAg), Hepatit C’ye karşı antikor (HCV) ve HIV-1/HIV-2’ye karşı antikor açısından reaksiyona yol açmadığı bulunmuştur. Bu ürün aynı zamanda henüz onaylanmış testi bulunmayan diğer insan kaynaklı maddeler de içerebilir. İyi laboratuvar uygulamasına uygun şekilde, tüm insan kaynaklı maddeler potansiyel bulaşıcı olarak dikkate alınmalıdır ve hasta örneklerinde uygulanan önlemlerin aynısı ile kullanılmalıdır.Profesyonel kullanım için www.bio-rad.com adresinde Malzeme Güvenlik Veri Sayfası (MSDS) mevcuttur.

Page 5: Lyphochek Immunoassay 370 Data Sheet

GLOSSARY GLOSSAR GLOSSAIRE GLOSSARIO GLOSARIO GLOSSÁRIO ORDLISTA ORDLISTE

ANALYTES

11-Deoxycortisol17-Alpha - Hydroxyprogesterone25-Hydroxy Vitamin D (1)AcetaminophenAdrenocorticotropic Hormone (ACTH)Alpha Fetoprotein (AFP)Aldosterone AmikacinAmiodarone (2)AmitriptylineAndrostenedioneAngiotensin I (1)Antithyroglobulin antibody (anti-TG Ab) (1)(2)

Antithyroid Peroxidase Antibodies (anti TPO-Ab) (1)(2)

CaffeineCalcitoninCarbamazepineCarbamazepine, FreeCarcinoembryonic Antigen (CEA)

ChloramphenicolCortisolC-PeptideCyclosporine (3)DesipramineDehydroepiandrosterone (DHEA)DHEA SulfateDigoxinDisopyramideEstradiolEstriol, FreeEstriol, Total (2)Estrogens, TotalEthosuximideFerritinFlecainide (3)FolateFructosamine (1)Follicle Stimulating Hormone (FSH)GastrinGentamicinGlucagon (1)Human Chorionic Gonadotropin (hCG)

hCG-Beta SubunitHuman Growth Hormone (hGH)

Immunoglobulin A (IgA) (1)Immunoglobulin E (IgE)Immunoglobulin G (IgG) (1)Immunoglobulin M (IgM) (1)ImipramineImmunoreactive Trypsinogen (IRT) (1)(2)

InsulinIron (1)Luteinizing Hormone (LH)LidocaineLithiumNAPANetilmicin (2)NortriptylineProstatic Acid Phosphatase (PAP)

PhenobarbitalPhenytoinPhenytoin, FreePrimidoneProcainamideProgesteroneProlactinPropanololProstate Specific Antigen (PSA)PSA, FreeParathyroid Hormone (PTH) ( )QuinidineSalicylateSex Hormone Binding Globulin (SHBG) (2)

Somatomedin-C (1)T3 FreeT3 TotalT3 UptakeT4 FreeT4 TotalThyroxine Binding Globulin (TBG) (1)

TestosteroneTestosterone, FreeTheophyllineThyroglobulin (1)Total Iron Binding Capacity (TIBC) (1)

TobramycinTricyclic Antidepressant Screen

Thyroid Stimulating Hormone (TSH)

Valproic AcidValproic Acid, FreeVancomycinVitamin B12

TERMS

MeanRangeRe-standardizationUnits

ANALYTE

11-Deoxycortisol17-Alpha - Hydroxyprogesteron25-Hydroxy-Vitamin D (1)AcetaminophenAdrenocorticotropes Hormon (ACTH)Alpha-Fetoprotein (AFP)AldosteronAmikacinAmiodaron (2)AmitriptylinAndrostendionAngiotensin I (1)Antithyreoglobulin-Antikörper (Anti-TG-AK) (1)(2)

Schilddrüsen-Peroxidase-Antikörper (Anti-TPO-AK) (1)(2)

CoffeinCalcitoninCarbamazepinCarbamazepin, freiCarcinoembryonales Antigen (CEA)

ChloramphenicolCortisolC-PeptidCyclosporin (3)DesipraminDehydroepiandrosteron (DHEA)DHEA-SulfatDigoxinDisopyramidÖstradiolÖstriol, freiÖstriol, gesamt (2)Östrogene, gesamtEthosuximidFerritinFlecainid (3)FolatFructosamin (1)Follikelstimulierendes Hormon (FSH)GastrinGentamycinGlucagon (1)Humanes Choriongonadotropin (hCG)

hCG-Beta-UntereinheitSomatotropes Hormon (STH) (hGH)

Immunoglobulin A (IgA) (1)Immunoglobulin E (IgE)Immunoglobulin G (IgG) (1)Immunoglobulin M (IgM) (1)ImipraminImmunreaktives Trypsinogen (IRT) (1)(2)

InsulinEisen (1)Luteinisierendes Hormon (LH)LidocainLithiumNAPANetilmicin (2)NortriptylinProstataspezifische saure Phosphatase (PSP) (PAP)

PhenobarbitalPhenytoinPhenytoin, freiPrimidonProcainamidProgesteronProlactinPropanololProstata-spezifisches Antigen (PSA)PSA, freiParathormon (PTH) ( )ChininSalicylatSHBG (2)

Somatomedin-C (1)T3, freiT3, gesamtT3-UptakeT4, freiT4, gesamtThyroxinbindendes Globulin (TBG) (1)

TestosteronTestosteron, freiTheophyllinThyreoglobulin (1)totale Eisenbindungskapazität (TEBK) (TIBC) (1)

TobramycinScreen für trizyklische Antidepressiva

Thyreoidea-stimulierendes Hormon (TSH)

ValproinsäureValproinsäure, freiVancomycinVitamin B12

BEGRIFFE

MittelwertBereichRestandardisierungEinheiten

ANALYTES

11-déoxycortisol17-alpha - hydroxyprogestérone25-hydroxy vitamine D (1)AcétaminophèneHormone corticotrope (ACTH)Alpha-fœtoprotéine (AFP)AldostéroneAmikacineAmiodarone (2)AmitriptylineAndrostènedioneAngiotensine I (1)Anticorps antithyroglobulinique (anti-TG Ab) (1)(2)

Anticorps antithyropéroxydase (anti TPO-Ab) (1)(2)

CaféineCalcitonineCarbamazépineCarbamazépine, libreAntigène carcino-embryonnaire (ACE) (CEA)

ChloramphénicolCortisolPeptide CCyclosporine (3)DésipramineDéshydro-épiandrostérone (DHEA)Sulfate de DHEADigoxineDisopyramideŒstradiolŒstriol, libreŒstriol, total (2)Œstrogènes, totales ÉthosuximideFerritineFlécainide (3)FolateFructosamine (1)Hormone folliculo-stimulante (FSH)GastrineGentamicineGlucagon (1)Gonadotrophine chorionique humaine (hCG)

Sous-unité hCG-bêtaHormone de croissance (hGH)

Immunoglobuline A (IgA) (1)Immunoglobuline E (IgE)Immunoglobuline G (IgG) (1)Immunoglobuline M (IgM) (1)ImipramineTrypsinogène immunoréactif (IRT) (1)(2)

InsulineFer (1)Hormone lutéinisante (LH)LidocaïneLithiumNAPANetilmicine (2)NortriptylinePhosphatase acide prostatique (PAP)

PhénobarbitalPhénytoïnePhénytoïne, librePrimidoneProcaïnamideProgestéroneProlactinePropanololAntigène prostatique spécifique (PSA)PSA, libreHormone parathyroïdienne (PTH) ( )QuinidineSalicylateSHBG (2)

Somatomédine C (1)T3, libreT3, totalT3, fixationT4, libreT4, totalGlobuline de transport de la thyroxine (TBG) (1)TestostéroneTestostérone, libreThéophyllineThyroglobuline (1)Capacité de fixation du fer, totale (TIBC) (1)

TobramycineDépistage des antidépresseurs tricycliques

Hormone de stimulation de la thyroïde (TSH)

Acide valproïqueAcide valproïque, libreVancomycineVitamine B12

TERMES

MoyennePlageRe-standardisationUnités

ANALITI

11-Deossicortisolo17-Alfa - idrossiprogesterone25-Idrossi-vitamina D (1)AcetaminofeneOrmone adrenocorticotropo (ACTH)Alfa-fetoproteina (AFP)AldosteroneAmikacinaAmiodarone (2)AmitriptilinaAndrostenedioneAngiotensina I (1)Anticorpo contro l’antitiroglobulina (anti-TG Ab) (1)(2)

Anticorpi contro la perossidasi dell’antitiroide (anti TPO-Ab) (1)(2)

CaffeinaCalcitoninaCarbamazepinaCarbamazepina liberaAntigene carcinoembrionico (CEA)

CloramfenicoloCortisoloC-PeptideCiclosporina (3)DesipraminaDeidroepiandrosterone (DHEA)DHEA SolfatoDigossinaDisopiramideEstradioloEstriolo liberoEstriolo totale (2)Estrogeni totaliEtosuximideFerritinaFlecainide (3)FolatoFruttosammina (1)Ormone follicolostimolante (FSH)GastrinaGentamicinaGlucagone (1)Gonadotropina corionica umana (hCG)

Sottounità hCG-BetaOrmone umano della crescita (hGH)

Immunoglobulina A (IgA) (1)Immunoglobulina E (IgE)Immunoglobulina G (IgG) (1)Immunoglobulina M (IgM) (1)ImipraminaTripsinogeno immunoreattivo (IRT) (1)(2)

InsulinaFerro (1)Ormone luteinizzante (LH)LidocainaLitioNAPANetilmicina (2)NortriptilinaFosfatasi acida prostatica (PAP)

FenobarbitaleFenitoinaFenitoina liberaPrimidoneProcainamideProgesteroneProlactinaPropanololoAntigene prostato specifico (PSA)PSA liberoOrmone paratiroideo (PTH) ( )QuinidinaSalicilatoSHBG (2)

Somatomedina-C (1)T3 liberoT3 totaleCaptazione del T3T4 liberoT4 totaleGlobulina legante la tirossina) (TBG) (1)

TestosteroneTestosterone liberoTeofillinaTiroglobulina (1)Capacità legante del ferro totale) (TIBC) (1)

TobramicinaControllo antidepressivo triciclico

Ormone stimolante la tiroide (TSH)

Acido valproicoAcido valproico liberoVancomicinaVitamina B12

TERMINI

MediaIntervalloRistandardizzazioneUnità

ANALITOS

11-Deoxicortisol17-Alfa - Hidroxiprogesterona25-Hidroxi Vitamina D (1)AcetaminofenoHormona adrenocorticotrópica (ACTH)Alfa-fetoproteína (AFP)AldosteronaAmikacinaAmiodarona (2)AmitriptilinaAndrostenodionaAngiotensina I (1)Anticuerpos antitiroglobulina (anti TG Ab) (1)(2)

Anticuerpos de la antiperoxidasa tiroidea (anti TPO Ab) (1)(2)

CafeínaCalcitoninaCarbamacepinaCarbamacepina, LibreAntígeno carcinoembrionario (CEA)

CloranfenicolCortisolPéptido CCiclosporina (3)DesipraminaDeshidroepiandrosterona (DHEA)Sulfato de DHEADigoxinaDisopiramidaEstradiolEstriol, LibreEstriol, Total (2)Estrógenos, TotalesEtosuximidaFerritinaFlecainida (3)FolatoFructosamina (1)FSH (Hormona estimulante del folículo)GastrinaGentamicinaGlucagón (1)Gonadotropina coriónica humana (hCG)

Subunidad hCG-BetaHormona Humana del Crecimiento (hGH)

Inmunoglobulina A (IgA) (1)Inmunoglobulina E (IgE)Inmunoglobulina G (IgG) (1)Inmunoglobulina M (IgM) (1)ImipraminaTripsinógeno inmunorreactivo (IRT) (1)(2)

InsulinaHierro (1)Hormona luteinizante (LH)LidocaínaLitioNAPA (N-Acetil-Procainamida)Netilmicina (2)NortriptilinaFosfatasa Ácida Prostática (PAP)

FenobarbitalFenitoínaFenitoína, LibrePrimidonaProcainamidaProgesteronaProlactinaPropanololAntígeno prostático específico (PSA)PSA, LibreHormona paratiroidea (PTH) ( )QuinidinaSalicilatoSHBG (2)

Somatomedina-C (1)T3 (libre)T3 (total)T3 (Captación)T4 (libre)T4 (total)Globulina fijadora de tiroxina (TBG) (1)

TestosteronaTestosterona, LibreTeofilinaTiroglobulina (1)Capacidad total de fijación de hierro (TIBC) (1)

TobramicinaScreening de antidepresivos tricíclicos

Hormona estimulante del tiroides (TSH)

Ácido valpróicoÁcido valpróico, LibreVancomicinaVitamina B12

TÉRMINOS

MediaRangoReestandarizaciónUnidades

ANALITOS

11-deoxicortisol17-alfa - hidroxiprogesterona25-hidroxi vitamina D (1)AcetaminofenoHormona adrenocorticotrófica (ACTH)Alfa-fetoproteína (AFP)AldosteronaAmikacinaAmiodarona (2)AmitriptilinaAndrostenedionaAngiotensina I (1)Anticorpo antitiroglobulina (anti-TG Ab) (1)(2)

Anticorpos antiperoxidase da tiróide (anti TPO-Ab) (1)(2)

CafeínaCalcitoninaCarbamazepinaCarbamazepina, LivreAntigénio carcinoembrionário (CEA)

CloranfenicolCortisolPeptídeo CCiclosporina (3)DesipraminaDeidroepiandrosterona (DHEA)Sulfato de DHEADigoxinaDisopiramidaEstradiolEstriol, LivreEstriol, Total (2)Estrogénios, TotalEtosuximidaFerritinaFlecainida (3)FolatoFrutosamina (1)Hormona foliculoestimulante (FSH)GastrinaGentamicinaGlucagona (1)Gonadotropina coriónica humana (hCG)

Subunidade beta hCGHormona humana do crescimento (hGH)

Imunoglobulina A (IgA) (1)Imunoglobulina E (IgE)Imunoglobulina G (IgG) (1)Imunoglobulina M (IgM) (1)ImipraminaTripsinogénio imunorreactivo (IRT) (1)(2)

InsulinaFerro (1)Hormona luteinizante (LH)LidocaínaLítioNAPANetilmicina (2)NortriptilinaFosfatase ácida prostática (PAP)

FenobarbitalFenitoinaFenitoina, LivrePrimidonaProcainamidaProgesteronaProlactinaPropanololAntigénio específico da próstata (PSA)PSA, LivreHormona paratiróide (PTH) ( )QuinidinaSalicilatoSHBG (2)

Somatomedina-C (1)T3 livreT3 totalAbsorção de T3T4 livreT4 totalGlobulina de ligação à tireoxina (TBG) (1)TestosteronaTestosterona, LivreTeofilinaTiroglobulina (1)Capacidade total de ligação ao ferro (TIBC) (1)

TobramicinaRastreio de antidepressivos tricíclicos

Hormona estimulante da tiróide (TSH)

Ácido valpróicoÁcido valpróico, LivreVancomicinaVitamina B12

TERMOS

MédiaLimitesRenormalizaçãoUnidades

ANALYTER

11-deoxikortisol17-alfa - hydroxiprogesteron25-hydroxi-vitamin D (1)AcetaminofenAdrenokortikotropt hormon (ACTH)Alfafetoprotein (AFP)AldosteronAmikacinAmiodaron (2)AmitriptylinAndrostenedionAngiotensin I (1)Antityroglobulinantikropp (anti-TG-Ak) (1)(2)

Antityreoida peroxidasantikroppar (anti- TPO-Ak) (1)(2)

KoffeinKalcitoninKarbamazepinKarbamazepin, frittCarcinoembryonalt antigen (CEA)

KloramfenikolKortisolC-peptidCyklosporin (3)DesipraminDehydroepiandrosteron (DHEA)DHEA-sulfatDigoxinDisopyramidÖstradiolÖstriol, frittÖstriol, totalt (2)Östrogener, totaltEtosuximidFerritinFlekainid (3)FolatFruktosamin (1)Follikelstimulerande hormon (FSH)GastrinGentamicinGlukagon (1)Humant koriongonadotropin (hCG)

hCG-beta-subenhetHumant tillväxthormon (hGH)

Immunglobulin A (IgA) (1)Immunglobulin E (IgE)Immunglobulin G (IgG) (1)Immunglobulin M (IgM) (1)ImipraminImmunreaktivt trypsinogen (IRT) (1)(2)

InsulinJärn (1)Luteiniserande hormon (LH)LidokainLitiumNAPA (n-acetylprokainamid)Netilmicin (2)NortriptylinProstataspecifikt surt fosfatas (PAP)

FenobarbitalFenytoinFenytoin, frittPrimidonProkainamidProgesteronProlaktinPropanololProstataspecifikt antigen (PSA)PSA, frittParathyreoideahormon (PTH) ( )KinidinSalicylatSHBG (2)

Somatomedin C (1)T3, frittT3, totaltT3 upptagT4, frittT4, totaltTyroxinbindande globulin (TBG) (1)

TestosteronTestosteron, frittTeofyllinTyroglobulin (1)Total järnbindande kapacitet (TIBC) (1)

TobramycinTricykliska antidepressiva medel, panel

Tyreoideastimulerande hormon (TSH)

ValproinsyraValproinsyra, friVancomycinVitamin B12

TERMER

MedelvärdeOmrådeRestandardiseringEnheter

ANALYTTER

11-deoxycortisol17-alpha-hydroxyprogesteron25-hydroxy-vitamin D (1)AcetaminophenAdrenokortikotropt hormon (ACTH)Alpha-fetoprotein (AFP)AldosteronAmikacinAmiodaron (2)AmitriptylinAndrostenedionAngiotensin I (1)Thyreoglobulin antistof (anti-TG Ab) (1)(2)

Thyreoidea peroxidase antistoffer (anti TPO-Ab) (1)(2)

KoffeinCalcitoninCarbamazepinCarbamazepin, fritCarcinoembryonalt antigen (CEA)

ChloramphenicolCortisolC-peptidCyclosporin (3)DesipraminDehydroepiandrosteron (DHEA)DHEA-sulfatDigoxinDisopyramidEstradiolEstriol, fritEstriol, total (2)Østrogener, total EthosuximidFerritinFlecainid (3)FolatFruktosamin (1)Follikelstimulerende hormon (FSH)GastrinGentamicinGlucagon (1)Humant choriongonadotropin (hCG)

hCG-beta subunitHumant væksthormon (hGH)

Immunoglobulin A (IgA) (1)Immunoglobulin E (IgE)Immunoglobulin G (IgG) (1)Immunoglobulin M (IgM) (1)ImipraminImmunreaktivt trypsinogen (IRT) (1)(2)

InsulinJern (1)Luteiniserende hormon (LH)LidocainLithiumNAPA (n-acetylprocainamid)Netilmycin (2)NortriptylinProstataspecifik sur phosphatase (PAP)

PhenobarbitalPhenytoinPhenytoin, fritPrimidonProcainamidProgesteronProlactinPropanololProstataspecifikt antigen (PSA)PSA, fritParathyreoidea- hormon (PTH) ( )QuinidinSalicylatSHBG (2)

Somatomedin-C (1)T3 fritT3 totalT3 UptakeT4-fritT4 totalThyroxinbindende globulin (TBG) (1)

TestosteronTestosteron, fritTheophyllinThyroglobulin (1)Total jernbindende kapacitet (TIBC) (1)

TobramycinTricykliske antidepressiva, screening

Thyroidea stimulerende hormon (TSH)

ValproatValproat, fritVancomycinVitamin B12

ORDLISTE

MiddelværdiOmrådeRestandardiseringEnheder

Page 6: Lyphochek Immunoassay 370 Data Sheet

METHODMethode // Méthode // Metodo // Método // Método // Metod // Metode

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

11 - DEOXYCORTISOL

MP BioMedicals ImmuChem DA RIA ng/mL § § § nmol/L § § §

17 - ALPHA - HYDROXYPROGESTERONE

DRG MTPL ng/mL 0.940 0.520 – 1.37 3.60 1.98 – 5.22 7.50 4.12 – 10.9 nmol/L 2.85 1.58 – 4.15 10.9 6.00 – 15.8 22.7 12.5 – 32.9

DSL Active Double Antibody RIA DSL-5000 ng/mL § § § nmol/L § § §

DSL Double Antibody RIA DSL-6800 ng/mL § § § nmol/L § § §

MP BioMedicals ImmuChem CT RIA ng/mL 0.920 0.750 – 1.09 3.00 2.40 – 3.60 6.50 5.20 – 7.80 nmol/L 2.79 2.27 – 3.30 9.09 7.27 – 10.9 19.7 15.8 – 23.6

MP BioMedicals ImmuChem DA RIA ng/mL 1.12 0.890 – 1.35 5.10 4.00 – 6.20 12.7 10.1 – 15.3 nmol/L 3.39 2.70 – 4.09 15.5 12.1 – 18.8 38.5 30.6 – 46.4

Siemens Coat-A-Count ng/mL § § § nmol/L § § §

25 - HYDROXY VITAMIN D (1)

DiaSorin 125I RIA ng/mL 18.0 13.7 – 22.3 22.8 17.3 – 28.3 19.3 14.7 – 23.9 nmol/L 44.9 34.2 – 55.7 56.9 43.2 – 70.6 48.2 36.7 – 59.7

ACETAMINOPHEN

Genzyme Diagnostics Enzymatic μg/mL 10.6 7.90 – 13.3 38.3 28.7 – 47.9 118 88.6 – 148 μmol/L 70.1 52.3 – 88.0 253 190 – 317 782 586 – 978

Syva Emit 2000 μg/mL 11.3 9.03 – 13.6 39.8 31.8 – 47.7 124 99.0 – 148 μmol/L 74.7 59.8 – 89.6 263 211 – 316 818 655 – 982

ACTH

Biomerica ELISA pg/mL 14.2 11.4 – 17.1 79.1 63.3 – 94.9 242 194 – 290 pmol/L 3.12 2.51 – 3.76 17.4 13.9 – 20.9 53.2 42.6 – 63.9

DiaSorin IRMA pg/mL 15.7 <10.0 – 21.9 60.0 42.0 – 78.0 140 103 – 178 pmol/L 3.45 <2.20 – 4.82 13.2 9.24 – 17.2 30.8 22.7 – 39.2

DiaSorin 125I RIA pg/mL <20.0 81.5 57.1 – 106 247 173 – 321 pmol/L <4.40 17.9 12.6 – 23.3 54.3 38.1 – 70.6

AFP

DRG AFP ELISA ng/mL 17.9 11.8 – 23.9 92.4 61.0 – 124 >193 IU/mL 14.8 9.78 – 19.9 76.7 50.6 – 103 >160

Monobind AccuBind ELISA ng/mL 17.2 11.5 – 22.9 88.6 59.4 – 118 195 130 – 258 IU/mL 14.3 9.58 – 19.0 73.5 49.3 – 97.8 162 108 – 214

Monobind AccuLite CLIA ng/mL 14.9 9.97 – 19.8 79.6 53.3 – 106 198 133 – 263 IU/mL 12.4 8.28 – 16.4 66.1 44.2 – 87.8 164 110 – 218

ALDOSTERONE

DSL Active Coated Tube RIA DSL-8600 pg/mL § § § pmol/L § § §

MP BioMedicals ImmuChem DA RIA pg/mL 38.0 31.0 – 45.0 142 112 – 172 420 324 – 516 pmol/L 105 85.9 – 125 393 310 – 476 1163 897 – 1429

Siemens Coat-A-Count pg/mL § § § pmol/L § § §

AMIKACIN

Syva Emit μg/mL 6.04 4.83 – 7.25 14.1 11.3 – 16.9 27.4 21.9 – 32.9 μmol/L 10.3 8.26 – 12.4 24.1 19.3 – 28.9 46.8 37.5 – 56.2

AMITRIPTYLINE

HPLC ng/mL 69.4 44.4 – 94.4 157 110 – 204 215 138 – 293 nmol/L 251 160 – 341 567 397 – 737 778 498 – 1058

ANDROSTENEDIONE

DRG Androstenedione ELISA ng/mL 0.720 0.400 – 1.04 2.28 1.26 – 3.31 6.26 3.44 – 9.07 nmol/L 2.51 1.40 – 3.63 7.96 4.40 – 11.6 21.8 12.0 – 31.7

DSL Active Coated Tube RIA DSL-3800 ng/mL § § § nmol/L § § §

DSL Double Antibody RIA DSL-4200 ng/mL § § § nmol/L § § §

MP BioMedicals ImmuChem DA RIA ng/mL 1.37 1.05 – 1.69 3.80 2.99 – 4.61 5.27 4.40 – 6.14 nmol/L 4.78 3.66 – 5.90 13.3 10.4 – 16.1 18.4 15.4 – 21.4

ANGIOTENSIN I (1)

Adaltis Renin MAIA ng/mL/hr 3.74 2.39 – 5.09 8.77 5.31 – 12.2 8.21 4.36 – 12.1 μg/L/hr 3.74 2.39 – 5.09 8.77 5.31 – 12.2 8.21 4.36 – 12.1

DiaSorin GammaCoat Plasma Renin Activity 125I RIA ng/mL/hr 2.90 2.10 – 3.70 8.80 6.50 – 11.1 7.50 5.60 – 9.40 μg/L/hr 2.90 2.10 – 3.70 8.80 6.50 – 11.1 7.50 5.60 – 9.40

C-PEPTIDE

Adaltis RIA ng/mL 1.17 0.740 – 1.60 5.43 3.31 – 7.54 6.90 4.80 – 9.00 nmol/L 0.387 0.245 – 0.530 1.80 1.10 – 2.50 2.28 1.59 – 2.98

DakoCytomation ELISA ng/mL § § § nmol/L § § §

DRG C-Peptide ELISA ng/mL 0.890 0.490 – 1.29 5.41 2.97 – 7.84 6.44 3.54 – 9.34 nmol/L 0.295 0.162 – 0.427 1.79 0.983 – 2.60 2.13 1.17 – 3.09

DSL C-Peptide of Insulin ELISA ng/mL § § § nmol/L § § §

DSL Double Antibody RIA DSL-7000 ng/mL § § § nmol/L § § §

Mercodia ELISA ng/mL 1.34 1.17 – 1.52 5.48 4.84 – 6.11 6.88 6.00 – 7.76 pmol/L 445 387 – 503 1813 1602 – 2023 2277 1985 – 2568

Monobind AccuBind ELISA ng/mL 1.07 0.720 – 1.42 4.58 3.07 – 6.09 5.85 3.92 – 7.78 nmol/L 0.354 0.238 – 0.470 1.52 1.02 – 2.02 1.94 1.30 – 2.58

Monobind AccuLite CLIA ng/mL 1.09 0.730 – 1.45 4.71 3.16 – 6.26 5.74 3.85 – 7.64 nmol/L 0.361 0.242 – 0.480 1.56 1.05 – 2.07 1.90 1.27 – 2.53

Siemens Double Antibody RIA ng/mL § § § nmol/L § § §

UBI Magiwel Quantitative ELISA ng/mL 0.740 0.530 – 0.950 4.61 3.25 – 5.97 6.43 4.51 – 8.35 nmol/L 0.245 0.175 – 0.314 1.53 1.08 – 1.98 2.13 1.49 – 2.76

CAFFEINE

HPLC μg/mL 1.90 1.52 – 2.28 7.72 6.17 – 9.26 17.7 14.1 – 21.2 μmol/L 9.78 7.83 – 11.7 39.7 31.8 – 47.7 91.0 72.8 – 109

CALCITONIN

Biomerica ELISA pg/mL 67.8 54.2 – 81.3 325 260 – 390 596 477 – 716 ng/L 67.8 54.2 – 81.3 325 260 – 390 596 477 – 716

DSL-1200 Double Antibody RIA pg/mL § § § ng/L § § §

CARBAMAZEPINE

Microgenics CEDIA II μg/mL 2.72 2.18 – 3.27 8.80 7.04 – 10.6 14.8 11.9 – 17.8 μmol/L 11.5 9.22 – 13.8 37.2 29.8 – 44.7 62.8 50.2 – 75.3

Syva Emit 2000 μg/mL 2.61 2.14 – 3.08 8.58 7.03 – 10.1 14.4 12.2 – 16.5 μmol/L 11.0 9.05 – 13.0 36.3 29.7 – 42.8 60.7 51.7 – 69.7

CEA

DRG MTPL ng/mL § § § μg/L § § §

Monobind AccuBind ELISA ng/mL 2.14 1.44 – 2.85 12.3 8.25 – 16.4 21.3 14.3 – 28.3 μg/L 2.14 1.44 – 2.85 12.3 8.25 – 16.4 21.3 14.3 – 28.3

Monobind AccuLite CLIA ng/mL 1.13 0.610 – 1.65 11.2 7.47 – 14.8 21.7 14.5 – 28.8 μg/L 1.13 0.610 – 1.65 11.1 7.47 – 14.8 21.6 14.5 – 28.8

Siemens Coat-A-Count IRMA ng/mL § § § μg/L § § §

CHLORAMPHENICOL

HPLC μg/mL 7.22 5.78 – 8.66 12.9 10.2 – 15.6 23.8 18.8 – 28.8 μmol/L 22.3 17.9 – 26.8 39.9 31.5 – 48.3 73.8 58.3 – 89.2

CORTISOL

DiaSorin GammaCoat 125I RIA μg/dL 2.60 1.50 – 3.70 19.9 13.8 – 26.0 43.7 29.3 – 58.1 nmol/L 71.8 41.4 – 102 549 381 – 718 1206 809 – 1604

DRG Cortisol ELISA ng/mL 28.5 18.2 – 38.7 181 116 – 246 305 195 – 415 nmol/L 78.6 50.3 – 107 499 319 – 679 843 540 – 1146

DSL Double Antibody RIA DSL-2000 μg/dL § § § nmol/L § § §

IBL LIA μg/dL § § § nmol/L § § §

MP BioMedicals Corti-Cote RIA μg/dL 2.60 2.20 – 3.00 18.8 15.7 – 21.9 35.2 29.0 – 41.4 nmol/L 71.8 60.7 – 82.8 519 433 – 604 972 800 – 1143

MP BioMedicals ImmuChem CT RIA μg/dL 4.40 3.50 – 5.30 30.0 25.0 – 35.0 43.4 35.8 – 51.0 nmol/L 121 96.6 – 146 828 690 – 966 1198 988 – 1408

Siemens Coat-A-Count μg/dL § § § nmol/L § § §

UBI Magiwel Quantitative ELISA μg/dL 2.54 1.66 – 3.41 16.6 11.7 – 21.5 30.3 21.9 – 38.7 nmol/L 70.1 45.8 – 94.1 458 323 – 593 836 604 – 1068

DESIPRAMINE

HPLC ng/mL 83.1 54.9 – 111 175 140 – 210 252 201 – 302 nmol/L 312 206 – 418 657 526 – 789 944 755 – 1132

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Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

DHEA

DRG ELISA ng/mL 0.640 0.350 – 0.930 3.75 2.06 – 5.44 4.33 2.38 – 6.28 nmol/L 2.22 1.21 – 3.23 13.0 7.15 – 18.9 15.0 8.26 – 21.8

DSL Double Antibody RIA DSL-8900 ng/mL § § § nmol/L § § §

DHEA-SULFATE

DRG DHEA-S ELISA μg/mL 0.600 0.330 – 0.870 1.57 0.860 – 2.27 5.97 3.29 – 8.66 μmol/L 1.62 0.891 – 2.35 4.24 2.32 – 6.13 16.1 8.88 – 23.4

DSL Double Antibody RIA ng/mL § § § μmol/L § § §

Monobind AccuBind ELISA μg/mL 0.740 0.490 – 0.980 1.57 1.05 – 2.09 5.59 3.33 – 7.84 μmol/L 2.00 1.32 – 2.65 4.24 2.83 – 5.64 15.1 8.99 – 21.2

MP BioMedicals ImmuChem CT RIA ng/mL 463 364 – 562 1186 939 – 1433 6107 5106 – 7108 μmol/L 1.25 0.983 – 1.52 3.20 2.54 – 3.87 16.5 13.8 – 19.2

Siemens Coat-A-Count RIA μg/dL § § § μmol/L § § §

DIGOXIN

Microgenics CEDIA II ng/mL § § § nmol/L § § §

Monobind AccuBind ELISA ng/mL <1.00 1.79 1.17 – 2.41 2.79 1.67 – 3.91 nmol/L <1.28 2.29 1.50 – 3.08 3.57 2.14 – 5.00

MP BioMedicals SPCS RIA ng/mL 0.420 0.320 – 0.520 1.60 1.33 – 1.87 2.76 2.17 – 3.35 nmol/L 0.538 0.410 – 0.666 2.05 1.70 – 2.39 3.53 2.78 – 4.29

Syva Emit 2000 ng/mL 0.450 0.250 – 0.660 1.74 1.37 – 2.11 2.96 2.42 – 3.50 nmol/L 0.576 0.320 – 0.845 2.23 1.75 – 2.70 3.79 3.10 – 4.48

DISOPYRAMIDE

Syva Emit μg/mL § § § μmol/L § § §

ESTRADIOL

Adaltis MAIA pg/mL 26.6 16.2 – 37.0 170 104 – 236 326 199 – 453 pmol/L 97.7 59.6 – 136 622 380 – 865 1195 729 – 1661

BioCheck EIA pg/mL 87.0 54.4 – 120 258 206 – 310 477 355 – 599 pmol/L 319 200 – 440 947 756 – 1138 1751 1303 – 2198

DiaSorin Clinical Assays pg/mL 38.4 30.0 – 46.8 157 120 – 194 373 251 – 495 pmol/L 141 110 – 172 576 440 – 712 1369 921 – 1817

DRG Estradiol ELISA pg/mL 118 66.1 – 170 214 120 – 309 322 180 – 463 pmol/L 433 243 – 624 787 441 – 1133 1181 661 – 1700

DSL Active RIA DSL-43100 pg/mL § § § pmol/L § § §

DSL Double Antibody RIA DSL-4400 pg/mL § § § pmol/L § § §

DSL Double Antibody RIA DSL-6800 (Ultra-sensitive Estradiol) pg/mL § § § pmol/L § § §

Monobind AccuBind pg/mL 54.3 36.4 – 72.3 191 128 – 254 438 282 – 594 pmol/L 199 134 – 265 702 470 – 933 1608 1035 – 2181

Monobind AccuLite pg/mL 57.0 38.2 – 75.9 207 168 – 247 420 354 – 487 pmol/L 209 140 – 278 761 618 – 905 1542 1298 – 1787

MP BioMedicals ImmuChem CT RIA pg/mL 23.0 18.0 – 28.0 184 149 – 219 574 450 – 698 pmol/L 84.4 66.1 – 103 675 547 – 804 2107 1652 – 2562

MP BioMedicals ImmuChem DA RIA pg/mL 39.0 31.0 – 47.0 238 200 – 276 639 545 – 733 pmol/L 143 114 – 172 873 734 – 1013 2345 2000 – 2690

Pantex EIA pg/mL 140 95.0 – 185 329 272 – 386 653 520 – 787 pmol/L 514 349 – 679 1207 998 – 1417 2397 1908 – 2888

Pantex Extraction DA pg/mL 47.0 30.0 – 65.0 235 178 – 292 548 466 – 629 pmol/L 172 110 – 239 862 653 – 1072 2011 1710 – 2308

Pantex Direct DA pg/mL 22.0 14.0 – 29.0 155 127 – 183 452 377 – 527 pmol/L 80.7 51.4 – 106 569 466 – 672 1659 1384 – 1934

Siemens Coat-A-Count RIA pg/mL § § § pmol/L § § §

Wallac DELFIA (2inc) TR-FIA pg/mL 50.0 36.1 – 63.9 206 156 – 258 444 333 – 556 nmol/L 0.180 0.130 – 0.230 0.740 0.560 – 0.930 1.60 1.20 – 2.00

Wallac DELFIA (IVF) TR-FIA pg/mL 55.6 38.9 – 72.2 217 164 – 272 417 306 – 528 nmol/L 0.200 0.140 – 0.260 0.780 0.590 – 0.980 1.50 1.10 – 1.90

ESTRIOL FREE

DRG Free Estriol ELISA ng/mL 1.97 1.08 – 2.86 7.10 3.90 – 10.3 13.1 7.19 – 19.0 nmol/L 6.84 3.75 – 9.92 24.6 13.5 – 35.7 45.4 24.9 – 65.8

DSL Active Ultra-Sensitive Unconjugated RIA ng/mL § § § nmol/L § § §

DSL Ultra-Sensitive Double Antibody RIA DSL-1400 ng/mL § § § nmol/L § § §

Siemens Coat-A-Count RIA ng/mL § § § nmol/L § § §

ESTROGENS TOTAL

MP BioMedicals ImmuChem DA RIA pg/mL <150 588 468 – 708 1260 972 – 1548 ng/L <150 588 468 – 708 1260 972 – 1548

ETHOSUXIMIDE

Syva Emit μg/mL 28.3 22.6 – 33.9 73.0 58.4 – 87.6 109 87.4 – 131 μmol/L 200 160 – 240 517 414 – 620 773 619 – 928

FERRITIN

BioCheck EIA ng/mL 44.9 29.9 – 59.9 101 69.9 – 133 231 164 – 297 μg/L 44.9 29.9 – 59.9 101 69.9 – 133 231 164 – 297

Bioclone ELEGANCE ELISA ng/mL § § § μg/L § § §

Monobind AccuBind ELISA ng/mL 68.0 45.6 – 90.5 105 70.4 – 140 266 178 – 354 μg/L 68.0 45.6 – 90.5 105 70.4 – 140 266 178 – 354

Monobind AccuLite CLIA ng/mL 61.3 41.1 – 81.6 101 67.5 – 134 282 189 – 375 μg/L 61.3 41.1 – 81.6 101 67.4 – 134 282 189 – 375

Ramco Fer-Iron II IRMA ng/mL 55.4 49.4 – 61.4 117 107 – 127 279 257 – 300 μg/L 55.4 49.4 – 61.4 117 107 – 127 279 257 – 300

Ramco Spectro-Ferritin MT EIA ng/mL 79.5 62.1 – 98.6 161 130 – 193 377 313 – 442 μg/L 79.5 62.1 – 98.6 161 130 – 193 377 313 – 442

UBI Magiwel Quantitative ELISA ng/mL 55.0 42.0 – 67.0 145 112 – 179 250 202 – 298 μg/L 55.0 42.0 – 67.0 145 112 – 179 250 202 – 298

FOLATE

MP BioMedicals SimulTRAC SNB RIA ng/mL 2.30 1.90 – 2.70 10.3 8.70 – 11.9 19.8 17.0 – 22.6 nmol/L 5.21 4.31 – 6.12 23.3 19.7 – 27.0 44.9 38.5 – 51.2

MP BioMedicals SimulTRAC SP RIA ng/mL 3.20 2.60 – 3.80 9.80 8.30 – 11.3 16.5 13.5 – 19.5 nmol/L 7.25 5.89 – 8.61 22.2 18.8 – 25.6 37.4 30.6 – 44.2

Siemens Solid Phase No Boil RIA ng/mL § § § nmol/L § § §

FSH

Adaltis MAIACLONE mIU/mL 9.76 6.74 – 12.8 34.2 25.3 – 43.2 53.2 38.2 – 68.3 IU/L 9.76 6.74 – 12.8 34.2 25.3 – 43.2 53.2 38.2 – 68.3

BioCheck EIA mIU/mL 6.20 4.80 – 7.70 25.0 15.0 – 35.1 45.9 30.8 – 60.9 IU/L 6.20 4.80 – 7.70 25.0 15.0 – 35.1 45.9 30.8 – 60.9

Bioclone ELEGANCE ELISA mIU/mL § § § IU/L § § §

Calbiotech ELISA mIU/mL <2.10 – 2.42 14.1 10.6 – 17.7 22.2 13.3 – 31.1 IU/L <2.10 – 2.42 14.1 10.6 – 17.7 22.2 13.3 – 31.1

DRG FSH ELISA mIU/mL 7.35 4.04 – 10.7 31.8 17.5 – 46.1 47.0 25.8 – 68.1 IU/L 7.35 4.04 – 10.7 31.8 17.5 – 46.1 47.0 25.8 – 68.1

Monobind AccuBind ELISA mIU/mL 6.25 4.19 – 8.32 29.4 19.7 – 39.1 53.4 35.8 – 71.0 IU/L 6.25 4.19 – 8.32 29.4 19.7 – 39.1 53.4 35.8 – 71.0

Monobind AccuLite CLIA mIU/mL 5.96 4.00 – 7.93 29.7 19.9 – 39.6 49.2 33.0 – 65.4 IU/L 5.96 4.00 – 7.93 29.7 19.9 – 39.6 49.2 33.0 – 65.4

MP BioMedicals ImmuChem CT IRMA mIU/mL 7.50 6.20 – 8.80 30.2 23.7 – 36.7 53.4 45.3 – 61.5 IU/L 7.50 6.20 – 8.80 30.2 23.7 – 36.7 53.4 45.3 – 61.5

UBI Magiwel Quantitative ELISA mIU/mL 3.88 2.21 – 5.56 16.9 11.4 – 22.5 32.3 22.9 – 41.6 IU/L 3.88 2.21 – 5.56 16.9 11.4 – 22.5 32.3 22.9 – 41.6

Wallac DELFIA hFSH TR-FIA mIU/mL 5.80 4.60 – 7.00 24.0 19.0 – 29.0 37.0 30.0 – 44.0 IU/L 5.80 4.60 – 7.00 24.0 19.0 – 29.0 37.0 30.0 – 44.0

GASTRIN

DiaSorin GammaDab 125I RIA pg/mL 50.0 32.3 – 67.7 203 153 – 253 432 301 – 563 ng/L 50.0 32.3 – 67.7 203 153 – 253 432 301 – 563

MP BioMedicals RIA pg/mL 63.0 50.0 – 76.0 412 326 – 496 913 716 – 1110 ng/L 63.0 50.0 – 76.0 412 326 – 496 913 716 – 1110

Siemens Double Antibody RIA pg/mL § § § ng/L § § §

GENTAMICIN

Microgenics CEDIA II μg/mL 2.12 1.70 – 2.54 4.66 3.73 – 5.59 7.57 6.06 – 9.08 μmol/L 4.43 3.54 – 5.32 9.74 7.79 – 11.7 15.8 12.7 – 19.0

Syva Emit 2000 μg/mL 2.05 1.77 – 2.32 4.39 3.74 – 5.05 6.94 5.90 – 7.97 μmol/L 4.28 3.70 – 4.85 9.18 7.82 – 10.6 14.5 12.3 – 16.7

hCG

Adaltis MAIACLONE mIU/mL 11.2 7.16 – 15.2 38.4 24.6 – 52.2 264 169 – 359 IU/L 11.2 7.16 – 15.2 38.4 24.6 – 52.2 264 169 – 359

BioCheck EIA mIU/mL 6.40 4.80 – 7.99 23.6 14.6 – 32.7 173 137 – 208 IU/L 6.40 4.80 – 7.99 23.6 14.6 – 32.7 173 137 – 208

Bioclone ELEGANCE ELISA mIU/mL § § § IU/L § § §

DRG hCG ELISA mIU/mL <5.00 12.9 8.02 – 17.9 101 62.4 – 139 IU/L <5.00 12.9 8.02 – 17.9 101 62.4 – 139

Monobind AccuBind ELISA mIU/mL 7.05 4.73 – 9.38 29.9 20.0 – 39.8 >225 IU/L 7.05 4.73 – 9.38 29.9 20.0 – 39.8 >225

Monobind AccuLite CLIA mIU/mL 7.73 3.57 – 11.9 33.6 22.5 – 44.7 >225 IU/L 7.73 3.57 – 11.9 33.6 22.5 – 44.7 >225

UBI Magiwel Quantitative ELISA mIU/mL 10.5 7.00 – 14.0 39.1 26.8 – 51.4 137 – >200 IU/L 10.5 7.00 – 14.0 39.1 26.8 – 51.4 137 – >200

Wallac DELFIA TR-FIA mIU/mL 8.50 6.00 – 11.0 34.0 26.0 – 43.0 281 225 – 337 IU/L 8.50 6.00 – 11.0 34.0 26.0 – 43.0 281 225 – 337

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Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

hCG-BETA SUBUNIT

DRG beta hCG ELISA mIU/mL 3.06 1.90 – 4.23 10.7 6.62 – 14.7 81.7 50.6 – 113 IU/L 3.06 1.90 – 4.23 10.7 6.62 – 14.7 81.7 50.6 – 113

hGH

BioCheck EIA ng/mL 3.80 2.17 – 5.43 9.54 7.34 – 11.7 20.1 14.7 – 25.5 μg/L 3.80 2.17 – 5.43 9.54 7.34 – 11.7 20.1 14.7 – 25.5

Bioclone ELEGANCE ELISA μIU/mL § § § mIU/L § § §

Calbiotech ELISA ng/mL 4.28 2.73 – 5.83 8.49 5.20 – 11.8 19.2 13.2 – 25.3 μg/L 4.28 2.73 – 5.83 8.49 5.20 – 11.8 19.2 13.2 – 25.3

DiaSorin hGH-CTK IRMA ng/mL 2.60 2.00 – 3.20 6.70 5.10 – 8.30 13.6 10.3 – 16.9 μg/L 2.60 2.00 – 3.20 6.70 5.10 – 8.30 13.6 10.3 – 16.9

DSL Active Coated Tube IRMA DSL-1900 ng/mL § § § μg/L § § §

DSL Active ELISA ng/mL § § § μg/L § § §

MEDIAGNOST ELISA μIU/mL 6.40 5.10 – 7.70 16.1 12.9 – 19.3 34.3 27.4 – 41.2 mIU/L 6.40 5.10 – 7.70 16.1 12.9 – 19.3 34.3 27.4 – 41.2

Monobind AccuBind ELISA μIU/mL § § § mIU/L § § §

Monobind AccuLite CLIA μIU/mL § § § mIU/L § § §

MP BioMedicals ImmuChem DA RIA ng/mL 5.60 4.50 – 6.70 12.3 9.90 – 14.7 25.1 20.8 – 29.4 μg/L 5.60 4.50 – 6.70 12.3 9.90 – 14.7 25.1 20.8 – 29.4

Wallac DELFIA TR-FIA ng/mL 2.50 2.00 – 3.00 6.15 5.00 – 7.31 13.5 10.8 – 16.2 mIU/L 6.50 5.20 – 7.80 16.0 13.0 – 19.0 35.0 28.0 – 42.0

IMIPRAMINE

HPLC ng/mL § § § nmol/L § § §

IMMUNOGLOBULIN E

BioCheck EIA IU/mL 289 193 – 385 60.5 46.6 – 74.3 79.2 49.6 – 109 kIU/L 289 193 – 385 60.5 46.6 – 74.3 79.2 49.6 – 109

Bioclone ELEGANCE ELISA IU/mL § § § kIU/L § § §

Monobind AccuBind ELISA IU/mL 375 332 – 419 74.4 49.8 – 98.9 95.2 63.8 – 127 kIU/L 375 332 – 419 74.4 49.8 – 98.9 95.2 63.8 – 127

Monobind AccuLite CLIA IU/mL 361 320 – 402 66.2 44.3 – 88.0 84.1 56.3 – 112 kIU/L 361 320 – 402 66.2 44.3 – 88.0 84.1 56.3 – 112

INSULIN

Calbiotech ELISA μIU/mL 13.6 11.4 – 15.8 55.4 44.2 – 66.7 >100 pmol/L 94.5 79.2 – 110 385 307 – 463 >695

DiaSorin INSIK-5 RIA μIU/mL 13.6 9.50 – 17.7 55.1 39.4 – 70.8 177 126 – >200 pmol/L 94.5 66.0 – 123 383 274 – 492 1229 875 – >1389

DRG ELISA (EIA-2935) μIU/mL 15.6 8.58 – 22.6 50.6 27.8 – 73.3 >100 pmol/L 108 59.6 – 157 351 193 – 509 >695

DSL Double Antibody RIA DSL-1600 μIU/mL § § § pmol/L § § §

Mercodia ELISA μIU/mL 14.8 13.4 – 16.3 47.0 41.0 – 53.0 140 128 – 152 pmol/L 103 93.1 – 113 326 285 – 368 972 889 – 1056

Mercodia ELISA (Iso-Insulin) μIU/mL 14.3 13.1 – 15.5 49.0 45.0 – 54.0 >100 pmol/L 99.3 91.0 – 108 340 313 – 375 >695

Monobind AccuBind ELISA μIU/mL 15.4 10.3 – 20.5 45.6 30.6 – 60.7 136 90.9 – 180 pmol/L 107 71.6 – 142 317 212 – 421 942 631 – 1253

Monobind AccuLite CLIA μIU/mL 18.1 8.16 – 28.0 40.0 30.5 – 49.6 140 93.7 – 186 pmol/L 125 56.7 – 194 278 212 – 344 971 651 – 1291

MP BioMedicals ImmuChem CT RIA μIU/mL 16.0 13.0 – 19.0 62.0 51.0 – 73.0 188 156 – 220 pmol/L 111 90.3 – 132 431 354 – 507 1306 1083 – 1528

Siemens Coat-A-Count RIA μIU/mL § § § pmol/L § § §

LH

Adaltis MAIACLONE mIU/mL 1.30 0.610 – 1.99 11.5 8.30 – 14.8 28.1 19.1 – 37.1 IU/L 1.30 0.610 – 1.99 11.5 8.30 – 14.8 28.1 19.1 – 37.1

BioCheck EIA mIU/mL 2.67 1.60 – 3.74 23.2 18.9 – 27.5 42.9 36.5 – 49.2 IU/L 2.67 1.60 – 3.74 23.2 18.9 – 27.5 42.9 36.5 – 49.2

Bioclone ELEGANCE ELISA mIU/mL § § § IU/L § § §

Calbiotech ELISA mIU/mL 2.83 2.18 – 3.49 32.8 25.1 – 40.5 >50.0 IU/L 2.83 2.18 – 3.49 32.8 25.1 – 40.5 >50.0

DRG LH Serum ELISA mIU/mL <1.00 21.9 12.1 – 31.8 29.0 15.9 – 42.0 IU/L <1.00 21.9 12.1 – 31.8 29.0 15.9 – 42.0

DSL ELISA 10-4600 mIU/mL § § § IU/L § § §

Monobind AccuBind ELISA mIU/mL 2.59 1.74 – 3.45 26.1 17.5 – 34.7 53.4 35.7 – 71.0 IU/L 2.59 1.74 – 3.45 26.1 17.5 – 34.7 53.4 35.7 – 71.0

Monobind AccuLite CLIA mIU/mL 2.00 1.34 – 2.66 23.9 16.0 – 31.7 49.2 33.0 – 65.4 IU/L 2.00 1.34 – 2.66 23.9 16.0 – 31.7 49.2 33.0 – 65.4

MP BioMedicals ImmuChem CT IRMA mIU/mL <2.50 20.1 16.3 – 23.9 46.6 38.4 – 54.8 IU/L <2.50 20.1 16.3 – 23.9 46.6 38.4 – 54.8

Wallac DELFIA hLH Spec TR-FIA mIU/mL 2.10 1.60 – 2.60 22.0 18.0 – 26.0 55.0 44.0 – 66.0 IU/L 2.10 1.60 – 2.60 22.0 18.0 – 26.0 55.0 44.0 – 66.0

LIDOCAINE

Syva Emit μg/mL 1.45 1.16 – 1.74 4.62 3.69 – 5.54 9.22 7.37 – 11.1 μmol/L 6.19 4.95 – 7.43 19.7 15.8 – 23.7 39.4 31.5 – 47.2

LITHIUM

Atomic Absorption mEq/L § § § mmol/L § § §

Flame Photometry mEq/L § § § mmol/L § § §

NAPA

Microgenics CEDIA μg/mL 1.88 1.50 – 2.25 4.99 3.99 – 5.99 11.2 8.97 – 13.5 μmol/L 6.77 5.42 – 8.12 18.0 14.4 – 21.6 40.5 32.4 – 48.6

Syva Emit 2000 μg/mL 1.96 1.57 – 2.35 5.05 4.04 – 6.06 11.8 9.29 – 14.3 μmol/L 7.08 5.67 – 8.48 18.2 14.6 – 21.9 42.5 33.5 – 51.5

NORTRIPTYLINE

HPLC ng/mL 31.7 25.3 – 38.0 87.0 69.6 – 104 172 110 – 233 nmol/L 120 96.3 – 144 331 264 – 397 652 417 – 887

PAP (PROSTATIC ACID PHOSPHATASE)

Siemens Coat-A-Count IRMA ng/mL § § § μg/L § § §

PHENOBARBITAL

Microgenics CEDIA II μg/mL 8.30 6.64 – 9.96 23.6 18.9 – 28.3 53.4 42.7 – 64.0 μmol/L 35.8 28.6 – 42.9 102 81.4 – 122 230 184 – 276

Syva Emit 2000 μg/mL 9.11 7.68 – 10.5 24.4 19.9 – 28.9 53.9 46.7 – 61.0 μmol/L 39.3 33.1 – 45.4 105 85.9 – 124 232 201 – 263

PHENYTOIN

Microgenics CEDIA II μg/mL 5.61 4.49 – 6.73 14.2 11.4 – 17.1 25.9 20.7 – 31.0 μmol/L 22.2 17.8 – 26.7 56.3 45.1 – 67.6 102 81.9 – 123

Syva Emit 2000 μg/mL 5.72 4.79 – 6.65 13.5 11.3 – 15.6 25.3 21.3 – 29.2 μmol/L 22.7 19.0 – 26.3 53.3 44.7 – 61.9 100 84.4 – 116

PRIMIDONE

Syva Emit μg/mL 2.81 2.25 – 3.38 5.92 4.74 – 7.10 11.9 9.53 – 14.3 μmol/L 12.9 10.3 – 15.5 27.1 21.7 – 32.5 54.6 43.7 – 65.5

PROCAINAMIDE

Microgenics CEDIA μg/mL 1.53 1.22 – 1.83 7.94 6.35 – 9.52 13.5 10.8 – 16.2 μmol/L 6.45 5.16 – 7.74 33.6 26.9 – 40.3 57.0 45.6 – 68.4

Syva Emit 2000 μg/mL 1.64 1.38 – 1.89 7.53 6.14 – 8.92 13.2 10.7 – 15.7 μmol/L 6.94 5.84 – 7.99 31.9 26.0 – 37.7 55.9 45.4 – 66.3

PROGESTERONE

Adaltis RIA ng/mL 0.860 0.390 – 1.33 5.25 2.99 – 7.51 14.5 7.27 – 21.7 nmol/L 2.73 1.24 – 4.23 16.7 9.51 – 23.9 46.1 23.1 – 69

BioCheck EIA ng/mL 0.478 <0.300 – 0.710 7.50 5.37 – 9.64 21.4 12.7 – 30.1 nmol/L 1.52 <0.954 – 2.26 23.9 17.1 – 30.7 68.1 40.4 – 95.7

Calbiotech ELISA ng/mL 1.36 0.840 – 1.88 8.49 7.46 – 9.53 19.7 16.6 – 22.8 nmol/L 4.32 2.67 – 5.98 27.0 23.7 – 30.3 62.6 52.8 – 72.5

DRG Progesterone ELISA ng/mL 0.860 0.470 – 1.25 10.0 5.52 – 14.6 24.3 13.4 – 35.3 nmol/L 2.73 1.49 – 3.98 31.9 17.6 – 46.3 77.3 42.5 – 112

DSL Active Coated Tube RIA DSL-3900 ng/mL § § § nmol/L § § §

DSL Double Antibody RIA DSL-3400 ng/mL § § § nmol/L § § §

Monobind AccuBind ELISA ng/mL 0.790 0.530 – 1.05 9.45 6.33 – 12.6 26.5 16.3 – 36.7 nmol/L 2.51 1.69 – 3.34 30.1 20.1 – 40.0 84.2 51.7 – 117

Monobind AccuLite CLIA ng/mL 0.790 0.530 – 1.05 9.62 6.44 – 12.8 26.2 18.5 – 33.8 nmol/L 2.51 1.69 – 3.34 30.6 20.5 – 40.7 83.2 58.8 – 108

MP BioMedicals ImmuChem CT RIA ng/mL 1.07 0.850 – 1.29 13.4 10.6 – 16.2 36.0 28.3 – 43.7 nmol/L 3.40 2.70 – 4.10 42.6 33.7 – 51.5 114 90.0 – 139

MP BioMedicals ImmuChem DA RIA ng/mL 0.450 0.340 – 0.560 8.00 6.80 – 9.20 21.6 17.4 – 25.8 nmol/L 1.43 1.08 – 1.78 25.4 21.6 – 29.3 68.7 55.3 – 82.0

Pantex Direct DA ng/mL 0.530 0.390 – 0.680 9.86 8.20 – 11.5 27.2 22.5 – 31.9 nmol/L 1.69 1.24 – 2.16 31.4 26.1 – 36.6 86.5 71.6 – 101

Pantex EIA ng/mL 1.85 1.17 – 2.54 15.3 12.7 – 17.9 30.7 26.4 – 35.0 nmol/L 5.88 3.72 – 8.08 48.6 40.2 – 57.0 97.6 84.0 – 111

Siemens Coat-A-Count RIA ng/mL § § § nmol/L § § §

Wallac DELFIA TR-FIA ng/mL 1.04 0.723 – 1.35 10.1 8.18 – 11.9 33.3 26.7 – >37.7 nmol/L 3.30 2.30 – 4.30 32.0 26.0 – 38.0 106 85.0 – >120

Page 9: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

PROLACTIN

Adaltis MAIACLONE ng/mL 9.51 5.79 – 13.2 29.2 13.9 – 44.5 58.1 30.0 – 86.2 μg/L 9.51 5.79 – 13.2 29.2 13.9 – 44.5 58.1 30.0 – 86.2

BioCheck EIA ng/mL 4.18 3.18 – 5.18 19.2 16.0 – 22.4 31.0 24.5 – 37.4 μg/L 4.18 3.18 – 5.18 19.2 16.0 – 22.4 31.0 24.5 – 37.4

Bioclone ELEGANCE ELISA μIU/mL § § § mIU/L § § §

DRG Prolactin ELISA ng/mL 5.79 3.19 – 8.40 18.3 10.1 – 26.5 37.3 20.5 – 54.1 μg/L 5.79 3.19 – 8.40 18.3 10.1 – 26.5 37.3 20.5 – 54.1

Monobind AccuBind ELISA ng/mL 6.94 4.65 – 9.23 21.9 14.6 – 29.1 44.6 29.9 – 59.3 μg/L 6.94 4.65 – 9.23 21.9 14.6 – 29.1 44.6 29.9 – 59.3

Monobind AccuLite CLIA ng/mL 6.44 4.06 – 8.82 20.6 10.5 – 30.8 45.0 25.4 – 64.6 μg/L 6.44 4.06 – 8.82 20.6 10.5 – 30.8 45.0 25.4 – 64.6

MP BioMedicals ImmuChem CT IRMA ng/mL 9.30 7.80 – 10.8 27.9 23.1 – 32.7 58.2 50.2 – 66.2 μg/L 9.30 7.80 – 10.8 27.9 23.1 – 32.7 58.2 50.2 – 66.2

Siemens Coat-A-Count IRMA ng/mL § § § μg/L § § §

UBI Magiwel Quantitative ELISA ng/mL 5.56 3.76 – 7.35 23.1 16.6 – 29.6 47.8 33.5 – 62.2 μg/L 5.56 3.76 – 7.35 23.1 16.6 – 29.6 47.8 33.5 – 62.2

Wallac DELFIA TR-FIA ng/mL 4.50 3.40 – 5.60 13.0 10.0 – 16.0 25.0 20.0 – 30.0 μg/L 4.50 3.40 – 5.60 13.0 10.0 – 16.0 25.0 20.0 – 30.0

PROPRANOLOL

HPLC ng/mL 37.2 29.8 – 44.7 77.7 62.2 – 93.2 185 148 – 222 nmol/L 144 115 – 172 300 240 – 360 713 570 – 855

PSA

Monobind AccuBind ELISA ng/mL 0.930 0.610 – 1.26 4.10 2.75 – 5.45 25.5 17.1 – 34.0 μg/L 0.930 0.610 – 1.26 4.10 2.75 – 5.45 25.5 17.1 – 34.0

Monobind AccuLite CLIA ng/mL 1.01 0.680 – 1.35 4.44 2.97 – 5.90 28.1 18.8 – 37.3 μg/L 1.01 0.680 – 1.35 4.44 2.97 – 5.90 28.1 18.8 – 37.3

QUINIDINE

Syva Emit 2000 μg/mL 0.820 0.560 – 1.08 2.55 2.05 – 3.06 4.42 3.75 – 5.09 μmol/L 2.53 1.72 – 3.33 7.85 6.31 – 9.42 13.6 11.6 – 15.7

SALICYLATE

Genzyme Diagnostics Enzymatic mg/dL <2.00 15.5 11.6 – 19.4 51.3 38.5 – 64.1 mmol/L <0.145 1.12 0.840 – 1.40 3.71 2.79 – 4.64

Syva Emit 2000 mg/dL 4.00 2.80 – 5.20 16.7 11.2 – 21.8 53.3 37.3 – 69.3 mmol/L 0.290 0.203 – 0.376 1.21 0.811 – 1.58 3.86 2.70 – 5.02

SOMATOMEDIN-C (1)

IDS Ltd. IGF-1 ELISA ng/mL 89.5 68.1 – 111 101 76.8 – 125 59.7 45.3 – 74.0 μg/L 89.5 68.1 – 111 101 76.8 – 125 59.7 45.3 – 74.0

MEDIAGNOST IGF-1-ELISA (IGFBP Blocked) ng/mL 93.0 75.0 – 112 110 88.0 – 132 79.0 63.0 – 95.0 μg/L 93.0 75.0 – 112 110 88.0 – 132 79.0 63.0 – 95.0

MEDIAGNOST IGF-1-RIA (IGFBP3 Blocked) ng/mL 119 95.0 – 143 144 115 – 173 137 110 – 164 μg/L 119 95.0 – 143 144 115 – 173 137 110 – 164

T3 FREE

DiaSorin Clinical Assays GammaCoat 125I RIA pg/mL 0.600 <0.500 – 0.860 2.90 1.60 – 4.20 8.20 5.20 – 11.2 pmol/L 0.924 <0.770 – 1.32 4.47 2.46 – 6.47 12.6 8.01 – 17.2

Monobind AccuBind ELISA pg/mL 2.09 1.40 – 2.79 4.90 3.29 – 6.52 7.50 5.02 – 9.97 pmol/L 3.22 2.16 – 4.30 7.55 5.07 – 10.0 11.6 7.73 – 15.4

Monobind AccuLite CLIA pg/mL 1.49 0.400 – 2.57 4.35 2.92 – 5.79 8.07 5.41 – 10.7 pmol/L 2.29 0.616 – 3.96 6.70 4.50 – 8.92 12.4 8.33 – 16.5

MP BioMedicals SPCS RIA pg/mL 1.25 0.960 – 1.54 5.33 4.53 – 6.13 8.30 6.90 – 9.70 pmol/L 1.93 1.48 – 2.37 8.21 6.98 – 9.44 12.8 10.6 – 14.9

T3 TOTAL

BioCheck EIA ng/mL 0.760 0.405 – 1.11 1.84 1.11 – 2.58 3.80 2.67 – 4.93 nmol/L 1.17 0.624 – 1.71 2.83 1.71 – 3.97 5.85 4.11 – 7.59

DiaSorin Clinical Assays GammaCoat 125I RIA ng/mL 0.740 0.560 – 0.920 2.20 1.60 – 2.80 3.70 2.80 – 4.60 nmol/L 1.14 0.862 – 1.42 3.39 2.46 – 4.31 5.70 4.31 – 7.08

Monobind AccuBind ELISA ng/mL 0.790 0.440 – 1.15 1.98 1.33 – 2.64 3.32 2.23 – 4.42 nmol/L 1.22 0.678 – 1.77 3.05 2.05 – 4.07 5.11 3.43 – 6.81

Monobind AccuLite CLIA ng/mL 0.750 0.280 – 1.22 1.92 1.29 – 2.56 3.13 2.10 – 4.17 nmol/L 1.16 0.431 – 1.88 2.96 1.99 – 3.94 4.82 3.23 – 6.42

MP BioMedicals SPCS RIA ng/dL 74.0 59.0 – 89.0 233 201 – 265 361 309 – 413 nmol/L 1.14 0.909 – 1.37 3.59 3.10 – 4.08 5.56 4.76 – 6.36

Siemens Coat-A-Count RIA ng/dL § § § nmol/L § § §

Wallac DELFIA TR-FIA ng/mL 0.974 0.539 – 1.43 2.53 2.01 – 3.05 3.64 2.92 – 4.35 nmol/L 1.50 0.830 – 2.20 3.90 3.10 – 4.70 5.60 4.50 – 6.70

T3 UPTAKE / T UPTAKE

Microgenics CEDIA % Uptake § § § % Uptake § § §

Microgenics DRI % Uptake 34.1 27.3 – 40.9 40.2 32.0 – 48.0 49.1 39.0 – >50.0 % Uptake 34.1 27.3 – 40.9 40.2 32.0 – 48.0 49.1 39.0 – >50.0

Monobind AccuBind ELISA % Uptake 31.9 21.4 – 42.5 39.7 26.6 – 52.8 46.1 30.9 – 61.3 % Uptake 31.9 21.4 – 42.5 39.7 26.6 – 52.8 46.1 30.9 – 61.3

Monobind AccuLite CLIA % Uptake 30.0 20.1 – 40.0 37.2 24.9 – 49.4 44.5 29.8 – 59.2 % Uptake 30.0 20.1 – 40.0 37.2 24.9 – 49.4 44.5 29.8 – 59.2

MP BioMedicals SPCS RIA % Uptake 37.1 31.9 – 42.3 42.4 36.9 – 47.9 50.1 43.5 – 56.7 % Uptake 37.1 31.9 – 42.3 42.4 36.9 – 47.9 50.1 43.5 – 56.7

T4 FREE

Adaltis Bridge pg/mL § § § pmol/L § § §

Bioclone ELEGANCE ELISA pg/mL § § § pmol/L § § §

DiaSorin Clinical Assays GammaCoat (Direct 1-Step) 125I RIA ng/dL 0.700 0.400 – 0.960 1.60 1.10 – 2.18 2.40 1.80 – 3.00 pmol/L 9.03 5.16 – 12.4 20.6 14.2 – 28.1 31.0 23.2 – 38.7

DiaSorin Clinical Assays GammaCoat (Two-Step) 125I RIA ng/dL 1.10 0.790 – 1.40 3.60 2.30 – 4.90 6.30 4.10 – 8.50 pmol/L 14.2 10.2 – 18.1 46.4 29.7 – 63.2 81.3 52.9 – 110

Monobind AccuBind ELISA ng/dL 1.00 0.670 – 1.33 2.07 1.38 – 2.75 3.02 2.14 – 4.25 pmol/L 12.9 8.64 – 17.2 26.7 17.8 – 35.5 39.0 27.6 – 54.8

Monobind AccuLite CLIA ng/dL 1.00 0.670 – 1.33 1.96 1.31 – 2.60 2.90 1.94 – 3.86 pmol/L 12.9 8.64 – 17.2 25.3 16.9 – 33.5 37.4 25.0 – 49.8

MP BioMedicals SPCS RIA ng/dL § § § pmol/L § § §

Siemens Coat-A-Count RIA ng/dL § § § pmol/L § § §

Wallac DELFIA TR-FIA ng/dL 1.24 0.853 – 1.63 4.73 3.80 – 5.66 >6.20 pmol/L 16.0 11.0 – 21.0 61.0 49.0 – 73.0 >80.0

T4 TOTAL

BioCheck EIA μg/dL 7.08 5.17 – 8.99 12.0 9.50 – 14.7 16.5 13.7 – 19.3 nmol/L 91.3 66.7 – 116 155 123 – 190 213 177 – 249

DiaSorin Clinical Assays GammaCoat M 125I RIA μg/dL 4.30 3.00 – 5.60 11.7 8.90 – 14.5 16.7 12.7 – 20.7 nmol/L 55.5 38.7 – 72.2 151 115 – 187 215 164 – 267

Microgenics CEDIA μg/dL 5.41 4.33 – 6.50 12.2 9.77 – 14.7 16.5 13.2 – 19.8 nmol/L 69.8 55.9 – 83.8 158 126 – 189 213 170 – 255

Microgenics DRI μg/dL 5.90 4.70 – 7.10 13.6 10.9 – 16.3 19.1 15.3 – 22.9 nmol/L 76.1 60.6 – 91.6 175 141 – 210 246 197 – 295

Monobind AccuBind ELISA μg/dL 5.30 3.55 – 7.05 11.2 7.51 – 14.9 16.2 10.9 – 21.6 nmol/L 68.4 45.8 – 90.9 145 96.9 – 192 209 140 – 279

Monobind AccuLite CLIA μg/dL 4.45 2.98 – 5.92 9.76 6.54 – 13.0 13.7 9.17 – 18.2 nmol/L 57.4 38.4 – 76.4 126 84.4 – 168 177 118 – 235

MP BioMedicals SPCS RIA μg/dL 5.30 4.50 – 6.10 11.5 9.50 – 13.5 16.8 14.2 – 19.4 nmol/L 68.4 58.1 – 78.7 148 123 – 174 217 183 – 250

Siemens Coat-A-Count RIA μg/dL § § § nmol/L § § §

Wallac DELFIA TR-FIA μg/dL 5.50 3.88 – 7.13 11.3 9.07 – 13.6 13.3 10.7 – 16.0 nmol/L 71.0 50.0 – 92.0 146 117 – 175 172 138 – 206

TESTOSTERONE

BioCheck EIA ng/mL 1.14 0.460 – 1.82 4.17 3.39 – 4.94 6.48 3.57 – 9.39 nmol/L 3.96 1.60 – 6.32 14.5 11.8 – 17.1 22.5 12.4 – 32.6

DiaSorin TESTO-CTK RIA ng/mL 1.10 0.760 – 1.40 3.40 2.30 – 4.50 7.30 5.10 – 9.50 nmol/L 3.82 2.64 – 4.86 11.8 7.98 – 15.6 25.3 17.7 – 33.0

DRG Testosterone ELISA ng/mL 2.22 1.29 – 3.15 5.98 3.47 – 8.50 9.69 5.62 – 13.8 nmol/L 7.70 4.48 – 10.9 20.8 12.0 – 29.5 33.6 19.5 – 47.7

DSL Active Coated Tube RIA DSL-4000 ng/mL § § § nmol/L § § §

DSL Double Antibody RIA DSL-4100 ng/mL § § § nmol/L § § §

MP Biomedicals ImmuChem DA RIA ng/mL 1.05 0.850 – 1.25 3.70 2.90 – 4.50 8.50 6.80 – 10.2 nmol/L 3.64 2.95 – 4.34 12.8 10.1 – 15.6 29.5 23.6 – 35.4

Siemens Coat-A-Count IRMA ng/mL § § § nmol/L § § §

TESTOSTERONE FREE

DRG Free Testosterone ELISA pg/mL § § § pmol/L § § §

DSL Active Free Testosterone RIA pg/mL § § § pmol/L § § §

DSL Free Testosterone EIA pg/mL § § § pmol/L § § §

THEOPHYLLINE

Microgenics CEDIA II μg/mL 3.75 3.00 – 4.50 13.1 10.5 – 15.7 28.6 22.9 – 34.4 μmol/L 20.8 16.7 – 25.0 72.7 58.2 – 87.2 159 127 – 191

Syva Emit 2000 μg/mL 4.53 3.84 – 5.22 13.9 11.2 – 16.6 30.0 24.7 – 35.3 μmol/L 25.1 21.3 – 29.0 77.3 62.4 – 92.2 166 137 – 196

TOBRAMYCIN

Microgenics CEDIA μg/mL 0.882 0.705 – 1.06 3.44 2.75 – 4.12 7.02 5.62 – 8.43 μmol/L 1.89 1.51 – 2.26 7.35 5.88 – 8.83 15.0 12.0 – 18.0

Syva Emit 2000 μg/mL 0.910 0.730 – 1.09 3.15 2.76 – 3.54 6.15 5.21 – 7.08 μmol/L 1.95 1.56 – 2.33 6.74 5.91 – 7.58 13.2 11.1 – 15.2

Page 10: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

TSH

Adaltis MAIACLONE μIU/mL 0.660 0.480 – 0.840 8.82 6.44 – 11.2 44.1 32.2 – >50.0 mIU/L 0.660 0.480 – 0.840 8.82 6.44 – 11.2 44.1 32.2 – >50.0

BioCheck EIA μIU/mL 0.430 <0.200 – 0.776 5.41 3.93 – 6.90 >25.0 mIU/L 0.430 <0.200 – 0.776 5.41 3.93 – 6.90 >25.0

Bioclone ELEGANCE ELISA μIU/mL § § § mIU/L § § §

Monobind AccuBind ELISA μIU/mL 0.420 0.160 – 0.690 5.93 3.97 – 7.88 35.7 23.9 – 47.5 mIU/L 0.420 0.160 – 0.690 5.93 3.97 – 7.88 35.7 23.9 – 47.5

Monobind AccuLite CLIA μIU/mL 0.460 0.190 – 0.720 6.36 4.26 – 8.45 34.6 23.2 – 46.0 mIU/L 0.460 0.190 – 0.720 6.36 4.26 – 8.45 34.6 23.2 – 46.0

MP BioMedicals ImmuChem CT IRMA μIU/mL 0.560 0.480 – 0.640 7.20 6.00 – 8.40 37.3 32.1 – 42.5 mIU/L 0.560 0.480 – 0.640 7.20 6.00 – 8.40 37.3 32.1 – 42.5

MP BioMedicals SPCS IRMA μIU/mL § § § mIU/L § § §

Siemens Coat-A-Count IRMA μIU/mL § § § mIU/L § § §

Wallac DELFIA hTSH Ultra TR-FIA μIU/mL 0.390 0.310 – 0.470 4.80 3.80 – 5.80 30.0 24.0 – 36.0 mIU/L 0.390 0.310 – 0.470 4.80 3.80 – 5.80 30.0 24.0 – 36.0

VALPROIC ACID

Microgenics CEDIA II μg/mL 36.1 28.9 – 43.3 85.4 68.4 – 103 126 101 – 152 μmol/L 250 200 – 300 592 474 – 711 876 701 – 1052

Syva Emit 2000 μg/mL 36.3 27.2 – 45.4 80.6 60.0 – 101 121 90.0 – 151 μmol/L 252 188 – 315 559 416 – 700 835 624 – 1046

VANCOMYCIN

Syva Emit 2000 μg/mL 7.05 5.64 – 8.45 19.1 15.3 – 22.9 33.9 27.1 – 40.7 μmol/L 4.86 3.89 – 5.83 13.2 10.5 – 15.8 23.4 18.7 – 28.1

VITAMIN B12

MP BioMedicals SIMUITRAC SNB RIA pg/mL 375 320 – 430 731 620 – 842 1372 1165 – 1579 pmol/L 277 236 – 317 539 458 – 621 1013 860 – 1165

MP BioMedicals SIMUITRAC SP RIA pg/mL 394 325 – 463 689 556 – 822 1220 1023 – 1417 pmol/L 291 240 – 342 508 410 – 607 900 755 – 1046

Page 11: Lyphochek Immunoassay 370 Data Sheet

INSTRUMENTInstrument // Appareil // Strumento // Instrumento // Instrumento // Instrument // Instrument

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

ABBOTT ARCHITECT cSYSTEM / AEROSET

Acetaminophen μg/mL 10.1 8.05 – 12.1 37.8 30.2 – 45.3 115 92.4 – 139 μmol/L 66.6 53.3 – 79.9 250 200 – 300 764 611 – 917

Amikacin μg/mL § § § μmol/L § § §

Carbamazepine μg/mL 2.92 2.34 – 3.51 9.07 7.26 – 10.9 14.3 11.5 – 17.2 μmol/L 12.4 9.90 – 14.8 38.4 30.7 – 46.0 60.7 48.5 – 72.8

CEA ng/mL 2.88 2.30 – 3.46 20.8 16.6 – 24.9 46.5 37.2 – 55.8 μg/L 2.88 2.30 – 3.46 20.8 16.6 – 24.9 46.5 37.2 – 55.8

Cortisol μg/dL 2.52 2.02 – 3.03 16.5 13.2 – 19.8 26.5 21.2 – 31.9 nmol/L 69.6 55.7 – 83.5 454 363 – 545 733 586 – 879

DHEA-Sulfate μg/dL 76.8 61.5 – 92.2 156 125 – 187 606 485 – 727 μmol/L 2.07 1.66 – 2.49 4.21 3.37 – 5.05 16.4 13.1 – 19.6

Digoxin ng/mL 0.556 0.445 – 0.667 1.83 1.46 – 2.20 3.01 2.41 – 3.61 nmol/L 0.712 0.570 – 0.854 2.34 1.88 – 2.81 3.85 3.08 – 4.62

Estradiol pg/mL 46.1 36.8 – 55.3 186 149 – 223 320 256 – 384 pmol/L 169 135 – 203 682 546 – 819 1175 940 – 1409

Ferritin ng/mL 70.6 56.5 – 84.7 159 127 – 191 388 311 – 466 μg/L 70.6 56.5 – 84.7 159 127 – 191 388 311 – 466

FSH mIU/mL 5.85 4.68 – 7.02 24.7 19.8 – 29.7 41.5 33.2 – 49.9 IU/L 5.85 4.68 – 7.02 24.7 19.8 – 29.7 41.5 33.2 – 49.9

Gentamicin μg/mL 2.06 1.65 – 2.48 4.50 3.60 – 5.40 7.11 5.69 – 8.54 μmol/L 4.31 3.45 – 5.17 9.41 7.52 – 11.3 14.9 11.9 – 17.8

hCG Total Beta mIU/mL 5.58 4.47 – 6.70 17.8 14.3 – 21.4 141 113 – 169 IU/L 5.58 4.47 – 6.70 17.8 14.3 – 21.4 141 113 – 169

Immunoglobulin E IU/mL § § § kIU/L § § §

Insulin μIU/mL 12.5 10.0 – 15.0 39.2 31.3 – 47.0 113 90.3 – 135 pmol/L 86.9 69.5 – 104 272 218 – 326 784 627 – 940

LH mIU/mL 1.80 1.44 – 2.16 16.9 13.5 – 20.2 39.9 31.9 – 47.8 IU/L 1.80 1.44 – 2.16 16.9 13.5 – 20.2 39.9 31.9 – 47.8

Lithium mEq/L 0.450 0.360 – 0.540 1.22 0.978 – 1.47 1.87 1.49 – 2.24 mmol/L 0.450 0.360 – 0.540 1.22 0.978 – 1.47 1.87 1.49 – 2.24

Phenobarbital μg/mL 8.87 7.09 – 10.6 23.4 18.7 – 28.0 51.6 41.3 – 62.0 μmol/L 38.2 30.6 – 45.9 101 80.6 – 121 223 178 – 267

Phenytoin μg/mL 5.69 4.55 – 6.82 13.5 10.8 – 16.2 24.3 19.4 – 29.1 μmol/L 22.5 18.0 – 27.0 53.5 42.8 – 64.2 96.2 77.0 – 115

Progesterone ng/mL 0.711 0.569 – 0.853 8.61 6.89 – 10.3 30.7 24.5 – 36.8 nmol/L 2.26 1.81 – 2.71 27.4 21.9 – 32.9 97.5 78.0 – 117

Prolactin ng/mL 8.23 6.59 – 9.88 24.6 19.7 – 29.5 49.6 39.7 – 59.6 μg/L 8.23 6.59 – 9.88 24.6 19.7 – 29.5 49.6 39.7 – 59.6

PSA ng/mL 0.874 0.699 – 1.05 3.42 2.74 – 4.11 21.3 17.0 – 25.5 μg/L 0.874 0.699 – 1.05 3.42 2.74 – 4.11 21.3 17.0 – 25.5

PSA Free ng/mL 0.486 0.389 – 0.583 2.29 1.83 – 2.74 15.7 12.6 – 18.9 μg/L 0.486 0.389 – 0.583 2.29 1.83 – 2.74 15.7 12.6 – 18.9

Salicylate mg/dL <5.00 15.5 12.4 – 18.5 49.4 39.5 – 59.3 mmol/L <0.362 1.12 0.895 – 1.34 3.58 2.86 – 4.29

T3 Free pg/mL 2.39 1.91 – 2.87 7.55 6.04 – 9.06 13.0 10.4 – 15.6 pmol/L 3.68 2.95 – 4.42 11.6 9.30 – 13.9 20.0 16.0 – 24.0

T3 Total ng/mL 0.722 0.577 – 0.866 2.22 1.77 – 2.66 2.99 2.39 – 3.59 nmol/L 1.11 0.889 – 1.33 3.42 2.73 – 4.10 4.61 3.69 – 5.53

T Uptake T Uptake

T3 Uptake / T Uptake (Unit) Unit 0.837 0.669 – 1.00 0.817 0.653 – 0.980 0.727 0.581 – 0.872 Unit 0.837 0.669 – 1.00 0.817 0.653 – 0.980 0.727 0.581 – 0.872

T4 Free ng/dL 0.953 0.763 – 1.14 2.61 2.09 – 3.13 >6.00 pmol/L 12.3 9.84 – 14.8 33.7 27.0 – 40.4 >77.4

T4 Total μg/dL 6.27 5.02 – 7.53 14.3 11.5 – 17.2 17.1 – >24.0 nmol/L 80.9 64.7 – 97.1 185 148 – 222 221 – >310

Theophylline μg/mL 4.70 3.76 – 5.64 13.4 10.7 – 16.1 29.1 23.3 – 34.9 μmol/L 26.1 20.9 – 31.3 74.5 59.6 – 89.4 161 129 – 194

Tobramycin (MULTIGENT) μg/mL § § § μmol/L § § §

TSH μIU/mL 0.384 0.307 – 0.461 4.78 3.83 – 5.74 27.2 21.8 – 32.6 mIU/L 0.384 0.307 – 0.461 4.78 3.83 – 5.74 27.2 21.8 – 32.6

Valproic Acid μg/mL 31.7 25.3 – 38.0 74.7 59.8 – 89.7 112 89.8 – 135 μmol/L 220 176 – 263 518 414 – 621 778 622 – 934

Vancomycin μg/mL 8.04 6.43 – 9.65 20.2 16.2 – 24.2 34.6 27.7 – 41.5 μmol/L 5.55 4.44 – 6.66 13.9 11.1 – 16.7 23.9 19.1 – 28.7

ABBOTT ARCHITECT i SYSTEMS

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL 6.20 4.96 – 7.44 13.8 11.1 – 16.6 24.2 19.3 – 29.0 μmol/L 24.6 19.7 – 29.5 54.8 43.9 – 65.8 95.8 76.6 – 115

Theophylline μg/mL 4.53 3.63 – 5.44 13.5 10.8 – 16.2 29.3 23.4 – 35.1 μmol/L 25.2 20.1 – 30.2 75.1 60.1 – 90.1 162 130 – 195

Vancomycin μg/mL 8.06 6.45 – 9.67 20.3 16.2 – 24.4 36.3 29.0 – 43.5 μmol/L 5.56 4.45 – 6.67 14.0 11.2 – 16.8 25.0 20.0 – 30.0

ABBOTT AxSYM

Acetaminophen μg/mL 12.4 9.93 – 14.9 41.0 32.8 – 49.1 122 97.7 – 147 μmol/L 82.1 65.7 – 98.5 271 217 – 325 808 646 – 969

AFP ng/mL 19.0 15.2 – 22.8 90.6 72.5 – 109 204 163 – 244 IU/mL 15.7 12.6 – 18.9 75.2 60.2 – 90.2 169 135 – 203

Carbamazepine μg/mL 2.71 2.17 – 3.25 8.60 6.88 – 10.3 14.6 11.7 – 17.5 μmol/L 11.5 9.17 – 13.7 36.4 29.1 – 43.6 61.8 49.4 – 74.1

CEA ng/mL 2.85 2.28 – 3.42 19.3 15.4 – 23.1 47.4 37.9 – 56.8 μg/L 2.85 2.28 – 3.42 19.3 15.4 – 23.1 47.3 37.9 – 56.8

Cortisol μg/dL 3.31 2.55 – 4.07 19.1 15.3 – 23.0 33.2 26.5 – 39.8 nmol/L 91.4 70.3 – 112 528 423 – 634 915 732 – 1098

Digoxin II ng/mL 0.512 0.409 – 0.614 1.72 1.38 – 2.07 2.71 2.17 – 3.25 nmol/L 0.655 0.524 – 0.786 2.20 1.76 – 2.64 3.47 2.77 – 4.16

Digoxin III ng/mL 0.503 0.372 – 0.634 1.81 1.45 – 2.17 2.95 2.36 – 3.54 nmol/L 0.644 0.476 – 0.811 2.32 1.85 – 2.78 3.77 3.02 – 4.53

Estradiol (4) pg/mL § § § pmol/L § § §

Ferritin ng/mL 69.1 55.2 – 82.9 163 130 – 196 397 318 – 476 μg/L 69.1 55.2 – 82.9 163 130 – 196 397 318 – 476

Folate ng/mL 3.10 2.14 – 4.06 7.29 5.83 – 8.75 12.3 9.84 – 14.8 nmol/L 7.02 4.85 – 9.20 16.5 13.2 – 19.8 27.9 22.3 – 33.4

FSH mIU/mL 6.35 5.08 – 7.62 26.2 21.0 – 31.4 44.8 35.8 – 53.8 IU/L 6.35 5.08 – 7.62 26.2 21.0 – 31.4 44.8 35.8 – 53.8

Gentamicin μg/mL 2.13 1.70 – 2.55 4.84 3.88 – 5.81 7.55 6.04 – 9.06 μmol/L 4.45 3.56 – 5.34 10.1 8.10 – 12.1 15.8 12.6 – 18.9

hCG Total Beta mIU/mL 5.79 4.63 – 6.95 23.0 18.4 – 27.6 181 145 – 218 IU/L 5.79 4.63 – 6.95 23.0 18.4 – 27.6 181 145 – 218

hTSH II μIU/mL 0.367 0.294 – 0.441 5.00 4.00 – 6.00 26.9 21.6 – 32.3 mIU/L 0.367 0.294 – 0.441 5.00 4.00 – 6.00 26.9 21.6 – 32.3

LH mIU/mL 1.94 1.55 – 2.33 19.5 15.6 – 23.3 48.1 38.5 – 57.8 IU/L 1.94 1.55 – 2.33 19.5 15.6 – 23.3 48.1 38.5 – 57.8

NAPA μg/mL 1.87 1.50 – 2.25 5.03 4.03 – 6.04 11.2 8.96 – 13.4 μmol/L 6.76 5.40 – 8.11 18.2 14.5 – 21.8 40.4 32.3 – 48.5

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL 6.47 5.17 – 7.76 14.1 11.3 – 16.9 24.0 19.2 – 28.8 μmol/L 25.6 20.5 – 30.7 55.9 44.7 – 67.1 95.0 76.0 – 114

Procainamide μg/mL 1.87 1.49 – 2.24 8.11 6.49 – 9.74 14.1 11.3 – 16.9 μmol/L 7.90 6.32 – 9.49 34.3 27.5 – 41.2 59.7 47.8 – 71.7

Progesterone ng/mL 0.692 0.554 – 0.830 9.15 7.32 – 11.0 27.0 21.6 – 32.3 nmol/L 2.20 1.76 – 2.64 29.1 23.3 – 34.9 85.7 68.6 – 103

Prolactin ng/mL 7.65 6.12 – 9.18 22.3 17.8 – 26.8 47.6 38.1 – 57.1 μg/L 7.65 6.12 – 9.18 22.3 17.8 – 26.8 47.6 38.1 – 57.1

PSA Free ng/mL 0.471 0.377 – 0.565 2.14 1.71 – 2.57 >10.0 μg/L 0.471 0.377 – 0.565 2.14 1.71 – 2.57 >10.0

PSA Total ng/mL 0.781 0.625 – 0.937 2.93 2.34 – 3.51 19.3 15.4 – 23.1 μg/L 0.781 0.625 – 0.937 2.93 2.34 – 3.51 19.3 15.4 – 23.1

Quinidine μg/mL 0.976 0.781 – 1.17 2.96 2.37 – 3.55 5.31 4.25 – 6.38 μmol/L 3.01 2.41 – 3.61 9.11 7.29 – 10.9 16.4 13.1 – 19.6

Salicylate mg/L 36.1 28.9 – 43.3 153 122 – 183 484 387 – 580 mmol/L 0.261 0.209 – 0.314 1.11 0.885 – 1.33 3.50 2.80 – 4.20

T3 Free pg/mL 1.82 1.35 – 2.29 6.79 5.43 – 8.14 14.3 11.3 – 17.3 pmol/L 2.80 2.07 – 3.53 10.5 8.36 – 12.5 22.0 17.4 – 26.6

T3 Total ng/mL 0.745 0.596 – 0.895 2.09 1.68 – 2.51 3.52 2.81 – 4.22 nmol/L 1.15 0.918 – 1.38 3.23 2.58 – 3.87 5.41 4.33 – 6.50

T3 Uptake / T Uptake (%) % Uptake § § § % Uptake § § §

T Uptake T Uptake

T3 Uptake / T Uptake (Unit) Unit 0.748 0.599 – 0.898 0.755 0.604 – 0.906 0.722 0.577 – 0.866 Unit 0.748 0.599 – 0.898 0.755 0.604 – 0.906 0.722 0.577 – 0.866

T4 Free ng/dL 0.678 0.543 – 0.814 1.46 1.17 – 1.75 3.01 2.41 – 3.61 pmol/L 8.75 7.00 – 10.5 18.8 15.1 – 22.6 38.8 31.0 – 46.5

T4 Total μg/dL 5.24 4.19 – 6.28 11.4 9.11 – 13.7 17.1 13.7 – 20.5 nmol/L 67.5 54.0 – 81.0 147 117 – 176 220 176 – 264

Testosterone ng/mL 1.34 1.07 – 1.61 4.03 3.23 – 4.84 6.79 5.43 – 8.15 nmol/L 4.65 3.72 – 5.58 14.0 11.2 – 16.8 23.6 18.9 – 28.3

Theophylline μg/mL 4.90 3.92 – 5.88 14.1 11.2 – 16.9 30.1 24.1 – 36.1 μmol/L 27.2 21.8 – 32.7 78.0 62.4 – 93.6 167 134 – 200

Tobramycin μg/mL 1.32 1.05 – 1.58 4.30 3.44 – 5.16 8.44 6.75 – 10.1 μmol/L 2.82 2.26 – 3.39 9.20 7.36 – 11.0 18.1 14.5 – 21.7

Tricyclic Antidepressant Screen ng/mL § § § ng/mL § § §

Valproic Acid μg/mL 34.3 27.4 – 41.2 78.9 63.1 – 94.7 109 87.4 – 131 μmol/L 238 190 – 285 547 437 – 656 757 605 – 908

Vancomycin μg/mL 8.01 6.41 – 9.61 20.5 16.4 – 24.6 35.4 28.3 – 42.5 μmol/L 5.53 4.42 – 6.63 14.2 11.3 – 17.0 24.4 19.5 – 29.3

Vitamin B12 (3C79) pg/mL 342 274 – 410 627 502 – 753 894 – >1200 pmol/L 252 202 – 303 463 370 – 556 660 – >886

ABBOTT IMx

CEA ng/mL § § § μg/L § § §

Digoxin ng/mL § § § nmol/L § § §

PSA ng/mL 0.813 0.650 – 0.975 3.12 2.50 – 3.75 20.3 16.3 – 24.4 μg/L 0.813 0.650 – 0.975 3.12 2.50 – 3.75 20.3 16.3 – 24.4

T4 Free ng/dL § § § pmol/L § § §

Page 12: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

ABBOTT IMx (continued)

T4 Total μg/dL 5.34 4.27 – 6.41 11.2 8.92 – 13.4 16.7 13.4 – 20.0 nmol/L 68.9 55.1 – 82.7 144 115 – 173 215 172 – 258

TSH-Ultra II μIU/mL 0.439 0.351 – 0.527 4.98 3.98 – 5.97 28.8 23.0 – 34.6 mIU/L 0.439 0.351 – 0.527 4.97 3.98 – 5.97 28.8 23.0 – 34.6

ABBOTT TDx / FLx

Acetaminophen μg/mL § § § μmol/L § § §

Amikacin μg/mL 6.51 5.21 – 7.81 15.3 12.3 – 18.4 30.4 24.3 – 36.5 μmol/L 11.1 8.91 – 13.4 26.2 21.0 – 31.5 52.0 41.6 – 62.3

Carbamazepine μg/mL 2.89 2.31 – 3.47 8.50 6.80 – 10.2 14.7 11.8 – 17.7 μmol/L 12.2 9.79 – 14.7 36.0 28.8 – 43.2 62.3 49.9 – 74.8

Carbamazepine Free μg/mL 1.07 0.853 – 1.28 3.28 2.63 – 3.94 5.41 4.33 – 6.50 μmol/L 4.51 3.61 – 5.41 13.9 11.1 – 16.7 22.9 18.3 – 27.5

Digoxin ng/mL 0.522 0.334 – 0.709 1.66 1.32 – 1.99 2.83 2.27 – 3.40 nmol/L 0.668 0.427 – 0.908 2.12 1.69 – 2.54 3.63 2.90 – 4.35

Gentamicin μg/mL 2.40 1.27 – 3.53 4.82 3.85 – 5.78 7.13 5.71 – 8.56 μmol/L 5.02 2.66 – 7.38 10.1 8.06 – 12.1 14.9 11.9 – 17.9

NAPA μg/mL 1.90 1.52 – 2.28 5.13 4.10 – 6.15 11.4 9.15 – 13.7 μmol/L 6.87 5.49 – 8.24 18.5 14.8 – 22.2 41.3 33.0 – 49.5

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL 6.92 5.53 – 8.30 14.6 11.7 – 17.5 24.3 19.4 – 29.1 μmol/L 27.4 21.9 – 32.9 57.9 46.3 – 69.4 96.1 76.9 – 115

Phenytoin Free μg/mL 0.816 0.653 – 0.979 1.98 1.58 – 2.37 3.01 2.41 – 3.62 μmol/L 3.23 2.59 – 3.88 7.83 6.26 – 9.39 11.9 9.55 – 14.3

Procainamide μg/mL 1.90 1.52 – 2.28 8.21 6.57 – 9.85 14.1 11.3 – 16.9 μmol/L 8.03 6.43 – 9.64 34.7 27.8 – 41.7 59.7 47.7 – 71.6

Quinidine μg/mL 1.03 0.821 – 1.23 2.95 2.36 – 3.54 5.24 4.19 – 6.28 μmol/L 3.16 2.53 – 3.79 9.08 7.27 – 10.9 16.1 12.9 – 19.4

Salicylate mg/dL 3.79 2.73 – 4.86 16.1 12.8 – 19.3 48.1 38.5 – 57.8 mmol/L 0.275 0.198 – 0.352 1.16 0.930 – 1.40 3.48 2.79 – 4.18

Theophylline μg/mL § § § μmol/L § § §

Tobramycin μg/mL § § § μmol/L § § §

Tricyclic Antidepressant Screen ng/mL § § § ng/mL § § §

Valproic Acid μg/mL § § § μmol/L § § §

Valproic Acid Free μg/mL § § § μmol/L § § §

Vancomycin μg/mL § § § μmol/L § § §

ALFA WASSERMANN ACE

Digoxin CEDIA ng/mL § § § nmol/L § § §

Ferritin ng/mL 76.8 63.3 – 90.3 132 108 – 155 328 252 – 403 μg/L 76.8 63.3 – 90.3 132 108 – 155 328 252 – 403

T3 Uptake CEDIA % Uptake 37.3 33.4 – 41.3 44.5 38.7 – >50.0 45.7 – >50.0 % Uptake 37.3 33.4 – 41.3 44.5 38.7 – >50.0 45.7 – >50.0

T4 Total (EIA) μg/dL 4.70 4.30 – 5.20 11.1 10.0 – 12.3 15.8 13.8 – >20.0 nmol/L 60.6 55.5 – 67.1 143 129 – 159 204 178 – >258

BECKMAN COULTER ACCESS / 2 / 2i

AFP ng/mL 18.8 15.8 – 21.8 90.6 76.1 – 105 204 171 – 236 IU/mL 15.6 13.1 – 18.1 75.2 63.1 – 87.2 169 142 – 196

CEA2 ng/mL 2.45 2.05 – 2.85 18.8 15.8 – 21.8 44.9 37.7 – 52.1 μg/L 2.45 2.05 – 2.85 18.8 15.8 – 21.8 44.9 37.7 – 52.1

Cortisol μg/dL 3.14 2.38 – 3.90 18.3 14.6 – 21.9 31.9 25.5 – 38.3 nmol/L 86.7 65.7 – 108 504 403 – 605 880 704 – 1056

DHEA-Sulfate μg/dL 56.8 47.7 – 65.9 116 97.3 – 134 441 370 – 511 μmol/L 1.53 1.29 – 1.78 3.13 2.63 – 3.63 11.9 9.99 – 13.8

Digoxin ng/mL 0.570 0.470 – 0.670 1.85 1.55 – 2.15 2.89 2.43 – 3.35 nmol/L 0.730 0.602 – 0.858 2.37 1.98 – 2.75 3.70 3.11 – 4.29

Estradiol pg/mL 97.3 73.9 – 121 353 294 – 411 753 632 – 873 pmol/L 357 271 – 443 1294 1080 – 1508 2763 2321 – 3205

Estriol Unconjugated ng/mL 0.954 0.668 – 1.24 2.93 2.46 – 3.39 5.84 4.90 – 6.77 nmol/L 3.31 2.32 – 4.30 10.1 8.53 – 11.8 20.3 17.0 – 23.5

Ferritin (3rd IS) ng/mL 53.9 45.3 – 62.6 120 101 – 139 282 237 – 327 μg/L 53.9 45.3 – 62.6 120 101 – 139 282 237 – 327

Folate ng/mL 2.72 2.26 – 3.18 6.94 5.84 – 8.04 12.0 10.1 – 13.9 nmol/L 6.16 5.12 – 7.21 15.7 13.2 – 18.2 27.1 22.8 – 31.5

FSH mIU/mL 7.37 6.19 – 8.55 30.4 25.2 – 35.6 49.6 41.7 – 57.5 IU/L 7.37 6.19 – 8.55 30.4 25.1 – 35.6 49.6 41.7 – 57.5

hCG Total Beta mIU/mL 5.66 4.76 – 6.56 18.2 15.3 – 21.1 131 110 – 152 IU/L 5.66 4.76 – 6.56 18.2 15.3 – 21.1 131 110 – 152

hGH (Ultrasensitive) (2nd IS) ng/mL 2.05 1.75 – 2.35 5.23 4.44 – 6.02 11.1 9.39 – 12.7 μg/L 2.05 1.75 – 2.35 5.23 4.44 – 6.02 11.1 9.39 – 12.7

Immunoglobulin E Total IU/mL 328 271 – 384 72.7 60.0 – 85.4 90.5 76.0 – 105 kIU/L 328 271 – 384 72.7 60.0 – 85.4 90.5 76.0 – 105

Insulin (Ultrasensitive) μIU/mL 13.2 11.1 – 15.3 42.4 35.6 – 49.1 125 105 – 145 pmol/L 91.7 77.0 – 106 294 247 – 341 869 730 – 1008

LH mIU/mL 1.65 1.39 – 1.91 17.7 14.8 – 20.5 39.5 33.2 – 45.8 IU/L 1.65 1.39 – 1.91 17.6 14.8 – 20.5 39.5 33.2 – 45.8

Progesterone ng/mL 0.940 0.780 – 1.10 10.4 8.73 – 12.1 27.1 22.5 – 31.6 nmol/L 2.99 2.48 – 3.50 33.1 27.8 – 38.4 86.1 71.7 – 100

Prolactin ng/mL 5.85 4.91 – 6.79 18.0 15.2 – 20.9 34.9 29.3 – 40.5 μg/L 5.85 4.91 – 6.79 18.0 15.2 – 20.9 34.9 29.3 – 40.5

PSA Free (Hybritech) ng/mL 0.630 0.530 – 0.730 2.82 2.36 – 3.28 17.5 14.7 – 20.3 μg/L 0.630 0.530 – 0.730 2.82 2.36 – 3.28 17.5 14.7 – 20.3

PSA Free (WHO 96 / 668) ng/mL 0.500 0.420 – 0.580 2.29 1.92 – 2.66 13.8 11.6 – 16.0 μg/L 0.500 0.420 – 0.580 2.29 1.92 – 2.66 13.8 11.6 – 16.0

PSA Total (Hybritech) ng/mL 1.10 0.920 – 1.28 4.24 3.56 – 4.92 26.9 22.6 – 31.2 μg/L 1.10 0.920 – 1.28 4.24 3.56 – 4.92 26.9 22.6 – 31.2

PSA Total (WHO 96/670) ng/mL 0.930 0.780 – 1.08 3.30 2.77 – 3.83 21.0 17.6 – 24.3 μg/L 0.930 0.780 – 1.08 3.30 2.77 – 3.83 21.0 17.6 – 24.3

T3 Free pg/mL 2.31 1.85 – 2.77 5.90 4.72 – 7.08 10.5 8.36 – 12.6 pmol/L 3.56 2.85 – 4.27 9.09 7.27 – 10.9 16.1 12.9 – 19.3

T3 Total ng/mL 0.820 0.680 – 0.960 2.01 1.69 – 2.33 2.96 2.48 – 3.44 nmol/L 1.26 1.05 – 1.48 3.10 2.60 – 3.59 4.56 3.82 – 5.30

T3 Uptake / T Uptake % Uptake 41.1 34.5 – 47.8 43.9 36.9 – 50.9 50.5 42.4 – 58.6 % Uptake 41.1 34.5 – 47.8 43.9 36.8 – 50.9 50.5 42.4 – 58.5

T4 Free ng/dL 0.900 0.760 – 1.04 2.46 2.06 – 2.86 4.88 4.10 – 5.66 pmol/L 11.6 9.80 – 13.4 31.7 26.6 – 36.9 63.0 52.9 – 73.0

T4 Total μg/dL 5.14 4.22 – 6.06 10.6 8.89 – 12.3 17.5 14.7 – 20.3 nmol/L 66.3 54.4 – 78.2 137 115 – 159 226 190 – 262

Testosterone ng/mL 1.36 1.14 – 1.58 4.25 3.57 – 4.93 7.68 6.46 – 8.90 nmol/L 4.72 3.96 – 5.48 14.7 12.4 – 17.1 26.6 22.4 – 30.9

TSH (Hypersensitive) μIU/mL 0.360 0.300 – 0.420 5.40 4.54 – 6.26 30.8 25.9 – 35.8 mIU/L 0.360 0.300 – 0.420 5.40 4.54 – 6.26 30.8 25.9 – 35.8

Vitamin B12 pg/mL 299 251 – 347 609 512 – 707 1309 1091 – >1500 pmol/L 221 185 – 256 449 378 – 521 966 805 – >1107

BECKMAN COULTER CX SERIES

Acetaminophen μg/mL 9.65 7.14 – 12.2 41.4 33.1 – 49.7 129 103 – 154 μmol/L 63.8 47.2 – 80.4 274 219 – 329 851 681 – 1021

Carbamazepine μg/mL § § § μmol/L § § §

Digoxin ng/mL <0.200 – 0.480 1.48 1.19 – 1.78 2.53 2.03 – 3.04 nmol/L <0.256 – 0.614 1.90 1.52 – 2.28 3.24 2.59 – 3.89

Gentamicin μg/mL § § § μmol/L § § §

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL § § § μmol/L § § §

Salicylate mg/dL § § § mmol/L § § §

Theophylline μg/mL 4.45 3.56 – 5.34 13.4 10.7 – 16.0 29.4 23.5 – 35.3 μmol/L 24.7 19.8 – 29.6 74.1 59.3 – 88.9 163 131 – 196

Tobramycin μg/mL § § § μmol/L § § §

Valproic Acid μg/mL § § § μmol/L § § §

Vancomycin μg/mL § § § μmol/L § § §

BECKMAN COULTER SYNCHRON LX /UniCel DxC SERIES

Acetaminophen μg/mL 11.1 <10.0 – 13.4 42.1 33.7 – 50.5 131 105 – 158 μmol/L 73.7 <66.1 – 88.4 278 223 – 334 869 695 – 1043

Carbamazepine μg/mL 2.29 <2.00 – 2.75 8.25 6.60 – 9.90 14.2 11.4 – 17.0 μmol/L 9.68 <8.46 – 11.6 34.9 27.9 – 41.9 60.0 48.0 – 72.0

Digoxin ng/mL <0.200 – 0.576 1.58 1.27 – 1.90 2.65 2.12 – 3.18 nmol/L <0.256 – 0.737 2.03 1.62 – 2.43 3.39 2.71 – 4.07

Gentamicin μg/mL 2.24 1.79 – 2.69 4.82 3.86 – 5.78 7.93 6.34 – 9.52 μmol/L 4.68 3.75 – 5.62 10.1 8.06 – 12.1 16.6 13.3 – 19.9

Iron (1) μg/dL 88.4 70.7 – 106 80.1 64.1 – 96.2 77.6 62.1 – 93.2 μmol/L 15.8 12.7 – 19.0 14.3 11.5 – 17.2 13.9 11.1 – 16.7

Phenobarbital μg/mL 8.60 6.88 – 10.3 22.3 17.8 – 26.7 48.5 38.8 – 58.2 μmol/L 37.1 29.7 – 44.5 96.0 76.8 – 115 209 167 – 251

Phenytoin μg/mL 5.88 4.71 – 7.06 13.5 10.8 – 16.2 23.2 18.6 – 27.9 μmol/L 23.3 18.6 – 28.0 53.5 42.8 – 64.2 92.0 73.6 – 110

Salicylate mg/dL <4.00 16.5 13.2 – 19.7 52.0 41.6 – 62.4 mmol/L <0.290 1.19 0.953 – 1.43 3.76 3.01 – 4.51

Theophylline μg/mL 4.34 3.47 – 5.21 13.3 10.6 – 16.0 29.9 24.0 – 35.9 μmol/L 24.1 19.3 – 28.9 73.8 59.0 – 88.5 166 133 – 199

Tobramycin μg/mL 0.800 0.632 – 0.968 3.66 2.93 – 4.39 7.42 5.94 – 8.90 μmol/L 1.71 1.35 – 2.07 7.83 6.27 – 9.40 15.9 12.7 – 19.1

Valproic Acid μg/mL 28.7 23.0 – 34.4 73.9 59.1 – 88.7 90.9 72.8 – 109 μmol/L 199 159 – 239 512 410 – 614 630 504 – 756

Vancomycin μg/mL 8.11 6.49 – 9.74 20.7 16.5 – 24.8 37.9 30.3 – 45.5 μmol/L 5.60 4.48 – 6.72 14.2 11.4 – 17.1 26.1 20.9 – 31.4

BECKMAN COULTER UniCel DxI

AFP ng/mL 18.1 15.2 – 21.0 86.4 72.6 – 100 196 165 – 227 IU/mL 15.0 12.6 – 17.4 71.7 60.3 – 83.2 163 137 – 189

CEA2 ng/mL 2.25 1.89 – 2.61 17.2 14.5 – 20.0 40.7 34.2 – 47.2 μg/L 2.25 1.89 – 2.61 17.2 14.5 – 20.0 40.7 34.2 – 47.2

Cortisol μg/dL 3.19 2.43 – 3.95 18.2 14.5 – 21.8 33.0 26.4 – 39.6 nmol/L 88.0 67.1 – 109 501 401 – 602 910 728 – 1092

Page 13: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

BECKMAN COULTER UniCel DxI (continued)

DHEA-Sulfate μg/dL 53.7 43.9 – 63.5 110 88.5 – 131 421 330 – 511 μmol/L 1.45 1.18 – 1.71 2.96 2.39 – 3.53 11.4 8.92 – 13.8

Digoxin ng/mL 0.550 0.470 – 0.630 1.80 1.52 – 2.08 2.82 2.36 – 3.28 nmol/L 0.704 0.602 – 0.806 2.30 1.95 – 2.66 3.61 3.02 – 4.20

Estradiol pg/mL 115 87.2 – 142 352 287 – 416 724 595 – 854 pmol/L 421 320 – 522 1290 1054 – 1526 2658 2182 – 3134

Estriol Free ng/mL 0.995 0.835 – 1.16 3.10 2.58 – 3.62 6.10 5.08 – >6.90 nmol/L 3.45 2.90 – 4.01 10.8 8.97 – 12.6 21.2 17.6 – >23.9

Ferritin (3rd IS) ng/mL 53.3 44.7 – 61.8 120 101 – 139 290 243 – 336 μg/L 53.3 44.7 – 61.8 120 101 – 139 290 243 – 336

Folate ng/mL 2.61 2.19 – 3.03 6.68 5.62 – 7.74 11.4 9.54 – 13.2 nmol/L 5.91 4.96 – 6.87 15.1 12.7 – 17.5 25.7 21.6 – 29.9

FSH mIU/mL 7.23 6.07 – 8.39 30.7 25.8 – 35.6 51.4 43.2 – 59.6 IU/L 7.23 6.07 – 8.39 30.7 25.8 – 35.6 51.4 43.2 – 59.6

hCG Total Beta mIU/mL 5.60 4.70 – 6.50 18.1 15.2 – 21.0 130 109 – 151 IU/L 5.60 4.70 – 6.50 18.1 15.2 – 21.0 130 109 – 151

hGH (Ultrasensitive) (2nd IS) ng/mL 1.89 1.51 – 2.26 4.82 3.91 – 5.73 10.4 8.72 – 12.1 μg/L 1.88 1.51 – 2.26 4.82 3.91 – 5.73 10.4 8.72 – 12.1

Immunoglobulin E Total IU/mL 306 253 – 360 63.7 53.5 – 73.9 83.5 70.2 – 96.9 kIU/L 306 253 – 360 63.7 53.5 – 73.8 83.5 70.2 – 96.9

Insulin (Ultrasensitive) μIU/mL 13.5 11.3 – 15.7 42.2 35.5 – 49.0 121 102 – 140 pmol/L 93.5 78.2 – 109 293 246 – 340 841 706 – 976

LH mIU/mL 1.54 1.30 – 1.78 17.4 14.6 – 20.2 40.0 33.6 – 46.4 IU/L 1.54 1.30 – 1.78 17.4 14.6 – 20.2 40.0 33.6 – 46.4

Progesterone ng/mL 1.06 0.700 – 1.42 11.3 9.10 – 13.4 29.9 21.6 – 38.1 nmol/L 3.37 2.23 – 4.52 35.8 28.9 – 42.7 94.9 68.6 – 121

Prolactin ng/mL 5.50 4.62 – 6.38 17.1 14.3 – 19.8 33.0 27.7 – 38.3 μg/L 5.50 4.62 – 6.38 17.1 14.3 – 19.8 33.0 27.7 – 38.3

PSA Total (WHO 96 / 670) ng/mL 0.960 0.810 – 1.11 3.33 2.80 – 3.86 21.0 17.7 – 24.4 μg/L 0.960 0.810 – 1.11 3.33 2.80 – 3.86 21.0 17.6 – 24.4

PSA Free (Hybritech) ng/mL 0.610 0.510 – 0.710 2.81 2.37 – 3.25 17.6 14.5 – 20.7 μg/L 0.610 0.510 – 0.710 2.81 2.37 – 3.25 17.6 14.5 – 20.7

PSA Free (WHO 96 / 668) ng/mL 0.480 0.400 – 0.560 2.28 1.92 – 2.64 13.9 11.5 – 16.3 μg/L 0.480 0.400 – 0.560 2.28 1.92 – 2.64 13.9 11.5 – 16.3

PSA Total (Hybritech) ng/mL 1.14 0.960 – 1.32 4.27 3.59 – 4.95 27.0 22.7 – 31.3 μg/L 1.14 0.960 – 1.32 4.27 3.59 – 4.95 27.0 22.6 – 31.3

T3 Free pg/mL 2.37 1.89 – 2.85 6.02 4.82 – 7.22 10.4 8.35 – 12.5 pmol/L 3.65 2.91 – 4.39 9.27 7.42 – 11.1 16.1 12.9 – 19.3

T3 Total ng/mL 0.850 0.690 – 1.01 2.09 1.75 – 2.43 3.06 2.52 – 3.60 nmol/L 1.31 1.06 – 1.56 3.22 2.70 – 3.74 4.71 3.88 – 5.54

T3 Uptake / T Uptake % Uptake 42.6 35.8 – 49.4 45.2 38.0 – 52.5 50.6 42.5 – 58.7 % Uptake 42.6 35.8 – 49.4 45.2 38.0 – 52.5 50.6 42.5 – 58.7

T4 Free ng/dL 0.860 0.720 – 1.00 2.41 1.99 – 2.83 5.07 4.25 – 5.89 pmol/L 11.1 9.29 – 12.9 31.1 25.7 – 36.5 65.4 54.8 – 76.0

T4 Total μg/dL 5.12 4.26 – 5.98 10.7 8.95 – 12.4 18.0 15.1 – 21.0 nmol/L 66.0 55.0 – 77.1 137 115 – 159 233 195 – 270

Testosterone ng/mL 1.41 1.19 – 1.63 4.10 3.38 – 4.82 7.26 6.10 – 8.42 nmol/L 4.89 4.13 – 5.66 14.2 11.7 – 16.7 25.2 21.2 – 29.2

TSH (Hypersensitive) μIU/mL 0.350 0.290 – 0.410 5.45 4.53 – 6.37 30.6 26.5 – 34.7 mIU/L 0.350 0.290 – 0.410 5.45 4.53 – 6.37 30.6 26.5 – 34.7

Vitamin B12 pg/mL 259 205 – 313 540 437 – 644 1201 936 – >1500 pmol/L 191 151 – 231 399 322 – 475 886 691 – >1107

BIOMÉRIEUX VIDAS

AFP ng/mL 15.7 11.3 – 20.0 74.7 55.4 – 94.0 166 135 – 198 IU/mL 13.0 9.40 – 16.6 62.0 46.0 – 78.0 138 112 – 164

CEA (S) ng/mL 1.71 <0.500 – 3.71 9.00 6.20 – 11.8 15.7 13.0 – 18.4 μg/L 1.71 <0.500 – 3.71 9.00 6.20 – 11.8 15.7 13.0 – 18.4

Digoxin ng/mL 0.510 0.310 – 0.700 1.79 1.39 – 2.18 2.95 2.36 – 3.55 nmol/L 0.653 0.397 – 0.896 2.29 1.78 – 2.79 3.78 3.02 – 4.54

Estradiol II pg/mL 74.5 50.0 – 99.0 325 255 – 396 770 618 – 923 pmol/L 273 184 – 363 1193 936 – 1453 2826 2268 – 3387

Ferritin ng/mL 70.0 45.0 – 95.0 149 113 – 185 373 284 – 462 μg/L 70.0 45.0 – 95.0 149 113 – 185 373 284 – 462

FSH mIU/mL 7.00 5.50 – 8.50 30.3 26.1 – 34.5 55.0 47.0 – 63.0 IU/L 7.00 5.50 – 8.50 30.3 26.1 – 34.5 55.0 47.0 – 63.0

hCG mIU/mL 9.20 5.80 – 12.6 38.0 29.0 – 47.0 304 241 – 367 IU/L 9.20 5.80 – 12.6 38.0 29.0 – 47.0 304 241 – 367

Immunoglobulin E IU/mL 341 259 – 423 65.0 31.0 – 99.0 85.0 50.0 – 120 kIU/L 341 259 – 423 65.0 31.0 – 99.0 85.0 50.0 – 120

LH mIU/mL 1.80 1.20 – 2.40 16.7 14.1 – 19.3 44.0 37.0 – 51.0 IU/L 1.80 1.20 – 2.40 16.7 14.1 – 19.3 44.0 37.0 – 51.0

Progesterone ng/mL 0.960 0.440 – 1.48 11.2 8.80 – 13.6 30.2 24.0 – 36.4 nmol/L 3.05 1.40 – 4.71 35.6 28.0 – 43.2 96.0 76.3 – 116

Prolactin ng/mL 6.20 4.20 – 8.20 21.7 16.8 – 26.6 48.0 34.0 – 61.0 μg/L 6.20 4.20 – 8.20 21.7 16.8 – 26.6 48.0 34.0 – 61.0

PSA ng/mL 1.14 0.690 – 1.59 4.00 3.20 – 4.80 23.5 19.1 – 27.9 μg/L 1.14 0.690 – 1.59 4.00 3.20 – 4.80 23.5 19.1 – 27.9

T3 Total ng/mL 0.851 0.610 – 1.09 2.32 1.85 – 2.79 3.25 2.60 – 3.90 nmol/L 1.31 0.940 – 1.68 3.57 2.85 – 4.29 5.00 4.00 – 6.00

T4 Free pg/mL 7.36 5.19 – 9.53 19.1 14.9 – 23.4 36.8 28.4 – 45.2 pmol/L 9.50 6.70 – 12.3 24.7 19.2 – 30.2 47.5 36.7 – 58.3

T4 Total μg/dL 5.81 4.50 – 7.13 11.4 9.15 – 13.6 17.8 14.5 – 21.2 nmol/L 75.0 58.0 – 92.0 147 118 – 176 230 187 – 273

Testosterone ng/mL 1.40 0.930 – 1.87 6.60 5.20 – 8.00 10.4 8.30 – 12.5 nmol/L 4.86 3.23 – 6.49 22.9 18.0 – 27.8 36.1 28.8 – 43.4

TSH μIU/mL 0.430 0.210 – 0.650 6.70 5.30 – 8.10 37.9 30.4 – 45.4 mIU/L 0.430 0.210 – 0.650 6.70 5.30 – 8.10 37.9 30.4 – 45.4

DIASORIN LIAISON

25-Hydroxy Vitamin D Total ng/mL 23.3 16.3 – 30.3 31.1 21.7 – 40.4 23.8 16.6 – 30.9 nmol/L 58.2 40.7 – 75.6 77.6 54.2 – 101 59.4 41.4 – 77.1

hGH ng/mL § § § μg/L § § §

OLYMPUS AU 400 / 600 / 640 / 680 / 2700 / 5400

Acetaminophen μg/mL 10.6 <10.0 – 15.9 37.5 28.2 – 46.9 113 85.0 – 142 μmol/L 70.1 <66.1 – 105 248 187 – 310 749 562 – 937

Carbamazepine μg/mL 2.60 1.60 – 3.60 8.30 6.20 – 10.3 14.0 10.5 – 17.4 μmol/L 11.0 6.77 – 15.2 35.1 26.2 – 43.6 59.2 44.4 – 73.6

Digoxin ng/mL 0.460 0.230 – 0.680 1.59 1.30 – 1.90 2.53 2.00 – 3.00 nmol/L 0.589 0.294 – 0.870 2.04 1.66 – 2.43 3.24 2.56 – 3.84

Ferritin ng/mL 60.4 48.3 – 72.5 143 115 – 172 391 313 – 469 μg/L 60.4 48.3 – 72.5 143 115 – 172 391 313 – 469

Gentamicin μg/mL 1.97 1.48 – 2.47 4.25 3.20 – 5.30 6.72 5.00 – 8.40 μmol/L 4.12 3.09 – 5.16 8.88 6.69 – 11.1 14.0 10.5 – 17.6

Lithium mEq/L 0.400 0.200 – 0.700 1.20 1.00 – 1.50 1.90 1.50 – 2.30 mmol/L 0.400 0.200 – 0.700 1.20 1.00 – 1.50 1.90 1.50 – 2.30

NAPA μg/mL 2.00 1.50 – 2.50 5.20 3.90 – 6.40 11.7 8.80 – 14.7 μmol/L 7.22 5.42 – 9.03 18.8 14.1 – 23.1 42.2 31.8 – 53.1

Phenobarbital μg/mL 9.20 7.20 – 11.2 22.7 18.2 – 27.3 49.2 39.4 – 59.1 μmol/L 39.7 31.0 – 48.3 97.8 78.4 – 118 212 170 – 255

Phenytoin μg/mL 5.60 4.20 – 7.00 12.8 9.60 – 16.0 22.5 16.9 – 28.2 μmol/L 22.2 16.6 – 27.7 50.7 38.0 – 63.4 89.1 66.9 – 112

Procainamide μg/mL 1.70 1.30 – 2.10 7.90 6.00 – 9.90 >12.0 μmol/L 7.19 5.50 – 8.88 33.4 25.4 – 41.9 >50.8

Quinidine μg/mL 0.830 0.620 – 1.03 2.50 1.87 – 3.12 4.33 3.25 – 5.41 μmol/L 2.56 1.91 – 3.17 7.70 5.76 – 9.61 13.3 10.0 – 16.7

Salicylate mg/dL 4.00 2.80 – 5.20 16.7 11.2 – 21.8 53.3 37.3 – 69.3 mmol/L 0.290 0.203 – 0.376 1.21 0.811 – 1.58 3.86 2.70 – 5.02

T3 Uptake / T Uptake (DRI) % Uptake 34.1 27.3 – 40.9 40.2 32.0 – 48.0 49.1 39.0 – >50.0 % Uptake 34.1 27.3 – 40.9 40.2 32.0 – 48.0 49.1 39.0 – >50.0

T4 Total (DRI) μg/dL 5.90 4.70 – 7.10 13.6 10.9 – 16.3 19.1 15.3 – 22.9 nmol/L 76.1 60.6 – 91.6 175 141 – 210 246 197 – 295

Theophylline μg/mL 4.30 3.20 – 5.40 12.5 9.00 – 16.0 25.9 19.0 – 32.0 μmol/L 23.9 17.8 – 30.0 69.4 50.0 – 88.8 144 105 – 178

Tobramycin μg/mL 0.900 0.500 – 1.30 2.90 2.20 – 3.60 6.00 4.50 – 7.50 μmol/L 1.93 1.07 – 2.78 6.21 4.71 – 7.70 12.8 9.63 – 16.1

Valproic Acid μg/mL 36.3 27.2 – 45.4 80.6 60.0 – 101 121 90.0 – 151 μmol/L 252 188 – 315 559 416 – 700 835 624 – 1046

Vancomycin μg/mL 6.70 5.00 – 8.40 18.6 14.9 – 22.4 32.9 26.3 – 39.5 μmol/L 4.62 3.45 – 5.80 12.8 10.3 – 15.5 22.7 18.1 – 27.3

OLYMPUS AU3000I

FSH mIU/mL 5.75 4.60 – 6.90 25.6 20.4 – 30.7 45.4 36.3 – 54.5 IU/L 5.75 4.60 – 6.90 25.5 20.4 – 30.7 45.4 36.3 – 54.5

hCG Beta (intact Beta + free Beta) mIU/mL 13.0 10.4 – 15.6 51.6 41.3 – 61.9 447 358 – 540 IU/L 13.0 10.4 – 15.6 51.6 41.3 – 61.9 447 358 – 540

LH mIU/mL 1.85 1.48 – 2.22 18.9 15.1 – 22.6 45.0 36.0 – 53.9 IU/L 1.85 1.48 – 2.22 18.9 15.1 – 22.6 45.0 36.0 – 53.9

Progesterone ng/mL 0.491 0.343 – 0.635 9.21 6.45 – 12.0 35.4 24.8 – 46.1 nmol/L 1.56 1.09 – 2.02 29.3 20.5 – 38.1 113 78.9 – 146

Prolactin ng/mL 8.89 7.11 – 10.7 27.2 21.7 – 32.6 57.8 46.2 – 69.3 μg/L 8.89 7.11 – 10.7 27.2 21.7 – 32.6 57.8 46.2 – 69.3

T3 Free pg/mL 4.24 3.39 – 5.08 8.97 7.18 – 10.8 17.2 13.8 – 20.7 pmol/L 6.53 5.22 – 7.82 13.8 11.0 – 16.6 26.6 21.2 – 31.9

T3 Total ng/mL 1.16 0.935 – 1.40 2.57 2.06 – 3.08 4.39 3.51 – 5.27 nmol/L 1.79 1.44 – 2.15 3.96 3.17 – 4.75 6.76 5.41 – 8.12

T Uptake T Uptake

T3 Uptake / T Uptake Unit 1.30 1.04 – 1.56 1.39 1.11 – 1.67 1.45 1.16 – 1.74 Unit 1.30 1.04 – 1.56 1.39 1.11 – 1.67 1.45 1.16 – 1.74

T4 Free ng/dL 1.13 0.905 – 1.36 2.66 2.13 – 3.19 5.01 4.01 – 6.01 pmol/L 14.6 11.7 – 17.5 34.3 27.5 – 41.2 64.6 51.7 – 77.5

T4 Total μg/dL 5.84 4.67 – 7.01 12.0 9.61 – 14.4 17.6 14.1 – 21.2 nmol/L 75.4 60.3 – 90.5 155 124 – 186 228 182 – 273

TSH μIU/mL 0.390 0.310 – 0.460 5.68 4.55 – 6.82 35.8 28.6 – 42.9 mIU/L 0.390 0.310 – 0.460 5.68 4.55 – 6.82 35.8 28.6 – 42.9

ORTHO CLINICAL DIAGNOSTICS VITROS ECI

AFP IU/mL § § § kIU/L § § §

CEA ng/mL 2.20 1.70 – 2.70 18.0 13.0 – 23.0 42.0 32.0 – 52.0 μg/L 2.20 1.70 – 2.70 18.0 13.0 – 23.0 42.0 32.0 – 52.0

Cortisol μg/dL 2.36 1.63 – 3.08 17.2 13.4 – 21.1 31.3 24.3 – 38.3 nmol/L 65.0 45.0 – 85.0 476 370 – 582 864 670 – 1058

Estradiol pg/mL § § § pmol/L § § §

Ferritin ng/mL 55.0 40.0 – 70.0 99.0 73.0 – 125 237 172 – 302 μg/L 55.0 40.0 – 70.0 99.0 73.0 – 125 237 172 – 302

Folate ng/mL § § § nmol/L § § §

FSH mIU/mL 4.80 3.60 – 6.00 22.0 18.0 – 26.0 36.0 28.0 – 44.0 IU/L 4.80 3.60 – 6.00 22.0 18.0 – 26.0 36.0 28.0 – 44.0

Page 14: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

ORTHO CLINICAL DIAGNOSTICS VITROS ECI (continued)

hCG II Total Beta (4th IS NIBSC 75/589) mIU/mL 10.0 7.00 – 13.0 41.0 31.0 – 51.0 317 239 – 395 IU/L 10.0 7.00 – 13.0 41.0 31.0 – 51.0 317 239 – 395

hCG Total Beta (3rd IS 75/537) mIU/mL § § § IU/L § § §

LH mIU/mL § § § IU/L § § §

Progesterone ng/mL § § § nmol/L § § §

Prolactin μIU/mL § § § mIU/L § § §

PSA ng/mL § § § μg/L § § §

T3 Free pg/mL 4.22 3.12 – 5.32 14.9 12.3 – 17.5 >22.7 pmol/L 6.50 4.80 – 8.20 23.0 19.0 – 27.0 >35.0

T3 Free II pg/mL 4.03 2.99 – 5.06 13.0 10.4 – 15.6 >22.7 pmol/L 6.20 4.60 – 7.80 20.0 16.0 – 24.0 >35.0

T3 Total ng/mL § § § nmol/L § § §

T3 Uptake / T Uptake % Uptake 40.0 33.0 – 47.0 50.0 41.0 – 59.0 >65.0 % Uptake 40.0 33.0 – 47.0 50.0 41.0 – 59.0 >65.0

T4 Free ng/dL 1.40 1.09 – 1.71 5.27 4.19 – 6.36 >6.98 pmol/L 18.0 14.0 – 22.0 68.0 54.0 – 82.0 >90.0

T4 Total μg/dL 5.04 4.11 – 5.97 11.6 9.53 – 13.6 17.7 14.7 – 20.6 nmol/L 65.0 53.0 – 77.0 149 123 – 175 228 190 – 266

TSH μIU/mL 0.200 0.100 – 0.300 4.10 3.00 – 5.20 23.0 17.0 – 29.0 mIU/L 0.200 0.100 – 0.300 4.10 3.00 – 5.20 23.0 17.0 – 29.0

Vitamin B12 pg/mL 381 234 – 528 797 489 – >1000 >1000 pmol/L 281 173 – 390 588 361 – >738 >738

ORTHO VITROS / VITROS FUSION 5,1 FS (WET, DRY SLIDE)

Acetaminophen μg/mL 12.0 9.60 – 14.4 44.3 35.5 – 53.2 141 112 – 169 μmol/L 79.4 63.5 – 95.2 293 235 – 352 929 743 – 1115

Carbamazepine μg/mL <3.00 6.95 5.56 – 8.34 11.0 8.79 – 13.2 μmol/L <12.7 29.4 23.5 – 35.3 46.5 37.2 – 55.8

Digoxin ng/mL 0.639 <0.400 – 0.894 1.97 1.58 – 2.36 2.96 2.37 – 3.55 nmol/L 0.817 <0.512 – 1.14 2.52 2.02 – 3.03 3.79 3.03 – 4.55

Iron (1) μg/dL 90.8 72.6 – 109 81.3 65.0 – 97.5 79.5 63.6 – 95.4 μmol/L 16.3 13.0 – 19.5 14.6 11.6 – 17.5 14.2 11.4 – 17.1

Lithium mEq/L 0.733 0.587 – 0.880 1.67 1.33 – 2.00 2.45 1.96 – 2.94 mmol/L 0.733 0.587 – 0.880 1.67 1.33 – 2.00 2.45 1.96 – 2.94

Phenobarbital μg/mL 8.83 7.06 – 10.6 24.1 19.3 – 28.9 54.6 43.7 – 65.5 μmol/L 38.0 30.4 – 45.6 104 83.1 – 125 235 188 – 282

Phenytoin μg/mL 5.97 4.77 – 7.16 11.8 9.45 – 14.2 18.1 14.5 – 21.7 μmol/L 23.6 18.9 – 28.4 46.8 37.4 – 56.2 71.7 57.3 – 86.0

Salicylate mg/dL 4.47 3.57 – 5.36 17.9 14.3 – 21.5 >40.0 mmol/L 0.323 0.259 – 0.388 1.29 1.04 – 1.55 >2.90

Theophylline μg/mL 2.72 2.17 – 3.26 15.7 12.6 – 18.8 38.1 30.5 – >40.0 μmol/L 15.1 12.1 – 18.1 87.1 69.7 – 105 211 169 – >222

Tobramycin μg/mL 0.835 0.668 – 1.00 2.84 2.27 – 3.41 6.23 4.98 – 7.47 μmol/L 1.79 1.43 – 2.14 6.08 4.86 – 7.29 13.3 10.7 – 16.0

ROCHE / HITACHI COBAS C SYSTEMS

Acetaminophen μg/mL 6.59 5.27 – 7.91 34.7 27.8 – 41.7 110 87.7 – 132 μmol/L 43.6 34.9 – 52.3 230 184 – 276 725 580 – 870

Carbamazepine μg/mL 2.67 2.13 – 3.20 8.45 6.76 – 10.1 14.6 11.7 – 17.6 μmol/L 11.3 9.02 – 13.5 35.8 28.6 – 42.9 61.9 49.5 – 74.2

Ferritin (Gen 3) ng/mL 79.6 63.6 – 95.5 159 128 – 191 379 303 – 455 μg/L 79.6 63.6 – 95.5 159 128 – 191 379 303 – 455

Gentamicin μg/mL 1.82 1.46 – 2.19 3.87 3.10 – 4.64 5.86 4.69 – 7.04 μmol/L 3.81 3.05 – 4.57 8.09 6.47 – 9.71 12.3 9.80 – 14.7

Iron (Gen 2) (1) μg/dL 91.9 73.5 – 110 85.7 68.6 – 103 84.8 67.8 – 102 μmol/L 16.5 13.2 – 19.7 15.3 12.3 – 18.4 15.2 12.1 – 18.2

Phenobarbital μg/mL 8.71 6.97 – 10.4 23.0 18.4 – 27.6 48.4 38.7 – 58.1 μmol/L 37.5 30.0 – 45.0 99.2 79.4 – 119 209 167 – 250

Phenytoin μg/mL 5.93 4.75 – 7.12 13.2 10.6 – 15.8 21.2 17.0 – 25.4 μmol/L 23.5 18.8 – 28.2 52.3 41.8 – 62.7 84.0 67.2 – 101

Salicylate mg/dL 3.67 2.94 – 4.41 15.9 12.7 – 19.1 51.2 41.0 – 61.5 mmol/L 0.266 0.213 – 0.319 1.15 0.921 – 1.38 3.71 2.97 – 4.45

Theophylline μg/mL 4.69 3.75 – 5.63 13.8 11.0 – 16.5 28.5 22.8 – 34.2 μmol/L 26.1 20.8 – 31.3 76.5 61.2 – 91.7 158 126 – 190

Valproic Acid μg/mL 36.3 29.0 – 43.5 81.7 65.4 – 98.1 122 97.6 – 146 μmol/L 251 201 – 302 566 453 – 680 845 676 – 1014

Vancomycin μg/mL 8.04 6.43 – 9.65 22.5 18.0 – 27.0 40.6 32.5 – 48.8 μmol/L 5.55 4.44 – 6.66 15.5 12.4 – 18.6 28.0 22.4 – 33.6

ROCHE COBAS INTEGRA

Acetaminophen μg/mL 6.34 5.08 – 7.61 36.2 29.0 – 43.4 102 81.9 – 123 μmol/L 42.0 33.6 – 50.3 239 191 – 287 677 542 – 813

Amikacin μg/mL 6.10 4.88 – 7.32 14.8 11.8 – 17.7 28.2 22.6 – 33.9 μmol/L 10.4 8.34 – 12.5 25.2 20.2 – 30.3 48.3 38.6 – 57.9

Carbamazepine μg/mL 3.02 2.41 – 3.62 9.18 7.35 – 11.0 16.2 13.0 – 19.5 μmol/L 12.8 10.2 – 15.3 38.8 31.1 – 46.6 68.7 54.9 – 82.4

Digoxin ng/mL 0.656 0.518 – 0.794 2.01 1.61 – 2.41 3.28 2.62 – 3.93 nmol/L 0.840 0.663 – 1.02 2.57 2.06 – 3.09 4.20 3.36 – 5.04

Fructosamine (1) μmol/L § § § μmol/L § § §

Gentamicin μg/mL § § § μmol/L § § §

Immunoglobulin A (1) mg/dL 176 141 – 212 173 138 – 208 175 140 – 210 mg/L 1763 1411 – 2116 1730 1384 – 2076 1753 1403 – 2104

Immunoglobulin G (1) mg/dL 786 628 – 943 848 678 – 1017 841 673 – 1010 g/L 7.86 6.28 – 9.43 8.48 6.78 – 10.2 8.41 6.73 – 10.1

Immunoglobulin M (1) mg/dL 69.2 55.3 – 83.0 79.8 63.9 – 95.8 76.5 61.2 – 91.8 mg/L 692 553 – 830 798 639 – 958 765 612 – 918

Lidocaine μg/mL § § § μmol/L § § §

Lithium mEq/L 0.498 0.398 – 0.597 1.34 1.07 – 1.61 2.06 1.65 – 2.47 mmol/L 0.498 0.398 – 0.597 1.34 1.07 – 1.61 2.06 1.65 – 2.47

NAPA μg/mL 1.85 1.48 – 2.22 5.20 4.16 – 6.24 10.6 8.48 – 12.7 μmol/L 6.68 5.34 – 8.01 18.8 15.0 – 22.5 38.3 30.6 – 45.9

Phenobarbital μg/mL 9.18 7.34 – 11.0 23.2 18.5 – 27.8 50.2 40.2 – 60.3 μmol/L 39.6 31.7 – 47.5 99.8 79.8 – 120 216 173 – 260

Phenytoin μg/mL 5.95 4.76 – 7.14 13.3 10.7 – 16.0 23.4 18.7 – 28.1 μmol/L 23.6 18.8 – 28.3 52.8 42.2 – 63.3 92.6 74.1 – 111

Phenytoin Free μg/mL § § § μmol/L § § §

Primidone μg/mL 2.90 2.32 – 3.48 5.73 4.58 – 6.87 12.0 9.57 – 14.4 μmol/L 13.3 10.6 – 15.9 26.2 21.0 – 31.5 54.8 43.8 – 65.8

Procainamide μg/mL 1.72 1.37 – 2.06 8.22 6.57 – 9.86 14.0 11.2 – 16.8 μmol/L 7.26 5.81 – 8.71 34.8 27.8 – 41.7 59.1 47.3 – 71.0

Quinidine μg/mL 0.900 0.720 – 1.08 2.70 2.16 – 3.24 5.00 4.00 – 6.00 μmol/L 2.77 2.22 – 3.33 8.32 6.65 – 9.98 15.4 12.3 – 18.5

Salicylate mg/dL 3.22 2.58 – 3.87 15.6 12.5 – 18.7 48.6 38.9 – 58.3 mmol/L 0.233 0.187 – 0.280 1.13 0.902 – 1.35 3.52 2.81 – 4.22

T3 Uptake / T Uptake % Uptake § § § % Uptake § § §

T4 Total μg/dL § § § nmol/L § § §

Theophylline μg/mL 4.95 3.96 – 5.94 14.2 11.4 – 17.1 29.6 23.7 – 35.5 μmol/L 27.5 22.0 – 33.0 79.0 63.2 – 94.8 164 131 – 197

TIBC (1) μg/dL § § § μmol/L § § §

Tobramycin μg/mL 0.685 0.548 – 0.822 3.06 2.44 – 3.67 6.05 4.84 – 7.25 μmol/L 1.47 1.17 – 1.76 6.54 5.23 – 7.85 12.9 10.3 – 15.5

Valproic Acid μg/mL 33.5 26.8 – 40.2 77.4 61.9 – 92.8 114 91.1 – 137 μmol/L 232 186 – 278 536 429 – 643 789 632 – 947

Vancomycin μg/mL 8.81 7.05 – 10.6 24.4 19.6 – 29.3 41.9 33.5 – 50.3 μmol/L 6.08 4.86 – 7.30 16.9 13.5 – 20.2 28.9 23.1 – 34.7

ROCHE ELECSYS / E 170 / COBAS E SYSTEMS

ACTH pg/mL 10.1 7.07 – 13.1 55.1 38.6 – 71.6 153 107 – 199 pmol/L 2.22 1.56 – 2.88 12.1 8.49 – 15.8 33.7 23.5 – 43.8

AFP (04481798) IU/mL 15.7 11.0 – 20.4 74.7 52.3 – 97.1 174 122 – 226 kIU/L 15.7 11.0 – 20.4 74.7 52.3 – 97.1 174 122 – 226

C-Peptide ng/mL 1.29 0.980 – 1.60 4.99 3.79 – 6.19 6.33 4.81 – 7.85 nmol/L 0.427 0.324 – 0.530 1.65 1.25 – 2.05 2.10 1.59 – 2.60

CEA (Gen 2) ng/mL 3.02 2.30 – 3.74 20.5 16.2 – 24.8 46.4 36.7 – 56.1 μg/L 3.02 2.30 – 3.74 20.5 16.2 – 24.8 46.4 36.7 – 56.1

Cortisol μg/dL 2.42 1.69 – 3.14 19.9 13.9 – 25.9 32.8 22.9 – 42.6 nmol/L 66.7 46.7 – 86.7 549 384 – 714 904 633 – 1175

DHEA-Sulfate μg/dL 74.8 56.8 – 92.8 151 115 – 187 592 450 – 734 μmol/L 2.02 1.53 – 2.51 4.08 3.11 – 5.05 16.0 12.2 – 19.8

Digoxin ng/mL 0.480 0.365 – 0.595 1.89 1.44 – 2.34 3.37 2.56 – 4.18 nmol/L 0.614 0.467 – 0.762 2.42 1.84 – 3.00 4.31 3.28 – 5.35

Estradiol (Gen 2) pg/mL 45.4 31.8 – 59.0 216 151 – 281 481 337 – 625 nmol/L 0.163 0.114 – 0.212 0.778 0.544 – 1.01 1.73 1.21 – 2.25

Ferritin ng/mL 85.8 65.2 – 106 182 138 – 226 425 323 – 527 μg/L 85.8 65.2 – 106 182 138 – 226 425 323 – 527

Folate (Gen 2) E 170 / e601 ng/mL 3.59 1.97 – 5.21 7.37 4.05 – 10.7 10.7 6.96 – 14.4 nmol/L 8.13 4.46 – 11.8 16.7 9.17 – 24.2 24.2 15.8 – 32.6

Folate (Gen 2) Elecsys 2010 / e411 ng/mL 4.33 2.38 – 6.28 7.72 4.25 – 11.2 11.5 7.48 – 15.5 nmol/L 9.81 5.39 – 14.2 17.5 9.63 – 25.4 26.1 16.9 – 35.1

Folate (Gen 3) E 170 / e601 ng/mL 3.84 2.11 – 5.57 7.39 4.06 – 10.7 10.2 6.63 – 13.8 nmol/L 8.70 4.78 – 12.6 16.7 9.20 – 24.2 23.1 15.0 – 31.3

Folate (Gen 3) Elecsys 2010 / e411 ng/mL 3.39 1.86 – 4.92 7.09 3.90 – 10.3 9.77 6.35 – 13.2 nmol/L 7.68 4.21 – 11.1 16.1 8.83 – 23.3 22.1 14.4 – 29.9

FSH mIU/mL 6.72 4.70 – 8.74 30.5 21.4 – 39.7 53.0 37.1 – 68.9 IU/L 6.72 4.70 – 8.74 30.5 21.4 – 39.7 53.0 37.1 – 68.9

hCG + Beta (Gen 2) mIU/mL 6.22 4.17 – 8.27 23.3 15.6 – 31.0 193 129 – 257 IU/L 6.22 4.17 – 8.27 23.3 15.6 – 31.0 193 129 – 257

hCG STAT (Gen 2) mIU/mL 8.10 5.43 – 10.8 30.8 20.6 – 41.0 261 175 – 347 IU/L 8.10 5.43 – 10.8 30.8 20.6 – 41.0 261 175 – 347

Immunoglobulin E (Gen 2) IU/mL 383 303 – 463 84.7 66.9 – 102 108 85.3 – 131 kIU/L 383 303 – 463 84.7 66.9 – 102 108 85.3 – 131

Insulin μIU/mL 14.9 11.3 – 18.5 48.3 36.7 – 59.9 143 109 – 177 pmol/L 103 78.5 – 128 335 255 – 416 993 757 – 1229

LH mIU/mL 2.40 1.82 – 2.98 22.7 17.3 – 28.1 51.6 39.2 – 64.0 IU/L 2.40 1.82 – 2.98 22.7 17.3 – 28.1 51.6 39.2 – 64.0

Progesterone ng/mL 0.414 0.228 – 0.600 9.12 5.84 – 12.4 27.1 17.3 – 36.9 nmol/L 1.32 0.725 – 1.91 29.0 18.6 – 39.4 86.2 55.0 – 117

Prolactin (Gen 2) ng/mL 7.83 5.94 – 9.72 23.2 17.6 – 28.7 49.0 37.3 – 60.8 μIU/mL 166 126 – 206 491 373 – 609 1039 790 – 1288

PSA E 170 / e601 ng/mL 0.993 0.755 – 1.23 3.91 2.97 – 4.85 23.9 18.2 – 29.6 μg/L 0.993 0.755 – 1.23 3.91 2.97 – 4.85 23.9 18.2 – 29.6

Page 15: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

ROCHE ELECSYS / E 170 / COBAS E SYSTEMS (continued)

PSA Elecsys 2010 / e411 ng/mL 1.03 0.783 – 1.28 3.94 2.99 – 4.89 24.0 18.2 – 29.8 μg/L 1.03 0.783 – 1.28 3.94 2.99 – 4.89 24.0 18.2 – 29.8

PSA Free (Gen 2) E 170 / e601 ng/mL 0.446 0.339 – 0.553 2.02 1.60 – 2.44 12.5 9.88 – 15.1 μg/L 0.446 0.339 – 0.553 2.02 1.60 – 2.44 12.5 9.88 – 15.1

PSA Free (Gen 2) Elecsys 2010 / e411 ng/mL 0.466 0.354 – 0.578 2.10 1.66 – 2.54 12.9 10.2 – 15.6 μg/L 0.466 0.354 – 0.578 2.10 1.66 – 2.54 12.9 10.2 – 15.6

T3 Free (Gen 2) pg/mL 2.44 1.71 – 3.17 8.05 6.12 – 10.0 14.5 11.0 – 18.0 pmol/L 3.75 2.63 – 4.88 12.4 9.42 – 15.4 22.3 16.9 – 27.7

T3 Total ng/mL 0.942 0.662 – 1.23 2.50 1.90 – 3.10 3.81 2.89 – 4.72 nmol/L 1.45 1.02 – 1.89 3.85 2.93 – 4.77 5.86 4.45 – 7.27

T3 Uptake / T Uptake TBI 0.968 0.765 – 1.17 0.697 0.551 – 0.843 0.360 0.252 – 0.468 TBI 0.968 0.765 – 1.17 0.697 0.551 – 0.843 0.360 0.252 – 0.468

T4 Free ng/dL 1.12 0.891 – 1.36 2.86 2.26 – 3.46 7.75 5.66 – >7.75 pmol/L 14.5 11.5 – 17.5 36.9 29.2 – 44.6 100 73.0 – >100

T4 Total μg/dL 5.76 4.38 – 7.14 11.4 8.68 – 14.1 15.9 12.1 – 19.7 nmol/L 74.3 56.5 – 92.1 147 112 – 182 205 156 – 254

Testosterone ng/mL 1.43 0.570 – 2.29 4.94 3.46 – 6.42 10.0 7.00 – 13.0 nmol/L 4.96 1.98 – 7.95 17.1 12.0 – 22.3 34.7 24.3 – 45.1

Thyroglobulin (1) ng/mL 7.75 5.89 – 9.61 8.98 6.82 – 11.1 7.81 5.94 – 9.68 μg/L 7.75 5.89 – 9.61 8.98 6.82 – 11.1 7.81 5.94 – 9.68

TSH μIU/mL 0.499 0.379 – 0.619 6.40 5.06 – 7.74 37.9 29.9 – 45.9 mIU/L 0.499 0.379 – 0.619 6.40 5.06 – 7.74 37.9 29.9 – 45.9

Vitamin B12 (Gen 2) E 170 / e601 pg/mL 382 233 – 531 676 473 – 879 1250 875 – 1625 pmol/L 282 172 – 392 499 349 – 649 923 646 – 1199

Vitamin B12 (Gen 2) Elecsys 2010 / e411 pg/mL 401 245 – 557 716 501 – 931 1270 889 – 1651 pmol/L 296 181 – 411 528 370 – 687 937 656 – 1218

ROCHE HITACHI / MODULAR

Carbamazepine II CEDIA μg/mL 2.72 2.18 – 3.27 8.80 7.04 – 10.6 14.8 11.9 – 17.8 μmol/L 11.5 9.22 – 13.8 37.2 29.8 – 44.7 62.8 50.2 – 75.3

Digoxin (Turbidimetric, Tina-quant) ng/mL 0.590 0.472 – 0.708 1.94 1.55 – 2.33 3.31 2.64 – 3.97 nmol/L 0.755 0.604 – 0.906 2.49 1.99 – 2.98 4.23 3.38 – 5.08

Digoxin II CEDIA ng/mL § § § nmol/L § § §

Ferritin ng/mL 77.6 62.1 – 93.1 157 126 – 189 372 297 – 446 μg/L 77.6 62.1 – 93.1 157 126 – 189 372 297 – 446

Fructosamine (1) μmol/L § § § μmol/L § § §

Gentamicin II CEDIA μg/mL 2.12 1.70 – 2.54 4.66 3.73 – 5.59 7.57 6.06 – 9.08 μmol/L 4.43 3.54 – 5.32 9.74 7.79 – 11.7 15.8 12.7 – 19.0

Iron (1) μg/dL 87.8 70.2 – 105 82.5 66.0 – 99.0 81.8 65.4 – 98.1 μmol/L 15.7 12.6 – 18.8 14.8 11.8 – 17.7 14.6 11.7 – 17.6

NAPA CEDIA μg/mL 1.88 1.50 – 2.25 4.99 3.99 – 5.99 11.2 8.97 – 13.5 μmol/L 6.77 5.42 – 8.12 18.0 14.4 – 21.6 40.5 32.4 – 48.6

Phenobarbital II CEDIA μg/mL 8.30 6.64 – 9.96 23.6 18.9 – 28.3 53.4 42.7 – 64.0 μmol/L 35.8 28.6 – 42.9 102 81.4 – 122 230 184 – 276

Phenytoin II CEDIA μg/mL 5.61 4.49 – 6.73 14.2 11.4 – 17.1 25.9 20.7 – 31.0 μmol/L 22.2 17.8 – 26.7 56.3 45.1 – 67.6 102 81.9 – 123

Procainamide CEDIA μg/mL 1.53 1.22 – 1.83 7.94 6.35 – 9.52 13.5 10.8 – 16.2 μmol/L 6.45 5.16 – 7.74 33.6 26.9 – 40.3 57.0 45.6 – 68.4

Salicylate mg/dL 3.82 2.83 – 4.82 16.7 13.4 – 20.0 49.8 39.8 – 59.7 mmol/L 0.277 0.205 – 0.349 1.21 0.967 – 1.45 3.60 2.88 – 4.32

T3 Uptake / T Uptake CEDIA % Uptake § § § % Uptake § § §

T4 Total CEDIA μg/dL 5.41 4.33 – 6.50 12.2 9.77 – 14.7 16.5 13.2 – 19.8 nmol/L 69.8 55.9 – 83.8 158 126 – 189 213 170 – 255

Theophylline II CEDIA μg/mL 3.75 3.00 – 4.50 13.1 10.5 – 15.7 28.6 22.9 – 34.4 μmol/L 20.8 16.7 – 25.0 72.7 58.2 – 87.2 159 127 – 191

Tobramycin II CEDIA μg/mL 0.882 0.705 – 1.06 3.44 2.75 – 4.12 7.02 5.62 – 8.43 μmol/L 1.89 1.51 – 2.26 7.35 5.88 – 8.83 15.0 12.0 – 18.0

Valproic Acid II CEDIA μg/mL 36.1 28.9 – 43.3 85.4 68.4 – 103 126 101 – 152 μmol/L 250 200 – 300 592 474 – 711 876 701 – 1052

Vancomycin (Emit 2000) μg/mL 7.05 5.64 – 8.45 19.1 15.3 – 22.9 33.9 27.1 – 40.7 μmol/L 4.86 3.89 – 5.83 13.2 10.5 – 15.8 23.4 18.7 – 28.1

SIEMENS ACS:180

Ferritin ng/mL § § § μg/L § § §

hCG Total (eTHCG) mIU/mL § § § IU/L § § §

LH mIU/mL § § § IU/L § § §

Testosterone ng/mL § § § nmol/L § § §

SIEMENS ADVIA CENTAUR / CENTAUR XP

AFP ng/mL 21.1 16.9 – 25.3 101 81.1 – 122 222 177 – 266 IU/mL 17.5 14.0 – 21.0 84.1 67.3 – 101 184 147 – 221

C-Peptide (CpS) ng/mL 0.988 0.790 – 1.19 4.41 3.53 – 5.29 5.65 4.52 – 6.78 nmol/L 0.327 0.261 – 0.392 1.46 1.17 – 1.75 1.87 1.50 – 2.24

Carbamazepine (CARB) μg/mL 2.77 2.22 – 3.33 8.55 6.84 – 10.3 14.2 11.3 – 17.0 μmol/L 11.7 9.38 – 14.1 36.2 28.9 – 43.4 60.0 48.0 – 72.0

CEA ng/mL 2.38 1.83 – 2.93 18.1 14.5 – 21.7 43.8 35.0 – 52.5 μg/L 2.38 1.83 – 2.93 18.1 14.5 – 21.7 43.8 35.0 – 52.5

Cortisol (COR) μg/dL 3.22 2.58 – 3.87 21.1 16.9 – 25.3 35.4 28.3 – 42.4 nmol/L 89.0 71.2 – 107 582 465 – 698 976 781 – 1171

Digoxin (DIG) ng/mL 0.610 0.488 – 0.732 1.89 1.51 – 2.27 2.89 2.31 – 3.46 nmol/L 0.781 0.625 – 0.937 2.42 1.93 – 2.90 3.69 2.96 – 4.43

Estradiol (E2-6 III) pg/mL 46.1 36.9 – 55.3 154 123 – 185 256 205 – 308 pmol/L 169 135 – 203 566 453 – 680 941 753 – 1129

Estradiol (E2-6) pg/mL 72.7 58.2 – 87.2 208 166 – 250 295 236 – 354 pmol/L 267 213 – 320 764 611 – 917 1084 867 – 1301

Ferritin (FER) ng/mL 70.8 56.6 – 84.9 159 127 – 191 385 308 – 462 μg/L 70.8 56.6 – 84.9 159 127 – 191 385 308 – 462

Folate (FOL) ng/mL 1.76 1.40 – 2.11 6.47 5.17 – 7.76 9.13 7.31 – 11.0 nmol/L 3.98 3.18 – 4.77 14.6 11.7 – 17.6 20.7 16.5 – 24.8

FSH mIU/mL 5.75 4.60 – 6.90 29.6 23.7 – 35.5 57.1 45.6 – 68.5 IU/L 5.75 4.60 – 6.90 29.6 23.7 – 35.5 57.1 45.6 – 68.5

Gentamicin (GENT) μg/mL 2.16 1.73 – 2.59 4.66 3.73 – 5.59 7.83 6.26 – 9.39 μmol/L 4.51 3.61 – 5.41 9.74 7.79 – 11.7 16.4 13.1 – 19.6

hCG Total (ThCG) mIU/mL 7.78 6.22 – 9.33 22.8 18.3 – 27.4 168 135 – 202 IU/L 7.78 6.22 – 9.33 22.8 18.3 – 27.4 168 135 – 202

Immunoglobulin E (IGE) IU/mL 355 284 – 426 68.5 54.8 – 82.2 89.8 71.8 – 108 kIU/L 355 284 – 426 68.5 54.8 – 82.2 89.8 71.8 – 108

Insulin (IRI) μIU/mL 17.6 14.1 – 21.2 59.2 47.4 – 71.0 181 145 – 217 pmol/L 122 97.9 – 147 411 329 – 493 1256 1004 – 1507

LH mIU/mL 1.99 1.59 – 2.39 22.0 17.6 – 26.4 50.4 40.3 – 60.5 IU/L 1.99 1.59 – 2.39 22.0 17.6 – 26.4 50.4 40.3 – 60.5

Phenobarbital (PHNB) μg/mL 9.85 7.88 – 11.8 25.2 20.2 – 30.3 57.6 46.0 – 69.1 μmol/L 42.4 33.9 – 50.9 109 87.0 – 130 248 198 – 298

Phenytoin (PHTN) μg/mL 6.84 5.47 – 8.21 16.2 13.0 – 19.5 30.3 24.2 – 36.3 μmol/L 27.1 21.7 – 32.5 64.3 51.5 – 77.2 120 95.9 – 144

Progesterone (PRGE) ng/mL 1.55 1.19 – 1.90 10.3 8.28 – 12.4 27.5 22.0 – 33.1 nmol/L 4.92 3.79 – 6.06 32.9 26.3 – 39.5 87.6 70.1 – 105

Prolactin (PRL) ng/mL 5.45 4.36 – 6.53 18.4 14.7 – 22.1 38.1 30.5 – 45.7 μg/L 5.45 4.36 – 6.53 18.4 14.7 – 22.1 38.1 30.5 – 45.7

PSA ng/mL 0.888 0.710 – 1.06 3.37 2.69 – 4.04 21.4 17.2 – 25.7 μg/L 0.887 0.710 – 1.06 3.37 2.69 – 4.04 21.4 17.2 – 25.7

PSA Complexed (cPSA) ng/mL § § § μg/L § § §

T3 Free (FT3) pg/mL 2.69 2.16 – 3.23 6.70 5.36 – 8.03 10.5 8.38 – 12.6 pmol/L 4.15 3.32 – 4.98 10.3 8.25 – 12.4 16.1 12.9 – 19.3

T3 Total (T3) (reagent lot 164 lower) ng/mL 0.815 0.652 – 0.978 2.44 1.95 – 2.93 3.70 2.96 – 4.44 nmol/L 1.26 1.00 – 1.51 3.76 3.01 – 4.51 5.70 4.56 – 6.83

T3 Uptake / T Uptake (TUp) (%) % Uptake 38.0 30.4 – 45.6 43.5 34.8 – 52.2 55.6 44.5 – 66.7 % Uptake 38.0 30.4 – 45.6 43.5 34.8 – 52.2 55.6 44.5 – 66.7

T4 Free (FRT4) ng/dL 0.877 0.701 – 1.05 2.05 1.64 – 2.46 4.77 3.82 – 5.73 pmol/L 11.3 9.05 – 13.6 26.4 21.2 – 31.7 61.6 49.3 – 73.9

T4 Total (T4) μg/dL 5.73 4.59 – 6.88 12.1 9.71 – 14.6 16.6 13.3 – 19.9 nmol/L 74.0 59.2 – 88.8 157 125 – 188 214 171 – 257

Testosterone (TSTO) ng/dL 148 119 – 178 481 385 – 578 880 704 – 1056 nmol/L 5.15 4.12 – 6.18 16.7 13.4 – 20.0 30.5 24.4 – 36.7

Theophylline2 (THEO2) μg/mL 5.57 4.46 – 6.69 15.8 12.6 – 18.9 28.2 22.5 – 33.8 μmol/L 30.9 24.7 – 37.1 87.6 70.1 – 105 156 125 – 188

Tobramycin (TOBR) μg/mL 0.945 0.756 – 1.13 3.63 2.90 – 4.35 6.47 5.18 – 7.77 μmol/L 2.02 1.62 – 2.43 7.76 6.21 – 9.31 13.8 11.1 – 16.6

TSH μIU/mL 0.459 0.367 – 0.551 6.16 4.93 – 7.39 34.9 28.0 – 41.9 mIU/L 0.459 0.367 – 0.551 6.16 4.93 – 7.39 34.9 28.0 – 41.9

TSH (Gen 3) (TSH-3) μIU/mL 0.429 0.343 – 0.515 5.81 4.64 – 6.97 31.8 25.4 – 38.2 mIU/L 0.429 0.343 – 0.515 5.81 4.64 – 6.97 31.8 25.4 – 38.2

TSH (TSH3-UL) μIU/mL § § § mIU/L § § §

Valproic Acid (VALP) μg/mL § § § μmol/L § § §

Vancomycin (VANC) μg/mL 6.06 4.85 – 7.28 16.4 13.1 – 19.7 27.2 21.8 – 32.7 μmol/L 4.18 3.35 – 5.02 11.3 9.06 – 13.6 18.8 15.0 – 22.6

Vitamin B12 (VB12) pg/mL 382 306 – 459 687 550 – 825 1391 1112 – 1669 pmol/L 282 226 – 338 507 406 – 609 1026 821 – 1231

SIEMENS ADVIA CENTAUR CP

AFP ng/mL 21.2 16.7 – 25.7 101 79.9 – 122 231 183 – 279 IU/mL 17.6 13.9 – 21.3 83.8 66.3 – 101 192 152 – 232

Carbamazepine (CARB) μg/mL 2.64 1.89 – 3.39 8.28 6.01 – 10.6 14.6 9.54 – 19.7 μmol/L 11.2 7.99 – 14.3 35.0 25.4 – 44.8 61.8 40.4 – 83.3

CEA ng/mL 2.37 1.51 – 3.22 16.6 13.3 – 19.9 43.0 34.4 – 51.6 μg/L 2.37 1.51 – 3.22 16.6 13.3 – 19.9 43.0 34.4 – 51.6

Cortisol (COR) μg/dL 3.13 2.04 – 4.22 20.4 14.2 – 26.6 35.5 24.8 – 46.2 nmol/L 86.4 56.3 – 116 563 392 – 734 980 684 – 1275

Digoxin (DIG) ng/mL 0.508 0.407 – 0.610 1.82 1.46 – 2.19 2.80 2.24 – 3.36 nmol/L 0.651 0.521 – 0.781 2.33 1.87 – 2.80 3.58 2.87 – 4.30

Estradiol (E2-6 III) pg/mL § § § pmol/L § § §

Ferritin (FER) ng/mL 71.3 52.1 – 90.5 155 113 – 197 377 266 – 488 μg/L 71.3 52.1 – 90.5 155 113 – 197 377 266 – 488

Folate (FOL) ng/mL 2.44 1.95 – 2.93 8.55 6.84 – 10.3 13.4 10.7 – 16.1 nmol/L 5.52 4.42 – 6.63 19.4 15.5 – 23.2 30.4 24.3 – 36.4

FSH mIU/mL 5.11 4.09 – 6.14 28.8 23.0 – 34.5 56.5 45.2 – 67.8 IU/L 5.11 4.09 – 6.14 28.8 23.0 – 34.5 56.5 45.2 – 67.8

hCG Total (ThCG) mIU/mL 7.05 5.64 – 8.46 21.7 17.4 – 26.1 160 128 – 192 IU/L 7.05 5.64 – 8.46 21.7 17.4 – 26.1 160 128 – 192

Immunoglobulin E (tIGE) IU/mL 366 216 – 516 70.8 44.7 – 96.9 94.1 58.8 – 129 kIU/L 366 216 – 516 70.8 44.7 – 96.9 94.1 58.8 – 129

LH mIU/mL 1.99 1.59 – 2.38 22.2 17.7 – 26.6 51.0 40.8 – 61.2 IU/L 1.99 1.59 – 2.38 22.2 17.7 – 26.6 51.0 40.8 – 61.2

Page 16: Lyphochek Immunoassay 370 Data Sheet

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

SIEMENS ADVIA CENTAUR CP (continued)

Phenobarbital (PHNB) μg/mL 8.83 6.17 – 11.5 23.0 16.6 – 29.4 49.3 36.1 – 62.5 μmol/L 38.1 26.6 – 49.6 99.1 71.5 – 127 212 156 – 269

Phenytoin (PHTN) μg/mL 7.00 5.39 – 8.62 16.1 12.6 – 19.6 30.1 23.6 – 36.6 μmol/L 27.7 21.3 – 34.1 63.8 49.9 – 77.6 119 93.5 – 145

Progesterone (PRGE) ng/mL 1.40 1.12 – 1.68 10.2 8.16 – 12.2 25.9 20.7 – 31.1 nmol/L 4.45 3.56 – 5.34 32.4 25.9 – 38.9 82.4 65.9 – 98.8

Prolactin (PRL) ng/mL 5.47 4.37 – 6.56 16.3 13.1 – 19.6 34.4 27.5 – 41.3 μg/L 5.47 4.37 – 6.56 16.3 13.1 – 19.6 34.4 27.5 – 41.3

PSA Complexed (cPSA) ng/mL 0.357 0.282 – 0.432 1.10 0.868 – 1.33 6.24 4.92 – 7.56 μg/L 0.357 0.282 – 0.432 1.10 0.868 – 1.33 6.24 4.92 – 7.56

PSA Total ng/mL 0.908 0.726 – 1.09 3.42 2.74 – 4.11 22.9 18.3 – 27.5 μg/L 0.908 0.726 – 1.09 3.42 2.74 – 4.11 22.9 18.3 – 27.5

T3 Free (FT3) pg/mL 2.65 2.14 – 3.16 6.45 5.25 – 7.66 9.19 7.48 – 10.9 pmol/L 4.08 3.30 – 4.87 9.93 8.09 – 11.8 14.2 11.5 – 16.8

T3 Total (T3) (reagent lot 164 lower) ng/mL 0.835 0.668 – 1.00 2.66 2.13 – 3.19 3.91 3.13 – 4.70 nmol/L 1.29 1.03 – 1.54 4.09 3.27 – 4.91 6.03 4.82 – 7.23

T3 Total (T3) (reagent lot 165 higher) ng/mL 0.854 0.664 – 1.04 2.70 2.15 – 3.25 4.02 3.21 – 4.83 nmol/L 1.32 1.02 – 1.60 4.16 3.31 – 5.01 6.19 4.94 – 7.44

T Uptake T Uptake

T3 Uptake / T Uptake (Tup) (Unit) Unit 1.63 1.29 – 1.97 1.29 1.02 – 1.56 1.97 1.56 – 2.38 Unit 1.63 1.29 – 1.97 1.29 1.02 – 1.56 1.97 1.56 – 2.38

T4 Free (FT4) ng/dL 0.908 0.701 – 1.12 2.34 1.86 – 2.82 5.70 4.52 – 6.89 pmol/L 11.7 9.04 – 14.4 30.2 24.0 – 36.4 73.5 58.3 – 88.9

T4 Total (T4) μg/dL 6.31 5.05 – 7.57 13.5 10.8 – 16.2 18.2 14.6 – 21.8 nmol/L 81.4 65.1 – 97.7 174 139 – 208 235 188 – 282

Testosterone (TSTO) ng/dL 152 98.5 – 205 461 326 – 596 841 611 – 1071 nmol/L 5.27 3.42 – 7.11 16.0 11.3 – 20.7 29.2 21.2 – 37.2

Theophylline2 (THEO2) μg/mL 4.65 3.26 – 6.05 14.5 11.6 – 17.4 30.0 24.0 – 36.0 μmol/L 25.8 18.1 – 33.6 80.5 64.4 – 96.6 167 133 – 200

TSH μIU/mL 0.489 0.377 – 0.601 6.79 5.29 – 8.29 35.6 27.8 – 43.4 mIU/L 0.489 0.377 – 0.601 6.79 5.29 – 8.29 35.6 27.8 – 43.4

TSH (Gen 3) (TSH-3) μIU/mL 0.455 0.359 – 0.550 6.13 4.23 – 8.03 35.9 27.7 – 44.2 mIU/L 0.454 0.359 – 0.550 6.13 4.23 – 8.03 35.9 27.7 – 44.2

TSH (TSH3-UL) μIU/mL § § § mIU/L § § §

Valproic Acid (VALP) μg/mL § § § μmol/L § § §

Vancomycin (VANC) μg/mL 5.54 4.16 – 6.93 14.6 11.2 – 18.0 25.1 20.1 – 30.1 μmol/L 3.82 2.87 – 4.78 10.1 7.73 – 12.4 17.3 13.9 – 20.8

Vitamin B12 (VB12) pg/mL 367 270 – 464 677 509 – 844 1334 1011 – 1657 pmol/L 271 199 – 342 500 376 – 623 984 746 – 1223

SIEMENS ADVIA CHEMISTRY SYSTEMS

Acetaminophen (ACET) μg/mL 12.8 10.3 – 15.4 44.8 35.9 – 53.8 132 106 – 159 μmol/L 84.8 67.8 – 102 297 237 – 356 876 701 – 1051

Carbamazepine (CARB) μg/mL 1.31 0.919 – 1.71 6.91 5.53 – 8.30 11.7 9.39 – 14.1 μmol/L 5.56 3.89 – 7.22 29.2 23.4 – 35.1 49.6 39.7 – 59.6

Carbamazepine_2 (CARB_2) (Emit 2000) μg/mL 2.30 1.70 – 2.90 8.90 7.10 – 10.7 13.7 11.0 – 16.4 μmol/L 9.73 7.19 – 12.3 37.6 30.0 – 45.3 58.0 46.5 – 69.4

Digoxin (DIG) ng/mL 0.458 0.321 – 0.596 1.95 1.46 – 2.43 2.88 2.16 – 3.59 nmol/L 0.587 0.411 – 0.763 2.49 1.87 – 3.11 3.68 2.76 – 4.60

Gentamicin (GENT) μg/mL 2.25 1.58 – 2.93 4.72 3.78 – 5.67 7.36 5.89 – 8.83 μmol/L 4.70 3.30 – 6.12 9.86 7.90 – 11.9 15.4 12.3 – 18.5

Immunoglobulin A (IGA_2) (1) mg/dL 193 154 – 231 194 155 – 232 201 161 – 241 mg/L 1928 1543 – 2314 1937 1550 – 2325 2009 1607 – 2410

Immunoglobulin G (IGG_2) (1) mg/dL 835 668 – 1002 854 683 – 1024 856 685 – 1027 g/L 8.35 6.68 – 10.0 8.54 6.83 – 10.2 8.56 6.85 – 10.3

Immunoglobulin M (IGM_2) (1) mg/dL 104 83.3 – 125 122 97.7 – 147 123 98.3 – 147 mg/L 1041 833 – 1250 1222 977 – 1466 1228 983 – 1474

Iron (IRON_2) (1) μg/dL 91.6 73.3 – 110 82.8 66.2 – 99.4 81.5 65.2 – 97.7 μmol/L 16.4 13.1 – 19.7 14.8 11.9 – 17.8 14.6 11.7 – 17.5

Lithium (LITH) mEq/L § § § mmol/L § § §

Phenobarbital (PHNB) μg/mL 8.70 6.96 – 10.4 23.1 18.5 – 27.8 48.9 39.1 – 58.7 μmol/L 37.5 30.0 – 45.0 99.7 79.8 – 120 211 169 – 253

Phenytoin (PHNY) μg/mL 6.15 4.92 – 7.37 14.3 11.5 – 17.2 25.1 20.1 – 30.2 μmol/L 24.3 19.5 – 29.2 56.7 45.4 – 68.1 99.6 79.7 – 119

Salicylate (SAL) mg/dL 4.24 2.93 – 5.55 16.4 13.1 – 19.6 50.1 40.0 – 60.1 mmol/L 0.307 0.212 – 0.402 1.18 0.947 – 1.42 3.62 2.90 – 4.35

Theophylline (THEO) μg/mL 4.95 3.96 – 5.94 13.7 11.0 – 16.4 28.6 22.9 – 34.3 μmol/L 27.5 22.0 – 33.0 76.0 60.8 – 91.2 159 127 – 190

Tobramycin (TOB) μg/mL 0.820 0.570 – 1.06 3.50 2.80 – 4.20 6.94 5.55 – 8.32 μmol/L 1.75 1.22 – 2.27 7.49 5.99 – 8.99 14.9 1.88 – 17.8

Tobramycin_2 (TOB_2) (Emit 2000) μg/mL 0.800 0.600 – 1.00 3.10 2.50 – 3.70 5.80 4.60 – 7.00 μmol/L 1.71 1.28 – 2.14 6.63 5.35 – 7.92 12.4 9.84 – 15.0

Valproic Acid (VPA) μg/mL 17.7 12.4 – 23.0 69.8 55.9 – 83.8 96.5 77.2 – 116 μmol/L 123 86.0 – 160 484 387 – 581 669 535 – 802

Vancomycin (VANC) μg/mL 9.14 7.31 – 11.0 22.4 17.9 – 26.9 39.3 31.5 – 47.2 μmol/L 6.31 5.04 – 7.59 15.5 12.4 – 18.6 27.1 21.7 – 32.6

SIEMENS BN100 / BNII / BN PROSPEC

Immunoglobulin A (1) mg/dL 198 158 – 238 197 157 – 236 209 167 – 251 mg/L 1980 1584 – 2376 1967 1573 – 2360 2093 1675 – 2512

Immunoglobulin E IU/mL 331 265 – 398 67.2 53.8 – 80.7 85.2 68.1 – 102 kIU/L 331 265 – 398 67.2 53.8 – 80.7 85.2 68.1 – 102

Immunoglobulin G (1) mg/dL 905 724 – 1086 941 753 – 1129 943 754 – 1131 g/L 9.05 7.24 – 10.9 9.41 7.53 – 11.3 9.43 7.54 – 11.3

Immunoglobulin M (1) mg/dL 90.1 72.1 – 108 103 82.4 – 124 109 87.0 – 131 mg/L 901 721 – 1081 1030 824 – 1236 1088 870 – 1305

SIEMENS DIMENSION SERIES

Acetaminophen μg/mL 14.8 11.8 – 17.7 45.0 36.0 – 54.0 130 104 – 156 μmol/L 97.8 78.2 – 117 297 238 – 357 859 687 – 1030

Carbamazepine μg/mL 2.72 2.17 – 3.26 8.12 6.49 – 9.74 13.7 11.0 – 16.5 μmol/L 11.5 9.19 – 13.8 34.3 27.5 – 41.2 58.0 46.4 – 69.6

Digoxin ng/mL 0.617 0.493 – 0.740 1.94 1.55 – 2.32 3.01 2.41 – 3.61 nmol/L 0.789 0.631 – 0.947 2.48 1.98 – 2.97 3.85 3.08 – 4.62

Ferritin ng/mL 73.7 58.9 – 88.4 156 125 – 187 352 281 – 422 μg/L 73.7 58.9 – 88.4 156 125 – 187 352 281 – 422

Gentamicin μg/mL 1.80 1.44 – 2.16 4.48 3.59 – 5.38 7.62 6.09 – 9.14 μmol/L 3.76 3.01 – 4.51 9.37 7.50 – 11.2 15.9 12.7 – 19.1

hCG mIU/mL 7.33 5.87 – 8.80 30.8 24.7 – 37.0 295 236 – 354 IU/L 7.33 5.87 – 8.80 30.8 24.7 – 37.0 295 236 – 354

Immunoglobulin A (1) mg/dL 171 137 – 205 173 138 – 208 182 145 – 218 mg/L 1710 1368 – 2052 1730 1384 – 2076 1817 1453 – 2180

Immunoglobulin G (1) mg/dL 805 644 – 966 829 663 – 994 837 670 – 1005 g/L 8.05 6.44 – 9.66 8.29 6.63 – 9.94 8.37 6.70 – 10.0

Immunoglobulin M (1) mg/dL 72.2 57.7 – 86.6 78.3 62.7 – 94.0 73.5 58.8 – 88.2 mg/L 722 577 – 866 783 627 – 940 735 588 – 882

Iron (1) μg/dL 88.6 70.9 – 106 81.3 65.0 – 97.5 79.4 63.5 – 95.3 μmol/L 15.9 12.7 – 19.0 14.5 11.6 – 17.5 14.2 11.4 – 17.0

Lithium mEq/L 0.453 0.363 – 0.544 1.23 0.985 – 1.48 1.87 1.50 – 2.25 mmol/L 0.453 0.363 – 0.544 1.23 0.985 – 1.48 1.87 1.50 – 2.25

Phenobarbital μg/mL 9.95 7.96 – 11.9 24.3 19.4 – 29.2 52.3 41.8 – 62.7 μmol/L 42.9 34.3 – 51.5 105 83.8 – 126 225 180 – 270

Phenytoin μg/mL 6.82 5.25 – 8.39 14.0 11.2 – 16.8 24.7 19.7 – 29.6 μmol/L 27.0 20.8 – 33.2 55.4 44.3 – 66.5 97.8 78.2 – 117

PSA (TPSA) Equimolar ng/mL 0.850 0.730 – 0.970 3.52 2.99 – 4.05 23.6 19.6 – 27.7 μg/L 0.850 0.730 – 0.970 3.52 2.99 – 4.05 23.6 19.6 – 27.7

PSA Free ng/mL 0.410 0.360 – 0.460 2.11 1.82 – 2.40 14.5 12.1 – 16.9 μg/L 0.410 0.360 – 0.460 2.11 1.82 – 2.40 14.5 12.1 – 16.9

Salicylate mg/dL 4.63 3.71 – 5.56 17.9 14.3 – 21.4 51.4 41.1 – 61.6 mmol/L 0.335 0.268 – 0.403 1.29 1.03 – 1.55 3.72 2.98 – 4.46

T3 Total (RF 414) ng/mL 0.890 0.530 – 1.25 2.33 1.81 – 2.85 3.63 2.80 – 4.45 nmol/L 1.37 0.816 – 1.93 3.59 2.79 – 4.39 5.59 4.31 – 6.85

T3 Uptake / T Uptake % Uptake 35.3 28.3 – 42.4 40.8 32.7 – 49.0 47.2 37.7 – 56.6 % Uptake 35.3 28.3 – 42.4 40.8 32.7 – 49.0 47.2 37.7 – 56.6

T4 Free (EXL LOCI Module) ng/dL 1.01 0.808 – 1.21 2.43 1.94 – 2.92 7.15 5.72 – 8.58 pmol/L 13.0 10.4 – 15.6 31.3 25.0 – 37.7 92.2 73.8 – 111

T4 Free (Heterogeneous Module) ng/dL 0.962 0.712 – 1.21 3.39 2.71 – 4.06 6.16 4.93 – 7.39 pmol/L 12.4 9.18 – 15.6 43.7 35.0 – 52.4 79.4 63.6 – 95.3

T4 Total μg/dL 5.89 4.71 – 7.07 12.7 10.1 – 15.2 18.3 14.7 – 22.0 nmol/L 76.0 60.8 – 91.2 164 131 – 196 236 189 – 284

Theophylline μg/mL 4.75 3.80 – 5.70 13.8 11.1 – 16.6 28.5 22.8 – 34.2 μmol/L 26.4 21.1 – 31.6 76.7 61.3 – 92.0 158 126 – 190

TIBC (Ferene) (1) μg/dL 291 233 – 349 324 259 – 389 302 242 – 363 μmol/L 52.1 41.7 – 62.5 58.0 46.4 – 69.6 54.1 43.3 – 64.9

Tobramycin μg/mL 0.540 0.432 – 0.648 2.81 2.24 – 3.37 5.96 4.77 – 7.15 μmol/L 1.16 0.924 – 1.39 6.00 4.80 – 7.20 12.8 10.2 – 15.3

TSH (EXL LOCI Module) μIU/mL 0.505 0.404 – 0.606 6.88 5.50 – 8.25 51.1 40.9 – 61.3 mIU/L 0.505 0.404 – 0.606 6.88 5.50 – 8.25 51.1 40.9 – 61.3

TSH (Heterogeneous Module) μIU/mL 0.345 0.276 – 0.414 5.15 4.12 – 6.18 31.3 25.0 – 37.6 mIU/L 0.345 0.276 – 0.414 5.15 4.12 – 6.18 31.3 25.0 – 37.6

Valproic Acid μg/mL § § § μmol/L § § §

Vancomycin μg/mL 7.67 6.13 – 9.20 21.5 17.2 – 25.8 37.2 29.8 – 44.7 μmol/L 5.29 4.23 – 6.35 14.8 11.8 – 17.8 25.7 20.5 – 30.8

SIEMENS DIMENSION VISTA SYSTEM

Acetaminophen μg/mL § § § μmol/L § § §

AFP (LOCI) ng/mL 19.6 15.7 – 23.5 99.2 79.4 – 119 239 191 – 287 IU/mL 16.3 13.0 – 19.5 82.3 65.9 – 98.8 198 159 – 238

Carbamazepine μg/mL § § § μmol/L § § §

CEA (LOCI) ng/mL 2.60 2.08 – 3.12 20.5 16.4 – 24.6 54.9 43.9 – 65.9 μg/L 2.60 2.08 – 3.12 20.5 16.4 – 24.6 54.9 43.9 – 65.9

Digoxin ng/mL § § § nmol/L § § §

Ferritin (LOCI) ng/mL 67.9 54.3 – 81.5 157 126 – 189 435 348 – 522 μg/L 67.9 54.3 – 81.5 157 126 – 189 435 348 – 522

Folate (LOCI) ng/mL 1.70 1.36 – 2.04 4.50 3.60 – 5.40 5.90 4.72 – 7.08 nmol/L 3.85 3.08 – 4.62 10.2 8.15 – 12.2 13.4 10.7 – 16.0

Gentamicin μg/mL § § § μmol/L § § §

hCG Beta (LOCI) mIU/mL 9.00 7.20 – 10.8 33.0 26.4 – 39.6 270 216 – 324 IU/L 9.00 7.20 – 10.8 33.0 26.4 – 39.6 270 216 – 324

Iron (1) μg/dL § § § μmol/L § § §

Lidocaine (PETINIA) μg/mL 1.60 1.28 – 1.92 4.50 3.60 – 5.40 8.80 7.04 – 10.6 μmol/L 6.83 5.47 – 8.20 19.2 15.4 – 23.1 37.6 30.1 – 45.1

Lithium mEq/L § § § mmol/L § § §

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Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

SIEMENS DIMENSION VISTA SYSTEM (continued)

NAPA (PETINIA) μg/mL 2.10 1.68 – 2.52 5.30 4.20 – 6.40 11.5 9.20 – 13.8 μmol/L 7.58 6.06 – 9.10 19.1 15.2 – 23.1 41.5 33.2 – 49.8

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL § § § μmol/L § § §

Procainamide (PETINIA) μg/mL 2.20 1.76 – 2.64 10.0 8.00 – 12.0 18.2 14.6 – 21.8 μmol/L 9.31 7.44 – 11.2 42.3 33.8 – 50.8 77.0 61.6 – 92.4

Salicylate mg/dL § § § mmol/L § § §

T3 Free (LOCI) pg/mL 2.23 1.78 – 2.68 8.73 6.98 – 10.5 15.9 12.7 – 19.1 pmol/L 3.43 2.75 – 4.12 13.4 10.7 – 16.1 24.5 19.6 – 29.4

T3 Total (IA) ng/mL 0.810 0.650 – 0.970 2.19 1.75 – 2.63 3.31 2.65 – 3.97 nmol/L 1.25 1.00 – 1.49 3.37 2.70 – 4.05 5.10 4.08 – 6.11

T3 Uptake / T Uptake % Uptake § § § % Uptake § § §

T4 Free (LOCI) ng/dL 1.08 0.860 – 1.30 2.47 1.98 – 2.96 6.87 5.50 – 8.24 pmol/L 13.9 11.1 – 16.8 31.9 25.5 – 38.2 88.6 71.0 – 106

T4 Total μg/dL § § § nmol/L § § §

Theophylline (PETINIA) μg/mL 4.90 3.92 – 5.88 14.6 11.7 – 17.5 30.2 24.2 – 36.2 μmol/L 27.2 21.8 – 32.6 81.0 64.8 – 97.2 168 134 – 201

TIBC (1) μg/dL § § § μmol/L § § §

Tobramycin μg/mL § § § μmol/L § § §

TSH (LOCI) μIU/mL 0.432 0.346 – 0.518 14.6 11.7 – 17.5 45.7 36.6 – 54.8 mIU/L 0.432 0.346 – 0.518 14.6 11.7 – 17.5 45.7 36.6 – 54.8

Valproic Acid (PETINIA) μg/mL 38.0 30.4 – 45.6 85.4 68.3 – 103 122 97.8 – 147 μmol/L 263 211 – 316 592 473 – 710 848 678 – 1017

Vancomycin μg/mL § § § μmol/L § § §

Vitamin B12 (LOCI) pg/mL 450 360 – 540 746 597 – 895 1402 1122 – 1682 pmol/L 332 266 – 399 550 440 – 661 1035 828 – 1242

SIEMENS IMMULITE

ACTH pg/mL § § § pmol/L § § §

AFP ng/mL 16.4 13.1 – 19.7 78.3 62.6 – 93.9 172 137 – 206 IU/mL 13.6 10.9 – 16.3 65.0 52.0 – 78.0 143 114 – 171

Androstenedione ng/mL § § § nmol/L § § §

C-Peptide ng/mL § § § nmol/L § § §

Calcitonin pg/mL § § § ng/L § § §

Carbamazepine μg/mL § § § μmol/L § § §

CEA ng/mL 2.96 2.37 – 3.56 23.1 18.5 – 27.7 58.0 46.4 – 69.6 μg/L 2.96 2.37 – 3.56 23.1 18.5 – 27.7 58.0 46.4 – 69.6

Cortisol μg/dL 2.96 2.37 – 3.55 19.5 15.6 – 23.4 40.2 32.2 – 48.3 nmol/L 81.7 65.4 – 98.1 537 430 – 645 1110 888 – 1333

DHEA-Sulfate μg/dL 57.7 46.2 – 69.2 120 96.2 – 144 517 413 – 620 μmol/L 1.56 1.25 – 1.87 3.25 2.60 – 3.90 13.9 11.2 – 16.7

Digoxin ng/mL § § § nmol/L § § §

Estradiol pg/mL 49.4 39.5 – 59.3 252 202 – 303 623 499 – 748 pmol/L 181 145 – 218 926 741 – 1111 2287 1830 – 2744

Estriol Free ng/mL § § § nmol/L § § §

Ferritin ng/mL 75.1 60.1 – 90.1 141 113 – 170 331 265 – 397 μg/L 75.1 60.1 – 90.1 141 113 – 170 331 265 – 397

Folate ng/mL 3.36 2.69 – 4.04 9.42 7.44 – 11.4 15.8 10.9 – 20.7 nmol/L 7.62 6.10 – 9.15 21.3 16.9 – 25.8 35.8 24.7 – 46.9

FSH mIU/mL 6.74 5.39 – 8.09 28.9 23.1 – 34.7 37.7 30.1 – 45.2 IU/L 6.74 5.39 – 8.09 28.9 23.1 – 34.7 37.7 30.1 – 45.2

hCG mIU/mL 9.06 7.25 – 10.9 35.3 28.2 – 42.3 280 224 – 336 IU/L 9.06 7.25 – 10.9 35.3 28.2 – 42.3 280 224 – 336

hCG Turbo mIU/mL § § § IU/L § § §

hGH ng/mL § § § μg/L § § §

Immunoglobulin E IU/mL § § § kIU/L § § §

Insulin μIU/mL 4.25 3.40 – 5.10 14.3 11.5 – 17.2 32.1 25.7 – 38.5 pmol/L 29.5 23.6 – 35.4 99.4 79.5 – 119 223 178 – 267

LH mIU/mL 2.42 1.93 – 2.90 24.4 19.5 – 29.3 59.5 47.6 – 71.3 IU/L 2.41 1.93 – 2.90 24.4 19.5 – 29.3 59.5 47.6 – 71.3

PAP ng/mL § § § μg/L § § §

Phenobarbital μg/mL § § § μmol/L § § §

Phenytoin μg/mL § § § μmol/L § § §

Progesterone ng/mL 0.907 0.598 – 1.21 8.55 6.84 – 10.3 >20.0 nmol/L 2.88 1.90 – 3.86 27.2 21.8 – 32.6 >63.6

Prolactin ng/mL § § § μg/L § § §

PSA ng/mL 0.980 0.784 – 1.18 4.10 3.28 – 4.92 22.1 17.7 – 26.5 μg/L 0.980 0.784 – 1.18 4.10 3.28 – 4.92 22.1 17.7 – 26.5

PSA (Gen 3) ng/mL § § § μg/L § § §

PSA Free ng/mL § § § μg/L § § §

T3 Free pg/mL § § § pmol/L § § §

T3 Total ng/dL 65.6 52.5 – 78.8 205 164 – 246 366 293 – 440 nmol/L 1.01 0.809 – 1.21 3.16 2.53 – 3.79 5.64 4.51 – 6.77

T3 Uptake / T Uptake % Uptake 34.3 27.4 – 41.1 43.4 34.7 – 52.1 55.6 44.5 – 66.7 % Uptake 34.3 27.4 – 41.1 43.4 34.7 – 52.1 55.6 44.5 – 66.7

T4 Free (LKF4) ng/dL 0.998 0.799 – 1.20 2.39 1.91 – 2.87 3.93 3.14 – 4.72 pmol/L 12.9 10.3 – 15.5 30.8 24.6 – 37.0 50.7 40.6 – 60.8

T4 Free (LKFT4) ng/dL 1.10 0.940 – 1.27 2.70 2.32 – 3.08 >6.00 pmol/L 14.2 12.1 – 16.4 34.8 29.9 – 39.7 >77.4

T4 Total μg/dL § § § nmol/L § § §

TBG (1) μg/mL § § § mg/L § § §

Testosterone ng/dL 202 162 – 243 576 461 – 691 1145 881 – 1408 nmol/L 7.02 5.61 – 8.42 20.0 16.0 – 24.0 39.7 30.6 – 48.8

Theophylline μg/mL § § § μmol/L § § §

TSH (Gen 3) μIU/mL 0.416 0.333 – 0.499 5.41 4.33 – 6.49 29.4 23.5 – 35.2 mIU/L 0.416 0.333 – 0.499 5.41 4.33 – 6.49 29.4 23.5 – 35.2

TSH Rapid μIU/mL 0.377 0.301 – 0.452 5.31 4.25 – 6.37 28.2 22.6 – 33.9 mIU/L 0.377 0.301 – 0.452 5.31 4.25 – 6.37 28.2 22.6 – 33.9

Valproic Acid μg/mL § § § μmol/L § § §

Vitamin B12 pg/mL 396 317 – 475 799 639 – 959 >1000 pmol/L 292 234 – 351 590 472 – 708 >738

SIEMENS IMMULITE 2000 / 2500

ACTH pg/mL § § § pmol/L § § §

AFP ng/mL 16.9 13.5 – 20.3 81.8 65.5 – 98.2 182 145 – 218 IU/mL 14.0 11.2 – 16.8 67.9 54.3 – 81.5 151 121 – 181

Androstenedione ng/mL 1.06 0.847 – 1.27 5.04 4.03 – 6.04 >10.0 nmol/L 3.70 2.96 – 4.44 17.6 14.1 – 21.1 >34.9

C-Peptide ng/mL 0.887 0.710 – 1.06 4.23 3.38 – 5.07 5.56 4.45 – 6.67 nmol/L 0.294 0.235 – 0.352 1.40 1.12 – 1.68 1.84 1.47 – 2.21

Calcitonin pg/mL 48.3 38.6 – 57.9 241 193 – 289 487 389 – 584 ng/L 48.3 38.6 – 57.9 241 193 – 289 487 389 – 584

Carbamazepine μg/mL 2.53 2.02 – 3.04 7.28 5.82 – 8.73 12.6 10.1 – 15.2 μmol/L 10.7 8.56 – 12.8 30.8 24.6 – 36.9 53.4 42.8 – 64.1

CEA ng/mL 2.60 2.08 – 3.12 21.5 17.2 – 25.8 53.8 43.0 – 64.5 μg/L 2.60 2.08 – 3.12 21.5 17.2 – 25.8 53.8 43.0 – 64.5

Cortisol μg/dL § § § nmol/L § § §

DHEA-Sulfate μg/dL 56.1 44.9 – 67.3 116 92.6 – 139 500 400 – 600 μmol/L 1.51 1.21 – 1.82 3.13 2.50 – 3.75 13.5 10.8 – 16.2

Digoxin ng/mL 0.637 0.509 – 0.764 2.07 1.65 – 2.48 3.36 2.68 – 4.03 nmol/L 0.815 0.652 – 0.978 2.65 2.12 – 3.17 4.29 3.44 – 5.15

Estradiol pg/mL 50.1 40.1 – 60.1 264 211 – 317 621 497 – 746 pmol/L 184 147 – 221 969 775 – 1163 2281 1824 – 2737

Estriol Free ng/mL § § § nmol/L § § §

Ferritin ng/mL 69.1 55.2 – 82.9 143 114 – 171 379 303 – 455 μg/L 69.1 55.2 – 82.9 143 114 – 171 379 303 – 455

Folate (Immulite 2000) ng/mL 3.08 2.43 – 3.72 7.96 6.29 – 9.63 12.2 9.77 – 14.7 nmol/L 6.98 5.51 – 8.44 18.0 14.2 – 21.8 27.7 22.1 – 33.2

Folate (Immulite 2500) ng/mL § § § nmol/L § § §

FSH mIU/mL 6.62 5.29 – 7.94 29.2 23.4 – 35.0 40.7 32.5 – 48.8 IU/L 6.62 5.29 – 7.94 29.2 23.4 – 35.0 40.7 32.5 – 48.8

Gastrin pg/mL § § § pmol/L § § §

hCG Total (Immulite 2500) mIU/mL 8.41 6.73 – 10.1 39.3 31.5 – 47.2 325 260 – 389 IU/L 8.41 6.73 – 10.1 39.3 31.5 – 47.2 325 260 – 389

hCG Total (Immulite 2000) mIU/mL 9.56 7.65 – 11.5 39.3 31.5 – 47.2 314 251 – 377 IU/L 9.56 7.65 – 11.5 39.3 31.5 – 47.2 314 251 – 377

hCG Total - Rapid (Immulite 2500) mIU/mL § § § IU/L § § §

hGH ng/mL 3.45 2.76 – 4.14 8.53 6.82 – 10.2 18.4 14.7 – 22.0 μg/L 3.45 2.76 – 4.14 8.53 6.82 – 10.2 18.4 14.7 – 22.0

Immunoglobulin E IU/mL 356 285 – 427 78.9 63.1 – 94.7 104 83.4 – 125 kIU/L 356 285 – 427 78.9 63.1 – 94.7 104 83.4 – 125

Insulin μIU/mL 4.13 3.31 – 4.96 15.1 12.1 – 18.1 36.5 29.2 – 43.8 pmol/L 28.7 23.0 – 34.5 105 83.9 – 126 253 203 – 304

LH (Immulite 2000) mIU/mL 2.31 1.85 – 2.78 24.7 19.8 – 29.6 62.1 49.7 – 74.5 IU/L 2.31 1.85 – 2.78 24.7 19.8 – 29.6 62.1 49.7 – 74.5

LH (Immulite 2500) mIU/mL § § § IU/L § § §

PAP ng/mL 1.42 1.13 – 1.70 23.7 18.9 – 28.4 54.3 43.5 – 65.2 μg/L 1.42 1.13 – 1.70 23.7 18.9 – 28.4 54.3 43.5 – 65.2

Phenobarbital μg/mL § § § μmol/L § § §

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Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

SIEMENS IMMULITE 2000 / 2500 (continued)

Phenytoin μg/mL 6.67 5.34 – 8.01 16.3 12.5 – 20.0 26.8 21.4 – 32.1 μmol/L 26.4 21.1 – 31.7 64.5 49.7 – 79.3 106 84.7 – 127

Progesterone ng/mL 0.820 0.656 – 0.984 8.53 6.83 – 10.2 23.3 18.7 – 28.0 nmol/L 2.61 2.09 – 3.13 27.1 21.7 – 32.6 74.2 59.4 – 89.0

Prolactin ng/mL 7.05 5.64 – 8.46 20.6 16.5 – 24.7 41.3 33.0 – 49.5 μg/L 7.05 5.64 – 8.46 20.6 16.5 – 24.7 41.3 33.0 – 49.5

PSA ng/mL § § § μg/L § § §

PSA (Gen 3) ng/mL 0.838 0.671 – 1.01 3.12 2.50 – 3.75 19.9 15.9 – 23.8 μg/L 0.838 0.671 – 1.01 3.12 2.50 – 3.75 19.9 15.9 – 23.8

PSA Free ng/mL 0.385 0.308 – 0.462 1.79 1.43 – 2.15 10.8 8.63 – 13.0 μg/L 0.385 0.308 – 0.462 1.79 1.43 – 2.15 10.8 8.63 – 13.0

T3 Free pg/mL 2.56 2.05 – 3.07 5.74 4.59 – 6.89 7.99 6.39 – 9.59 pmol/L 3.94 3.15 – 4.73 8.84 7.07 – 10.6 12.3 9.85 – 14.8

T3 Total ng/dL § § § nmol/L § § §

T3 Uptake / T Uptake % Uptake 37.0 29.6 – 44.4 45.2 36.1 – 54.2 56.2 44.9 – 67.4 % Uptake 37.0 29.6 – 44.4 45.2 36.1 – 54.2 56.2 44.9 – 67.4

T4 Free (L2KFT4/L5KFT4) ng/dL 1.14 1.01 – 1.27 2.85 2.54 – 3.16 >6.00 pmol/L 14.7 13.0 – 16.4 36.8 32.8 – 40.8 >77.4

T4 Total μg/dL § § § nmol/L § § §

TBG (1) μg/mL 14.5 11.6 – 17.4 15.9 12.7 – 19.0 16.0 12.8 – 19.2 mg/L 14.5 11.6 – 17.4 15.9 12.7 – 19.0 16.0 12.8 – 19.2

Testosterone ng/dL 175 140 – 210 546 437 – 656 1014 811 – 1216 nmol/L 6.08 4.86 – 7.30 19.0 15.2 – 22.8 35.2 28.1 – 42.2

Theophylline μg/mL 4.36 3.49 – 5.23 15.0 12.0 – 18.1 35.2 28.1 – 42.2 μmol/L 24.2 19.4 – 29.0 83.5 66.8 – 100 195 156 – 234

TSH (Gen 3) μIU/mL § § § mIU/L § § §

TSH Rapid μIU/mL 0.373 0.299 – 0.448 5.14 4.11 – 6.17 28.0 22.4 – 33.6 mIU/L 0.373 0.299 – 0.448 5.14 4.11 – 6.17 28.0 22.4 – 33.6

Valproic Acid μg/mL 35.0 28.0 – 42.0 83.3 66.7 – 100 131 105 – 157 μmol/L 242 194 – 291 578 462 – 693 905 724 – 1086

Vitamin B12 (Immulite 2000) pg/mL 365 292 – 438 762 609 – 914 >1000 pmol/L 269 215 – 323 562 450 – 674 >738

Vitamin B12 (Immulite 2500) pg/mL § § § pmol/L § § §

SIEMENS VIVA-E, V-TWIN SERIES

Acetaminophen (Emit 2000) μg/mL 11.4 9.69 – 13.2 40.6 35.2 – 45.9 122 104 – 141 μmol/L 75.7 64.1 – 87.2 268 233 – 304 810 689 – 931

Amikacin (Emit) μg/mL 5.98 5.26 – 6.71 14.6 12.9 – 16.4 31.7 26.4 – 36.9 μmol/L 10.2 8.99 – 11.5 25.0 22.0 – 28.0 54.1 45.1 – 63.1

Caffeine (Emit) μg/mL 2.18 1.74 – 2.61 7.41 6.42 – 8.41 15.6 13.5 – 17.7 μmol/L 11.2 8.96 – 13.4 38.2 33.1 – 43.3 80.5 69.7 – 91.4

Carbamazepine (Emit 2000) μg/mL 2.61 2.14 – 3.08 8.58 7.03 – 10.1 14.4 12.2 – 16.5 μmol/L 11.0 9.05 – 13.0 36.3 29.7 – 42.8 60.7 51.7 – 69.7

Digoxin (Emit 2000) ng/mL 0.450 0.250 – 0.660 1.74 1.37 – 2.11 2.96 2.42 – 3.50 nmol/L 0.576 0.320 – 0.845 2.23 1.75 – 2.70 3.79 3.10 – 4.48

Ethosuximide (Emit) μg/mL 27.2 23.8 – 30.6 66.7 58.7 – 74.8 110 96.8 – 123 μmol/L 193 169 – 216 473 416 – 529 779 686 – 873

Gentamicin (Emit 2000) μg/mL 2.05 1.77 – 2.32 4.39 3.74 – 5.05 6.94 5.90 – 7.97 μmol/L 4.28 3.70 – 4.85 9.18 7.82 – 10.6 14.5 12.3 – 16.7

NAPA (Emit 2000) μg/mL 1.96 1.57 – 2.35 5.05 4.04 – 6.06 11.8 9.29 – 14.3 μmol/L 7.08 5.67 – 8.48 18.2 14.6 – 21.9 42.5 33.5 – 51.5

Phenobarbital (Emit 2000) μg/mL 9.11 7.68 – 10.5 24.4 19.9 – 28.9 53.9 46.7 – 61.0 μmol/L 39.3 33.1 – 45.4 105 85.9 – 124 232 201 – 263

Phenytoin (Emit 2000) μg/mL 5.72 4.79 – 6.65 13.5 11.3 – 15.6 25.3 21.3 – 29.2 μmol/L 22.7 19.0 – 26.3 53.3 44.7 – 61.9 100 84.4 – 116

Primidone (Emit) μg/mL 2.99 2.62 – 3.36 6.02 5.29 – 6.74 11.8 10.4 – 13.2 μmol/L 13.7 12.0 – 15.4 27.6 24.2 – 30.9 54.0 47.5 – 60.5

Procainamide (Emit 2000) μg/mL 1.64 1.38 – 1.89 7.53 6.14 – 8.92 13.2 10.7 – 15.7 μmol/L 6.94 5.84 – 7.99 31.9 26.0 – 37.7 55.9 45.4 – 66.3

Quinidine (Emit 2000) μg/mL 0.820 0.560 – 1.08 2.55 2.05 – 3.06 4.42 3.75 – 5.09 μmol/L 2.53 1.72 – 3.33 7.85 6.31 – 9.42 13.6 11.6 – 15.7

Theophylline (Emit 2000) μg/mL 4.53 3.84 – 5.22 13.9 11.2 – 16.6 30.0 24.7 – 35.3 μmol/L 25.1 21.3 – 29.0 77.3 62.4 – 92.2 166 137 – 196

Tobramycin (Emit 2000) μg/mL 0.910 0.730 – 1.09 3.15 2.76 – 3.54 6.15 5.21 – 7.08 μmol/L 1.95 1.56 – 2.33 6.74 5.91 – 7.58 13.2 11.1 – 15.2

Valproic Acid (Emit 2000) μg/mL 34.6 29.0 – 40.1 77.5 68.2 – 86.8 117 101 – 132 μmol/L 240 201 – 278 537 473 – 602 808 699 – 916

Vancomycin (Emit 2000) μg/mL 6.07 4.57 – 7.57 19.3 15.6 – 22.9 32.9 25.9 – 40.0 μmol/L 4.19 3.15 – 5.22 13.3 10.8 – 15.8 22.7 17.8 – 27.6

TOSOH AIA SYSTEMS

AFP (ST AIA-PACK) ng/mL 18.4 14.7 – 22.1 85.0 68.0 – 102 181 145 – 218 IU/mL 15.3 12.2 – 18.3 70.6 56.4 – 84.7 150 120 – 181

C-Peptide (ST AIA-PACK) ng/mL 0.920 0.400 – 1.44 4.40 2.80 – 5.90 6.00 4.60 – 7.30 nmol/L 0.305 0.132 – 0.477 1.46 0.927 – 1.95 1.99 1.52 – 2.42

CEA (ST AIA-PACK) ng/mL 3.50 2.80 – 4.20 25.3 20.3 – 30.4 56.9 45.5 – 68.3 μg/L 3.50 2.80 – 4.20 25.3 20.3 – 30.4 56.9 45.5 – 68.3

Cortisol (ST AIA-PACK) μg/dL 2.70 1.90 – 3.50 18.5 12.9 – 24.0 30.3 24.2 – 36.4 nmol/L 74.5 52.4 – 96.6 511 356 – 662 836 668 – 1005

Estradiol (ST AIA-PACK) pg/mL 192 115 – 269 494 374 – 613 989 789 – 1190 pmol/L 705 422 – 987 1813 1373 – 2250 3630 2896 – 4367

Ferritin (ST AIA-PACK) ng/mL 58.1 40.6 – 75.5 126 88.0 – 164 304 213 – 395 μg/L 58.1 40.6 – 75.5 126 88.0 – 164 304 213 – 395

Folate (AIA-PACK) (1800) ng/mL 3.90 2.60 – 5.30 10.5 6.80 – 14.2 16.9 11.0 – >20.0 nmol/L 8.84 5.89 – 12.0 23.8 15.4 – 32.2 38.3 24.9 – >45.3

Folate (AIA-PACK) (600 II) ng/mL 5.00 3.30 – 6.80 10.9 7.10 – 14.7 16.9 11.0 – >20.0 nmol/L 11.3 7.48 – 15.4 24.7 16.1 – 33.3 38.3 24.9 – >45.3

Folate (AIA-PACK) (NexIA) ng/mL 4.20 2.80 – 5.70 10.7 7.00 – 14.5 17.9 11.7 – >20.0 nmol/L 9.52 6.34 – 12.9 24.2 15.9 – 32.9 40.6 26.5 – >45.3

FSH (ST AIA-PACK) mIU/mL 8.40 5.90 – 10.9 33.2 23.2 – 43.1 50.7 35.5 – 65.9 IU/L 8.40 5.90 – 10.9 33.2 23.2 – 43.1 50.7 35.5 – 65.9

hCG Total Beta (ST AIA-PACK) mIU/mL 9.20 7.40 – 11.1 35.3 28.3 – 42.4 268 214 – 321 IU/L 9.20 7.40 – 11.1 35.3 28.3 – 42.4 268 214 – 321

hGH (ST AIA-PACK) ng/mL 2.70 1.90 – 3.50 6.90 5.50 – 8.30 14.7 11.8 – 17.7 μg/L 2.70 1.90 – 3.50 6.90 5.50 – 8.30 14.7 11.8 – 17.7

Immunoglobulin E II (AIA-PACK) IU/mL 356 285 – 427 68.4 54.7 – 82.0 88.4 70.7 – 106 kIU/L 356 285 – 427 68.4 54.7 – 82.0 88.4 70.7 – 106

Insulin (IRI) (ST AIA-PACK) μIU/mL 16.3 13.0 – 19.5 54.0 43.2 – 64.9 149 120 – 179 pmol/L 113 90.3 – 135 375 300 – 451 1035 833 – 1243

LH II (ST AIA-PACK) mIU/mL 1.82 1.46 – 2.18 20.3 16.2 – 24.3 50.9 40.8 – 61.1 IU/L 1.82 1.46 – 2.18 20.3 16.2 – 24.3 50.9 40.8 – 61.1

PAP (ST AIA-PACK) ng/mL 0.810 0.440 – 1.17 17.8 14.3 – 21.4 28.0 – >40.0 μg/L 0.810 0.440 – 1.17 17.8 14.3 – 21.4 28.0 – >40.0

Progesterone (ST AIA-PACK) ng/mL 0.980 0.590 – 1.37 10.1 7.10 – 13.2 28.5 20.0 – 37.1 nmol/L 3.12 1.88 – 4.36 32.1 22.6 – 42.0 90.6 63.6 – 118

Prolactin (ST AIA-PACK) ng/mL <1.00 – 1.69 6.80 5.50 – 8.10 4.80 3.80 – 5.70 μg/L <1.00 – 1.69 6.80 5.50 – 8.10 4.80 3.80 – 5.70

PSA (ST AIA-PACK) ng/mL 0.920 0.640 – 1.19 3.40 2.40 – 4.40 20.6 14.4 – 26.8 μg/L 0.920 0.640 – 1.19 3.40 2.40 – 4.40 20.6 14.4 – 26.8

T3 Free (ST AIA-PACK) pg/mL 2.90 2.00 – 3.80 10.8 7.60 – 14.0 19.5 – >25.0 pmol/L 4.47 3.08 – 5.85 16.6 11.7 – 21.6 30.0 – >38.5

T3 Total (ST AIA-PACK) ng/mL 0.900 0.630 – 1.18 2.20 1.80 – 2.70 3.40 2.70 – 4.10 nmol/L 1.39 0.970 – 1.82 3.39 2.77 – 4.16 5.24 4.16 – 6.31

T3 Uptake / T Uptake (ST AIA-PACK) % Uptake 34.6 27.7 – 41.5 40.1 34.1 – 46.2 48.0 40.8 – 55.3 % Uptake 34.6 27.7 – 41.5 40.1 34.1 – 46.2 48.0 40.8 – 55.3

T4 Free (ST AIA-PACK) ng/dL 1.08 0.750 – 1.40 3.00 2.10 – 3.90 5.20 – >9.00 pmol/L 13.9 9.68 – 18.1 38.7 27.1 – 50.3 67.1 – >116

T4 Total (ST AIA-PACK) μg/dL 5.50 4.40 – 6.60 11.4 9.10 – 13.7 17.4 13.9 – 20.6 nmol/L 71.0 56.8 – 85.1 147 117 – 177 224 179 – 266

Testosterone (ST AIA-PACK) ng/dL 167 117 – 217 502 352 – 653 1061 742 – 1379 nmol/L 5.79 4.06 – 7.53 17.4 12.2 – 22.7 36.8 25.7 – 47.9

TSH (ST AIA-PACK) μIU/mL 0.450 0.310 – 0.580 6.30 5.00 – 7.60 36.0 28.8 – 43.2 mIU/L 0.450 0.310 – 0.580 6.30 5.00 – 7.60 36.0 28.8 – 43.2

TSH 3G (AIA-PACK) μIU/mL 0.440 0.310 – 0.570 5.90 4.70 – 7.00 36.1 28.9 – 43.4 mIU/L 0.440 0.310 – 0.570 5.90 4.70 – 7.00 36.1 28.9 – 43.4

Vitamin B12 (AIA-PACK) (1800) pg/mL 468 304 – 631 866 563 – 1169 1739 1130 – >2100 pmol/L 345 224 – 466 639 415 – 863 1283 834 – >1550

Vitamin B12 (AIA-PACK) (600II) pg/mL 544 354 – 734 1031 670 – 1392 2048 1331 – >2100 pmol/L 401 261 – 542 761 494 – 1027 1511 982 – >1550

Vitamin B12 (AIA-PACK) (NexIA) pg/mL 523 340 – 706 972 632 – 1312 1958 1273 – >2100 pmol/L 386 251 – 521 717 466 – 968 1445 939 – >1550

WALLAC AUTODELFIA

Estradiol (2inc) pg/mL 50.0 36.1 – 63.9 206 156 – 258 444 333 – 556 nmol/L 0.180 0.130 – 0.230 0.740 0.560 – 0.930 1.60 1.20 – 2.00

Estradiol (IVF) pg/mL 55.6 38.9 – 72.2 217 164 – 272 417 306 – 528 nmol/L 0.200 0.140 – 0.260 0.780 0.590 – 0.980 1.50 1.10 – 1.90

hCG mIU/mL 8.50 6.00 – 11.0 34.0 26.0 – 43.0 281 225 – 337 IU/L 8.50 6.00 – 11.0 34.0 26.0 – 43.0 281 225 – 337

hFSH mIU/mL 5.80 4.60 – 7.00 24.0 19.0 – 29.0 37.0 30.0 – 44.0 IU/L 5.80 4.60 – 7.00 24.0 19.0 – 29.0 37.0 30.0 – 44.0

hGH ng/mL 2.50 2.00 – 3.00 6.15 5.00 – 7.31 13.5 10.8 – 16.2 mIU/L 6.50 5.20 – 7.80 16.0 13.0 – 19.0 35.0 28.0 – 42.0

hLH (Spec) mIU/mL 2.10 1.60 – 2.60 22.0 18.0 – 26.0 55.0 44.0 – 66.0 IU/L 2.10 1.60 – 2.60 22.0 18.0 – 26.0 55.0 44.0 – 66.0

hTSH Ultra μIU/mL 0.390 0.310 – 0.470 4.80 3.80 – 5.80 30.0 24.0 – 36.0 mIU/L 0.390 0.310 – 0.470 4.80 3.80 – 5.80 30.0 24.0 – 36.0

Progesterone ng/mL 1.04 0.723 – 1.35 10.1 8.18 – 11.9 33.3 26.7 – >37.7 nmol/L 3.30 2.30 – 4.30 32.0 26.0 – 38.0 106 85.0 – >120

Prolactin ng/mL 4.50 3.40 – 5.60 13.0 10.0 – 16.0 25.0 20.0 – 30.0 μg/L 4.50 3.40 – 5.60 13.0 10.0 – 16.0 25.0 20.0 – 30.0

T3 Total ng/mL 0.974 0.539 – 1.43 2.53 2.01 – 3.05 3.64 2.92 – 4.35 nmol/L 1.50 0.830 – 2.20 3.90 3.10 – 4.70 5.60 4.50 – 6.70

T4 Free ng/dL 1.24 0.853 – 1.63 4.73 3.80 – 5.66 >6.20 pmol/L 16.0 11.0 – 21.0 61.0 49.0 – 73.0 >80.0

T4 Total μg/dL 5.50 3.88 – 7.13 11.3 9.07 – 13.6 13.3 10.7 – 16.0 nmol/L 71.0 50.0 – 92.0 146 117 – 175 172 138 – 206

Page 19: Lyphochek Immunoassay 370 Data Sheet

FOOTNOTES // Fussnoten // Notes // Note a pie’ pagina // Notas a pie de página // Notas de rodapé // Fotnoter // Fodnoter

ENGLISH For this lot of control: Parathyroid Hormone: No claim is made for expected values or stability. (1) Indicates endogenous levels only. (2) No claim is made for expected value or stability. (3) Values are not provided. (4) Dilute Level 3 according to manufacturer’s recommendation for patient specimens with Estradiol values >250 pg/mL (917.5 pmol/L). § The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad Sales or Technical Services Group. ❖ INTERNATIONAL USE ONLY - The following section contains data for methods that are not available for diagnostic use in the United States.

DEUTSCH Für diese Kontrollencharge: Parathormon:

Es können keine Angaben hinsichtlich der erwarteten Werte oder der Stabilität gemacht werden. (1) Nur endogene Konzentrationen. (2) Es können keine Angaben hinsichtlich der erwarteten Werte oder der Stabilität gemacht werden. (3) Keine Wertangaben. (4) Level 3 ist nach den Empfehlungen des Herstellers bei Patientenproben mit Estradiolwerten >250 pg/ml (917,5 pmol/l) zu verdünnen. § Für die Ermittlung der Zielwerte für diesen Test standen nicht genügend Zielwertermittler zur Verfügung. Falls Ihre Einrichtung interessiert ist, bei künftigen Zielwertermittlungen für diesen Test teilzunehmen, kontaktieren Sie bitte das Kundendienst-Team Ihrer lokalen Bio-Rad Niederlassung. NUR ZUM GEBRAUCH AUSSERHALB DER USA - Der folgende Abschnitt enthält Zielwertangaben für Tests / Methoden, die in den USA nicht für diagnostische Zwecke erhältlich sind.

FRANÇAIS Pour ce lot de contrôle : Hormone parathyroïdienne :

Aucune information n’est fournie au sujet des valeurs attendues ou de la stabilité. (1) Indique des taux endogènes uniquement. (2) Aucune revendication n’est faite concernant les valeurs attendues ou la stabilité. (3) Les valeurs ne sont pas fournies. (4) Diluer le produit de niveau 3 conformément aux instructions fournies par le fabricant pour les échantillons de patients ayant des valeurs d’œstradiol supérieures à 250 pg/ml (917,5 pmol/l). § Le nombre de données n’a pas été suffisant pour définir la moyenne et les limites acceptables pour ce dosage en raison du manque de laboratoires pour établir ces valeurs. Si votre laboratoire souhaite participer à l’élaboration de ces valeurs, veuillez contacter votre correspondant Bio-Rad. À UTILISER UNIQUEMENT HORS DES ÉTATS-UNIS - La section suivante contient des données concernant des méthodes qui ne sont pas disponibles pour un usage diagnostique aux États-Unis.

ITALIANO Per questo lotto di controllo Ormone paratiroideo:

Non vengono forniti i valori attesi, né i dati di stabilità. (1) Solo livelli endogeni. (2) Non vengono forniti i valori attesi, né i dati di stabilità. (3) Valori non forniti. (4) Diluire il Livello 3 secondo le raccomandazioni del fabbricante relative ai campioni dei pazienti con valori di estradiolo >250 pg/ml (917,5 pmol/l). § A causa della bassa o nulla partecipazione nell’assegnazione valori, la media e gli intervalli di riferimento per questo dosaggio non sono stati definiti. Contattare gli uffici locali per maggiori chiarimenti. SOLO PER USO INTERNAZIONALE - La sezione che segue contiene dati per metodi ad uso diagnostico che non sono disponibili negli Stati Uniti.

ESPAÑOL Para este lote de control: Hormona paratiroidea:

No se garantizan los valores previstos ni la estabilidad. (1) Sólo indica niveles endógenos. (2) No se garantiza el valor previsto ni la estabilidad. (3) No se proporcionan valores. (4) Disuelva el nivel 3 según la recomendación del fabricante para muestras de pacientes con valores de Estradiol >250 pg/ml (917,5 pmol/l). § Debido a la baja o nula participación en la asignación de valores, no se ha podido establecer los valores medios y rangos aceptables de este ensayo. Si su centro de trabajo está interesado en participar en la valoración de este ensayo, por favor contacte con su oficina local de Bio-Rad. SÓLO PARA USO INTERNACIONAL - El siguiente apartado presenta información referente a métodos no disponibles para uso diagnóstico en Estados Unidos.

PORTUGUÊS Para este lote de controlo: Hormona paratiróide:

Não foi feita qualquer afirmação em relação aos valores esperados ou à estabilidade. (1) Indica apenas níveis endógenos. (2) Não foi feita qualquer afirmação em relação ao valor esperado ou à estabilidade. (3) Não são fornecidos valores. (4) Dilua o Nível 3 de acordo com a recomendação do fabricante para amostras de doentes com valores de Estradiol >250 pg/mL (917,5 pmol/L). § Os dados necessários para a obtenção da média e do intervalo de referência para este analíto não foram obtidos dada a limitada participação na atribuição de valores. Se estiver interessado em participar no nosso Programa de Atribuição de Valores, por favor entre em contacto com o seu representante local. APENAS PARA UTILIZAÇÃO INTERNACIONAL - A secção que se segue contém dados para métodos que não estão disponíveis para utilização em diagnóstico nos Estados Unidos.

SVENSKA För denna kontrollbatch: Parathyreoideahormon:

Inga utfästelser avseende förväntade värden eller hållbarhetstider görs. (1) Anger endast endogena nivåer. (2) Inga utfästelser avseende förväntade värden eller hållbarhetstider görs. (3) Värden tillhandahålls ej. (4) Späd nivå 3 enligt tillverkarens rekommendation för patientprover med östradiolvärden >250 pg/mL (917,5 pmol/L). § Nödvändig data för att fastställa medelvärden och acceptabla mätområden för denna analys kunde inte insamlas på grund av ett alltför begränsat deltagarantal vid tilldelning av värden. Om din institution/ditt laboratorium önskar deltaga i programmet för tilldelning av värden (Value Assignment Program) för denna analys, var god kontakta Bio-Rads försäljningsavdelning eller tekniska serviceavdelning. ENDAST FÖR INTERNATIONELLT BRUK - Följande avsnitt innehåller data för metoder som inte är tillgängliga för diagnostiskt bruk i USA.

DANSK Til dette kontrolparti: Parathyreoidea- hormon:

Der er ikke fastsat forventede værdier eller holdbarhed. (1) Angiver kun endogene niveauer. (2) Der er ikke fastsat forventede værdier eller holdbarhed. (3) Værdier er ikke angivet. (4) Fortynd niveau 3 iht. producentens anbefaling vedr. patientprøver med estradiol-værdier på >250 pg/mL (917,5 pmol/L). § P.g.a. for lille tilslutning til vores “Value Assignment Program” har det desværre ikke været muligt at have middelværdien og standart variationenværdien med på denne analyse. Skulle du/i være iinteresseret i at deltage i dette program for denne analyse, så kontakt venligst det lokale Bio-Rad. KUN TIL INTERNATIONAL BRUG - Følgende afsnit indeholder data til metoder, der ikke er tilgængelige til diagnostisk anvendelse i USA.

Page 20: Lyphochek Immunoassay 370 Data Sheet

Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

- INTERNATIONAL USE ONLY -

The following section contains

data for methods that are not

available for diagnostic use in

the United States.

Page 21: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

METHODMethode // Méthode // Metodo // Método // Método // Metod // Metode

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

17 - ALPHA - HYDROXYPROGESTERONE

DiaMetra ELISA ng/mL 0.580 <0.100 – 0.960 2.87 1.80 – 3.94 7.64 4.51 – 10.8 nmol/L 1.76 <0.303 – 2.91 8.70 5.45 – 11.9 23.1 13.7 – 32.6

DIAsource RIA CT ng/mL 1.22 0.960 – 1.47 3.67 3.00 – 4.35 6.84 4.42 – 9.26 nmol/L 3.70 2.91 – 4.45 11.1 9.09 – 13.2 20.7 13.4 – 28.1

IBL ELISA ng/mL § § § nmol/L § § §

Immunotech Beckman Coulter RIA ng/mL 1.02 0.680 – 1.35 3.40 2.70 – 4.10 7.85 6.20 – 9.50 nmol/L 3.09 2.06 – 4.09 10.3 8.18 – 12.4 23.8 18.8 – 28.8

ACETAMINOPHEN

Cambridge Life Sciences Paracetamol μg/mL 13.5 10.7 – 16.2 45.2 36.1 – 54.3 130 104 – 156 μmol/L 89.0 71.0 – 107 299 239 – 359 858 686 – 1030

ACTH

BRAHMS Diagnostica LIA pg/mL 19.0 14.0 – 24.0 125 102 – 148 282 242 – 322 pmol/L 4.18 3.08 – 5.28 27.5 22.4 – 32.6 62.0 53.2 – 70.8

BRAHMS Diagnostica RIA pg/mL 18.0 13.0 – 23.0 127 107 – 147 285 238 – 332 pmol/L 3.96 2.86 – 5.06 27.9 23.5 – 32.3 62.7 52.4 – 73.0

Cisbio Bioassays ELSA pg/mL 79.0 55.0 – 103 310 250 – 370 620 490 – 750 pmol/L 17.4 12.1 – 22.7 68.2 55.0 – 81.4 136 108 – 165

DIAsource IRMA pg/mL 12.4 8.70 – 16.2 55.9 39.1 – 72.7 147 103 – 192 pmol/L 2.73 1.91 – 3.56 12.3 8.60 – 16.0 32.3 22.7 – 42.2

Immunotech Beckman Coulter IRMA pg/mL <13.4 60.6 42.4 – 78.7 209 146 – 272 pmol/L <2.95 13.3 9.33 – 17.3 46.0 32.1 – 59.8

AFP

BioCheck EIA ng/mL 21.3 13.3 – 29.2 110 70.9 – 148 269 172 – >300 IU/mL 17.7 11.0 – 24.2 91.3 58.8 – 123 223 143 – >249

Bioserv ELISA IU/mL § § § kIU/L § § §

Cisbio Bioassays ELSA2 ng/mL 29.6 23.2 – 36.0 128 102 – 154 243 194 – 292 IU/mL 24.6 19.3 – 29.9 106 84.7 – 128 202 161 – 242

Cisbio Bioassays RG IU/mL 15.4 12.3 – 18.5 67.0 54.0 – 80.0 141 113 – 169 kIU/L 15.4 12.3 – 18.5 67.0 54.0 – 80.0 141 113 – 169

DiaMetra ELISA ng/mL 12.4 9.01 – 15.8 61.0 48.2 – 73.7 98.3 71.1 – 126 IU/mL 10.3 7.48 – 13.1 50.6 40.0 – 61.2 81.6 59.0 – 104

DiaSorin IRMA-mat IU/mL 13.7 9.60 – 17.8 69.3 53.7 – 84.9 150 119 – 182 kIU/L 13.7 9.60 – 17.8 69.3 53.7 – 84.9 150 119 – 182

DIAsource IRMA IU/mL 21.6 15.6 – 27.7 115 86.0 – 144 300 188 – 411 kIU/L 21.6 15.6 – 27.7 115 86.0 – 144 300 188 – 411

Immunotech Beckman Coulter Screen IRMA ng/mL 19.9 16.0 – 23.7 105 82.2 – 128 213 159 – >265 IU/mL 16.5 13.3 – 19.7 87.2 68.2 – 106 177 132 – >220

Immunotech Beckman Coulter IRMA ng/mL 18.8 15.7 – 22.0 95.8 78.6 – 113 213 182 – 243 IU/mL 15.6 13.0 – 18.3 79.5 65.2 – 93.7 177 151 – 202

Inst. of Isotopes IRMA CT IU/mL 15.0 12.0 – 18.0 74.3 59.4 – 89.1 156 125 – 188 kIU/L 15.0 12.0 – 18.0 74.3 59.4 – 89.1 156 125 – 188

NETRIA IRMA Bead IU/mL 20.0 14.0 – 26.0 77.0 66.0 – 88.0 140 124 – 155 kIU/L 20.0 14.0 – 26.0 77.0 66.0 – 88.0 140 124 – 155

Radim ALISEI ng/mL 16.9 11.4 – 22.5 87.2 68.7 – 106 196 153 – 239 IU/mL 14.1 9.47 – 18.6 72.4 57.0 – 87.7 163 127 – 199

Radim IRMA CT ng/mL 15.9 11.8 – 20.0 76.6 53.3 – 100 154 108 – 200 IU/mL 13.2 9.78 – 16.6 63.6 44.2 – 83.0 128 89.6 – 166

Siemens Coat-A-Count IRMA IU/mL § § § kIU/L § § §

Wallac DELFIA hAFP TR-FIA ng/mL 18.1 14.5 – 21.7 86.7 69.9 – 104 190 152 – 229 IU/mL 15.0 12.0 – 18.0 72.0 58.0 – 86.0 158 126 – 190

Wallac DELFIA Xpress hAFP ng/mL 18.1 14.5 – 21.7 88.0 69.9 – 106 195 157 – 234 IU/mL 15.0 12.0 – 18.0 73.0 58.0 – 88.0 162 130 – 194

ALDOSTERONE

Adaltis MAIA pg/mL 142 82.0 – 201 343 199 – 488 660 383 – 937 pmol/L 392 227 – 556 951 552 – 1351 1828 1061 – 2597

Cisbio Bioassays RIACT pg/mL 42.0 34.0 – 50.0 124 99.0 – 149 199 149 – 249 pmol/L 116 94.2 – 139 343 274 – 413 551 413 – 690

DiaMetra ELISA Microplate pg/mL § § § pmol/L § § §

DiaSorin ALDOCTK-2 RIA pg/mL 98.2 68.2 – 128 317 250 – 385 642 469 – 815 pmol/L 272 189 – 355 878 693 – 1066 1778 1299 – 2258

Immunotech Beckman Coulter RIA pg/mL <40.0 181 110 – 252 492 285 – 699 pmol/L <111 501 305 – 698 1363 789 – 1936

ZenTech RIAZENCo pg/mL 151 121 – 181 355 284 – 426 683 547 – 820 pmol/L 418 334 – 501 983 786 – 1179 1893 1514 – 2271

ANDROSTENEDIONE

DiaMetra ELISA ng/mL 0.570 0.150 – 1.00 3.13 1.86 – 4.40 9.15 5.49 – >10.0 nmol/L 1.99 0.524 – 3.49 10.9 6.49 – 15.4 31.9 19.2 – >34.9

DIAsource RIA CT ng/mL 0.920 0.720 – 1.12 3.29 2.72 – 3.86 7.41 6.06 – 8.76 nmol/L 3.21 2.51 – 3.91 11.5 9.49 – 13.5 25.9 21.1 – 30.6

Immunotech Beckman Delta 4 RIA ng/mL 0.880 0.510 – 1.25 2.70 1.60 – 3.80 5.80 3.20 – 8.40 nmol/L 3.07 1.78 – 4.36 9.42 5.58 – 13.3 20.2 11.2 – 29.3

ZenTech RIAZENCo ng/mL 0.740 0.590 – 0.890 2.73 2.19 – 3.28 7.06 5.65 – 8.47 nmol/L 2.58 2.06 – 3.11 9.53 7.64 – 11.4 24.6 19.7 – 29.6

ANGIOTENSIN I (1)

Cisbio Bioassays Active Renin (Gen 3) pg/mL 33.0 26.0 – 40.0 59.0 47.0 – 71.0 60.0 48.0 – 72.0 pmol/L 25.5 20.1 – 30.9 45.5 36.3 – 54.8 46.3 37.1 – 55.6

DiaSorin RENCTK RIA ng/mL/hr 2.20 1.70 – 2.70 5.00 3.60 – 6.40 4.30 3.20 – 5.40 μg/L/hr 2.20 1.70 – 2.70 5.00 3.60 – 6.40 4.30 3.20 – 5.40

ZenTech RIAZEN Renin Plasma Activity ng/mL/hr 3.74 2.39 – 5.09 8.77 5.31 – 12.2 8.21 4.36 – 12.1 μg/L/hr 3.74 2.39 – 5.09 8.77 5.31 – 12.2 8.21 4.36 – 12.1

C-PEPTIDE

DIAsource C-PEP II RIA CT ng/mL 0.997 0.544 – 1.45 4.59 3.41 – 5.77 6.04 3.02 – 9.06 pmol/mL 0.330 0.180 – 0.480 1.52 1.13 – 1.91 2.00 1.00 – 3.00

Immunotech Beckman Coulter IRMA ng/mL 1.38 0.879 – 1.88 5.26 3.93 – 6.59 6.85 5.91 – 7.79 pmol/L 456 291 – 622 1742 1302 – 2182 2267 1956 – 2577

Technogenetics MYRIA IRMA ng/mL 1.18 0.876 – 1.48 4.83 3.63 – 6.04 6.95 5.14 – 8.76 nmol/L 0.390 0.290 – 0.490 1.60 1.20 – 2.00 2.30 1.70 – 2.90

CALCITONIN

Cisbio Bioassays IRMA pg/mL 75.0 60.0 – 90.0 250 200 – 300 350 280 – 420 ng/L 75.0 60.0 – 90.0 250 200 – 300 350 280 – 420

DIAsource CT IRMA pg/mL 45.1 40.2 – 50.0 172 151 – 193 238 207 – 270 ng/L 45.1 40.2 – 50.0 172 151 – 193 238 207 – 270

EUROIMMUN IRMA CT pg/mL 65.0 52.0 – 78.0 258 206 – 310 501 401 – 601 ng/L 65.0 52.0 – 78.0 258 206 – 310 501 401 – 601

IBL IRMA pg/mL 56.0 45.0 – 67.0 277 222 – 333 511 409 – 614 ng/L 56.0 45.0 – 67.0 277 222 – 333 511 409 – 614

Inst. of Isotopes hCalcitonin IRMA CT pg/mL 55.0 44.0 – 66.0 247 197 – 296 443 355 – 532 ng/L 55.0 44.0 – 66.0 247 197 – 296 443 355 – 532

Medipan IRMA Magnum pg/mL 55.0 42.0 – 78.0 215 160 – 270 430 325 – 535 ng/L 55.0 42.0 – 78.0 215 160 – 270 430 325 – 535

Medipan SELco IRMA pg/mL 64.0 48.0 – 80.0 270 205 – 335 490 370 – 610 ng/L 64.0 48.0 – 80.0 270 205 – 335 490 370 – 610

CARBAMAZEPINE

Sekisui CEDIA II μg/mL 2.80 2.20 – 3.40 8.90 7.10 – 10.6 14.8 11.8 – 17.7 μmol/L 11.8 9.31 – 14.4 37.6 30.0 – 44.8 62.6 49.9 – 74.9

Sekisui Nanopia TDM μg/mL 2.00 1.60 – 2.40 7.90 6.30 – 9.50 13.4 10.7 – 16.1 μmol/L 8.46 6.77 – 10.2 33.4 26.6 – 40.2 56.7 45.3 – 68.1

CEA

BioCheck EIA ng/mL 2.37 1.05 – 3.69 19.6 15.1 – 24.1 42.0 29.1 – 54.9 μg/L 2.37 1.05 – 3.69 19.6 15.1 – 24.1 42.0 29.1 – 54.9

Calbiotech ELISA ng/mL 3.51 1.89 – 5.14 32.6 19.9 – 45.4 >50.0 μg/L 3.51 1.89 – 5.14 32.6 19.9 – 45.4 >50.0

Cisbio Bioassays ELSA2 ng/mL 3.50 2.80 – 4.20 17.3 13.8 – 20.8 36.0 29.0 – 43.0 μg/L 3.50 2.80 – 4.20 17.3 13.8 – 20.8 36.0 29.0 – 43.0

Cisbio Bioassays RIACT ng/mL 1.86 1.49 – 2.23 12.6 10.1 – 15.1 29.8 23.6 – 36.0 μg/L 1.86 1.49 – 2.23 12.6 10.1 – 15.1 29.8 23.6 – 36.0

DiaMetra ELISA ng/mL 2.62 1.01 – 4.20 14.9 11.1 – 18.7 27.4 18.4 – 36.5 μg/L 2.62 1.01 – 4.20 14.9 11.1 – 18.7 27.4 18.4 – 36.5

DiaSorin IRMA-coat ng/mL 3.50 2.70 – 4.30 27.0 21.6 – 32.4 63.0 50.3 – 75.7 μg/L 3.50 2.70 – 4.30 27.0 21.6 – 32.4 63.0 50.3 – 75.7

DIAsource IRMA ng/mL 2.28 1.40 – 3.17 19.0 16.1 – 22.0 47.2 35.1 – 59.4 μg/L 2.28 1.40 – 3.17 19.0 16.1 – 22.0 47.2 35.1 – 59.4

Inst.of Isotopes IRMA CT ng/mL 2.40 1.90 – 2.90 17.1 13.7 – 20.5 39.4 31.5 – 47.3 μg/L 2.40 1.90 – 2.90 17.1 13.7 – 20.5 39.4 31.5 – 47.3

NETRIA IRMA Bead ng/mL 1.85 1.40 – 2.30 16.9 10.9 – 22.9 72.3 41.0 – 104 μg/L 1.85 1.40 – 2.30 16.9 10.9 – 22.9 72.3 41.0 – 104

Radim ALISEI ng/mL 4.85 2.70 – 7.00 34.3 24.5 – 44.0 57.5 46.4 – 68.5 μg/L 4.85 2.70 – 7.00 34.3 24.5 – 44.0 57.5 46.4 – 68.5

Radim IRMA CT ng/mL 3.00 2.30 – 3.65 20.2 14.2 – 26.1 39.7 29.4 – 50.0 μg/L 3.00 2.30 – 3.65 20.2 14.2 – 26.1 39.7 29.4 – 50.0

UBI Magiwel Quantitative ELISA ng/mL 2.36 1.51 – 3.20 16.3 11.8 – 20.7 21.2 – >30.0 μg/L 2.36 1.51 – 3.20 16.3 11.8 – 20.7 21.2 – >30.0

Page 22: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

CHLORAMPHENICOL

EuroProxima EIA μg/mL 5.60 4.40 – 6.90 9.70 7.20 – 12.2 18.5 13.3 – 23.7 μmol/L 17.3 13.6 – 21.4 30.0 22.3 – 37.8 57.3 41.2 – 73.4

CORTISOL

ADALTIS RIA Bridge ng/mL § § § nmol/L § § §

Calbiotech ELISA ng/mL 29.1 21.4 – 36.8 187 164 – 209 391 346 – 437 nmol/L 80.3 59.0 – 102 516 453 – 577 1079 955 – 1206

CIS-Bio International - Schering Spectra RIA μg/dL 2.27 1.91 – 2.63 16.1 13.8 – 18.4 28.7 24.3 – 33.1 nmol/L 62.6 52.6 – 72.5 445 382 – 508 792 670 – 914

DiaMetra ELISA ng/mL 17.5 <10.0 – 30.9 205 109 – 300 349 230 – 469 nmol/L 48.4 <27.6 – 85.4 565 302 – 828 964 633 – 1295

Immunotech Beckman Coulter RIA μg/dL 2.82 0.779 – 4.86 14.9 5.69 – 24.0 22.3 11.7 – 32.9 nmol/L 77.7 21.5 – 134 410 157 – 663 616 323 – 909

Monobind AccuBind ELISA μg/dL 3.35 2.25 – 4.46 18.9 12.6 – 25.1 30.9 20.7 – 41.2 nmol/L 92.5 62.1 – 123 521 349 – 693 854 572 – 1136

Monobind AccuLite CLIA μg/dL 3.37 2.26 – 4.48 19.9 13.3 – 26.4 32.0 21.5 – 42.6 nmol/L 93.0 62.4 – 124 549 368 – 730 884 592 – 1176

NETRIA EIA Microtitre Plate μg/dL 3.89 2.61 – 5.18 11.1 9.82 – 12.4 24.3 21.0 – 27.5 nmol/L 108 72.0 – 143 306 271 – 341 670 580 – 760

Orion Diagnostics Spectria RIA μg/dL 2.27 1.91 – 2.63 16.1 13.8 – 18.4 28.7 24.3 – 33.1 nmol/L 62.6 52.6 – 72.5 445 382 – 508 792 670 – 914

Radim ALISEI ng/mL 44.3 27.5 – 61.0 216 140 – 292 285 196 – 373 nmol/L 122 75.9 – 168 596 386 – 806 785 541 – 1029

Radim RIA CT ng/mL 39.1 20.0 – 58.1 248 172 – 324 426 280 – 571 nmol/L 108 55.2 – 160 684 475 – 894 1174 773 – 1576

Wallac DELFIA TR-FIA μg/dL § § § nmol/L § § §

DHEA

Immunotech Beckman Coulter RIA ng/mL 0.755 0.300 – 1.21 2.56 1.02 – 4.09 5.75 2.30 – 9.20 nmol/L 2.62 1.04 – 4.20 8.88 3.54 – 14.2 20.0 7.98 – 31.9

DHEA-SULFATE

CIS-Bio International / Schering Spectria RIA μg/dL § § § μmol/L § § §

DiaMetra ELISA μg/mL 0.600 0.360 – 0.840 1.29 0.690 – 1.90 4.61 2.89 – 6.33 μmol/L 1.62 0.972 – 2.27 3.48 1.86 – 5.13 12.4 7.80 – 17.1

DIAsource RIA CT μg/dL 68.5 59.6 – 77.4 136 106 – 165 473 429 – 517 μmol/L 1.85 1.61 – 2.09 3.67 2.86 – 4.46 12.8 11.6 – 14.0

Immunotech Beckman Coulter RIA μg/dL 64.5 47.0 – 82.0 136 99.0 – 172 846 491 – >900 μmol/L 1.74 1.27 – 2.21 3.66 2.67 – 4.64 22.8 13.3 – >24.3

Orion Diagnostica Spectra RIA μg/dL § § § μmol/L § § §

Radim ALISEI μg/mL 1.15 0.510 – 1.80 2.70 1.40 – 4.00 7.00 3.50 – >10.0 μmol/L 3.10 1.38 – 4.86 7.29 3.78 – 10.8 18.9 9.45 – >27.0

Radim RIA CT μg/mL 0.460 0.250 – 0.670 1.24 0.560 – 1.93 7.44 4.27 – 10.6 μmol/L 1.24 0.675 – 1.81 3.35 1.51 – 5.21 20.1 11.5 – 28.6

DIGOXIN

Sekisui DRI Latex Turbidity Immunoassay (DPC) ng/mL 0.640 0.510 – 0.770 1.98 1.59 – 2.38 3.16 2.52 – 3.79 nmol/L 0.819 0.653 – 0.986 2.53 2.04 – 3.05 4.04 3.23 – 4.85

ESTRADIOL

CIS-Bio International / Schering Spectria RIA pg/mL 29.2 22.6 – 36.0 172 146 – 197 436 373 – 499 pmol/L 107 82.8 – 132 630 536 – 724 1601 1369 – 1833

CIS-Bio International / Schering Spectria Sensitive RIA pg/mL 16.7 12.4 – 21.0 73.8 59.9 – 87.7 181 134 – 229 pmol/L 61.2 45.4 – 76.9 271 220 – 322 666 490 – 841

Cisbio Bioassays RIACT pg/mL 11.2 7.80 – 14.6 293 236 – 350 610 490 – 730 pmol/L 41.1 28.6 – 53.6 1075 866 – 1285 2239 1798 – 2679

DiaMetra ELISA Microplate pg/mL § § § pmol/L § § §

DIAsource RIA CT pg/mL 71.6 50.1 – 93.1 181 126 – 235 298 224 – 371 pmol/L 263 184 – 342 664 462 – 862 1094 822 – 1362

Immunotech Beckman Coulter RIA pg/mL 16.0 6.40 – 25.5 70.0 55.0 – 85.0 172 131 – 213 pmol/L 58.5 23.5 – 93.6 257 202 – 312 631 481 – 782

Orion Diagnostica Spectria Sensitive RIA pg/mL 16.7 12.4 – 21.0 73.8 59.9 – 87.7 181 134 – 229 pmol/L 61.2 45.4 – 76.9 271 220 – 322 666 490 – 841

Orion Diagnostica Spectria RIA pg/mL 29.2 22.6 – 36.0 172 143 – 197 436 373 – 499 pmol/L 107 82.8 – 132 630 526 – 724 1601 1369 – 1833

Radim RIA CT pg/mL 40.0 <20.0 – 80.0 250 140 – 359 673 472 – 873 pmol/L 147 <73.4 – 294 918 514 – 1318 2470 1732 – 3204

ESTRIOL FREE

Adaltis MAIA ng/mL 2.11 1.05 – 3.16 5.55 3.57 – 7.52 7.92 4.98 – 10.9 nmol/L 7.32 3.64 – 11.0 19.3 12.4 – 26.1 27.5 17.3 – 37.7

DiaMetra ELISA Microplate ng/mL § § § nmol/L § § §

Immunotech Beckman Unconjugated Estriol RIA ng/mL 1.35 0.800 – 1.90 5.10 3.40 – 6.80 10.5 7.00 – 13.9 nmol/L 4.68 2.78 – 6.59 17.7 11.8 – 23.6 36.3 24.3 – 48.2

Radim RIA CT ng/mL 2.55 1.69 – 3.42 6.55 5.00 – 8.10 12.7 9.00 – 16.4 nmol/L 8.85 5.86 – 11.9 22.7 17.4 – 28.1 44.1 31.2 – 56.9

Wallac DELFIA Unconjugated Estriol (UE3) TR-FIA ng/mL 1.96 1.38 – 2.54 6.34 4.32 – 8.36 12.1 9.80 – >14.4 nmol/L 6.80 4.80 – 8.80 22.0 15.0 – 29.0 42.0 34.0 – >50.0

Wallac DELFIA Xpress Unconjugated Estriol (UE3) ng/mL 1.64 1.15 – 2.13 6.34 4.32 – 8.36 9.22 7.49 – 11.0 nmol/L 5.70 4.00 – 7.40 22.0 15.0 – 29.0 32.0 26.0 – 38.0

ZenTech RIAZEN ng/mL 2.11 1.05 – 3.16 5.55 3.57 – 7.52 7.92 4.98 – 10.9 nmol/L 7.32 3.64 – 11.0 19.3 12.4 – 26.1 27.5 17.3 – 37.7

FERRITIN

DiaMetra ELISA ng/mL 56.0 31.8 – 80.2 118 82.1 – 154 221 131 – 311 μg/L 56.0 31.8 – 80.2 118 82.1 – 154 221 131 – 311

DiaSorin IRMA-mat ng/mL 67.3 51.2 – 83.4 144 109 – 179 355 270 – 440 μg/L 67.3 51.2 – 83.4 144 109 – 179 355 270 – 440

Immunotech Beckman Coulter IRMA ng/mL 73.2 46.8 – 100 144 98.5 – 189 318 226 – 410 μg/L 73.2 46.8 – 100 144 98.5 – 189 318 226 – 410

NETRIA IRMA Bead ng/mL 74.5 68.0 – 81.0 143 109 – 176 377 305 – 448 μg/L 74.5 68.0 – 81.0 143 109 – 176 377 305 – 448

Radim ALISEI ng/mL 87.5 65.0 – 110 164 118 – 210 340 200 – 480 μg/L 87.5 65.0 – 110 164 118 – 210 340 200 – 480

Radim IRMA CT ng/mL 66.3 53.1 – 79.4 135 110 – 160 263 173 – 353 μg/L 66.3 53.1 – 79.4 135 110 – 160 263 173 – 353

Wallac DELFIA TR-FIA ng/mL 55.0 41.0 – 69.0 142 107 – 178 350 263 – 438 μg/L 55.0 41.0 – 69.0 142 107 – 178 350 263 – 438

FOLATE

Wallac DELFIA TR-FIA ng/mL § § § nmol/L § § §

FSH

Bioserv ELISA mIU/mL 6.50 4.50 – 8.50 29.5 26.0 – 33.0 55.0 40.0 – 70.0 IU/L 6.50 4.50 – 8.50 29.5 26.0 – 33.0 55.0 40.0 – 70.0

DiaMetra ELISA mIU/mL 7.41 4.96 – 9.85 31.0 20.9 – 41.1 49.3 27.2 – 71.3 IU/L 7.41 4.96 – 9.85 31.0 20.9 – 41.1 49.3 27.2 – 71.3

DIAsource IRMA mIU/mL 6.55 5.51 – 7.59 28.4 25.3 – 31.6 47.8 42.1 – 53.5 IU/L 6.55 5.51 – 7.59 28.4 25.3 – 31.6 47.8 42.1 – 53.5

Immunotech Beckman Coulter IRMA mIU/mL 4.88 3.96 – 5.80 29.8 26.8 – 32.8 46.3 40.4 – 52.1 IU/L 4.88 3.96 – 5.80 29.8 26.8 – 32.8 46.3 40.4 – 52.1

Inst.of Isotopes hFSH IRMA CT mIU/mL 7.40 5.90 – 8.90 28.3 22.6 – 34.0 45.2 36.2 – 54.2 IU/L 7.40 5.90 – 8.90 28.3 22.6 – 34.0 45.2 36.2 – 54.2

NETRIA IRMA Bead mIU/mL 8.10 6.40 – 9.80 22.5 20.1 – 25.0 49.5 41.0 – 58.0 IU/L 8.10 6.40 – 9.80 22.5 20.1 – 25.0 49.5 41.0 – 58.0

Radim ALISEI mIU/mL 9.70 5.80 – 13.7 37.0 26.5 – 47.6 61.4 35.8 – 87.1 IU/L 9.70 5.80 – 13.7 37.0 26.5 – 47.6 61.4 35.8 – 87.1

Radim IRMA CT mIU/mL 8.40 5.80 – 11.0 30.0 24.0 – 36.0 37.7 27.7 – 47.7 IU/L 8.40 5.80 – 11.0 30.0 24.0 – 36.0 37.7 27.7 – 47.7

GASTRIN

Cisbio Bioassays GASK-PR μIU/mL 64.0 51.0 – 77.0 330 260 – 400 870 700 – 1040 μIU/mL 64.0 51.0 – 77.0 330 260 – 400 870 700 – 1040

GENTAMICIN

EuroProxima EIA μg/mL 2.00 1.30 – 2.70 4.60 3.10 – 6.10 7.00 4.70 – 9.30 μmol/L 4.18 2.72 – 5.64 9.61 6.48 – 12.7 14.6 9.82 – 19.4

GLUCAGON (1)

Adaltis RIA pg/mL 158 99.9 – 217 174 101 – 246 142 79.2 – 206 ng/L 158 99.9 – 217 174 101 – 246 142 79.2 – 206

ZenTech RIAZEN pg/mL 158 99.9 – 217 176 101 – 246 142 79.2 – 206 ng/L 158 99.9 – 217 176 101 – 246 142 79.2 – 206

hCG

Bioserv ELISA mIU/mL 4.00 2.00 – 6.00 11.0 8.00 – 14.0 85.0 60.0 – 110 IU/L 4.00 2.00 – 6.00 11.0 8.00 – 14.0 85.0 60.0 – 110

Calbiotech ELISA mIU/mL 18.4 13.0 – 23.7 60.8 48.0 – 73.6 238 221 – >250 IU/L 18.4 13.0 – 23.7 60.8 48.0 – 73.6 238 221 – >250

Cisbio Bioassays RG mIU/mL 7.90 6.30 – 9.50 29.8 23.6 – 36.0 256 202 – 310 IU/L 7.90 6.30 – 9.50 29.8 23.6 – 36.0 256 202 – 310

DIAsource hCG + Beta IRMA mIU/mL 9.28 6.50 – 12.1 30.8 23.5 – 38.0 194 162 – 225 IU/L 9.28 6.50 – 12.1 30.8 23.5 – 38.0 194 162 – 225

Page 23: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

hCG (continued)

Immunotech Beckman Coulter IRMA mIU/mL 5.69 2.90 – 8.49 17.5 13.9 – 21.0 135 119 – 152 IU/L 5.69 2.90 – 8.49 17.5 13.9 – 21.0 135 119 – 152

Netria IRMA Bead mIU/mL § § § IU/L § § §

hCG-BETA SUBUNIT

Cisbio Bioassays ELSA FbHCG ng/mL <0.040 <0.040 0.210 0.170 – 0.250 μg/L <0.040 <0.040 0.210 0.170 – 0.250

DiaMetra ELISA mIU/mL 1.57 <1.00 – 2.55 9.27 5.91 – 12.6 102 71.7 – 132 IU/L 1.57 <1.00 – 2.55 9.27 5.91 – 12.6 102 71.7 – 132

Inst.of Isotopes IRMA CT mIU/mL 11.3 9.00 – 13.5 41.7 33.4 – 50.1 338 270 – 406 IU/L 11.3 9.00 – 13.5 41.7 33.4 – 50.1 338 270 – 406

Radim ALISEI mIU/mL 7.75 4.00 – 11.5 22.2 14.8 – 29.6 153 115 – 190 IU/L 7.75 4.00 – 11.5 22.2 14.8 – 29.6 153 115 – 190

Radim IRMA CT mIU/mL 4.09 1.49 – 6.70 16.9 12.0 – 21.7 182 119 – 246 IU/L 4.09 1.49 – 6.70 16.9 12.0 – 21.7 182 119 – 246

NETRIA IRMA Bead mIU/mL 8.10 6.00 – 10.0 17.0 14.0 – 20.0 185 140 – 230 IU/L 8.10 6.00 – 10.0 17.0 14.0 – 20.0 185 140 – 230

hGH

Adaltis MAIACLONE μIU/mL 10.7 7.47 – 14.0 28.0 21.0 – 34.9 54.1 42.9 – 65.3 mIU/L 10.7 7.47 – 14.0 28.0 21.0 – 34.9 54.1 42.9 – 65.3

Bioclone IRMA μIU/mL § § § mIU/L § § §

Cisbio Bioassays RIACT μIU/mL 6.60 5.30 – 7.90 18.6 14.9 – 22.3 38.0 30.0 – 46.0 mIU/L 6.60 5.30 – 7.90 18.6 14.9 – 22.3 38.0 30.0 – 46.0

DiaMetra ELISA Microplate μIU/mL 16.4 11.5 – 21.3 44.1 10.1 – 78.2 101 61.7 – 141 mIU/L 16.4 11.5 – 21.3 44.1 10.1 – 78.2 101 61.7 – 141

DIAsource IRMA μIU/mL 5.92 5.04 – 6.79 15.1 12.9 – 17.3 38.6 29.4 – 47.9 mIU/L 5.92 5.04 – 6.79 15.1 12.9 – 17.3 38.6 29.4 – 47.9

IDS S.A. IRMA Coated Tubes μIU/mL 10.5 7.30 – 13.6 27.4 20.0 – 34.8 60.5 46.0 – 75.0 mIU/L 10.5 7.30 – 13.6 27.4 20.0 – 34.8 60.5 46.0 – 75.0

Immunotech Beckman Coulter IRMA μIU/mL 7.60 5.30 – 9.90 18.9 13.8 – 23.9 40.2 30.5 – 49.8 mIU/L 7.60 5.30 – 9.90 18.9 13.8 – 23.9 40.2 30.5 – 49.8

Inst.of Isotopes IRMA CT μIU/mL 9.00 7.20 – 10.8 23.2 18.6 – 27.8 50.7 40.6 – 60.8 mIU/L 9.00 7.20 – 10.8 23.2 18.6 – 27.8 50.7 40.6 – 60.8

NETRIA IRMA Bead μIU/mL 7.20 5.10 – 9.30 18.0 14.0 – 22.0 39.5 34.0 – 45.0 mIU/L 7.20 5.10 – 9.30 18.0 14.0 – 22.0 39.5 34.0 – 45.0

Radim ALISEI ng/mL § § § μg/L § § §

Radim IRMA CT ng/mL 4.15 2.80 – 5.50 8.25 6.50 – 10.0 16.0 12.0 – 20.0 μg/L 4.15 2.80 – 5.50 8.25 6.50 – 10.0 16.0 12.0 – 20.0

IMMUNOGLOBULIN E

Adaltis Total IgE Bridge IU/mL § § § kIU/L § § §

Allergopharma ELISA IU/mL 427 299 – 555 89.0 62.0 – 116 124 87.0 – 161 kIU/L 427 299 – 555 89.0 62.0 – 116 124 87.0 – 161

Bioclone IRMA IU/mL § § § kIU/L § § §

DiaMetra ELISA IU/mL >286 88.4 57.3 – 120 112 81.1 – 143 kIU/L >286 88.4 57.3 – 120 112 81.1 – 143

EUROIMMUN Total IgE ELISA IU/mL 319 223 – 415 64.0 45.0 – 83.0 80.0 56.0 – 104 kIU/L 319 223 – 415 64.0 45.0 – 83.0 80.0 56.0 – 104

Immunotech Beckman Coulter Total IRMA IU/mL 330 220 – 440 68.5 48.0 – 89.0 89.0 65.0 – 113 kIU/L 330 220 – 440 68.5 48.0 – 89.0 89.0 65.0 – 113

Phadia ImmunoCAP total IgE IU/mL 341 238 – 444 72.0 50.0 – 94.0 94.0 66.0 – 123 kIU/L 341 238 – 444 72.0 50.0 – 94.0 94.0 66.0 – 123

Radim Total BRIO IU/mL 382 185 – 579 74.5 47.0 – 102 104 69.0 – 139 kIU/L 382 185 – 579 74.5 47.0 – 102 104 69.0 – 139

Radim Total IRMA CT IU/mL 385 235 – 535 75.0 53.0 – 97.0 71.0 50.0 – 92.0 kIU/L 385 235 – 535 75.0 53.0 – 97.0 71.0 50.0 – 92.0

Radim ALLERgen Total IU/mL 266 190 – 341 57.0 40.0 – 74.0 73.0 53.0 – 93.0 kIU/L 266 190 – 341 57.0 40.0 – 74.0 73.0 53.0 – 93.0

Siemens Coat-A-Count IRMA IU/mL § § § kIU/L § § §

ZenTech IRMAZENCO IU/mL § § § kIU/L § § §

INSULIN

Adaltis RIA μIU/mL 23.0 12.0 – 33.9 75.0 39.1 – 111 >137 pmol/L 160 83.3 – 235 521 271 – 771 >954

Cisbio Bioassays BI-Insulin-IRMA μIU/mL 18.4 14.7 – 22.1 55.0 44.0 – 66.0 155 124 – 186 pmol/L 128 102 – 153 382 306 – 458 1076 861 – 1292

CIS Bio International / Schering μIU/mL § § § pmol/L § § §

DakoCytomation ELISA μIU/mL § § § pmol/L § § §

DiaMetra ELISA μIU/mL 14.3 10.4 – 18.1 42.6 32.4 – 52.8 95.3 64.1 – 126 pmol/L 99.2 72.5 – 126 296 225 – 367 662 445 – 878

DIAsource IRMA μIU/mL 16.8 12.6 – 21.0 59.5 50.9 – 68.0 189 164 – 215 pmol/L 117 87.5 – 146 413 354 – 472 1313 1139 – 1493

Immunotech Beckman Coulter IRMA μIU/mL 13.2 11.4 – 15.0 44.4 40.6 – 48.1 137 122 – 151 pmol/L 91.7 79.2 – 104 308 282 – 334 951 847 – 1049

Kanto Cias (Biomajesty) μIU/mL 15.1 11.3 – 18.9 51.3 43.6 – 59.0 >100 pmol/L 105 78.5 – 131 356 303 – 410 >695

Technogenetics MYRIA IRMA μIU/mL 15.3 11.6 – 19.0 53.5 40.0 – 67.0 135 105 – 165 pmol/L 106 80.6 – 132 372 278 – 465 938 729 – 1146

UBI Magiwel Quantitative ELISA μIU/mL 17.7 12.0 – 23.4 57.6 41.2 – 74.0 154 110 – 199 pmol/L 123 83.3 – 163 400 286 – 514 1070 764 – 1382

LH

Bioserv ELISA mIU/mL 3.50 2.00 – 5.00 28.5 24.0 – 33.0 46.5 38.0 – 55.0 IU/L 3.50 2.00 – 5.00 28.5 24.0 – 33.0 46.5 38.0 – 55.0

DiaMetra ELISA mIU/mL 2.69 1.15 – 4.24 24.8 16.8 – 32.9 47.8 34.1 – 61.5 IU/L 2.69 1.15 – 4.24 24.8 16.8 – 32.9 47.8 34.1 – 61.5

DIAsource IRMA mIU/mL 1.52 0.550 – 2.50 16.0 13.9 – 18.1 41.7 38.3 – 45.1 IU/L 1.52 0.550 – 2.50 16.0 13.9 – 18.1 41.7 38.3 – 45.1

Immunotech Beckman Coulter IRMA mIU/mL 1.78 1.38 – 2.17 21.4 17.4 – 25.5 46.2 41.8 – 50.6 IU/L 1.78 1.38 – 2.17 21.4 17.4 – 25.5 46.2 41.8 – 50.6

Inst.of Isotopes hLH IRMA CT mIU/mL 1.91 1.53 – 2.29 20.2 16.2 – 24.2 49.8 39.8 – 59.8 IU/L 1.91 1.53 – 2.29 20.2 16.2 – 24.2 49.8 39.8 – 59.8

NETRIA IRMA Bead mIU/mL 2.40 1.80 – 3.80 23.0 19.0 – 27.0 >100 IU/L 2.40 1.80 – 3.80 23.0 19.0 – 27.0 >100

Radim ALISEI mIU/mL 2.51 1.40 – 3.62 23.9 16.5 – 31.2 31.0 22.7 – 39.3 IU/L 2.51 1.40 – 3.62 23.9 16.5 – 31.2 31.0 22.7 – 39.3

Radim IRMA CT mIU/mL 1.59 0.890 – 2.30 20.0 15.0 – 25.0 18.9 10.0 – 27.8 IU/L 1.59 0.890 – 2.30 20.0 15.0 – 25.0 18.9 10.0 – 27.8

PAP (PROSTATIC ACID PHOSPHATASE)

Cisbio Bioassays ELSA ng/mL 1.53 1.22 – 1.84 26.5 21.0 – 32.0 >52.0 μg/L 1.53 1.22 – 1.84 26.5 21.0 – 32.0 >52.0

PHENOBARBITAL

Sekisui CEDIA II μg/mL 9.70 7.70 – 11.6 24.9 19.9 – 29.9 55.6 44.5 – 66.8 μmol/L 41.8 33.2 – 50.0 107 85.8 – 129 240 192 – 288

Sekisui Nanopia TDM μg/mL 8.30 6.70 – 10.0 23.9 19.1 – 28.6 53.2 42.6 – 63.8 μmol/L 35.8 28.9 – 43.1 103 82.3 – 123 229 184 – 275

PHENYTOIN

Sekisui CEDIA II μg/mL 5.20 4.20 – 6.30 12.9 10.3 – 15.5 23.7 19.0 – 28.5 μmol/L 20.6 16.6 – 24.9 51.1 40.8 – 61.4 93.9 75.2 – 113

Sekisui Nanopia TDM μg/mL 6.10 4.80 – 7.30 14.3 11.4 – 17.1 26.4 21.1 – 31.6 μmol/L 24.2 19.0 – 28.9 56.6 45.1 – 67.7 105 83.6 – 125

PRIMIDONE

Sekisui DRI (DPC) EIA μg/mL § § § μmol/L § § §

PROGESTERONE

Bioclone ELEGANCE ELISA ng/mL § § § nmol/L § § §

Cisbio Bioassays RIACT ng/mL 0.210 0.150 – 0.270 9.70 7.80 – 11.6 33.0 26.0 – 40.0 nmol/L 0.668 0.477 – 0.859 30.8 24.8 – 36.9 105 82.7 – 127

DiaMetra ELISA ng/mL <0.680 8.95 1.89 – 16.0 34.2 8.60 – 59.8 nmol/L <2.16 28.5 6.01 – 50.9 109 27.3 – 190

DIAsource RIA CT ng/mL 1.08 0.670 – 1.49 9.32 5.96 – 12.7 20.2 14.8 – 25.6 nmol/L 3.43 2.13 – 4.74 29.6 19.0 – 40.4 64.2 47.1 – 81.4

EuroProxima EIA ng/mL 0.410 0.360 – 0.470 7.30 5.20 – 9.40 22.6 19.2 – 25.9 nmol/L 1.30 1.14 – 1.49 23.2 16.5 – 29.9 71.9 61.1 – 82.4

Immunotech Beckman Coulter RIA ng/mL 0.460 0.240 – 0.680 9.30 6.80 – 11.8 29.5 20.0 – 39.0 nmol/L 1.46 0.763 – 2.16 29.6 21.6 – 37.5 93.8 63.6 – 124

NETRIA Progesterone RIA Bead ng/mL § § § nmol/L § § §

Orion Diagnostica Spectria RIA ng/mL 0.623 0.431 – 0.824 7.99 6.26 – 9.69 19.8 15.2 – 24.3 nmol/L 1.98 1.37 – 2.62 25.4 19.9 – 30.8 62.9 48.3 – 77.4

PROLACTIN

Bioserv ELISA ng/mL 9.00 7.00 – 11.0 24.5 20.0 – 29.0 80.0 60.0 – 100 μg/L 9.00 7.00 – 11.0 24.5 20.0 – 29.0 80.0 60.0 – 100

DiaMetra ELISA ng/mL 6.04 4.11 – 7.97 17.9 10.8 – 25.0 37.4 26.8 – 48.1 μg/L 6.04 4.11 – 7.97 17.9 10.8 – 25.0 37.4 26.8 – 48.1

DIAsource IRMA ng/mL 3.13 2.12 – 4.13 11.2 8.80 – 13.6 24.2 21.9 – 26.4 μg/L 3.13 2.12 – 4.13 11.2 8.80 – 13.6 24.2 21.9 – 26.4

Page 24: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

PROLACTIN (continued)

Immunotech Beckman Coulter IRMA ng/mL 5.28 3.98 – 6.57 15.3 12.9 – 17.7 28.8 23.4 – 34.1 μg/L 5.28 3.98 – 6.57 15.3 12.9 – 17.7 28.8 23.4 – 34.1

Inst.of Isotopes hPRL IRMA CT μIU/mL 216 173 – 259 669 535 – 803 1362 1090 – 1634 mIU/L 216 173 – 259 669 535 – 803 1362 1090 – 1634

NETRIA IRMA Bead μIU/mL 173 144 – 202 416 370 – 610 577 531 – 623 mIU/L 173 144 – 202 416 370 – 610 577 531 – 623

Radim ALISEI ng/mL 5.50 4.00 – 7.00 16.5 13.0 – 20.0 27.5 20.0 – 35.0 μg/L 5.50 4.00 – 7.00 16.5 13.0 – 20.0 27.5 20.0 – 35.0

Radim IRMA CT ng/mL 6.00 4.00 – 8.00 19.5 15.0 – 24.0 40.0 30.0 – 50.0 μg/L 6.00 4.00 – 8.00 19.5 15.0 – 24.0 40.0 30.0 – 50.0

PSA

BioCheck EIA ng/mL 1.24 <1.00 – 1.90 4.84 3.70 – 5.98 33.5 24.7 – 42.2 μg/L 1.24 <1.00 – 1.90 4.84 3.70 – 5.98 33.5 24.7 – 42.2

Cisbio Bioassays RIACT ng/mL 1.03 0.820 – 1.24 4.10 3.30 – 4.90 23.0 18.4 – 27.6 μg/L 1.03 0.820 – 1.24 4.10 3.30 – 4.90 23.0 18.4 – 27.6

DiaMetra ELISA t-PSA ng/mL 0.970 <0.500 – 1.63 4.45 2.72 – 6.18 25.8 16.0 – 35.6 μg/L 0.970 <0.500 – 1.63 4.45 2.72 – 6.18 25.8 16.0 – 35.6

Immunotech Beckman Coulter IRMA ng/mL 0.770 0.560 – 0.980 2.98 2.57 – 3.39 19.2 17.5 – 21.0 μg/L 0.770 0.560 – 0.980 2.98 2.57 – 3.39 19.2 17.5 – 21.0

Inst.of Isotopes IRMA CT ng/mL 1.06 0.850 – 1.28 4.35 3.48 – 5.22 29.7 23.8 – 35.7 μg/L 1.06 0.850 – 1.28 4.35 3.48 – 5.22 29.7 23.8 – 35.7

NETRIA IRMA Bead ng/mL 0.310 0.160 – 0.540 4.60 3.20 – 6.00 21.0 17.0 – 25.0 μg/L 0.310 0.160 – 0.540 4.60 3.20 – 6.00 21.0 17.0 – 25.0

Wallac DELFIA ProStatus PSA EQM ng/mL 0.900 0.720 – 1.10 3.50 2.80 – 4.20 22.0 18.0 – 26.0 μg/L 0.900 0.720 – 1.10 3.50 2.80 – 4.20 22.0 18.0 – 26.0

Wallac DELFIA ProStatus PSA Total ng/mL 0.960 0.770 – 1.20 3.50 2.80 – 4.20 22.0 18.0 – 26.0 μg/L 0.960 0.770 – 1.20 3.50 2.80 – 4.20 22.0 18.0 – 26.0

PSA FREE

BioCheck EIA ng/mL § § § μg/L § § §

Calbiotech ELISA ng/mL 0.314 0.190 – 0.440 2.44 0.650 – 4.24 12.7 7.85 – 17.6 μg/L 0.314 0.190 – 0.440 2.44 0.650 – 4.24 12.7 7.85 – 17.6

Cisbio Bioassays RIACT ng/mL 0.430 0.340 – 0.520 1.57 1.26 – 1.88 9.90 7.90 – 11.9 μg/L 0.430 0.340 – 0.520 1.57 1.26 – 1.88 9.90 7.90 – 11.9

DiaMetra ELISA ng/mL 0.730 <0.500 – 1.38 4.55 2.98 – 6.12 >10.0 μg/L 0.730 <0.500 – 1.38 4.55 2.98 – 6.12 >10.0

Immunotech Beckman Coulter IRMA ng/mL 0.320 0.150 – 0.480 1.76 1.28 – 2.25 11.1 6.39 – 15.8 μg/L 0.320 0.150 – 0.480 1.76 1.28 – 2.25 11.1 6.39 – 15.8

Inst.of Isotopes IRMA CT ng/mL § § § μg/L § § §

Monobind AccuBind ELISA ng/mL 0.770 0.480 – 1.05 3.50 2.35 – 4.66 >10.0 μg/L 0.770 0.480 – 1.05 3.50 2.35 – 4.66 >10.0

Monobind AccuLite CLIA ng/mL 0.630 0.380 – 0.870 3.18 2.13 – 4.23 >10.0 μg/L 0.630 0.380 – 0.870 3.18 2.13 – 4.23 >10.0

Wallac DELFIA ProStatus PSA Free ng/mL 0.520 0.420 – 0.620 2.30 1.80 – 2.80 15.0 12.0 – 18.0 μg/L 0.520 0.420 – 0.620 2.30 1.80 – 2.80 15.0 12.0 – 18.0

SALICYLATE

Cambridge Life Sciences EIA mg/dL § § § mmol/L § § §

SOMATOMEDIN-C (1)

Bioclone IGF-1 RIA ng/mL § § § μg/L § § §

Immunotech Beckman Coulter IGF-1 IRMA ng/mL § § § μg/L § § §

T3 FREE

Adaltis Bridge pg/mL § § § pmol/L § § §

BRAHMS Diagnostica RIA SPART pg/mL 2.99 2.27 – 3.70 13.0 10.4 – 15.6 27.3 21.4 – 33.1 pmol/L 4.60 3.50 – 5.70 20.0 16.0 – 24.0 42.0 33.0 – 51.0

BRAHMS Diagnostica RIA pg/mL 2.14 1.62 – 2.66 4.61 3.70 – 5.52 4.03 3.05 – 5.00 pmol/L 3.30 2.50 – 4.10 7.10 5.70 – 8.50 6.20 4.70 – 7.70

Cisbio Bioassays RG pg/mL 2.23 1.78 – 2.68 7.00 5.60 – 8.40 13.5 10.8 – 16.2 pmol/L 3.43 2.74 – 4.13 10.8 8.62 – 12.9 20.8 16.6 – 24.9

Demeditec Diagnostics Pbr (DE 16099110) pg/mL § § § pmol/L § § §

Demeditec Diagnostics RIA/CT (DE 06100) pg/mL 2.92 2.50 – 3.34 10.1 8.60 – 11.5 19.4 16.6 – 22.3 pmol/L 4.50 3.85 – 5.15 15.5 13.3 – 17.7 29.9 25.5 – 34.3

DiaMetra ELISA pg/mL 1.96 1.05 – 2.87 4.52 2.99 – 6.04 7.10 4.47 – 9.72 pmol/L 3.02 1.62 – 4.42 6.96 4.60 – 9.30 10.9 6.88 – 15.0

DiaSorin FT3 CTK pg/mL 2.14 1.62 – 2.66 4.61 3.70 – 5.52 4.03 3.05 – 5.00 pmol/L 3.30 2.50 – 4.10 7.10 5.70 – 8.50 6.20 4.70 – 7.70

EUROIMMUN FT3 RIA CT pg/mL 2.60 1.20 – 4.00 9.40 7.50 – 11.3 >26.0 pmol/L 4.00 1.85 – 6.16 14.5 11.6 – 17.4 >40.0

Immunotech Beckman Coulter RIA pg/mL 2.34 1.94 – 2.74 7.53 6.42 – 8.70 14.6 11.5 – 17.8 pmol/L 3.61 2.99 – 4.22 11.6 9.88 – 13.4 22.5 17.7 – 27.4

Medipan SELco RIA pg/mL 2.86 2.21 – 3.51 10.4 8.12 – 12.7 >26.0 pmol/L 4.40 3.40 – 5.40 16.0 12.5 – 19.5 >40.0

Technogenetics Liso-Phase RIA - 2 step pg/mL 2.60 1.90 – 3.30 14.8 11.0 – >16.0 >16.0 pmol/L 4.00 2.93 – 5.08 22.8 16.9 – >24.6 >24.6

Technogenetics PBR RIA - 1 step pg/mL 2.47 1.82 – 3.12 9.74 7.14 – 12.3 25.3 18.2 – 32.5 pmol/L 3.80 2.80 – 4.80 15.0 11.0 – 19.0 39.0 28.0 – 50.0

Trinity Biotech Amerlex RIA pg/mL 2.53 1.81 – 3.25 7.42 6.48 – 8.36 19.6 16.0 – 23.2 pmol/L 3.89 2.78 – 5.01 11.4 9.98 – 12.9 30.2 24.7 – 35.8

Wallac DELFIA TR-FIA pg/mL 2.86 1.56 – 4.16 12.3 9.09 – 15.6 28.6 21.4 – 35.7 pmol/L 4.40 2.40 – 6.40 19.0 14.0 – 24.0 44.0 33.0 – 55.0

ZenTech RIAZENCo pg/mL 2.95 2.36 – 3.53 9.65 7.72 – 11.6 19.9 16.0 – 23.9 pmol/L 4.54 3.63 – 5.44 14.9 11.9 – 17.8 30.7 24.6 – 36.9

T3 TOTAL

Adaltis Bridge ng/mL § § § nmol/L § § §

BRAHMS Diagnostica RIA ng/dL 84.4 58.4 – 110 188 149 – 227 279 201 – 357 nmol/L 1.30 0.900 – 1.70 2.90 2.30 – 3.50 4.30 3.10 – 5.50

Cisbio Bioassays RG ng/mL 0.510 0.410 – 0.610 1.65 1.32 – 1.98 2.49 1.99 – 2.99 nmol/L 0.785 0.631 – 0.939 2.54 2.03 – 3.05 3.83 3.06 – 4.60

DiaMetra ELISA ng/dL 80.4 51.0 – 110 198 130 – 265 293 159 – 427 nmol/L 1.24 0.785 – 1.69 3.04 2.01 – 4.08 4.51 2.45 – 6.57

DiaSorin T3 CTK ng/mL 0.844 0.584 – 1.10 1.88 1.49 – 2.27 2.79 2.01 – 3.57 nmol/L 1.30 0.900 – 1.70 2.90 2.30 – 3.50 4.30 3.10 – 5.50

DIAsource RIA CT ng/dL 64.9 42.9 – 87.0 208 177 – 240 317 286 – 348 nmol/L 1.00 0.660 – 1.34 3.21 2.72 – 3.70 4.88 4.40 – 5.36

Immunotech Beckman Coulter RIA ng/dL 66.9 40.3 – 94.2 197 168 – 227 282 207 – 356 nmol/L 1.03 0.620 – 1.45 3.04 2.58 – 3.50 4.34 3.19 – 5.49

NETRIA RIA Bead ng/mL 1.07 0.909 – 1.23 1.85 1.56 – 2.14 2.92 2.60 – 3.25 nmol/L 1.65 1.40 – 1.90 2.85 2.40 – 3.30 4.50 4.00 – 5.00

Radim ALISEI ng/mL 0.880 0.560 – 1.20 2.90 1.80 – 4.00 4.61 3.05 – 6.18 nmol/L 1.36 0.862 – 1.85 4.47 2.77 – 6.16 7.10 4.70 – 9.52

Radim RIA CT ng/mL 0.800 0.500 – 1.10 2.13 1.10 – 3.16 2.68 1.50 – 3.87 nmol/L 1.23 0.770 – 1.69 3.28 1.69 – 4.87 4.13 2.31 – 5.96

T3 UPTAKE / T UPTAKE

Immunotech Beckman Coulter RIA % Uptake 41.5 36.3 – 46.6 45.8 40.3 – 51.3 50.2 45.1 – 55.3 % Uptake 41.5 36.3 – 46.6 45.8 40.3 – 51.3 50.2 45.1 – 55.3

T4 FREE

BRAHMS Diagnostica LIA pg/mL § § § pmol/L § § §

BRAHMS Diagnostica RIA pg/mL 11.6 7.75 – 15.5 29.5 24.8 – 34.1 56.6 49.6 – 63.6 pmol/L 15.0 10.0 – 20.0 38.0 32.0 – 44.0 73.0 64.0 – 82.0

Cisbio Bioassays RG pg/mL 8.50 6.40 – 10.6 26.4 20.8 – 32.0 40.0 32.0 – 48.0 pmol/L 11.0 8.26 – 13.7 34.1 26.8 – 41.3 51.6 41.3 – 61.9

Demeditec Diagnostics Pbr (DE 16099120) ng/dL § § § pmol/L § § §

Demeditec Diagnostics RIA/CT (DE 07100) ng/dL 1.01 0.853 – 1.16 2.37 2.04 – 2.71 4.36 3.74 – 4.97 pmol/L 13.0 11.0 – 15.0 30.6 26.3 – 34.9 56.2 48.3 – 64.1

DiaMetra ELISA ng/dL 0.950 0.490 – 1.40 1.93 1.36 – 2.50 3.04 1.96 – 4.12 pmol/L 12.3 6.32 – 18.1 24.9 17.5 – 32.3 39.2 25.3 – 53.1

DiaSorin FT4 CTK pg/mL 11.6 7.75 – 15.5 29.5 24.8 – 34.1 56.6 49.6 – 63.6 pmol/L 15.0 10.0 – 20.0 38.0 32.0 – 44.0 73.0 64.0 – 82.0

EUROIMMUN FT4 RIA CT pg/mL 10.1 8.00 – 12.2 25.0 20.0 – 30.0 53.0 42.0 – 64.0 pmol/L 13.0 10.3 – 15.7 32.3 25.8 – 38.7 68.4 54.2 – 82.6

Immunotech Beckman Coulter RIA pg/mL 8.91 7.50 – 10.4 22.9 19.2 – 26.5 43.4 37.6 – 49.2 pmol/L 11.5 9.67 – 13.4 29.5 24.8 – 34.2 56.0 48.5 – 63.5

Inst.of Isotopes One-Step RIA CT ng/dL 1.04 0.829 – 1.25 2.62 2.10 – 3.15 5.92 4.74 – 7.11 pmol/L 13.4 10.7 – 16.1 33.8 27.1 – 40.6 76.4 61.1 – 91.7

Medipan SELco RIA ng/dL 0.930 0.744 – 1.15 2.56 2.09 – 3.02 5.50 4.73 – 6.28 pmol/L 12.0 9.60 – 14.8 33.0 27.0 – 39.0 71.0 61.0 – 81.0

NETRIA RIA Bead ng/dL 0.946 0.798 – 1.09 2.16 1.79 – 2.52 4.02 3.28 – 4.77 pmol/L 12.2 10.3 – 14.1 27.8 23.1 – 32.5 51.9 42.3 – 61.5

Technogenetics Liso-Phase RIA - Two-Step pg/mL 8.20 6.00 – 10.4 36.5 27.0 – >40.0 >40.0 pmol/L 10.6 7.74 – 13.4 47.1 34.8 – >51.6 >51.6

Technogenetics PBR RIA - 1-Step pg/mL 13.2 10.1 – 16.3 39.9 29.5 – 50.4 >62.0 pmol/L 17.0 13.0 – 21.0 51.5 38.0 – 65.0 >80.0

Trinity Biotech Amerlex RIA ng/dL 0.845 0.700 – 0.989 2.54 1.86 – 3.22 6.29 4.56 – 8.03 pmol/L 10.9 9.03 – 12.8 32.7 24.0 – 41.5 81.2 58.8 – 104

ZenTech RIAZENCo pg/mL 9.12 7.29 – 10.9 23.8 19.1 – 28.6 58.6 46.9 – 70.3 pmol/L 11.8 9.40 – 14.1 30.8 24.6 – 36.9 75.6 60.5 – 90.7

Page 25: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

T4 TOTAL

BRAHMS Diagnostica RIA μg/dL 6.05 5.04 – 7.05 13.4 10.5 – 16.4 20.6 14.0 – 27.3 nmol/L 78.0 65.0 – 91.0 173 135 – 211 266 180 – 352

Cisbio Bioassays RG ng/mL 49.0 39.0 – 59.0 109 87.0 – 131 169 135 – 203 nmol/L 63.2 50.3 – 76.1 141 112 – 169 218 174 – 262

DiaMetra ELISA μg/dL 5.69 3.88 – 7.50 10.6 7.16 – 14.0 15.2 10.9 – 19.5 nmol/L 73.4 50.1 – 96.8 136 92.4 – 180 196 141 – 251

DiaSorin T4 CTK μg/dL 6.05 5.04 – 7.05 13.4 10.5 – 16.4 20.6 14.0 – 27.3 nmol/L 78.0 65.0 – 91.0 173 135 – 211 266 180 – 352

DIAsource RIA CT μg/dL 4.50 3.25 – 5.75 10.6 8.22 – 13.0 13.7 11.1 – 16.4 nmol/L 58.1 41.9 – 74.2 137 106 – 168 177 143 – 211

Immunotech Beckman Coulter RIA μg/dL 5.16 3.23 – 7.09 12.2 9.46 – 15.1 16.4 13.2 – 19.6 nmol/L 66.6 41.7 – 91.5 158 122 – 195 212 170 – 253

NETRIA RIA Bead μg/dL 3.68 2.95 – 4.42 10.2 8.14 – 12.3 13.7 10.8 – 16.6 nmol/L 47.5 38.0 – 57.0 132 105 – 159 176 139 – 214

Radim RIA CT ng/mL 63.1 44.2 – 82.0 115 80.0 – 150 165 105 – 225 nmol/L 81.4 57.0 – 106 148 103 – 194 213 135 – 290

TBG (1)

BRAHMS Diagnostica RIA μg/mL 16.0 13.0 – 19.0 16.6 13.6 – 19.6 16.6 13.6 – 19.6 mg/L 16.0 13.0 – 19.0 16.6 13.6 – 19.6 16.6 13.6 – 19.6

ZenTech RIAZEN μg/mL 16.5 13.2 – 19.8 16.7 13.4 – 20.1 17.1 13.7 – 20.6 mg/L 16.5 13.2 – 19.8 16.7 13.4 – 20.0 17.1 13.7 – 20.6

TESTOSTERONE

CIS Bio International / Schering Spectria RIA ng/mL 1.23 0.939 – 1.52 3.98 3.14 – 4.81 7.03 5.94 – 8.16 nmol/L 4.26 3.26 – 5.26 13.8 10.9 – 16.7 24.4 20.6 – 28.3

DiaMetra ELISA ng/mL 0.170 <0.100 – 0.310 4.08 2.59 – 5.57 11.3 5.45 – >16.0 nmol/L 0.590 <0.347 – 1.08 14.2 8.99 – 19.3 39.2 18.9 – >55.5

DIAsource RIA CT ng/mL 0.780 0.640 – 0.910 2.63 1.84 – 3.42 4.02 2.46 – 5.58 nmol/L 2.71 2.22 – 3.16 9.13 6.38 – 11.9 13.9 8.54 – 19.4

Immunotech Beckman Coulter Direct RIA ng/mL 1.56 0.900 – 2.21 3.70 2.40 – 5.00 6.00 4.20 – 7.80 nmol/L 5.41 3.12 – 7.67 12.8 8.33 – 17.4 20.8 14.6 – 27.1

Immunotech Beckman Coulter Extraction RIA ng/mL 0.890 0.440 – 1.34 4.15 2.70 – 5.60 7.85 4.10 – 11.6 nmol/L 3.09 1.53 – 4.65 14.4 9.37 – 19.4 27.2 14.2 – 40.3

Monobind AccuBind ELISA ng/mL 1.81 1.21 – 2.41 4.71 3.16 – 6.26 9.37 6.28 – >12.0 nmol/L 6.28 4.20 – 8.36 16.3 11.0 – 21.7 32.5 21.8 – >41.6

Monobind AccuLite CLIA ng/mL 1.66 1.11 – 2.21 4.80 3.21 – 6.38 8.99 6.41 – 11.6 nmol/L 5.76 3.85 – 7.67 16.7 11.1 – 22.1 31.2 22.2 – 40.1

Orion Diagnostica Spectria RIA ng/mL 1.23 0.939 – 1.52 3.98 3.14 – 4.81 7.03 5.94 – 8.16 nmol/L 4.26 3.26 – 5.26 13.8 10.9 – 16.7 24.4 20.6 – 28.3

Radim RIA CT ng/mL 1.50 1.00 – 2.00 4.41 2.83 – 6.00 9.60 7.10 – 12.1 nmol/L 5.21 3.47 – 6.94 15.3 9.82 – 20.8 33.3 24.6 – 42.0

UBI Magiwel Quantitative ELISA ng/mL 1.26 0.860 – 1.65 4.04 2.72 – 5.36 8.09 5.63 – 10.5 nmol/L 4.37 2.98 – 5.73 14.0 9.44 – 18.6 28.1 19.5 – 36.4

Wallac DELFIA TR-FIA ng/mL 1.30 0.720 – 1.87 5.76 4.32 – 7.20 9.51 7.20 – 11.8 nmol/L 4.50 2.50 – 6.50 20.0 15.0 – 25.0 33.0 25.0 – 41.0

TESTOSTERONE FREE

DiaMetra ELISA pg/mL 0.220 <0.200 – 0.490 7.06 2.85 – 11.3 22.9 11.9 – 33.9 pmol/L 0.763 <0.694 – 1.70 24.5 9.89 – 39.1 79.5 41.2 – 118

THEOPHYLLINE

Sekisui CEDIA II μg/mL 4.40 3.50 – 5.30 14.2 11.4 – 17.1 29.8 23.8 – 35.8 μmol/L 24.4 19.4 – 29.4 78.8 63.3 – 94.9 165 132 – 199

Sekisui Nanopia TDM μg/mL 4.40 3.50 – 5.30 13.4 10.7 – 16.0 29.1 23.2 – 34.9 μmol/L 24.4 19.4 – 29.4 74.4 59.4 – 88.8 162 129 – 194

TSH

BRAHMS Diagnostica LIA μIU/mL 0.570 0.470 – 0.670 7.20 6.00 – 8.40 43.0 37.0 – 49.0 mIU/L 0.570 0.470 – 0.670 7.20 6.00 – 8.40 43.0 37.0 – 49.0

BRAHMS Diagnostica RIA μIU/mL 0.650 0.550 – 0.750 8.00 7.20 – 8.80 48.0 41.0 – 55.0 mIU/L 0.650 0.550 – 0.750 8.00 7.20 – 8.80 48.0 41.0 – 55.0

Cisbio Bioassays RG μIU/mL 0.620 0.500 – 0.740 7.10 5.70 – 8.50 42.0 34.0 – 50.0 mIU/L 0.620 0.500 – 0.740 7.10 5.70 – 8.50 42.0 34.0 – 50.0

Demeditec Diagnostics 1hr IRMA/CT (DE 15100) μIU/mL 0.440 0.360 – 0.520 6.40 5.50 – 7.30 38.0 32.8 – 43.2 mIU/L 0.440 0.360 – 0.520 6.40 5.50 – 7.30 38.0 32.8 – 43.2

Demeditec Diagnostics hs IRMA/CT (DE 16099033) μIU/mL § § § mIU/L § § §

DiaMetra ELISA μIU/mL 0.560 <0.200 – 0.920 6.04 4.01 – 8.06 >20.0 mIU/L 0.560 <0.200 – 0.920 6.04 4.01 – 8.06 >20.0

DiaSorin TSH CTK3 μIU/mL 0.650 0.550 – 0.750 8.00 7.20 – 8.80 48.0 41.0 – 55.0 mIU/L 0.650 0.550 – 0.750 8.00 7.20 – 8.80 48.0 41.0 – 55.0

DIAsource IRMA μIU/mL 0.570 0.360 – 0.770 6.66 6.00 – 7.33 38.6 33.8 – 43.4 mIU/L 0.570 0.360 – 0.770 6.66 6.00 – 7.33 38.6 33.8 – 43.4

EUROIMMUN TSH IRMA CT μIU/mL 0.560 0.450 – 0.670 6.90 5.50 – 8.30 39.4 31.5 – 47.3 mIU/L 0.560 0.450 – 0.670 6.90 5.50 – 8.30 39.4 31.5 – 47.3

Immunotech Beckman Coulter IRMA IM 2123 μIU/mL 0.390 0.220 – 0.560 5.75 5.21 – 6.29 36.3 31.8 – 40.8 mIU/L 0.390 0.220 – 0.560 5.75 5.21 – 6.29 36.3 31.8 – 40.8

Immunotech Beckman Coulter IRMA IM 3712 μIU/mL 0.450 0.290 – 0.610 6.73 5.45 – 8.01 38.8 32.3 – 45.3 mIU/L 0.450 0.290 – 0.610 6.73 5.45 – 8.01 38.8 32.3 – 45.3

Inst.of Isotopes Turbo IRMA CT μIU/mL 0.490 0.390 – 0.590 6.40 5.10 – 7.70 35.6 28.5 – 42.7 mIU/L 0.490 0.390 – 0.590 6.40 5.10 – 7.70 35.6 28.5 – 42.7

Medipan Magnum Rapid IRMA Kit # 1470 μIU/mL 0.480 0.360 – 0.600 6.50 4.90 – 8.10 36.0 26.4 – 45.6 mIU/L 0.480 0.360 – 0.600 6.50 4.90 – 8.10 36.0 26.4 – 45.6

Medipan SELco Rapid IRMA Kit # 1450 μIU/mL 0.550 0.420 – 0.680 7.20 5.40 – 9.00 40.0 30.0 – 50.0 mIU/L 0.550 0.420 – 0.680 7.20 5.40 – 9.00 40.0 30.0 – 50.0

NETRIA IRMA Bead μIU/mL 0.750 0.500 – 1.00 7.25 5.30 – 9.20 40.0 31.0 – 51.9 mIU/L 0.750 0.500 – 1.00 7.25 5.30 – 9.20 40.0 31.0 – 51.9

Radim ALISEI μIU/mL 0.350 0.200 – 0.500 4.35 2.50 – 6.20 33.2 19.6 – 46.8 mIU/L 0.350 0.200 – 0.500 4.35 2.50 – 6.20 33.2 19.6 – 46.8

Radim IRMA CT μIU/mL 0.410 0.200 – 0.620 4.20 3.20 – 5.20 17.1 9.20 – 25.0 mIU/L 0.410 0.200 – 0.620 4.20 3.20 – 5.20 17.1 9.20 – 25.0

Technogenetics MYRIA IRMA μIU/mL 0.370 0.280 – 0.460 5.75 4.30 – 7.20 31.5 23.0 – 40.0 mIU/L 0.370 0.280 – 0.460 5.75 4.30 – 7.20 31.5 23.0 – 40.0

Trinity Biotech Captia ELISA μIU/mL § § § mIU/L § § §

VALPROIC ACID

Sekisui CEDIA μg/mL 36.8 29.4 – 44.1 88.3 70.6 – 106 130 104 – >150 μmol/L 255 204 – 306 612 489 – 734 900 720 – >1040

Sekisui Nanopia TDM μg/mL 35.4 28.3 – 42.5 83.0 66.4 – 99.6 121 96.9 – 145 μmol/L 245 196 – 295 575 460 – 690 839 672 – 1007

VITAMIN B12

Wallac DELFIA TR-FIA pg/mL 312 234 – 390 557 417 – 696 1061 795 – 1327 pmol/L 230 173 – 288 411 308 – 514 783 587 – 979

Page 26: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

INSTRUMENTInstrument // Appareil // Strumento // Instrumento // Instrumento // Instrument // Instrument

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

ABBOTT ARCHITECT CSYSTEM / AEROSET

Fructosamine (Sentinel) (1) μmol/L § § § μmol/L § § §

ABBOTT ARCHITECT i SYSTEMS

AFP ng/mL 20.9 16.7 – 25.1 91.7 73.4 – 110 189 151 – 227 IU/mL 17.3 13.9 – 20.8 76.1 60.9 – 91.3 157 125 – 188

C-Peptide ng/mL § § § nmol/L § § §

Folate ng/mL 3.40 2.72 – 4.08 7.95 6.36 – 9.54 14.6 11.7 – 17.5 nmol/L 7.70 6.16 – 9.24 18.0 14.4 – 21.6 33.0 26.4 – 39.6

Testosterone ng/mL 1.62 1.30 – 1.95 4.89 3.91 – 5.87 8.95 7.16 – 10.7 nmol/L 5.63 4.50 – 6.75 17.0 13.6 – 20.4 31.1 24.8 – 37.3

Valproic Acid μg/mL § § § μmol/L § § §

Vitamin B12 (C609) pg/mL 349 279 – 419 622 498 – 747 963 771 – 1156 pmol/L 258 206 – 309 459 367 – 551 711 569 – 853

ABBOTT AxSYM

Insulin μIU/mL § § § pmol/L § § §

TSH (Gen 3) μIU/mL 0.400 0.320 – 0.480 5.42 4.34 – 6.51 30.5 24.4 – 36.6 mIU/L 0.400 0.320 – 0.480 5.42 4.34 – 6.51 30.5 24.4 – 36.6

Vitamin B12 (8K20) pg/mL § § § pmol/L § § §

ADALTIS ECLECTICA

AFP ng/mL § § § μg/L § § §

C-Peptide ng/mL § § § nmol/L § § §

CEA ng/mL § § § μg/L § § §

Cortisol μg/dL § § § nmol/L § § §

DHEA-Sulfate μg/dL § § § μmol/L § § §

Estradiol pg/mL § § § nmol/L § § §

Estriol Unconjugated ng/mL § § § nmol/L § § §

Ferritin ng/mL § § § μg/L § § §

FSH mIU/mL § § § IU/L § § §

hCG mIU/mL § § § IU/L § § §

Insulin μIU/mL § § § pmol/L § § §

LH mIU/mL § § § IU/L § § §

Progesterone ng/mL § § § nmol/L § § §

Prolactin μIU/mL § § § mIU/L § § §

PSA ng/mL § § § μg/L § § §

PSA Free ng/mL § § § μg/L § § §

T3 Free pg/mL § § § pmol/L § § §

T3 Total ng/mL § § § nmol/L § § §

T4 Free ng/dL § § § pmol/L § § §

T4 Total μg/dL § § § nmol/L § § §

Testosterone ng/mL § § § nmol/L § § §

TSH μIU/mL § § § mIU/L § § §

BIOMÉRIEUX VIDAS

Cortisol (S) ng/mL 21.0 10.0 – 32.0 164 75.0 – 253 300 138 – 462 nmol/L 58.0 27.6 – 88.3 453 207 – 698 828 381 – 1275

PSA Free ng/mL 0.630 0.430 – 0.830 2.78 2.15 – 3.41 >10.0 μg/L 0.630 0.430 – 0.830 2.78 2.15 – 3.41 >10.0

T3 Free pg/mL 2.21 1.49 – 2.92 7.53 5.78 – 9.29 13.0 9.74 – 16.2 pmol/L 3.40 2.30 – 4.50 11.6 8.90 – 14.3 20.0 15.0 – 25.0

TSH 3 μIU/mL 0.340 0.240 – 0.440 4.94 3.44 – 6.44 29.5 20.2 – 38.8 mIU/L 0.340 0.240 – 0.440 4.94 3.44 – 6.44 29.5 20.2 – 38.8

BIOMÉRIEUX VIDIA

Ferritin ng/mL 84.0 66.0 – 102 173 137 – 209 396 313 – 479 μg/L 84.0 66.0 – 102 173 137 – 209 396 313 – 479

PSA ng/mL 0.960 0.670 – 1.25 3.60 3.00 – 4.20 21.3 17.4 – 25.2 μg/L 0.960 0.670 – 1.25 3.60 3.00 – 4.20 21.3 17.4 – 25.2

T3 Free pg/mL 2.99 1.69 – 4.29 11.7 7.79 – 15.6 21.4 14.3 – 28.6 pmol/L 4.60 2.60 – 6.60 18.0 12.0 – 24.0 33.0 22.0 – 44.0

T4 Free ng/dL 0.791 0.550 – 1.03 1.97 1.38 – 2.56 4.03 2.79 – 5.27 pmol/L 10.2 7.10 – 13.3 25.4 17.8 – 33.0 52.0 36.0 – 68.0

TSH μIU/mL 0.400 0.250 – 0.550 5.70 4.70 – 6.70 34.0 27.0 – 41.0 mIU/L 0.400 0.250 – 0.550 5.70 4.70 – 6.70 34.0 27.0 – 41.0

DIASORIN LIAISON

ACTH pg/mL 26.3 18.4 – 34.2 175 125 – 225 374 308 – 440 pmol/L 5.79 4.05 – 7.52 38.5 27.5 – 49.5 82.3 67.8 – 96.8

AFP IU/mL 17.0 14.6 – 19.4 77.6 65.2 – 90.0 176 149 – 203 kIU/L 17.0 14.6 – 19.4 77.6 65.2 – 90.0 176 149 – 203

C-Peptide ng/mL 1.42 1.09 – 1.75 5.73 4.92 – 6.54 7.00 6.03 – 7.97 nmol/L 0.470 0.361 – 0.579 1.90 1.63 – 2.16 2.32 2.00 – 2.64

Calcitonin pg/mL 68.5 47.9 – 89.1 271 190 – 352 506 354 – 658 ng/L 68.5 47.9 – 89.1 271 190 – 352 506 354 – 658

CEA ng/mL 2.60 2.25 – 2.95 18.0 15.7 – 20.3 44.1 38.5 – 49.7 μg/L 2.60 2.25 – 2.95 18.0 15.7 – 20.3 44.1 38.5 – 49.7

Cortisol μg/dL 2.17 1.64 – 2.70 14.3 11.2 – 17.4 26.9 21.0 – 32.8 nmol/L 59.9 45.3 – 74.5 395 309 – 480 742 580 – 905

DHEA-Sulfate μg/dL § § § μmol/L § § §

Estradiol pg/mL 76.3 41.9 – 111 246 135 – 357 762 488 – 1037 nmol/L 0.275 0.151 – 0.400 0.886 0.486 – 1.29 2.74 1.76 – 3.73

Ferritin ng/mL 71.7 61.5 – 81.9 160 133 – 187 398 334 – 462 μg/L 71.7 61.5 – 81.9 160 133 – 187 398 334 – 462

FSH mIU/mL 7.50 6.35 – 8.65 32.4 27.8 – 37.0 54.7 48.3 – 61.1 IU/L 7.50 6.35 – 8.65 32.4 27.8 – 37.0 54.7 48.3 – 61.1

hCG mIU/mL 4.72 3.29 – 6.15 15.7 12.9 – 18.5 145 128 – 162 IU/L 4.72 3.29 – 6.15 15.7 12.9 – 18.5 145 128 – 162

Insulin μIU/mL § § § pmol/L § § §

LH mIU/mL 2.53 1.81 – 3.25 24.4 19.5 – 29.3 65.2 51.3 – 79.1 IU/L 2.53 1.81 – 3.25 24.4 19.5 – 29.3 65.2 51.3 – 79.1

Progesterone ng/mL <0.400 7.40 4.70 – 10.1 20.9 13.4 – 28.4 nmol/L <1.27 23.5 14.9 – 32.1 66.5 42.6 – 90.3

Prolactin μIU/mL 144 126 – 162 455 405 – 505 930 837 – 1023 mIU/L 144 126 – 162 455 405 – 505 930 837 – 1023

PSA ng/mL 0.820 0.670 – 0.970 3.17 2.66 – 3.68 21.5 18.3 – 24.7 μg/L 0.820 0.670 – 0.970 3.17 2.66 – 3.68 21.5 18.3 – 24.7

T3 Free pg/mL 2.46 2.21 – 2.71 8.46 7.41 – 9.51 16.7 13.4 – 20.0 pmol/L 3.79 3.40 – 4.17 13.0 11.4 – 14.6 25.7 20.6 – 30.8

T3 Total ng/dL 83.3 54.9 – 112 234 205 – 263 353 308 – 398 nmol/L 1.28 0.845 – 1.72 3.60 3.16 – 4.05 5.44 4.74 – 6.13

T4 Free ng/dL 1.03 0.880 – 1.18 3.11 2.65 – 3.57 6.53 5.64 – 7.42 pmol/L 13.3 11.4 – 15.2 40.1 34.2 – 46.1 84.2 72.8 – 95.7

T4 Total μg/dL 4.16 3.00 – 5.32 10.5 8.50 – 12.5 14.9 12.0 – 17.8 nmol/L 53.7 38.7 – 68.6 135 110 – 161 192 155 – 230

Testosterone ng/mL 1.33 0.850 – 1.80 3.66 2.34 – 4.98 5.16 3.61 – 6.71 nmol/L 4.62 2.95 – 6.25 12.7 8.12 – 17.3 17.9 12.5 – 23.3

TSH μIU/mL 0.510 0.430 – 0.590 6.61 5.87 – 7.35 37.6 31.3 – 43.9 mIU/L 0.510 0.430 – 0.590 6.61 5.87 – 7.35 37.6 31.3 – 43.9

DIASORIN RIA-MAT 280

AFP IRMA-MAT IU/mL § § § kIU/L § § §

CEA IRMA-COAT ng/mL § § § μg/L § § §

KAINOS QUARTUS IMMUNOCUBE

AFP ng/mL 18.7 14.9 – 22.4 89.7 71.8 – 108 207 165 – 248 IU/mL 15.5 12.4 – 18.6 74.5 59.6 – 89.4 171 137 – 206

C-Peptide ng/mL 1.41 0.990 – 1.84 6.05 4.84 – 7.26 7.80 6.24 – 9.36 nmol/L 0.467 0.328 – 0.609 2.00 1.60 – 2.40 2.58 2.07 – 3.10

CEA ng/mL 2.21 1.77 – 2.65 17.6 14.1 – 21.1 40.5 32.4 – 48.5 μg/L 2.21 1.77 – 2.65 17.6 14.1 – 21.1 40.5 32.4 – 48.5

Page 27: Lyphochek Immunoassay 370 Data Sheet

INTERNATIONAL USE ONLY -The following section contains data for methods that are not available for diagnostic use in the United States.

Level 1 - 40231 Level 2 - 40232 Level 3 - 40233 Level 1 - 40231 Level 2 - 40232 Level 3 - 40233

Units Mean Range Mean Range Mean Range SI Mean Range Mean Range Mean Range

KAINOS QUARTUS IMMUNOCUBE (continued)

Ferritin ng/mL 63.9 47.9 – 79.9 148 111 – 184 328 246 – 410 μg/L 63.9 47.9 – 79.9 148 111 – 184 328 246 – 410

FSH mIU/mL § § § IU/L § § §

hCG mIU/mL § § § IU/L § § §

Immunoglobulin E IU/mL § § § kIU/L § § §

Insulin μIU/mL 15.1 12.1 – 18.1 56.0 44.8 – 67.2 176 141 – 212 pmol/L 105 83.9 – 126 389 311 – 466 1224 979 – 1469

LH mIU/mL § § § IU/L § § §

Prolactin ng/mL § § § μg/L § § §

PSA ng/mL 0.820 0.570 – 1.06 3.21 2.25 – 4.18 20.7 16.5 – 24.8 μg/L 0.820 0.570 – 1.06 3.21 2.25 – 4.18 20.6 16.5 – 24.8

T3 Free pg/mL 2.55 1.65 – 3.44 6.62 4.63 – 8.61 20.8 15.6 – >25.0 pmol/L 3.93 2.54 – 5.30 10.2 7.13 – 13.3 32.0 24.0 – >38.5

T4 Free ng/dL 1.01 0.660 – 1.36 3.15 2.20 – 4.09 4.47 3.35 – 5.58 pmol/L 13.0 8.51 – 17.5 40.6 28.4 – 52.8 57.7 43.2 – 72.0

TSH μIU/mL 0.410 0.290 – 0.540 6.09 4.87 – 7.30 34.1 27.3 – >40.0 mIU/L 0.410 0.290 – 0.540 6.09 4.87 – 7.30 34.1 27.3 – >40.0

MITSUBISHI KAGAKU

AFP II (LPIA-S500 / NV7) LPIA ng/mL 23.5 18.8 – 28.2 101 80.4 – 121 220 176 – 264 IU/mL 19.5 15.6 – 23.4 83.4 66.7 – 100 182 146 – 219

Carbamazepine (LPIA-S500 / NV7) LPIA μg/mL <2.00 – 2.10 7.40 5.90 – 8.90 13.0 10.4 – 15.6 μmol/L <8.46 – 8.88 31.3 25.0 – 37.6 55.0 44.0 – 66.0

CEA (LPIA-A700) FIA ng/mL 1.45 1.20 – 1.70 10.8 8.70 – 13.0 24.5 19.6 – 29.4 μg/L 1.45 1.20 – 1.70 10.8 8.70 – 13.0 24.5 19.6 – 29.4

CEA (LPIA-S500 / NV7) LPIA ng/mL <2.50 13.8 11.1 – 16.6 34.8 27.8 – 41.7 μg/L <2.50 13.8 11.1 – 16.6 34.8 27.8 – 41.7

Digoxin (LPIA-S500 / NV7) LPIA ng/mL 0.610 <0.500 – 0.730 1.90 1.50 – 2.20 3.30 2.60 – 4.00 nmol/L 0.781 <0.640 – 0.934 2.43 1.92 – 2.82 4.22 3.33 – 5.12

Phenobarbital (LPIA-S500 / NV7) LPIA μg/mL 9.70 7.70 – 11.6 24.8 19.8 – 29.7 52.3 41.8 – 62.8 μmol/L 41.8 33.2 – 50.0 107 85.3 – 128 225 180 – 271

Phenytoin (LPIA-S500 / NV7) LPIA μg/mL 6.50 5.20 – 7.80 13.8 11.0 – 16.6 24.6 19.6 – 29.5 μmol/L 25.7 20.6 – 30.9 54.6 43.6 – 65.7 97.4 77.6 – 117

T3 Free (LPIA-A700) FIA pg/mL 2.50 1.80 – 3.30 6.40 5.20 – 7.70 10.5 8.40 – 12.6 pmol/L 3.85 2.77 – 5.08 9.86 8.01 – 11.9 16.2 12.9 – 19.4

T4 Free (LPIA-A700) FIA ng/dL 0.950 0.670 – 1.20 3.20 2.60 – 3.80 6.10 4.90 – 7.30 pmol/L 12.3 8.64 – 15.5 41.3 33.5 – 49.0 78.7 63.2 – 94.2

Theophylline (LPIA-S500 / NV7) LPIA μg/mL 4.80 3.80 – 5.70 12.9 10.3 – 15.5 28.8 23.0 – 34.5 μmol/L 26.6 21.1 – 31.6 71.6 57.2 – 86.0 160 128 – 191

TSH (LPIA-A700) FIA μIU/mL 0.450 0.320 – 0.590 5.40 4.40 – 6.50 29.6 23.7 – 35.6 mIU/L 0.450 0.320 – 0.590 5.40 4.40 – 6.50 29.6 23.7 – 35.6

Valproic Acid (LPIA-S500 / NV7) LPIA μg/mL 36.6 29.3 – 43.9 72.7 58.2 – 87.3 104 82.9 – 124 μmol/L 254 203 – 304 504 403 – 605 719 574 – 862

OLYMPUS AU 400 / 600 / 640 / 680 / 2700 / 5400

Acetaminophen (Paracetamol) (Europe) μg/mL <15.0 44.3 35.4 – 53.2 123 98.7 – 148 μmol/L <99.0 293 234 – 352 816 653 – 979

Ferritin (Europe) ng/mL § § § μg/L § § §

Immunoglobulin A (1) (Europe) mg/dL § § § mg/L § § §

Immunoglobulin G (1) (Europe) mg/dL 832 666 – 999 857 686 – 1029 855 684 – 1026 g/L 8.32 6.66 – 9.99 8.57 6.86 – 10.3 8.55 6.84 – 10.3

Immunoglobulin M (1) (Europe) mg/dL 76.7 61.4 – 92.1 86.3 69.1 – 104 84.0 67.2 – 101 mg/L 767 614 – 921 863 691 – 1036 840 672 – 1008

OLYMPUS AU3000I

AFP IU/mL 14.3 11.4 – 17.1 74.7 59.8 – 89.7 184 147 – 220 kIU/L 14.3 11.4 – 17.1 74.7 59.8 – 89.7 184 147 – 220

CEA ng/mL 3.48 2.79 – 4.18 19.2 15.4 – 23.0 40.8 32.6 – 48.9 μg/L 3.48 2.79 – 4.18 19.2 15.4 – 23.0 40.8 32.6 – 48.9

Cortisol ng/mL 27.0 21.6 – 32.4 187 150 – 224 320 256 – 384 nmol/L 74.5 59.6 – 89.4 516 413 – 619 883 707 – 1060

Estradiol pg/mL 50.2 40.1 – 60.2 226 181 – 271 421 336 – 505 pmol/L 184 147 – 221 830 664 – 996 1543 1235 – 1852

hCG Beta-s (short intact Beta + free Beta) mIU/mL 10.4 8.29 – 12.4 45.1 36.1 – 54.2 383 306 – 460 IU/L 10.4 8.29 – 12.4 45.1 36.1 – 54.2 383 306 – 460

PSA ng/mL 1.01 0.760 – 1.26 4.15 3.11 – 5.18 27.4 20.5 – 34.2 μg/L 1.01 0.760 – 1.26 4.15 3.11 – 5.18 27.4 20.5 – 34.2

PSA Free ng/mL 0.500 0.380 – 0.630 2.34 1.76 – 2.93 15.1 11.3 – 18.9 μg/L 0.500 0.380 – 0.630 2.34 1.76 – 2.93 15.1 11.3 – 18.9

T3 Free II pg/mL 1.60 0.929 – 2.27 7.05 5.64 – 9.28 11.6 9.28 – 13.9 pmol/L 2.47 1.43 – 3.50 10.8 8.68 – 14.3 17.9 14.3 – 21.4

ORTHO CLINICAL DIAGNOSTICS VITROS ECI

TSH -30 μIU/mL 0.300 0.200 – 0.400 6.20 4.50 – 7.90 34.0 25.0 – 43.0 mIU/L 0.300 0.200 – 0.400 6.20 4.50 – 7.90 34.0 25.0 – 43.0

SIEMENS ADVIA CENTAUR / CENTAUR XP

DHEA-Sulfate μg/dL 55.3 35.9 – 74.7 105 68.3 – 142 330 215 – 446 μmol/L 1.49 0.969 – 2.02 2.84 1.84 – 3.83 8.91 5.81 – 12.0

SIEMENS ADVIA CENTAUR CP

Immunoglobulin E (Japan) IU/mL 366 275 – 457 70.8 53.7 – 87.9 94.1 71.5 – 117 kIU/L 366 275 – 457 70.8 53.7 – 87.9 94.1 71.5 – 117

SIEMENS VIVA

Acetaminophen (Emit 2000) μg/mL 11.4 9.69 – 13.2 40.6 35.2 – 45.9 122 104 – 141 μmol/L 75.7 64.1 – 87.2 268 233 – 304 810 689 – 931

Amikacin (Emit) μg/mL 5.98 5.26 – 6.71 14.6 12.9 – 16.4 31.7 26.4 – 36.9 μmol/L 10.2 8.99 – 11.5 25.0 22.0 – 28.0 54.1 45.1 – 63.1

Caffeine (Emit) μg/mL 2.18 1.74 – 2.61 7.41 6.42 – 8.41 15.6 13.5 – 17.7 μmol/L 11.2 8.96 – 13.4 38.2 33.1 – 43.3 80.5 69.7 – 91.4

Carbamazepine (Emit 2000) μg/mL 2.61 2.14 – 3.08 8.58 7.03 – 10.1 14.4 12.2 – 16.5 μmol/L 11.0 9.05 – 13.0 36.3 29.7 – 42.8 60.7 51.7 – 69.7

Digoxin (Emit 2000) ng/mL 0.450 0.250 – 0.660 1.74 1.37 – 2.11 2.96 2.42 – 3.50 nmol/L 0.576 0.320 – 0.845 2.23 1.75 – 2.70 3.79 3.10 – 4.48

Ethosuximide (Emit) μg/mL 27.2 23.8 – 30.6 66.7 58.7 – 74.8 110 96.8 – 123 μmol/L 193 169 – 216 473 416 – 529 779 686 – 873

Gentamicin (Emit 2000) μg/mL 2.05 1.77 – 2.32 4.39 3.74 – 5.05 6.94 5.90 – 7.97 μmol/L 4.28 3.70 – 4.85 9.18 7.82 – 10.6 14.5 12.3 – 16.7

NAPA (Emit 2000) μg/mL 1.96 1.57 – 2.35 5.05 4.04 – 6.06 11.8 9.29 – 14.3 μmol/L 7.08 5.67 – 8.48 18.2 14.6 – 21.9 42.5 33.5 – 51.5

Phenobarbital (Emit 2000) μg/mL 9.11 7.68 – 10.5 24.4 19.9 – 28.9 53.9 46.7 – 61.0 μmol/L 39.3 33.1 – 45.4 105 85.9 – 124 232 201 – 263

Phenytoin (Emit 2000) μg/mL 5.72 4.79 – 6.65 13.5 11.3 – 15.6 25.3 21.3 – 29.2 μmol/L 22.7 19.0 – 26.3 53.3 44.7 – 61.9 100 84.4 – 116

Primidone (Emit) μg/mL 2.99 2.62 – 3.36 6.02 5.29 – 6.74 11.8 10.4 – 13.2 μmol/L 13.7 12.0 – 15.4 27.6 24.2 – 30.9 54.0 47.5 – 60.5

Procainamide (Emit 2000) μg/mL 1.64 1.38 – 1.89 7.53 6.14 – 8.92 13.2 10.7 – 15.7 μmol/L 6.94 5.84 – 7.99 31.9 26.0 – 37.7 55.9 45.4 – 66.3

Quinidine (Emit 2000) μg/mL 0.820 0.560 – 1.08 2.55 2.05 – 3.06 4.42 3.75 – 5.09 μmol/L 2.53 1.72 – 3.33 7.85 6.31 – 9.42 13.6 11.6 – 15.7

Theophylline (Emit 2000) μg/mL 4.53 3.84 – 5.22 13.9 11.2 – 16.6 30.0 24.7 – 35.3 μmol/L 25.1 21.3 – 29.0 77.3 62.4 – 92.2 166 137 – 196

Tobramycin (Emit 2000) μg/mL 0.910 0.730 – 1.09 3.15 2.76 – 3.54 6.15 5.21 – 7.08 μmol/L 1.95 1.56 – 2.33 6.74 5.91 – 7.58 13.2 11.1 – 15.2

Valproic Acid (Emit 2000) μg/mL 34.6 29.0 – 40.1 77.5 68.2 – 86.8 117 101 – 132 μmol/L 240 201 – 278 537 473 – 602 808 699 – 916

Vancomycin (Emit 2000) μg/mL 6.07 4.57 – 7.57 19.3 15.6 – 22.9 32.9 25.9 – 40.0 μmol/L 4.19 3.15 – 5.22 13.3 10.8 – 15.8 22.7 17.8 – 27.6

WALLAC AUTODELFIA

C-Peptide ng/mL § § § pmol/L § § §

Cortisol μg/dL § § § nmol/L § § §

Estriol Unconjugated (uE3) ng/mL 1.96 1.38 – 2.54 6.34 4.32 – 8.36 12.1 9.80 – >14.4 nmol/L 6.80 4.80 – 8.80 22.0 15.0 – 29.0 42.0 34.0 – >50.0

Ferritin ng/mL 55.0 41.0 – 69.0 142 107 – 178 350 263 – 438 μg/L 55.0 41.0 – 69.0 142 107 – 178 350 263 – 438

Folate ng/mL 2.12 1.50 – 2.74 6.41 4.86 – 7.95 8.83 6.62 – 11.0 nmol/L 4.80 3.40 – 6.20 14.5 11.0 – 18.0 20.0 15.0 – 25.0

hAFP ng/mL 18.1 14.5 – 21.7 86.7 69.9 – 104 190 152 – 229 IU/mL 15.0 12.0 – 18.0 72.0 58.0 – 86.0 158 126 – 190

Insulin μIU/mL § § § pmol/L § § §

PSA EQM ProStatus ng/mL 0.900 0.720 – 1.10 3.50 2.80 – 4.20 22.0 18.0 – 26.0 μg/L 0.900 0.720 – 1.10 3.50 2.80 – 4.20 22.0 18.0 – 26.0

PSA Free ProStatus ng/mL 0.520 0.420 – 0.620 2.30 1.80 – 2.80 15.0 12.0 – 18.0 μg/L 0.520 0.420 – 0.620 2.30 1.80 – 2.80 15.0 12.0 – 18.0

PSA Total ProStatus ng/mL 0.960 0.770 – 1.20 3.50 2.80 – 4.20 22.0 18.0 – 26.0 μg/L 0.960 0.770 – 1.20 3.50 2.80 – 4.20 22.0 18.0 – 26.0

T3 Free pg/mL 3.38 1.88 – 4.87 14.3 11.0 – 18.2 >48.7 pmol/L 5.20 2.90 – 7.50 22.0 17.0 – 28.0 >75.0

Testosterone ng/mL 1.30 0.720 – 1.87 5.76 4.32 – 7.20 9.51 7.20 – 11.8 nmol/L 4.50 2.50 – 6.50 20.0 15.0 – 25.0 33.0 25.0 – 41.0

Vitamin B12 pg/mL 312 234 – 390 557 417 – 696 1061 795 – 1327 pmol/L 230 173 – 288 411 308 – 514 783 587 – 979

Page 28: Lyphochek Immunoassay 370 Data Sheet

NOTES

Page 29: Lyphochek Immunoassay 370 Data Sheet

NOTES

Page 30: Lyphochek Immunoassay 370 Data Sheet
Page 31: Lyphochek Immunoassay 370 Data Sheet

Abbott Laboratories, Abbott Park, IllinoisAdaltis Italia S.P.A., Montecelio, ItalyAlfa Wassermann, Inc., West Caldwell, New JerseyAllergopharma Joachim Ganzer KG, Reinbeck, GermanyBeckman Coulter Inc., Brea, CaliforniaBeckman Coulter Inc., Chaska, MinnesotaBeckman Coulter Biomedical Ltd., O’Callaghan’s Mills, IrelandBioclone, Regents Park, NSW, AustraliaBioChek, Foster City, CaliforniaBiomerica, Inc., Newport Beach, CaliforniabioMérieux, Lyon, FranceBioserv GmbH, Greifswald, GermanyBRAHMS Diagnostica GmbH, Berlin, GermanyCalbiotech Inc., Spring Valley, CaliforniaCambridge Life Sciences, Ely, United KingdomCisbio Bioassays, Bagnols sur Ceze, FranceDakoCytomation Ltd., Cambridgeshire, United KingdomDEMEDITEC Diagnostics, Kiel, GermanyDiaMetra, Foligno, ItalyDiagnostic Systems Laboratories, Webster, TexasDiaSorin Biomedica Diagnostics, Vercelli, ItalyDiaSorin, Stillwater, Minnesota

DIASource Europe S.A., Nivelles, BelgiumDRG Instruments GmbH, Marburg, GermanyEuro-Diagnostica AB, Malmö, Sweden Euroimmun GmbH, Lubeck, GermanyEuro Proxima B.V., Arnhem, NetherlandsGenzyme Diagnostics, Cambridge, MassachusettsHycor Biomedical, Kassel, GermanyIBL, Hamburg, GermanyIDS-LTD, Immuno Diagnostic Systems, Ltd., Bolden, United KingdomIDS S.A., Sclessin (Liège), BelgiumIMMUNOTECH Beckman Coulter, Marseille, FranceInstitute of Isotopes, Budapest, HungaryKainos, Tokyo, JapanMediagnost GmbH, Reutlingen, GermanyMEDIPAN Diagnostica, Selchow, GermanyMercodia, Uppsala, SwedenMicrogenics, Freemont, CaliforniaMitsubishi Kagaku Medical Co., LTD, Ibaraki, JapanMP Biomedicals, Inc., Solon, OhioMonobind, Lake Forest, CaliforniaNetria, London, United KingdomOlympus America Inc., Irving, Texas

Orion Diagnostica, Turku, FinlandOrtho Clinical Diagnostics, Cardiff, United KingdomOrtho-Clinical Diagnostics, A Johnson and Johnson Company, Rochester, New YorkPantex Inc., Santa Monica, CaliforniaPerkinElmer Life and Analytical Sciences, Inc., Waltham, Massachusetts Phadia AB, Uppsala, SwedenRADIM, Rome, ItalyRamco Laboratories, Inc., Stafford, TexasRoche Diagnostics GmbH, Penzberg, GermanyRoche Diagnostics, Indianapolis, IndianaSekisui Medical Co., Ltd., Tokyo, JapanSentinel, Milano, ItalySiemens Healthcare Diagnostics Inc., Newark, DelewareSiemens Healthcare Diagnostics Inc., Tarrytown, New YorkTechnogenetics, Milano, ItalyTOSOH Bioscience, San Francisco, CaliforniaTrinity Biotech, Co., Wicklow, IrelandTrinity Biotech, Jamestown, New YorkUnited Biotech Inc., Mountain View, CaliforniaPerkinElmer, Wallac Oy, Turku, FinlandZenTech SA, Angleur, Belgium

UNITED STATES, Bio-Rad Laboratories, Irvine, CA

FRANCE, Bio-Rad3 boulevard Raymond Poincaré92430 Marnes-la-CoquettePhone: (33) 1-4795-6000 / Fax: (33) 1-4741-9133

© 2009 ALL RIGHTS RESERVED. PRINTED IN U.S.A.

MANUFACTURERS LISTED // Angegebene Hersteller // Fabricants indiqués // Produttori elencati // Lista de fabricante // Fabricantes enunciados // Angivna tillverkare // Anførte producenter

Page 32: Lyphochek Immunoassay 370 Data Sheet

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