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  • 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

    ENGLISHINTENDED USELyphochek 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 PRINCIPLEThe 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.

    REAGENTThis 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 STABILITYThis product will be stable until the expiration date when stored unopened at 2 to 8C. Once the control is reconstituted all analytes will be stable for 7 days when stored tightly capped at 2 to 8C 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 20 to 70C with the following exceptions: no frozen stability claim is supplied for ACTH, Aldosterone, Calcitonin and C-Peptide. Once thawed, do not refreeze the control; discard remaining material.This product is shipped under ambient conditions.

    RECONSTITUTION INSTRUCTIONUsing 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 25C) and swirl gently to ensure homogeneity. After each use, promptly replace the stopper and return to 2 to 8C storage.

    PROCEDUREThis 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 Ofce 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 VALUESThe mean values printed in this insert were derived from replicate analyses and are specic for this lot of product. The tests listed were performed by the 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 modications. 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 CHARACTERISTICSThis 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.

    DEUTSCHVORGESEHENER VERWENDUNGSZWECKDie Lyphochek Immunoassay Plus Control ist ein Qualittskontrollserum fr die quantitative Bestimmung der in dieser Packungsbeilage angegebenen Analyte, mit Zielwertangaben.

    EINLEITUNG UND ZUSAMMENFASSUNGDie Verwendung entsprechender Kontrollmaterialien dient der objektiven Beurteilung der Qualitt von im Labor durchgefhrten Untersuchungen und ist ein unerlsslicher Bestandteil der guten Laborpraxis. Die drei Level dieser Kontrolle ermglichen eine umfassende Qualittssicherung ber den gesamten klinisch relevanten Bereich.

    REAGENZDieses Produkt wurde aus Humanserum hergestellt und enthlt Zustze menschlichen und tierischen Ursprungs, Chemikalien und Medikamente. Level 1 enthlt auerdem Stabilisatoren. Die Kontrolle wurde zur Verbesserung der Stabilitt lyophilisiert.

    LAGERUNG UND HALTBARKEITDieses Produkt ist bis zum angegebenen Haltbarkeitsdatum stabil, wenn es ungeffnet bei 2-8C gelagert wird. Nach Rekonstitution der Kontrolle sind alle Analyte 7 Tage stabil, sofern die Kontrolle dicht verschlossen bei 2-8C 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 mssen 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 20 bis 70C gelagert wird. Ausnahmen: Fr ACTH, Aldosteron, Calcitonin und C-Peptid knnen keine Angaben hinsichtlich der Stabilitt nach Einfrieren gemacht werden. Die Kontrolle nach dem Auftauen nicht erneut einfrieren; restliches Material verwerfen.Dieses Produkt wird unter Umgebungsbedingungen versandt.

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

    HANDHABUNGDas Produkt ist genau wie eine Patientenprobe zu behandeln und in bereinstimmung mit den Vorschriften des Gerte-, Kit- oder Reagenzherstellers anzuwenden.Die Entsorgung aller Abflle ist nach den geltenden rtlichen Bestimmungen vorzunehmen. Falls die Verpackung beschdigt ist, nehmen Sie bitte Kontakt zur Bio-Rad-Niederlassung auf.

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

    WERTEERMITTLUNGDie in dieser Packungsbeilage angegebenen Mittelwerte stammen aus Vielfachbestimmungen und gelten speziell fr diese Produktcharge. Die Bestimmungen wurden vom Hersteller und/oder von unabhngigen Laboratorien mit vom Hersteller untersttzten Reagenzien durchgefhrt; dazu wurde eine reprsentative Stichprobe dieser Produktcharge eingesetzt. Die im Labor erzielten Werte sollten im entsprechenden Akzeptanzbereich liegen; die tatschlich erzielten Werte knnen jedoch whrend der Lebensdauer dieser Kontrolle von den angegebenen Zielwerten abweichen. Abweichungen im Laufe der Zeit und zwischen verschiedenen Laboratorien sind mglicherweise auf unterschiedliche Labortechniken, Gerte und Reagenzien oder auf Modikationen der vom Hersteller angegebenen Testmethoden zurckzufhren. Jedem Labor wird empfohlen, eigene Mittelwerte und Akzeptanzbereiche zu ermitteln und die aufgefhrten Werte nur als Richtwerte zu betrachten.Aktualisierte Zielwerttabellen nden Sie im Internet unter www.qcnet.com/de.

    SPEZIFISCHE EIGENSCHAFTENDieses gefriergetrocknete Produkt wurde nach strengen Qualittsstandards hergestellt. Um reproduzierbare Ergebnisse von Flschchen zu Flschchen sicherzustellen, muss die Kontrolle sachgerecht gelagert und wie angegeben gehandhabt werden. + Wichtige Produktinformationen in der Funote beachten.

    FRANAISUTILISATIONLyphochek Immunoassay Plus Control est un srum titr de contrle de la qualit permettant de surveiller la prcision des tests raliss en laboratoire pour les analytes dont la liste gure sur cette notice.

    INTRODUCTION ET PRINCIPELutilisation de produits de contrle de la qualit est indique pour valuer de faon objective la prcision des mthodes et des techniques utilises, et fait partie intgrante des bonnes pratiques de laboratoire. Trois concentrations sont disponibles an de permettre un contrle de la qualit sur lensemble de la plage de valeurs cliniques.

    RACTIFCe produit est prpar partir de srum humain auquel ont t ajouts des constituants dorigine humaine et animale, des produits chimiques et des mdicaments thrapeutiques. Le niveau 1 contient galement des stabilisants. Le contrle est fourni sous forme lyophilise pour assurer une meilleure stabilit.

    CONSERVATION ET STABILITCe produit restera stable jusqu la date de premption en acon non ouvert et conserv entre 2 et 8C. Une fois le contrle reconstitu, tous les analytes resteront stables pendant 7 jours en acon convenablement ferm et conserv entre 2 et 8C. Exceptions : (1) Le folate et lantigne prostatique spcique (PSA) seront stables pendant 3 jours aprs reconstitution. (2) Le peptide-C est stable pendant un jour aprs reconstitution. (3) LACTH, la calcitonine, la gastrine et le PSA libre doivent tre titrs immdiatement aprs reconstitution.Une fois le contrle reconstitu et congel, tous les analytes resteront stables pendant 20 jours en acon convenablement ferm et conserv entre 20 et 70C. Exceptions : Aucune garantie de stabilit de conglation nest fournie pour lACTH, laldostrone, la calcitonine et le peptide C. Une fois le contrle dcongel, ne pas le recongeler, et liminer le produit restant.Ce produit est expdi sous conditions ambiantes.

    INSTRUCTIONS POUR LA RECONSTITUTIONA laide dune pipette volumtrique, reconstituer chaque acon avec 5,0 ml deau distille ou dsionise. Replacer le bouchon et laisser le produit reposer pendant 15 minutes. Avant utilisation, amener le contrle la temprature ambiante (entre 18 et 25C) et homogniser en imprimant un lger mouvement de rotation au acon. Aprs chaque utilisation, remettre rapidement le bouchon et conserver entre 2 et 8C.

    MODE OPRATOIRECe produit doit tre trait comme les chantillons de patients, en respectant les instructions accompagnant lappareil, le kit ou le ractif utiliss.Tout dchet doit tre limin conformment aux rglementations en vigueur dans le laboratoire pour le traitement des dchets. Si le conditionnement est endommag, contacter votre service technique Bio-Rad local.

    LIMITES 1. Ne pas utiliser ce produit aprs la date de premption. 2. En cas de contamination microbienne ou de trouble excessif du produit reconstitu, liminer le acon. 3. Ce produit nest pas conu pour tre utilis comme talon.

    DTERMINATION DES VALEURSLes valeurs moyennes indiques sur cette notice ont t dtermines partir danalyses rptes et concernent spciquement ce lot de produit. Les essais indiqus ont t raliss par le fabricant et/ou par des laboratoires indpendants laide de ractifs accepts par le fabricant et sur un chantillonnage reprsentatif de ce lot de contrle. Les moyennes obtenues par un laboratoire donn doivent se trouver dans la plage de valeurs acceptables correspondante ; cependant, les moyennes obtenues par le laboratoire peuvent varier par rapport aux valeurs indiques pendant la dure de vie de ce contrle. Les variations dans le temps et entre laboratoires peuvent tre dues des diffrences de mthodes, dappareils et de ractifs employs par chaque laboratoire ou des modications de la mthode danalyse employe par le fabricant. Il est recommand chaque laboratoire dtablir ses propres moyennes et plages de valeurs acceptables et de nutiliser les valeurs fournies qu titre indicatif.Consulter le site www.qcnet.com pour obtenir une mise jour de la notice.

    CARACTRISTIQUESCe produit lyophilis est fabriqu selon des normes rigoureuses de contrle de la qualit. Pour obtenir des rsultats reproductibles dun acon lautre, le contrle doit tre convenablement conserv et manipul, tel que dcrit dans cette notice. + Consulter les notes de bas de page pour dimportantes informations sur le produit.

    0459 EXP 2014-07-31Level 1 40261Level 2 40262Level 3 40263

    40260

    Printed // Gedruckt // Imprim // Stampato // Impreso // Impresso // Tryckt // Trykt 2011-12 1536

    In Vitro Diagnostic Medical DeviceMedizinprodukt fr die In-vitro-Diagnostik

    Appareil mdical de diagnostic in vitroDispositivo diagnostico in vitro

    Dispositivo mdico para diagnstico in vitroDispositivo mdico de diagnstico in vitro

    Medicinteknisk produkt fr in vitro-diagnostikIn vitro diagnostisk medicinsk udstyr

    European ConformityCE-Konformittskennzeichnung

    Conformit aux normes europennes Conformit europea

    Conformidad europeaConformidade com as normas europeias

    Europeisk verensstmmelseEuropisk overensstemmelse

    Temperature LimitationTemperaturbeschrnkung

    Limite de tempratureLimite di temperatura

    Limitacin de temperaturaLimites de temperaturaTemperaturbegrnsningTemperaturbegrnsning

    Consult Instructions for UseGebrauchsanweisung beachten

    Consulter la notice demploiConsultare le istruzioni per luso

    Consulte las instrucciones de usoConsulte as instrues de utilizao

    Ls bruksanvisningenBenyt brugsanvisninger

    Lot NumberChargen-Nr.

    Numro de lot Numero di lottoNmero de lote Nmero de lote Satsnummer

    Batchnummer

    EXPUse by (YYYY-MM-DD)

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

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

    Anvnd fre (-MM-DD)Anvend fr (-MM-DD)

    ManufacturerHerstellerFabricantProduttoreFabricanteFabricanteTillverkareProducent

    Authorized RepresentativeBevollmchtigter

    Reprsentant agrRappresentante autorizzatoRepresentante autorizadoRepresentante autorizadoAuktoriserad representantAutoriseret reprsentant

    Catalog NumberKatalognummer

    Numro de catalogueNumero di catalogoNmero de catlogoNmero de catlogo

    KatalognummerKatalognr.

    Caution, Consult Accompanying DocumentsAchtung, Gebrauchsanweisung beachtenAttention, consulter les documents joints

    Attenzione, consultare la documentazione allegataAdvertencia, consulte los documentos incluidosAteno, consulte a documentao fornecida

    Obs! Se medfljande dokumentNB! Se medflgende dokumenter

    Reconstitute WithRekonstitutieren mit reconstituer avec

    Ricostituito conReconstituir conReconstituir com

    Sp ut medRekonstitueret med

    5.0 mL H2O

  • ITALIANOUSO PREVISTOIl Lyphochek Immunoassay Plus Control un siero di controllo di qualit, dosato, formulato per monitorare la precisione delle procedure di analisi di laboratorio per gli analiti elencati nel presente inserto.

    SOMMARIO E PRINCIPIOLuso di materiali per il controllo di qualit 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 nellambito di tutto lintervallo clinico sono disponibili tre livelli di controllo.

    REATTIVOQuesto prodotto 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 fornito in forma liola per aumentarne la stabilit.

    CONSERVAZIONE E STABILITQuesto prodotto stabile no alla data di scadenza quando viene conservato, non aperto, a 2-8C. Una volta ricostituito il controllo, tutti gli analiti sono stabili per 7 giorni quando il controllo conservato ben chiuso a 2-8C, con le seguenti eccezioni: (1) Folati e PSA sono stabili per 3 giorni dopo la ricostituzione. (2) C-Peptide 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 20 / 70C con le seguenti eccezioni: non vengono fornite dichiarazioni di stabilit per ACTH, Aldosterone, 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 RICOSTITUZIONECon una pipetta volumetrica, ricostituire ogni acone con 5,0 ml di acqua distillata o deionizzata. Chiudere e lasciare riposare il controllo per 15 minuti. Prima delluso, lasciare riposare il controllo a temperatura ambiente (18-25C) e agitarlo delicatamente per garantire lomogeneit del contenuto. Dopo ogni uso, chiudere immediatamente con il tappo e conservare il prodotto a 2-8C.

    PROCEDURAQuesto 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 riuti. Nel caso di danni alla confezione, contattare gli ufci Bio-Rad o lagente 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 acone. 3. Questo prodotto non concepito per luso come standard di riferimento.

    ASSEGNAZIONE DEI VALORII valori medi riportati in questo inserto sono il risultato di analisi in replicato e sono specici per questo lotto di prodotto. Le analisi elencate sono state effettuate dal produttore e/o da laboratori indipendenti utilizzando reagenti forniti dal produttore ed una campionatura rappresentativa di questo lotto di controllo. Le medie di ciascun laboratorio dovrebbero rientrare nel corrispondente intervallo di accettabilit; tuttavia i valori medi del laboratorio possono variare rispetto a quelli dichiarati per il periodo di validit del presente controllo. Le variazioni nel tempo e tra laboratori possono essere causate da differenze nelle metodologie, nelle strumentazioni o nei reagenti di ogni laboratorio, o da modiche metodologiche dei produttori. Ogni laboratorio deve stabilire le proprie medie e i relativi intervalli di accettabilit ed utilizzare i valori pubblicati sullinserto solo come guida.Consultare il sito www.qcnet.it per informazioni sullaggiornamento dellinserto.

    CARATTERISTICHEQuesto un prodotto liolo stabilizzato preparato sotto un rigido controllo standard di qualit. Per ottenere una consistente uniformit di risultati da acone a acone, si raccomanda una corretta conservazione e un corretto uso, come descritto. + Vedere importanti informazioni sul prodotto indicate nella sezione delle note a pi pagina.

    ESPAOLUSO INTENCIONADOLyphochek Immunoassay Plus Control tiene un uso intencionado como suero valorado para el control de la calidad y con el n de supervisar la precisin de los procedimientos de anlisis del laboratorio y para los analitos que se enumeran en este prospecto.

    INTRODUCCIN Y PRINCIPIOEl uso de materiales para el control de la calidad est indicado para la evaluacin objetiva de la precisin de los mtodos y las tcnicas en uso, y forma parte integral de las buenas prcticas del laboratorio. Existen tres niveles de control para permitir supervisar el funcionamiento dentro del rango clnico.

    REACTIVOSEste producto est preparado a partir de suero humano al que se aaden constituyentes de origen humano y animal, productos quimicos y drogas teraputicas. El nivel 1 contiene tambin estabilizadores. El control se suministra liolizado para una mayor estabilidad.

    CONSERVACIN Y ESTABILIDADEste producto permanecer estable hasta la fecha de caducidad, siempre que est almacenado sin abrir a una temperatura entre 2 y 8C. Una vez reconstituido el control, si se almacena bien tapado entre 2 y 8C, todos los analitos permanecern estables durante 7 das, con las siguientes excepciones: (1) Folato y PSA permanecern estables durante 3 das despus de la reconstitucin. (2) Peptida-C permanece estable durante 1 da despus de la reconstitucin. (3) ACTH (hormona adrenocorticotrpica), Calcitonina, Gastrina y PSA Libre deben ser valorados inmediatamente despus de la reconstitucin.Una vez reconstituido y congelado el control, si se almacena bien tapado entre 20 y 70C, todos los analitos permanecern estables durante 20 das, con las siguientes excepciones: ACTH, Aldosterona, Calcitonina y Pptido C, cuya estabilidad en congelacin 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 RECONSTITUCINUtilizando una pipeta volumtrica, 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 25C) y grelo en crculos con suavidad para garantizar su homogeneidad. Tras cada uso, tpelo inmediatamente y consrvelo de nuevo entre 2 y 8C.

    PROCEDIMIENTOEste 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 gestin de residuos. En el caso de que el envoltorio haya sufrido daos, pngase en contacto con la ocina de ventas o con el Servicio tcnico local de Bio-Rad.

    LIMITACIONES 1. Este producto no debe utilizarse despus de la fecha de caducidad. 2. Si hubiese indicios de contaminacin microbiana o exceso de turbidez en el producto reconstituido, deseche el vial. 3. Este producto no est previsto para ser utilizado como estndar.

    ASIGNACIN DE VALORESLos valores medios que guran en este prospecto se obtuvieron a partir de la replicacin de anlisis y son especcos de este lote del producto. Las pruebas fueron realizadas por el fabricante 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 tcnicas del laboratorio, su instrumental y sus reactivos, o a modicaciones introducidas en el mtodo de medida del fabricante. Se recomienda que cada laboratorio establezca sus propias medias y rangos aceptables y utilicen los que aqu se proporcionan slo como orientacin.Puede consultar las actualizaciones de prospectos en la pgina web www.qcnet.com.

    CARACTERSTICAS ESPECFICAS DE FUNCIONAMIENTOste es un producto liolizado que ha sido fabricado segn las ms estrictas normas de control de la calidad. Para obtener valores de ensayo coherentes entre viales, ser necesario almacenar y manipular el control segn se indica. + Consulte informacin importante sobre el producto en la nota al pie de pgina.

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

    SUMRIO E PRINCPIOA utilizao de materiais de controlo da qualidade indicada como uma avaliao objectiva da preciso de mtodos e tcnicas aplicados e parte integrante das boas prticas laboratoriais. Encontram-se disponveis trs nveis de controlo para permitir aferir o desempenho dentro dos limites clnicos.

    REAGENTEEste produto preparado a partir de soro humano acrescido de constituintes de origem humana e animal, qumicos e frmacos teraputicos. O nvel 1 tambm contm estabilizadores. O controlo fornecido sob forma liolizada para maior estabilidade.

    ARMAZENAMENTO E ESTABILIDADEEste produto permanecer estvel at ao m do prazo de validade desde que seja armazenado por abrir a uma temperatura de 2 a 8C. Depois de o controlo ter sido reconstitudo, todos os analitos permanecero estveis durante 7 dias desde que o produto seja armazenado com a tampa rmemente apertada a uma temperatura de 2 a 8C, com as seguintes excepes: (1) O Folato e o PSA permanecem estveis durante 3 dias aps a reconstituio. (2) O Peptdeo C permanecer estvel durante 1 dia aps a reconstituio. (3) A ACTH, a Calcitonina, a Gastrina e o PSA Livre devem ser ensaiados imediatamente aps a reconstituio.Depois de reconstituir e congelar o controlo, todos os analitos permanecero estveis durante 20 dias desde que sejam armazenados com a tampa rmemente apertada a uma temperatura de 20 a 70C, com as seguintes excepes: no se proporciona qualquer armao de estabilidade congelada para a ACTH, a Aldosterona, a Calcitonina e o Peptdeo C. Depois de ter descongelado, o controlo no deve voltar a ser congelado; descarte qualquer material restante.Este produto enviado em condies de temperatura ambiente.

    INSTRUES DE RECONSTITUIOUtilizando uma pipeta volumtrica, reconstitua cada frasco com 5,0 ml de gua 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 25C) e agite suavemente o frasco para assegurar a homogeneidade. Aps cada utilizao, reponha imediatamente a tampa e volte a armazenar a uma temperatura de 2 a 8C.

    PROCEDIMENTOEste produto deve ser tratado da mesma forma que as amostras de pacientes e utilizado de acordo com as instrues que acompanham o instrumento, dispositivo ou reagente que est a ser utilizado.Elimine todos os materiais descartados de acordo com as disposies locais em vigor para a eliminao de resduos biolgicos. Na eventualidade de observar danos na embalagem, contacte a Bio-Rad Laboratories.

    LIMITAES 1. Este produto no deve ser utilizado aps o m do prazo de validade. 2. Caso se verique uma contaminao microbiana ou turvao excessiva no produto reconstitudo, descarte o frasco. 3. Este produto no deve ser utilizado como padro.

    VALORIZAESOs valores mdios impressos neste folheto derivam de anlises repetidas e so especcos para este lote do produto. Os testes listados foram executados pelo fabricante e/ou por laboratrios independentes utilizando reagentes suportados pelo fabricante e uma amostra representativa deste lote de controlo. As mdias laboratoriais individuais devem estar dentro dos limites correspondentes aceitveis; no entanto, as mdias laboratoriais podem variar dos valores listados durante o tempo de durao deste controlo. Variaes ao longo do tempo e entre laboratrios podem dever-se a diferenas de tcnicas, instrumentos ou reagentes, ou a modicaes nas tcnicas de teste pelo fabricante. Recomenda-se que cada laboratrio estabelea as suas prprias mdias e limites aceitveis e utilize os que so fornecidos apenas como guias.Consulte o site www.qcnet.com para obter informaes sobre actualizaes de folhetos informativos.

    CARACTERSTICAS ESPECFICAS DE DESEMPENHOEste produto liolizado e fabricado de acordo com os mais rgidos padres de controlo da qualidade. Para obter valorizaes consistentes de frasco para frasco, o controlo deve ser manuseado e armazenado de acordo com o descrito. + Consulte informao importante sobre o produto na nota de rodap.

    SVENSKAAVSEDD ANVNDNINGLyphochek Immunoassay Plus Control r ett analyserat kvalitetskontrollserum avsett fr kontroll av precisionen i testfrfaranden p laboratorium, fr de analyter som anges i denna bipacksedel.

    SAMMANFATTNING OCH PRINCIPAnvndning av kvalitetskontrollmaterial r indicerad fr objektiv utvrdering av precisionen i anvnda metoder och tekniker och ingr i god laboratoriepraxis. Tre kontrollniver nns tillgngliga, fr kontroll av prestandan inom det kliniska mtomrdet.

    REAGENSDenna produkt r framstlld av humanserum med tillsatser av humant och animaliskt ursprung, kemikalier samt lkemedel. Niv 1 innehller ven stabiliseringsmedel. Kontrollen tillhandahlles i frystorkad form fr kad hllbarhet.

    FRVARING OCH STABILITETDenna produkt r stabil fram till utgngsdatum vid frvaring i oppnad frpackning vid 2 8C. Efter att kontrollen har rekonstituerats och vid frvaring i ttt frsluten aska vid 2 8C r alla analyter stabila i 7 dagar, med fljande undantag: (1) Folat och PSA r stabila i 3 dagar efter rekonstituering. (2) C-peptid r stabil 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 frvaring i ttt frsluten aska vid 20 till 70C r alla analyter stabila i 20 dagar, med fljande undantag: inga utfstelser kan gras betrffande hllbarheten i fruset tillstnd av ACTH, aldosteron, kalcitonin eller C-peptid. Nr askan vl har tinats fr kontrollen ej ter frysas utan resterande material skall kasseras.Denna produkt transporteras vid omgivningstemperatur.

    ANVISNINGAR FR REKONSTITUERINGAnvnd en volumetrisk pipett och rekonstituera varje aska med 5,0 mL destillerat eller avjoniserat vatten. Stt p proppen igen och lt kontrollen st i 15 minuter. Lt kontrollen uppn rumstemperatur (1825C) innan den anvnds och snurra sedan frsiktigt fr hand s att den blandas ordentligt Efter varje anvndning skall askan omedelbart frslutas med propp och sttas tillbaka i kylfrvaring vid 2-8C.

    FRFARANDEDenna produkt skall behandlas p samma stt som patientprover och anvndas enligt anvisningarna fr de instrument, kit och reagenser som anvnds.Kasserat material skall hanteras enligt de avfallsbestmmelser som utfrdats av lokala myndigheter. Om frpackningen r skadad kontaktas nrmaste Bio-Rad Laboratories frsljningsavdelning eller teknisk serviceavdelning.

    BEGRNSNINGAR 1. Denna produkt skall inte anvndas efter utgngsdatum. 2. Vid tecken p mikrobiell kontaminering eller om den rekonstituerade vtskan r mycket grumlig skall askan kasseras. 3. Denna produkt r inte avsedd att anvndas som en standard.

    NOMINELLA VRDENDe medelvrden som anges i denna bipacksedel har tagits fram genom replikatanalyser och r specika fr denna produktbatch. De angivna testerna har utfrts av tillverkaren och/eller oberoende laboratorier med anvndning av reagens som stds av tillverkaren och representativa prover av denna kontrollbatch. Medelvrdena p det enskilda laboratoriet br ligga inom motsvarande acceptabla omrde; laboratoriets medelvrden kan dock skilja sig frn de angivna vrdena under kontrollens livstid. Variationer ver tid och frn laboratorium till laboratorium kan bero p skillnader i laboratorieteknik, instrument och reagens, eller p modieringar av tillverkarens testmetoder. Vi rekommenderar att varje laboratorium faststller sina egna medelvrden och acceptabla omrden och endast betraktar de hri angivna vrdena som vgledande.Besk www.qcnet.com fr aktuell bipacksedelsinformation.

    SPECIFIKA PRODUKTEGENSKAPERDenna produkt r en frystorkad produkt som framstlls enligt strikta kvalitetskontrollstandarder. Fr reproducerbara analysresultat frn aska till aska skall kontrollen frvaras och hanteras korrekt, enligt anvisningarna. + Se viktig produktinformation i fotnoten.

    Lyphochek Immunoassay Plus Control, Levels 1, 2 and 3

  • DANSKTILSIGTET ANVENDELSELyphochek Immunoassay Plus Control er beregnet til anvendelse som en analyseret kvalitetskontrolserum med henblik p overvgning af prcisionen af laboratoriets analysemetoder for de analytter, der er angivet i indlgssedlen.

    RESUM OG PRINCIPAnvendelsen af kvalitetskontrolmateriale er tilsigtet som en objektiv vurdering af de anvendte metoders og teknikkers prcision og er en integreret del af god laboratoriepraksis. Der ndes tre kontrolniveauer tilgngelige til overvgning af prstationen inden for det kliniske omrde.

    REAGENSDette produkt er fremstillet af human serum tilsat bestanddele af human og animalsk oprindelse, kemikalier og terapeutiske medikamenter. Niveau 1 indeholder ogs stabilisatorer. Denne kontrol leveres i frysetrret form for forget stabilitet.

    OPBEVARING OG STABILITETDette produkt er holdbart til udlbsdatoen ved opbevaring ubnet ved 2-8C. Efter rekonstituering er alle analytter holdbare i 7 dage ved opbevaring med tt lukket lg ved 2-8C, med flgende undtagelser: (1) Folat og PSA vil vre holdbare i 3 dage efter rekonstituering. (2) C-peptid er holdbart i 1 dag efter rekonstituering. (3) ACTH, calcitonin, gastrin og frit PSA br analyseres umiddelbart efter rekonstituering.Efter rekonstituering og frysning vil alle analytter vre holdbare i 20 dage ved opbevaring med tt lukket lg ved 20 till 70C, med flgende undtagelser: Der er intet fastsat om stabilitet efter frysning af ACTH, aldosteron, calcitonin og C-peptid. Optet kontrolmaterialet m ikke fryses igen; resten af materialet kasseres.Dette produkt forsendes i uklet tilstand.

    VEJLEDNING I REKONSTITUERINGHver ampul rekonstitueres med 5,0 ml destilleret eller deioniseret vand ved hjlp af en volumetrisk pipette. St omgende lget p igen, og lad kontrolmaterialet st i 15 minutter. Inden analysering skal kontrolmaterialet have stuetemperatur (18-25C) og blandes forsigtigt for at sikre homogenitet. Efter hver brug lukkes glasset straks igen og anbringes ved 2-8C.

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

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

    TILDELING AF VRDIERDe middelvrdier, der er trykt i denne indlgsseddel, blev udledt af gentagne analyser og er specikke for dette produktlot. De angivne analyser blev udfrt af producenten og/eller uafhngige laboratorier vha. reagenser understttet af producenten og en reprsentativ prve af dette lot af kontrolmateriale. Individuelle laboratoriemiddelvrdier br ligge inden for det i indlgssedlen angivne acceptable referenceomrde, men kan dog variere i forhold til de angivne vrdier i lbet af kontrolmaterialets levetid. Variationer over tid og imellem laboratorier kan skyldes forskellige laboratorieteknikker, instrumenter og reagenser eller modikationer i testmetoder fra producentens side. Det anbefales, at laboratorier fastlgger deres egne middelvrdier og acceptable referenceomrder og kun betragter de medflgende vrdier som vejledende.Der henvises til www.qcnet.com vedr. opdateringer af indlgssedlen.

    SPECIFIKKE YDELSESEGENSKABERDette produkt er et frysetrret produkt, der er produceret under strenge kvalitetskontrolkrav. Kontrolmaterialet skal opbevares korrekt og hndteres som anvist for at give plidelige resultater. + Se vigtige oplysninger om produktet i fodnoten.

    TRKEKULLANIM AMACILyphochek Immunoassay Plus Control, laboratuvar test prosedrlerinin bu prospektste listelenen analitler iin kesinliinin takip edilmesi amacyla deerleri bilinen bir kalite kontrol serumu olarak kullanlmas iindir.

    ZET VE PRENSPKalite kontrol materyallerinin kullanlmas, allan yntemlerin ve tekniklerin kesinlii ile ilgili objektif bir deerlendirme yaplmas iindir ve iyi laboratuvar uygulamalarnn ayrlmaz bir parasdr. Klinik aralkta performansn takip edilmesi iin seviye kontrol mevcuttur.

    REAKTFBu rn, insan ve hayvan kaynakl bileenler, kimyasallar ve teraptik ilalarn eklendii insan serumundan hazrlanmaktadr. Seviye 1 stabilizatr de iermektedir. Kontrol stabilitenin arttrlmas amacyla liyolize formda salanmaktadr.

    SAKLAMA VE STABLTEBu rn almadan 2 ila 8C arasnda saklandnda son kullanma tarihine kadar stabildir. Kontrol hazrlandktan sonra, skca kapatlp 2 ila 8C arasnda saklandnda aadaki istisnalar dnda tm analitler 7 gn stabildir: (1) Folat ve PSA 3 gn stabildir, (2) C-Peptid 1 gn stabildir, (3) ACTH, Kalsitonin, Gastrin ve Serbest PSA hazrlandktan sonra hemen test edilmelidir.Kontrol hazrlandktan ve dondurulduktan sonra, skca kapatlp -20 ila -70C arasnda saklandnda aadaki istisnalar dnda tm analitler 20 gn stabildir: ACTH, Aldosteron, Kalsitonin ve C-Peptid iin herhangi bir donmu halde stabilite nerisinde bulunulmamtr. Kontrol zdrdkten sonra tekrar dondurmayn; kalan atn.Bu rn ortam koullar altnda sevk edilir.

    HAZIRLAMA TALMATLARIHacimsel bir pipet kullanarak 5,0 mL distile veya deiyonize su ile her akonun iindekileri sulandrn. Kapan yerine takn ve kontrol 15 dakika bekletin. Numune almadan nce kontroln oda scaklna (18 ila 25C) gelmesini bekleyin ve homojen hale gelmesini salamak iin yavaa kartrn. Her kullanmdan sonra kapa derhal yerine takn ve 2 ila 8C arasnda saklayn.

    PROSEDRBu rn hasta rnekleri ile ayn muameleye tabi tutulmaldr ve kullanlmakta olan cihaz, kit veya reaktif ile birlikte verilen talimatlara uygun olarak allmaldr. Herhangi bir atk malzemeyi yerel atk ynetimi yetkililerinin gereklerine uygun olarak atn. Ambalajda hasar olmas durumunda, Bio-Rad Laboratories Sat Osi veya Bio-Rad Laboratories Teknik Servisi ile irtibata gein.

    SINIRLAMALAR 1. Bu rn son kullanma tarihinden sonra kullanlmamaldr. 2. Sulandrlan rnde mikrobiyal kontaminasyona veya ar trbiditeye dair bir gsterge varsa, akonu atn. 3. Bu rnn bir standart olarak kullanlmas amalanmamtr.

    DEERLERN TAYN EDLMESBu prospektste yazl olan ortalama deerler tekrar tekrar yaplan analizlerden elde edilmitir ve rnn bu lotuna zgdr. Listelenen testler, reticinin salad reaktier ve kontroln bu lotunun temsili bir numunesi kullanlarak retici ve/veya bamsz laboratuvarlar tarafndan gerekletirilmitir. Ayr ayr laboratuvar ortalamalar karlk gelen kabul edilebilir aralk ierisinde olmaldr; bununla birlikte laboratuvar ortalamalar bu kontroln mr sresince listelenen deerlerden farkl olabilir. Zaman ierisindeki ve laboratuvarlar arasndaki deiiklikler laboratuvar teknii, cihaz ve reaktierdeki farkllklar veya reticinin test yntemindeki modikasyonlar neden olabilir. Her laboratuvarn kendi ortalamalarn ve kabul edilebilir aralklarn belirlemeleri ve verilen bu deerleri sadece klavuz olarak kullanmalar nerilir.Gncel prospekts bilgileri iin www.qcnet.com adresine bakn.

    SPESFK PERFORMANS ZELLKLERBu rn, sk kalite kontrol standartlar altnda retilmi dondurularak kurutulmu bir rndr. Flakondan akona tutarl test deerleri elde etmek iin kontroln belirtilen ekillerde saklanmas ve kullanlmas gerekmektedir. + Dipnotta listelenen nemli rn bilgisine bakn.DPNOTLAR + Kontroln bu lotu iin: Siklosporin: Beklenen deerler veya stabilite iin herhangi bir neride bulunulmamtr. (1) Sadece endojen seviyeleri gsterir. (2) Beklenen deer veya stabilite iin herhangi bir neride bulunulmamtr. (3) Deerler verilmemitir. (4) Seviye 3, reticinin stradiol deerleri >250 pg/mL (917,5 pmol/L) olan hasta rnekleri iin verdii nerilere gre seyreltin. N/A Uygulanamaz V Basm aamasnda veri mevcut deil. Ltfen bilgi aln. Bu test ile ilgili ortalama deerlerin ve kabul edilebilir aralklarn belirlenmesi iin gereken veriler tayine snrl sayda katlmdan dolay salanamamtr. Merkeziniz bu test ile ilgili Deer Tayini Programna katlmay dnyorsa, ltfen yerel Bio-Rad Sat veya Teknik Servis Grubu ile irtibata gein. Y SADECE ULUSLARARASI KULLANIM - Aadaki blm Birleik Devletlerde diagnostik kullanm iin mevcut olmayan yntemlere dair veriler iermektedir.

    Lyphochek Immunoassay Plus Control31282871PSA32C-13ACTHPSA-20-7020ACTHC-5.0mL151825 28 1. 2. 3. MEAN http://www.qcnet.com/JP + + : : (1) (2) (3) (4) 250 pg/mL917.5 pmol/L 3 N/A V : 0120-9250469:0017:30

    Lyphochek Immunoassay Plus Control, Levels 1, 2 and 3

  • WARNING // Warnung // Attention // Avvertenze // Precaucin // Aviso // Varning // Advarsel // UyariENGLISHBiological 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 infektis zu behandeln.Jede zur Herstellung dieser Kontrolle verwendete Einheit von menschlichen Spendern wurde mit von der amerikanischen Arzneimittelbehrde FDA (Food and Drug Administration) zugelassenen Methoden getestet und als nicht-reaktiv bezglich Hepatitis-B-Oberchen-Antigen (HBsAg), Antikrper gegen Hepatitis C (HCV) und Antikrper gegen HIV-1/HIV-2 befunden. Das Produkt enthlt mglicherweise auch andere Bestandteile menschlichen Ursprungs, fr die keine zugelassenen Tests existieren. In bereinstimmung mit der guten Laborpraxis sollten alle Materialien menschlichen Ursprungs als potenziell infektis betrachtet und mit der gleichen Sorgfalt wie Patientenproben behandelt werden.Sicherheitsdatenbltter (MSDS) stehen Ihnen im Internet unter www.bio-rad.com zur Verfgung.

    FRANAISProduit dorigine biologique. A considrer comme potentiellement infectieux.Chaque unit de produit provenant dun donneur humain et utiliseutilis dans la prparation de ce contrle a t analyse laide de mthodes approuves par la FDA et a prsent des rsultats ngatifs pour lantigne de surface de lhpatite B (AgHBs), et les anticorps de lhpatite C (VHC) et du VIH-1/VIH-2. Il est possible que ce produit contienne dautres substances dorigine

    humaine pour lesquelles il nexiste pas de test agr. Conformment aux bonnes pratiques de laboratoire, toute substance dorigine humaine doit tre considre comme potentiellement infectieuse et manipule avec les mmes prcautions que les chantillons provenant de patients.Une che de scurit (FDS) est disposition des utilisateurs professionnels sur le site www.bio-rad.com.

    ITALIANOMateriale di origine biologica. Trattare come potenzialmente infettivo.Ciascuna unit donatore utilizzata per preparare questo controllo, stata testata mediante metodi approvati dalla FDA ed risultata non reattiva per lantigene di supercie dellepatite B (HBsAg), lanticorpo contro lepatite C (HCV) e lanticorpo contro lHIV-1/HIV-2. Questo prodotto pu 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, perci 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.

    ESPAOLMaterial de origen biolgico. Manipular como potencialmente infeccioso.Todas las unidades de donantes humanos utilizadas en la fabricacin de este control se han analizado segn mtodos de anlisis aceptados por la FDA (agencia estadounidense para alimentos y frmacos) y se ha determinado que no reaccionan contra el antgeno supercial 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 anlisis homologados. De acuerdo con las prcticas 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 cha de datos de seguridad (MSDS) est disponible para los usuarios profesionales en www.bio-rad.com.

    PORTUGUSMaterial de origem biolgica. Tratar como potencialmente infeccioso.Cada ddiva humana utilizada no fabrico deste controlo foi testada pelos mtodos aprovados pela FDA (Administrao dos Alimentos e Frmacos dos Estados Unidos), tendo sido considerada no reactiva em antignios de superfcie da hepatite B (HBsAg), anticorpo da hepatite C (VHC) e anticorpos VIH-1/VIH-2. Este produto tambm poder conter outros materiais de origem humana para os quais no existem testes aprovados. De acordo com as boas prticas laboratoriais, todo o material de origem humana deve ser considerado potencialmente infeccioso, pelo que dever ser manuseado com as mesmas precaues utilizadas com as amostras dos pacientes.Existem chas de dados de segurana (MSDS) disponveis para os utilizadores prossionais em www.bio-rad.com.

    SVENSKAMaterial av biologiskt ursprung. Skall behandlas som potentiellt infektist.Varje enhet frn humana donatorer till denna kontroll har testats enligt FDA-godknda metoder och har visat sig icke-reaktiv fr hepatit B ytantigen (HBsAg), antikroppar mot hepatit C (HCV) och antikroppar mot HIV-1/HIV-2. Denna produkt kan ven innehlla annat material av humant ursprung, fr vilket godknda tester saknas. Enligt god laboratoriepraxis br alla material av humant ursprung betraktas som potentiellt infektisa och hanteras enligt samma frsiktighetsregler som patientprover.Skerhetsdatablad fr laboratoriepersonal nns p www.bio-rad.com.

    DANSKBiologisk kildemateriale. Br 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 overadeantigen (HBsAg), antistof mod hepatitis C (HCV) og antistof mod HIV-1/HIV-2. Dette produkt kan ogs indeholde andet humant kildemateriale, for hvilket der ikke ndes godkendte tests. I overensstemmelse med

    god laboratoriepraksis br alle materialer af human oprindelse betragtes som potentiel smittekilde og hndteres efter samme forholdsregler som patientprver.Professionelle brugere kan f sikkerhedsdatabladet (MSDS) p www.bio-rad.com.

    TRKEBiyolojik kaynakl madde. Potansiyel bulac olarak muamele edin.Bu kontroln retiminde kullanlan her bir insan donr birimi FDA tarafndan kabul edilen yntemlerle test edilmitir ve Hepatit B Yzey Antijeni (HBsAg), Hepatit Cye kar antikor (HCV) ve HIV-1/HIV-2ye kar antikor asndan reaksiyona yol amad bulunmutur. Bu rn ayn zamanda henz onaylanm testi bulunmayan dier insan kaynakl maddeler de ierebilir. yi laboratuvar uygulamasna uygun ekilde, tm insan kaynakl maddeler potansiyel bulac olarak dikkate alnmaldr ve hasta rneklerinde uygulanan nlemlerin ayns ile kullanlmaldr.Profesyonel kullanm iin www.bio-rad.com adresinde Malzeme Gvenlik Veri Sayfas (MSDS) mevcuttur.

    HBsHCVHIV-1/2FDAGLP [email protected]

  • GLOSSARY GLOSSAR GLOSSAIRE GLOSSARIO GLOSARIO GLOSSRIO ORDLISTA ORDLISTE

    ANALYTES11-Deoxycortisol (3)17-Alpha - Hydroxyprogesterone25-Hydroxy Vitamin D (1)AcetaminophenAdrenocorticotropic Hormone (ACTH)Alpha Fetoprotein (AFP)Aldosterone AmikacinAmiodarone (2)Amitriptyline (3)AndrostenedioneAngiotensin I (1)Antithyroglobulin antibody (anti-TG Ab) (1) (2)

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

    Caffeine (3)CalcitoninCarbamazepineCarbamazepine, Free (3)Carcinoembryonic Antigen (CEA)

    ChloramphenicolCortisolC-PeptideCyclosporine (+)DesipramineDehydroepiandrosterone (DHEA)DHEA SulfateDigoxinDisopyramide (3)EstradiolEstriol, FreeEstriol, Total (2)Estrogens, Total (3)Ethosuximide (3)FerritinFlecainide (3)FolateFructosamine (1)Follicle Stimulating Hormone (FSH)GastrinGentamicinGlucagon (1) (3)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) (2)

    InsulinIron (1)Luteinizing Hormone (LH)Lidocaine (3)LithiumNAPANetilmicin (2)NortriptylineProstatic Acid Phosphatase (PAP)

    PhenobarbitalPhenytoinPhenytoin, Free (3)Primidone (3)ProcainamideProgesteroneProlactinPropanololProstate Specic Antigen (PSA)PSA, FreeParathyroid Hormone (PTH) (2)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, Free (3)VancomycinVitamin B12

    TERMSMeanN/A (Not Applicable)RangeRe-standardizationUnits

    ANALYTE11-Deoxycortisol (3)17-Alpha - Hydroxyprogesteron25-Hydroxy-Vitamin D (1)AcetaminophenAdrenocorticotropes Hormon (ACTH)Alpha-Fetoprotein (AFP)AldosteronAmikacinAmiodaron (2)Amitriptylin (3)AndrostendionAngiotensin I (1)Antithyreoglobulin-Antikrper (Anti-TG-AK) (1) (2)

    Schilddrsen-Peroxidase-Antikrper (Anti-TPO-AK) (2)

    Coffein (3)CalcitoninCarbamazepinCarbamazepin, frei (3)Carcinoembryonales Antigen (CEA)

    ChloramphenicolCortisolC-PeptidCyclosporin (+)DesipraminDehydroepiandrosteron (DHEA)DHEA-SulfatDigoxinDisopyramid (3)stradiolstriol, freistriol, gesamt (2)strogene, gesamt (3)Ethosuximid (3)FerritinFlecainid (3)FolatFructosamin (1)Follikelstimulierendes Hormon (FSH)GastrinGentamycinGlucagon (1) (3)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) (2)

    InsulinEisen (1)Luteinisierendes Hormon (LH)Lidocain (3)LithiumNAPANetilmicin (2)NortriptylinProstataspezische saure Phosphatase (PSP) (PAP)

    PhenobarbitalPhenytoinPhenytoin, frei (3)Primidon (3)ProcainamidProgesteronProlactinPropanololProstata-spezisches Antigen (PSA)PSA, freiParathormon (PTH) (2)ChininSalicylatSHBG (2)

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

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

    TobramycinScreen fr trizyklische Antidepressiva

    Thyreoidea-stimulierendes Hormon (TSH)

    ValproinsureValproinsure, frei (3)VancomycinVitamin B12

    BEGRIFFEMittelwertN/A (Nicht Anwendbar)BereichRestandardisierungEinheiten

    ANALYTES11-doxycortisol (3)17-alpha - hydroxyprogestrone25-hydroxy vitamine D (1)ActaminophneHormone corticotrope (ACTH)Alpha-ftoprotine (AFP)AldostroneAmikacineAmiodarone (2)Amitriptyline (3)AndrostnedioneAngiotensine I (1)Anticorps antithyroglobulinique (anti-TG Ab) (1) (2)

    Anticorps antithyroproxydase (anti TPO-Ab) (2)

    Cafine (3)CalcitonineCarbamazpineCarbamazpine, libre (3)Antigne carcino-embryonnaire (ACE) (CEA)

    ChloramphnicolCortisolPeptide CCyclosporine (+)DsipramineDshydro-piandrostrone (DHEA)Sulfate de DHEADigoxineDisopyramide (3)stradiolstriol, librestriol, total (2)strognes, totales (3)thosuximide (3)FerritineFlcainide (3)FolateFructosamine (1)Hormone folliculo-stimulante (FSH)GastrineGentamicineGlucagon (1) (3)Gonadotrophine chorionique humaine (hCG)

    Sous-unit hCG-btaHormone de croissance (hGH)

    Immunoglobuline A (IgA) (1)Immunoglobuline E (IgE)Immunoglobuline G (IgG) (1)Immunoglobuline M (IgM) (1)ImipramineTrypsinogne immunoractif (IRT) (2)

    InsulineFer (1)Hormone lutinisante (LH)Lidocane (3)LithiumNAPANetilmicine (2)NortriptylinePhosphatase acide prostatique (PAP)

    PhnobarbitalPhnytonePhnytone, libre (3)Primidone (3)ProcanamideProgestroneProlactinePropanololAntigne prostatique spcique (PSA)PSA, libreHormone parathyrodienne (PTH) (2)QuinidineSalicylateSHBG (2)

    Somatomdine C (1)T3, libreT3, totalT3, xationT4, libreT4, totalGlobuline de transport de la thyroxine (TBG) (1)TestostroneTestostrone, libreThophyllineThyroglobuline (1)Capacit de xation du fer, totale (TIBC) (1)

    TobramycineDpistage des antidpresseurs tricycliques

    Hormone de stimulation de la thyrode (TSH)

    Acide valproqueAcide valproque, libre (3)VancomycineVitamine B12

    TERMESMoyenneN/A (Nicht Anwendbar)PlageRe-standardisationUnits

    ANALITI11-Deossicortisolo (3)17-Alfa - idrossiprogesterone25-Idrossi-vitamina D (1)AcetaminofeneOrmone adrenocorticotropo (ACTH)Alfa-fetoproteina (AFP)AldosteroneAmikacinaAmiodarone (2)Amitriptilina (3)AndrostenedioneAngiotensina I (1)Anticorpo contro lantitiroglobulina (anti-TG Ab) (1) (2)

    Anticorpi contro la perossidasi dellantitiroide (anti TPO-Ab) (2)

    Caffeina (3)CalcitoninaCarbamazepinaCarbamazepina libera (3)Antigene carcinoembrionico (CEA)

    CloramfenicoloCortisoloC-PeptideCiclosporina (+)DesipraminaDeidroepiandrosterone (DHEA)DHEA SolfatoDigossinaDisopiramide (3)EstradioloEstriolo liberoEstriolo totale (2)Estrogeni totali (3)Etosuximide (3)FerritinaFlecainide (3)FolatoFruttosammina (1)Ormone follicolostimolante (FSH)GastrinaGentamicinaGlucagone (1) (3)Gonadotropina corionica umana (hCG)

    Sottounit hCG-BetaOrmone umano della crescita (hGH)

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

    InsulinaFerro (1)Ormone luteinizzante (LH)Lidocaina (3)LitioNAPANetilmicina (2)NortriptilinaFosfatasi acida prostatica (PAP)

    FenobarbitaleFenitoinaFenitoina libera (3)Primidone (3)ProcainamideProgesteroneProlactinaPropanololoAntigene prostato specico (PSA)PSA liberoOrmone paratiroideo (PTH) (2)QuinidinaSalicilatoSHBG (2)

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

    TestosteroneTestosterone liberoTeollinaTiroglobulina (1)Capacit legante del ferro totale) (TIBC) (1)

    TobramicinaControllo antidepressivo triciclico

    Ormone stimolante la tiroide (TSH)

    Acido valproicoAcido valproico libero (3)VancomicinaVitamina B12

    TERMINIMediaN/A (Non Applicabile)IntervalloRistandardizzazioneUnit

    ANALITOS11-Deoxicortisol (3)17-Alfa - Hidroxiprogesterona25-Hidroxi Vitamina D (1)AcetaminofenoHormona adrenocorticotrpica (ACTH)Alfa-fetoprotena (AFP)AldosteronaAmikacinaAmiodarona (2)Amitriptilina (3)AndrostenodionaAngiotensina I (1)Anticuerpos antitiroglobulina (anti TG Ab) (1) (2)

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

    Cafena (3)CalcitoninaCarbamacepinaCarbamacepina, Libre (3)Antgeno carcinoembrionario (CEA)

    CloranfenicolCortisolPptido CCiclosporina (+)DesipraminaDeshidroepiandrosterona (DHEA)Sulfato de DHEADigoxinaDisopiramida (3)EstradiolEstriol, LibreEstriol, Total (2)Estrgenos, Totales (3)Etosuximida (3)FerritinaFlecainida (3)FolatoFructosamina (1)FSH (Hormona estimulante del folculo)GastrinaGentamicinaGlucagn (1) (3)Gonadotropina corinica humana (hCG)

    Subunidad hCG-BetaHormona Humana del Crecimiento (hGH)

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

    InsulinaHierro (1)Hormona luteinizante (LH)Lidocana (3)LitioNAPA (N-Acetil-Procainamida)Netilmicina (2)NortriptilinaFosfatasa cida Prosttica (PAP)

    FenobarbitalFenitonaFenitona, Libre (3)Primidona (3)ProcainamidaProgesteronaProlactinaPropanololAntgeno prosttico especco (PSA)PSA, LibreHormona paratiroidea (PTH) (2)QuinidinaSalicilatoSHBG (2)

    Somatomedina-C (1)T3 (libre)T3 (total)T3 (Captacin)T4 (libre)T4 (total)Globulina jadora de tiroxina (TBG) (1)

    TestosteronaTestosterona, LibreTeolinaTiroglobulina (1)Capacidad total de jacin de hierro (TIBC) (1)

    TobramicinaScreening de antidepresivos tricclicos

    Hormona estimulante del tiroides (TSH)

    cido valpricocido valprico, Libre (3)VancomicinaVitamina B12

    TRMINOSMediaN/A (No Aplicable)RangoReestandarizacinUnidades

    ANALITOS11-deoxicortisol (3)17-alfa - hidroxiprogesterona25-hidroxi vitamina D (1)AcetaminofenoHormona adrenocorticotrca (ACTH)Alfa-fetoprotena (AFP)AldosteronaAmikacinaAmiodarona (2)Amitriptilina (3)AndrostenedionaAngiotensina I (1)Anticorpo antitiroglobulina (anti-TG Ab) (1) (2)

    Anticorpos antiperoxidase da tiride (anti TPO-Ab) (2)

    Cafena (3)CalcitoninaCarbamazepinaCarbamazepina, Livre (3)Antignio carcinoembrionrio (CEA)

    CloranfenicolCortisolPeptdeo CCiclosporina (+)DesipraminaDeidroepiandrosterona (DHEA)Sulfato de DHEADigoxinaDisopiramida (3)EstradiolEstriol, LivreEstriol, Total (2)Estrognios, Total (3)Etosuximida (3)FerritinaFlecainida (3)FolatoFrutosamina (1)Hormona foliculoestimulante (FSH)GastrinaGentamicinaGlucagona (1) (3)Gonadotropina corinica humana (hCG)

    Subunidade beta hCGHormona humana do crescimento (hGH)

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

    InsulinaFerro (1)Hormona luteinizante (LH)Lidocana (3)LtioNAPANetilmicina (2)NortriptilinaFosfatase cida prosttica (PAP)

    FenobarbitalFenitoinaFenitoina, Livre (3)Primidona (3)ProcainamidaProgesteronaProlactinaPropanololAntignio especco da prstata (PSA)PSA, LivreHormona paratiride (PTH) (2)QuinidinaSalicilatoSHBG (2)

    Somatomedina-C (1)T3 livreT3 totalAbsoro de T3T4 livreT4 totalGlobulina de ligao tireoxina (TBG) (1)TestosteronaTestosterona, LivreTeolinaTiroglobulina (1)Capacidade total de ligao ao ferro (TIBC) (1)

    TobramicinaRastreio de antidepressivos tricclicos

    Hormona estimulante da tiride (TSH)

    cido valpricocido valprico, Livre (3)VancomicinaVitamina B12

    TERMOSMdiaN/A (No Aplicvel)LimitesRenormalizaoUnidades

    ANALYTER11-deoxikortisol (3)17-alfa - hydroxiprogesteron25-hydroxi-vitamin D (1)AcetaminofenAdrenokortikotropt hormon (ACTH)Alfafetoprotein (AFP)AldosteronAmikacinAmiodaron (2)Amitriptylin (3)AndrostenedionAngiotensin I (1)Antityroglobulinantikropp (anti-TG-Ak) (1) (2)

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

    Koffein (3)KalcitoninKarbamazepinKarbamazepin, fritt (3)Carcinoembryonalt antigen (CEA)

    KloramfenikolKortisolC-peptidCyklosporin (+)DesipraminDehydroepiandrosteron (DHEA)DHEA-sulfatDigoxinDisopyramid (3)stradiolstriol, frittstriol, totalt (2)strogener, totalt (3)Etosuximid (3)FerritinFlekainid (3)FolatFruktosamin (1)Follikelstimulerande hormon (FSH)GastrinGentamicinGlukagon (1) (3)Humant koriongonadotropin (hCG)

    hCG-beta-subenhetHumant tillvxthormon (hGH)

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

    InsulinJrn (1)Luteiniserande hormon (LH)Lidokain (3)LitiumNAPA (n-acetylprokainamid)Netilmicin (2)NortriptylinProstataspecikt surt fosfatas (PAP)

    FenobarbitalFenytoinFenytoin, fritt (3)Primidon (3)ProkainamidProgesteronProlaktinPropanololProstataspecikt antigen (PSA)PSA, frittParathyreoideahormon (PTH) (2)KinidinSalicylatSHBG (2)

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

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

    TobramycinTricykliska antidepressiva medel, panel

    Tyreoideastimulerande hormon (TSH)

    ValproinsyraValproinsyra, fri (3)VancomycinVitamin B12

    TERMERMedelvrdeN/A (Gller Ej)OmrdeRestandardiseringEnheter

    ANALYTTER11-deoxycortisol (3)17-alpha-hydroxyprogesteron25-hydroxy-vitamin D (1)AcetaminophenAdrenokortikotropt hormon (ACTH)Alpha-fetoprotein (AFP)AldosteronAmikacinAmiodaron (2)Amitriptylin (3)AndrostenedionAngiotensin I (1)Thyreoglobulin antistof (anti-TG Ab) (1) (2)

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

    Koffein (3)CalcitoninCarbamazepinCarbamazepin, frit (3)Carcinoembryonalt antigen (CEA)

    ChloramphenicolCortisolC-peptidCyclosporin (+)DesipraminDehydroepiandrosteron (DHEA)DHEA-sulfatDigoxinDisopyramid (3)EstradiolEstriol, fritEstriol, total (2)strogener, total (3)Ethosuximid (3)FerritinFlecainid (3)FolatFruktosamin (1)Follikelstimulerende hormon (FSH)GastrinGentamicinGlucagon (1) (3)Humant choriongonadotropin (hCG)

    hCG-beta subunitHumant vksthormon (hGH)

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

    InsulinJern (1)Luteiniserende hormon (LH)Lidocain (3)LithiumNAPA (n-acetylprocainamid)Netilmycin (2)NortriptylinProstataspecik sur phosphatase (PAP)

    PhenobarbitalPhenytoinPhenytoin, frit (3)Primidon (3)ProcainamidProgesteronProlactinPropanololProstataspecikt antigen (PSA)PSA, fritParathyreoidea- hormon (PTH) (2)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, frit (3)VancomycinVitamin B12

    ORDLISTEMiddelvrdiN/A (Ikke anvendeligt)OmrdeRestandardiseringEnheder

  • METHODMethode // Mthode // Metodo // Mtodo // Mtodo // Metod // Metode

    Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    17-ALPHA-HYDROXYPROGESTERONE DRG MTPL ng/mL V V V nmol/L V V VIBL ELISA ng/mL 0.630 0.350 0.910 2.25 1.58 2.91 4.74 2.97 6.51 nmol/L 1.91 1.06 2.76 6.82 4.79 8.82 14.4 9.00 19.7

    MP BioMedicals ImmuChem CT RIA ng/mL nmol/L

    MP BioMedicals ImmuChem DA RIA ng/mL nmol/L

    Siemens Coat-A-Count (TKOP) ng/mL 1.57 1.23 1.91 5.10 4.00 6.20 10.7 9.40 12.0 nmol/L 4.76 3.73 5.79 15.5 12.1 18.8 32.4 28.5 36.4

    25-HYDROXY VITAMIN D (1)DiaSorin 125I RIA ng/mL 17.2 13.1 21.3 20.9 15.9 25.9 23.0 17.5 28.5 nmol/L 42.9 32.7 53.2 52.2 39.7 64.6 57.4 43.7 71.1

    ACETAMINOPHEN Emit 2000 g/mL 34.9

    MP BioMedicals ImmuChem DA RIA ng/mL nmol/L

    Siemens Coat-A-Count (Direct, TKAN) ng/mL 3.10 2.50 3.70 >10.0 >10.0 nmol/L 10.8 8.73 12.9 >34.9 >34.9

    ANGIOTENSIN I (1)DiaSorin GammaCoat Plasma Renin Activity 125I RIA ng/mL/hr 2.70 1.96 3.44 8.46 6.25 10.7 6.87 5.10 8.64 g/L/hr 2.70 1.96 3.44 8.46 6.25 10.7 6.87 5.10 8.64

    Radim Renin MAIA ng/mL/hr 3.81 2.33 5.23 10.9 5.43 16.5 8.94 3.58 14.3 g/L/hr 3.81 2.33 5.23 10.9 5.43 16.5 8.94 3.58 14.3

    C-PEPTIDE Calbiotech ELISA ng/mL 1.26 1.03 1.48 6.34 4.69 7.98 9.91 9.34 >10.0 nmol/L 0.420 0.343 0.493 2.11 1.56 2.66 3.30 3.11 >3.33

    DRG C-Peptide ELISA ng/mL V V V nmol/L V V VMercodia ELISA ng/mL 1.27 0.964 1.57 5.53 4.53 6.52 >12.3 pmol/L 422 321 523 1840 1509 2171 >4100

    Monobind AccuBind ELISA ng/mL 1.37 0.910 1.82 6.51 4.36 8.66 >10.0 nmol/L 0.456 0.303 0.606 2.17 1.45 2.88 >3.33

    Monobind AccuLite CLIA ng/mL 1.30 0.870 1.73 6.07 4.07 8.08 >10.0 nmol/L 0.433 0.290 0.576 2.02 1.36 2.69 >3.33

    Radim RIA ng/mL 1.32 0.480 2.17 6.66 2.72 10.6 14.8 8.35 >20.0 nmol/L 0.440 0.160 0.723 2.22 0.906 3.53 4.93 2.78 >6.66

    CALCITONIN Biomerica ELISA pg/mL 65.5 49.1 82.0 382 326 437 706 606 807 ng/L 65.5 49.1 82.0 382 326 437 706 606 807

    CARBAMAZEPINE CEDIA II g/mL 2.86 1.96 3.76 8.22 6.90 9.54 14.4 12.4 16.5 mol/L 12.1 8.29 15.9 34.8 29.2 40.4 60.9 52.5 69.8

    Emit 2000 g/mL 2.97 2.23 3.71 7.91 6.32 9.49 12.9 10.3 15.5 mol/L 12.6 9.43 15.7 33.5 26.7 40.1 54.7 43.6 65.6

    Sekisui Medical g/mL 3.00 1.80 4.10 8.30 5.80 10.7 14.4 11.5 17.3 mol/L 12.7 7.61 17.3 35.1 24.5 45.3 60.9 48.6 73.2

    Sekisui Medical Nanopia g/mL 2.00 1.20 2.90 7.90 5.50 10.3 13.8 11.1 16.6 mol/L 8.46 5.08 12.3 33.4 23.3 43.6 58.4 47.0 70.2

    CARCINOEMBRYONIC ANTIGEN (CEA) DRG MTPL ng/mL V V V g/L V V VMonobind AccuBind ELISA ng/mL 2.12 1.33 2.91 11.2 7.50 14.9 20.1 13.4 26.7 g/L 2.12 1.33 2.91 11.2 7.50 14.9 20.1 13.4 26.7

    Monobind AccuLite CLIA ng/mL 1.94 1.24 2.64 10.1 5.53 14.7 18.9 13.6 24.2 g/L 1.94 1.24 2.64 10.1 5.53 14.7 18.9 13.6 24.2

    Siemens Coat-A-Count IRMA (IKCA) ng/mL 104

    DEHYDROEPIANDROSTERONE-SULFATE DRG DHEA-S ELISA g/mL V V V mol/L V V VImmunotech Beckman Coulter DHEA-S-7 RIA ng/mL 601 491 710 1587 1160 2015 4640 2653 6627 nmol/L 1623 1326 1917 4285 3132 5441 12528 7163 17893

    Monobind AccuBind ELISA g/mL 0.790 0.460 1.12 2.28 1.36 3.20 7.18 5.49 >8.00 mol/L 2.13 1.24 3.02 6.16 3.67 8.64 19.4 14.8 >21.6

    Monobind AccuLite CLIA g/mL 0.830 0.560 1.11 2.12 1.42 2.81 6.77 4.80 >8.00 mol/L 2.24 1.51 3.00 5.72 3.83 7.59 18.3 13.0 >21.6

    MP BioMedicals ImmuChem CT RIA ng/mL mol/L

    Siemens Coat-A-Count (TKDS) g/dL 46.3 33.8 58.8 120 103 137 395 335 455 mol/L 1.25 0.913 1.59 3.23 2.78 3.69 10.7 9.04 12.3

    DESIPRAMINE HPLC ng/mL 79.8 63.9 95.8 162 130 195 241 193 289 nmol/L 299 239 359 609 487 731 903 723 1084

  • Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    DIGOXIN CEDIA II ng/mL nmol/L

    Emit 2000 ng/mL 0.470 0.230 0.700 1.55 1.24 1.90 2.70 2.16 3.20 nmol/L 0.602 0.294 0.896 1.98 1.59 2.43 3.46 2.76 4.10

    Monobind AccuBind ELISA ng/mL 0.620 0.420 0.830 1.89 1.26 2.51 3.19 2.42 3.96 nmol/L 0.794 0.538 1.06 2.42 1.61 3.21 4.08 3.10 5.07

    Monobind AccuLite (CLIA) ng/mL 0.590 0.400 0.790 1.91 1.28 2.54 3.15 2.57 3.73 nmol/L 0.755 0.512 1.01 2.44 1.64 3.25 4.03 3.29 4.77

    MP BioMedicals SPCS RIA ng/mL nmol/L

    Sekisui Medical DRI Digoxin (SMD) ng/mL nmol/L

    Sekisui Medical Nanopia ng/mL 0.460 0.270 0.640 1.50 1.05 1.95 2.68 2.15 3.22 nmol/L 0.589 0.346 0.819 1.92 1.34 2.50 3.43 2.75 4.12

    ESTRADIOL BioCheck EIA pg/mL pmol/L

    Calbiotech pg/mL 54.3 33.7 75.0 178 109 247 459 293 625 nmol/L 0.196 0.121 0.270 0.640 0.392 0.888 1.65 1.05 2.25

    DRG Estradiol ELISA pg/mL V V V pmol/L V V VImmunotech Beckman Coulter Ultra-Sensitive RIA (DSL 4800) pg/mL 43.9 29.1 58.6 71.2 51.3 91.1 159 214 104 nmol/L 0.158 0.105 0.211 0.256 0.185 0.328 0.572 0.770 0.374

    Monobind AccuBind pg/mL 95.5 64.0 127 206 138 274 389 318 459 pmol/L 350 235 466 756 506 1005 1426 1167 1686

    Monobind AccuLite pg/mL 106 44.3 168 215 135 295 408 262 553 pmol/L 389 162 617 790 496 1083 1497 962 2031

    MP BioMedicals ImmuChem CT RIA pg/mL pmol/L

    MP BioMedicals ImmuChem DA RIA pg/mL pmol/L

    Pantex 100 uL Direct 125I pg/mL 85.0 66.0 104 175 141 209 322 256 387 pmol/L 312 242 382 642 517 767 1182 940 1420

    Pantex EIA pg/mL pmol/L

    Pantex Extraction DA pg/mL 77.0 57.0 97.0 192 161 224 446 378 514 pmol/L 283 209 356 705 591 822 1637 1387 1886

    Radim MAIA pg/mL 62.1 37.9 86.3 171 104 238 313 191 436 pmol/L 228 139 317 627 383 872 1150 702 1599

    Siemens Coat-A-Count (TKE2-ALT) pg/mL 200

    Radim MAIACLONE mIU/mL 10.5 6.70 14.2 35.4 22.7 48.2 266 170 361 IU/L 10.5 6.70 14.2 35.4 22.7 48.2 266 170 361

    Siemens Coat-A-Count IRMA (IKCG) mIU/mL 8.50 6.50 10.5 29.0 25.0 33.0 311 265 357 IU/L 8.50 6.50 10.5 29.0 25.0 33.0 311 265 357

    UBI Magiwel ELISA mIU/mL IU/L

    Wallac DELFIA TR-FIA mIU/mL 8.40 5.90 11.0 31.0 23.0 39.0 286 229 343 IU/L 8.40 5.90 11.0 31.0 23.0 39.0 286 229 343

    HUMAN GROWTH HORMONE (hGH) BioCheck EIA ng/mL g/L

    Calbiotech ELISA ng/mL 4.51 3.33 5.69 12.4 10.7 14.2 25.6 18.5 32.7 g/L 4.51 3.33 5.69 12.4 10.7 14.2 25.6 18.5 32.7

    DiaSorin HGH-CTK IRMA ng/mL 2.81 2.14 3.48 7.95 6.04 9.86 17.2 13.1 21.3 g/L 2.81 2.14 3.48 7.95 6.04 9.86 17.2 13.1 21.3

    MEDIAGNOST ELISA IU/mL 7.20 5.80 8.70 20.4 16.3 24.4 40.5 32.4 48.6 mIU/L 7.20 5.80 8.70 20.4 16.3 24.4 40.5 32.4 48.6

    Monobind AccuBind ELISA IU/mL 10.2 6.85 13.6 31.6 21.2 42.0 74.1 49.7 98.6 mIU/L 10.2 6.85 13.6 31.6 21.2 42.0 74.1 49.7 98.6

    Monobind AccuLite CLIA IU/mL 9.84 6.59 13.1 31.4 21.1 41.8 69.5 46.5 92.4 mIU/L 9.84 6.59 13.1 31.4 21.1 41.8 69.5 46.5 92.4

    MP BioMedicals ImmuChem DA RIA ng/mL g/L

    Wallac DELFIA TRFIA ng/mL 2.58 2.08 3.08 7.69 6.15 9.23 16.2 13.1 19.2 mIU/L 6.70 5.40 8.00 20.0 16.0 24.0 42.0 34.0 50.0

    IGF-I / SOMATOMEDIN C (1)IDS Ltd. IFG-1 ELISA ng/mL 127 96.8 158 165 125 204 107 81.6 133 g/L 127 96.8 158 165 125 204 107 81.6 133

    MEDIAGNOST IGF-1 (IGFBP Blocked) ng/mL 148 119 178 170 136 204 162 130 194 g/L 148 119 178 170 136 204 162 130 194

    MEDIAGNOST IGF-1 - ELISA (IGFBP Blocked) ng/mL 126 101 152 152 122 182 105 84.0 126 g/L 126 101 152 152 122 182 105 84.0 126

  • Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    IMIPRAMINE HPLC ng/mL 127 101 152 178 142 213 297 238 357 nmol/L 453 362 543 634 507 760 1061 849 1274

    IMMUNOGLOBULIN E (IgE) BioCheck EIA IU/mL kIU/L

    Monobind AccuBind ELISA IU/mL >300 95.6 64.1 127 76.7 51.4 102 kIU/L >300 95.6 64.1 127 76.7 51.4 102

    Monobind AccuLite CLIA IU/mL >300 100 67.1 133 80.8 54.2 108 kIU/L >300 100 67.1 133 80.8 54.2 108

    INSULIN Calbiotech ELISA IU/mL 14.4 10.6 18.3 55.8 46.6 64.9 >100 pmol/L 100 73.3 127 387 324 451 >695

    DiaSorin INSIK-5 RIA IU/mL 17.6 12.3 22.9 53.4 38.2 68.6 >200 pmol/L 122 85.4 159 371 265 476 >1389

    DRG ELISA (EIA-2935) IU/mL V V V pmol/L V V VMercodia ELISA IU/mL 15.9 13.1 18.7 47.0 40.0 53.0 167 149 186 pmol/L 110 91.0 130 326 278 368 1160 1035 1292

    Mercodia ELISA (Iso-Insulin) IU/mL 16.3 14.6 18.1 49.0 44.0 55.0 >100 pmol/L 113 101 126 340 306 382 >695

    Monobind AccuBind ELISA IU/mL 16.5 11.1 22.0 42.8 28.6 56.9 148 99.0 197 pmol/L 115 76.8 152 297 199 395 1026 688 1365

    Monobind AccuLite CLIA IU/mL 13.2 8.82 17.5 38.7 25.9 51.5 144 96.7 192 pmol/L 91.4 61.3 122 269 180 357 1003 672 1334

    MP BioMedicals ImmuChem CT RIA IU/mL pmol/L

    Siemens Coat-A-Count (TKIN-ALT) IU/mL

  • Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    SALICYLATE Emit 2000 mg/dL 3.10 2.17 4.00 15.4 10.8 20.0 48.5 34.0 63.1 mmol/L 0.224 0.157 0.290 1.11 0.780 1.45 3.51 2.46 4.57

    Sekisui (Genzyme) Diagnostics mg/dL 50.0

    Monobind AccuBind ELISA % Uptake 29.7 19.9 39.5 36.3 24.3 48.2 45.4 30.4 60.4 % Uptake 29.7 19.9 39.5 36.3 24.3 48.2 45.4 30.4 60.4

    Monobind AccuLite CLIA % Uptake 29.6 19.8 39.4 36.0 24.1 47.8 44.3 29.7 58.9 % Uptake 29.6 19.8 39.4 36.0 24.1 47.8 44.3 29.7 58.9

    MP BioMedicals SPCS RIA % Uptake % Uptake

    Siemens Coat-A-Count (TKTU) % Uptake 29.0 26.0 32.0 34.0 31.0 37.0 42.0 38.0 46.0 % Uptake 29.0 26.0 32.0 34.0 31.0 37.0 42.0 38.0 46.0

    T3-FREE DiaSorin Clinical Assays GammaCoat 125I RIA pg/mL 34.7

    DRG Testosterone ELISA ng/mL V V V nmol/L V V VIBL LIA ng/dL 130 84.5 175 524 340 707 845 549 1140 nmol/L 4.51 2.93 6.07 18.2 11.8 24.5 29.3 19.1 39.6

    MP Biomedicals ImmuChem DA RIA ng/mL nmol/L

    Pantex Direct (125I) ng/mL 1.10 0.900 1.31 4.65 3.58 5.73 7.55 6.23 8.87 nmol/L 3.82 3.12 4.55 16.1 12.4 19.9 26.2 21.6 30.8

    Siemens Coat-A-Count (Total, TKTT) ng/dL 139 103 175 551 457 645 827 679 975 nmol/L 4.82 3.57 6.07 19.1 15.9 22.4 28.7 23.6 33.8

    TESTOSTERONE-FREE Calbiotech pg/mL 0.982 0.690 1.28 8.48 7.53 9.42 14.6 11.6 17.7 pmol/L 3.41 2.39 4.44 29.4 26.1 32.7 50.8 40.2 61.3

    Immunotech Beckman Coulter Active RIA pg/mL 3.02 1.22 4.82 16.5 9.09 23.9 32.6 17.1 48.0 pmol/L 10.5 4.23 16.7 57.3 31.5 82.9 113 59.3 167

    Siemens Coat-A-Count (TKTF) pg/mL 2.70 1.72 3.70 8.50 6.80 10.2 17.0 14.3 19.7 pmol/L 9.37 5.97 12.8 29.5 23.6 35.4 59.0 49.6 68.4

    THEOPHYLLINE CEDIA II g/mL 4.22 2.27 6.17 14.6 11.3 17.9 26.4 22.6 30.1 mol/L 23.4 12.6 34.2 81.0 62.7 99.3 147 125 167

    Emit 2000 g/mL 4.57 3.66 5.49 15.0 12.0 18.0 25.3 20.3 30.4 mol/L 25.4 20.3 30.5 83.3 66.6 99.9 141 112 169

    Sekisui Medical g/mL 4.80 2.90 6.70 15.1 10.6 19.6 26.5 21.2 31.8 mol/L 26.6 16.1 37.2 83.8 58.8 109 147 118 176

    Sekisui Medical Nanopia g/mL 4.60 2.80 6.40 13.5 9.40 17.5 24.4 19.5 29.2 mol/L 25.5 15.5 35.5 74.9 52.2 97.1 135 108 162

    THYROID STIMULATING HORMONE (TSH) BioCheck EIA IU/mL mIU/L

    Calbiotech IU/mL 40.0 mIU/L 40.0

    Monobind AccuBind ELISA IU/mL 0.460 0.280 0.640 5.86 3.93 7.80 36.9 24.7 >40.0 mIU/L 0.460 0.280 0.640 5.86 3.93 7.80 36.9 24.7 >40.0

    Monobind AccuLite CLIA IU/mL 0.380 0.060 0.690 5.79 3.77 7.81 36.4 24.4 >40.0 mIU/L 0.380 0.060 0.690 5.79 3.77 7.81 36.4 24.4 >40.0

    MP BioMedicals ImmuChem CT IRMA IU/mL mIU/L

    Radim MAIACLONE IU/mL 0.720 0.530 0.920 8.40 6.13 10.7 44.6 32.5 >50.0 mIU/L 0.720 0.530 0.920 8.40 6.13 10.7 44.6 32.5 >50.0

    UBI Magiwel ELISA IU/mL mIU/L

    Wallac DELFIA hTSH Ultra TR-FIA IU/mL 0.470 0.380 0.560 6.10 4.90 7.30 36.0 29.0 43.0 mIU/L 0.470 0.380 0.560 6.10 4.90 7.30 36.0 29.0 43.0

    TOBRAMYCIN CEDIA g/mL 0.900 0.060 1.74 3.40 2.40 4.50 6.70 5.30 8.20 mol/L 1.93 0.128 3.72 7.28 5.14 9.63 14.3 11.3 17.5

    Emit 2000 g/mL 0.815 0.650 0.980 3.23 2.58 3.88 5.91 4.43 7.38 mol/L 1.74 1.39 2.10 6.91 5.52 8.30 12.6 9.48 15.8

    VALPROIC ACID CEDIA II g/mL 31.6 24.1 39.1 78.7 63.7 93.7 126 104 148 mol/L 219 167 271 545 441 649 874 720 1028

    Emit 2000 g/mL 31.7 25.4 38.1 71.6 57.3 85.9 112 89.4 134 mol/L 220 176 264 496 397 595 774 619 929

    Sekisui Medical g/mL 36.9 22.1 51.6 85.5 59.8 111 131 104 >150 mol/L 256 153 358 593 414 770 904 723 >1040

    Sekisui Medical Nanopia g/mL 33.4 20.0 46.7 73.8 51.7 95.9 112 89.8 135 mol/L 231 139 324 511 358 665 778 622 934

  • Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    VANCOMYCIN Emit 2000 g/mL 5.46 4.09 6.82 16.8 13.5 20.2 30.9 24.7 37.1 mol/L 3.76 2.82 4.71 11.6 9.32 13.9 21.3 17.0 25.6

    VITAMIN B12 MP BioMedicals SIMUITRAC SNB RIA pg/mL pmol/L

    MP BioMedicals SIMUITRAC SP RIA pg/mL pmol/L

    Siemens Solid Phase No Boil (Dualcount, KDSP) pg/mL 441 371 511 588 512 664 973 857 1089 pmol/L 325 274 377 434 378 490 718 632 804

  • INSTRUMENTGert // Appareil // Strumento // Instrumento // Instrumento // Instrument // Instrument

    Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    ABBOTT ARCHITECT cSYSTEM Acetaminophen (MULTIGENT) g/mL 9.77 7.81 11.7 34.3 27.4 41.1 108 86.3 129 mol/L 64.7 51.7 77.6 227 181 272 714 571 857

    Amikacin (MULTIGENT) g/mL mol/L

    Carbamazepine g/mL 2.81 2.25 3.38 8.30 6.64 9.96 14.5 11.6 17.4 mol/L 11.9 9.52 14.3 35.1 28.1 42.1 61.3 49.0 73.6

    Digoxin (MULTIGENT) ng/mL 0.458 0.353 0.564 1.73 1.38 2.07 2.84 2.27 3.40 nmol/L 0.587 0.452 0.722 2.21 1.77 2.65 3.63 2.90 4.35

    Ferritin ng/mL 78.0 62.4 93.7 146 116 175 439 351 526 g/L 78.0 62.4 93.7 146 116 175 439 351 526

    Gentamicin (MULTIGENT) g/mL 2.48 1.99 2.98 4.82 3.85 5.78 7.55 6.04 9.06 mol/L 5.19 4.15 6.23 10.1 8.05 12.1 15.8 12.6 18.9

    Immunoglobulin A (IgA) (1) mg/dL 168 135 202 160 128 192 160 128 193 mg/L 1683 1346 2019 1604 1283 1924 1604 1283 1925

    Immunoglobulin E (IgE) (MULTIGENT) IU/mL 294 235 353 96.0 76.8 115 78.2 62.6 93.9 kIU/L 294 235 353 96.0 76.8 115 78.2 62.6 93.9

    Immunoglobulin G (IgG) (1) mg/dL 818 655 982 772 617 926 859 687 1031 g/L 8.18 6.55 9.82 7.72 6.17 9.26 8.59 6.87 10.3

    Immunoglobulin M (IgM) (1) mg/dL 68.5 54.8 82.2 70.7 56.6 84.8 83.5 66.8 100 mg/L 685 548 822 707 566 848 835 668 1002

    Iron (1) g/dL 102 81.7 123 83.8 67.0 101 75.6 60.5 90.8 mol/L 18.3 14.6 21.9 15.0 12.0 18.0 13.5 10.8 16.2

    Lithium (MULTIGENT) mEq/L 0.487 0.438 0.535 1.28 1.15 1.41 1.93 1.74 2.12 mmol/L 0.487 0.438 0.535 1.28 1.15 1.41 1.93 1.74 2.12

    Phenobarbital g/mL 8.54 6.83 10.3 24.4 19.5 29.3 52.2 41.8 62.6 mol/L 36.8 29.5 44.2 105 84.1 126 225 180 270

    Phenytoin g/mL 6.13 4.90 7.35 13.6 10.9 16.3 23.8 19.0 28.6 mol/L 24.3 19.4 29.1 53.9 43.1 64.7 94.3 75.4 113

    Salicylate (MULTIGENT) mg/dL 45.3

    Follicle Stimulating Hormone (FSH) mIU/mL 5.43 4.35 6.52 23.0 18.4 27.6 36.3 29.0 43.6 IU/L 5.43 4.35 6.52 23.0 18.4 27.6 36.3 29.0 43.6

    Gentamicin (iGentamicin) g/mL 2.34 1.88 2.81 4.55 3.64 5.46 7.41 5.93 8.89 mol/L 4.90 3.92 5.88 9.51 7.61 11.4 15.5 12.4 18.6

    Human Chorionic Gonadotropin (hCG) (Total Beta) mIU/mL 5.67 4.54 6.80 22.0 17.6 26.3 167 134 201 IU/L 5.67 4.54 6.80 22.0 17.6 26.3 167 134 201

    Insulin IU/mL 13.9 11.1 16.6 41.6 33.3 50.0 143 115 172 pmol/L 96.4 77.1 116 289 231 347 996 797 1195

    Luteinizing Hormone (LH) mIU/mL 1.26 1.01 1.51 15.0 12.0 18.0 39.0 31.2 46.8 IU/L 1.26 1.01 1.51 15.0 12.0 18.0 39.0 31.2 46.8

    Luteinizing Hormone (LH) (02P40, Re-standardization) mIU/mL 1.23 0.980 1.47 15.5 12.4 18.6 41.2 33.0 49.4 IU/L 1.23 0.980 1.47 15.5 12.4 18.6 41.2 33.0 49.4

    Phenobarbital (iPhenobarbital) g/mL 9.39 7.51 11.3 25.5 20.4 30.7 55.3 44.3 66.4 mol/L 40.5 32.4 48.6 110 88.1 132 238 191 286

    Phenytoin (iPhenytoin) g/mL 6.25 5.00 7.50 13.3 10.7 16.0 23.6 18.9 28.3 mol/L 24.8 19.8 29.7 52.8 42.2 63.4 93.3 74.7 112

    Progesterone ng/mL 0.678 0.543 0.814 8.51 6.81 10.2 23.5 18.8 28.2 nmol/L 2.16 1.73 2.59 27.1 21.7 32.5 74.8 59.9 89.8

    Prolactin ng/mL 8.70 6.96 10.4 24.4 19.5 29.3 55.6 44.5 66.7 g/L 8.70 6.96 10.4 24.4 19.5 29.3 55.6 44.5 66.7

    Prostate Specic Antigen, Free ng/mL 0.430 0.344 0.516 1.51 1.20 1.81 11.9 9.51 14.3 g/L 0.430 0.344 0.516 1.51 1.20 1.81 11.9 9.51 14.3

    Prostate Specic Antigen, Total ng/mL 0.830 0.664 0.996 2.30 1.84 2.77 16.1 12.9 19.3 g/L 0.830 0.664 0.996 2.30 1.84 2.77 16.1 12.9 19.3

    T Uptake T Uptake

    T3 Uptake / T-Uptake Unit 0.937 0.749 1.12 0.932 0.745 1.12 0.837 0.669 1.00 Unit 0.937 0.749 1.12 0.932 0.745 1.12 0.837 0.669 1.00

    T3 Free pg/mL 2.21 1.77 2.65 5.34 4.27 6.41 10.6 8.49 12.7 pmol/L 3.40 2.72 4.08 8.22 6.58 9.86 16.3 13.1 19.6

    T3 Total ng/mL 0.807 0.645 0.968 1.68 1.34 2.02 2.66 2.13 3.20 nmol/L 1.24 0.994 1.49 2.59 2.07 3.11 4.10 3.28 4.92

    T4 Free ng/dL 0.983 0.787 1.18 2.15 1.72 2.58 4.63 3.71 5.56 pmol/L 12.7 10.1 15.2 27.8 22.2 33.3 59.8 47.8 71.7

    T4 Total g/dL 5.32 4.26 6.39 11.8 9.47 14.2 18.0 14.4 21.6 nmol/L 68.6 54.9 82.4 153 122 183 232 186 279

    Theophylline (iTheophylline) g/mL 4.62 3.69 5.54 14.2 11.3 17.0 25.7 20.6 30.9 mol/L 25.6 20.5 30.8 78.7 62.9 94.4 143 114 171

    Thyroid Stimulating Hormone (TSH) IU/mL 0.421 0.337 0.505 5.36 4.28 6.43 30.5 24.4 36.6 mIU/L 0.421 0.337 0.505 5.36 4.28 6.43 30.5 24.4 36.6

    Valproic Acid (iValproic Acid) g/mL 31.3 25.0 37.5 72.3 57.9 86.8 122 97.8 147 mol/L 217 173 260 501 401 602 847 678 1017

    Vancomycin (iVancomycin) g/mL 6.65 5.32 7.98 19.4 15.6 23.3 35.8 28.7 43.0 mol/L 4.59 3.67 5.50 13.4 10.7 16.1 24.7 19.8 29.7

    Vitamin B12 (7K61) pg/mL 462 369 554 642 514 770 1128 902 1353 pmol/L 341 273 409 474 379 569 832 666 999

    ABBOTT AxSYM Acetaminophen g/mL 11.3 9.03 13.5 38.5 30.8 46.2 119 95.3 143 mol/L 74.7 59.8 89.7 255 204 306 788 631 946

    Alpha Fetoprotein ng/mL 23.6 18.9 28.3 111 88.9 133 198 158 237 IU/mL 19.6 15.7 23.5 92.3 73.8 111 164 131 197

    Carbamazepine g/mL 2.97 2.38 3.57 8.64 6.91 10.4 15.5 12.4 18.6 mol/L 12.6 10.1 15.1 36.5 29.2 43.8 65.7 52.5 78.8

    Carcinoembryonic Antigen (3K47) ng/mL 2.77 2.22 3.32 19.3 15.5 23.2 43.7 34.9 52.4 g/L 2.77 2.22 3.32 19.3 15.5 23.2 43.7 34.9 52.4

    Cortisol g/dL 3.37 2.49 4.25 19.6 15.7 23.5 34.2 27.3 41.0 nmol/L 93.1 68.9 117 540 432 648 943 754 1131

    Digoxin (II) ng/mL 0.558 0.446 0.670 1.86 1.49 2.24 2.91 2.33 3.50 nmol/L 0.714 0.571 0.857 2.38 1.91 2.86 3.73 2.98 4.47

    Digoxin (III) ng/mL 0.582 0.460 0.704 2.10 1.68 2.52 2.98 2.38 3.57 nmol/L 0.745 0.589 0.901 2.69 2.15 3.23 3.81 3.05 4.57

    Estradiol (7A63-20) (4) pg/mL 68.2 50.4 85.9 126 96.7 154 207 163 250 pmol/L 250 185 315 461 355 567 758 599 917

    Ferritin ng/mL 80.1 64.1 96.1 161 129 193 486 389 584 g/L 80.1 64.1 96.1 161 129 193 486 389 584

    Folate ng/mL 3.63 2.91 4.36 8.25 6.60 9.90 15.2 12.2 18.2 nmol/L 8.23 6.59 9.88 18.7 15.0 22.4 34.4 27.5 41.3

    Follicle Stimulating Hormone (FSH) mIU/mL 5.96 4.77 7.15 26.8 21.4 32.1 44.1 35.3 52.9 IU/L 5.96 4.77 7.15 26.8 21.4 32.1 44.1 35.3 52.9

    Gentamicin g/mL 2.45 1.96 2.93 5.03 4.02 6.03 7.69 6.15 9.23 mol/L 5.11 4.09 6.13 10.5 8.41 12.6 16.1 12.9 19.3

    Human Chorionic Gonadotropin

    (hCG) (Total Beta, Q reagent lot) mIU/mL 6.46 5.16 7.75 28.4 22.7 34.1 241 193 289 IU/L 6.46 5.16 7.75 28.4 22.7 34.1 241 193 289

    Luteinizing Hormone (LH) mIU/mL 1.70 1.36 2.04 19.1 15.2 22.9 52.5 42.0 63.0 IU/L 1.70 1.36 2.04 19.1 15.2 22.9 52.5 42.0 63.0

    N-Acetyl Procainamide (NAPA) g/mL mol/L

    Phenobarbital g/mL 8.61 6.89 10.3 23.0 18.4 27.6 50.5 40.4 60.6 mol/L 37.1 29.7 44.5 99.3 79.4 119 218 174 261

    Phenytoin g/mL 6.56 5.24 7.87 13.9 11.1 16.7 22.9 18.3 27.5 mol/L 26.0 20.8 31.1 55.0 44.0 66.1 90.7 72.5 109

    Procainamide g/mL mol/L

    Progesterone ng/mL 0.656 0.486 0.827 8.93 7.14 10.7 20.4 16.3 24.4 nmol/L 2.09 1.54 2.63 28.4 22.7 34.1 64.8 51.8 77.7

    Prolactin ng/mL 7.68 6.14 9.21 20.6 16.5 24.7 45.2 36.2 54.2 g/L 7.68 6.14 9.21 20.6 16.5 24.7 45.2 36.2 54.2

    Prostate Specic Antigen, Free ng/mL 0.391 0.313 0.469 1.36 1.09 1.63 11.4 9.08 13.6 g/L 0.391 0.313 0.469 1.36 1.09 1.63 11.4 9.08 13.6

    Prostate Specic Antigen, Total ng/mL 0.759 0.607 0.911 2.07 1.65 2.48 15.1 12.0 18.1 g/L 0.759 0.607 0.911 2.07 1.65 2.48 15.1 12.0 18.1

    Quinidine g/mL 0.892 0.714 1.07 2.79 2.23 3.35 4.62 3.70 5.54 mol/L 2.75 2.20 3.30 8.59 6.87 10.3 14.2 11.4 17.1

    Salicylate mg/L 32.0 23.1 41.0 149 119 178 442 354 531 mmol/L 0.232 0.167 0.297 1.08 0.860 1.29 3.20 2.56 3.84

    T3 Uptake / T-Uptake (%) % Uptake % Uptake

    T Uptake T Uptake

    T3 Uptake / T-Uptake (Unit) Unit Unit

    T3 Free pg/mL 1.38

  • Level 1 - 40261 Level 2 - 40262 Level 3 - 40263 Level 1 - 40261 Level 2 - 40262 Level 3 - 40263

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

    ABBOTT AxSYM (continued)Thyroid Stimulating Hormone (TSH) (hTSHII) IU/mL 0.384 0.307 0.461 5.75 4.60 6.90 33.4 26.7 40.1 mIU/L 0.384 0.307 0.461 5.75 4.60 6.90 33.4 26.7 40.1

    Tobramycin g/mL 1.12 0.892 1.34 4.48 3.31 5.64 8.00 6.40 9.60 mol/L 2.39 1.91 2.86 9.58 7.09 12.1 17.1 13.7 20.6

    Tricyclic Antidepressants (TCA ) class ng/mL 311 249 373 566 453 680 935 748 >1000 nmol/L 1108 887 1330 2020 1616 2424 3333 2666 >3566

    Valproic Acid g/mL 32.3 25.9 38.8 70.6 56.5 84.7 113 90.7 136 mol/L 224 179 269 489 391 587 786 629 943

    Vancomycin g/mL 7.18 5.75 8.62 20.9 16.8 25.1 37.5 30.0 45.0 mol/L 4.96 3.97 5.95 14.4 11.6 17.3 25.9 20.7 31.0

    Vitamin B12 pg/mL 390 312 468 579 463 695 1018 814 1221 pmol/L 288 230 345 427 342 513 751 601 901

    ALFA WASSERMANN ACE Ferritin ng/mL 77.0 64.0 90.0 130 108 152 368 323 413 g/L 77.0 64.0 90.0 130 108 152 368 323 413

    T3 Uptake / T-Uptake (CEDIA) % Uptake 34.1 30.0 38.2 40.8 36.4 45.2 49.3 45.1 >50.0 % Uptake 34.1 30.0 38.2 40.8 36.4 45.2 49.3 45.1 >50.0

    T4 Total g/dL 5.10 4.10 6.10 11.5 10.2 12.8 15.9 12.9 18.9 nmol/L 65.8 52.9 78.7 148 132 165 205 166 244

    BECKMAN COULTER ACCESS / 2 / 2i Alpha Fetoprotein ng/mL 23.3 19.6 27.0 108 90.3 125 201 169 233 IU/mL 19.3 16.3 22.4 89.2 75.0 104 167 140 194

    Carcinoembryonic Antigen (Enhanced, CEA2) ng/mL 2.52 2.12 2.92 19.3 16.2 22.4 42.0 35.3 48.7 g/L 2.52 2.12 2.92 19.3 16.2 22.4 42.0 35.3 48.7

    Cortisol g/dL 2.95 2.25 3.65 18.3 14.7 22.0 33.2 26.5 39.8 nmol/L 81.4 62.1 101 505 404 606 915 732 1098

    Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) g/dL 60.4 50.7 70.0 155 130 180 492 411 573 mol/L 1.63 1.37 1.89 4.19 3.52 4.85 13.3 11.1 15.5

    Digoxin ng/mL 0.530 0.430 0.630 1.86 1.56 2.16 2.97 2.49 3.45 nmol/L 0.678 0.550 0.806 2.38 2.00 2.76 3.80 3.19 4.42

    Estradiol (Re-standardization) pg/mL 149 113 185 362 297 427 678 569 786 pmol/L 547 416 679 1327 1089 1566 2486 2089 2884

    Estriol, Free (Unconjugated) ng/mL 1.11 0.933 1.29 3.26 2.74 3.78 5.73 4.81 6.64 nmol/L 3.86 3.24 4.47 11.3 9.49 13.1 19.9 16.7 23.1

    Ferritin ng/mL 58.9 49.5 68.4 111 92.9 128 324 272 376 g/L 58.9 49.5 68.4 111 92.9 128 324 272 376

    Folate (Improved) ng/mL 3.16 2.66 3.66 7.08 5.92 8.20 13.4 11.3 15.6 nmol/L 7.16 6.03 8.29 16.0 13.4 18.6 30.4 25.5 35.2

    Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.51 5.43 7.59 24.1 20.0 28.2 36.5 30.6 42.4 IU/L 6.51 5.43 7.59 24.1 20.0 28.2 36.5 30.6 42.4

    Human Chorionic Gonadotropin (hCG) (Total Beta) mIU/mL 5.63 4.73 6.53 21.7 18.2 25.1 155 130 180 IU/L 5.63 4.73 6.53 21.7 18.2 25.1 155 130 180

    Human Growth Hormone (hGH) (Ultrasensitive) ng/mL 2.25 1.91 2.58 6.39 5.44 7.35 12.8 10.8 14.7 g/L 2.25 1.91 2.58 6.39 5.44 7.35 12.8 10.8 14.7

    Immunoglobulin E (IgE) (Total) IU/mL 399 335 463 117 97.4 136 96.8 81.0 113 kIU/L 399 335 463 117 97.4 136 96.8 81.0 113

    Insulin (Ultrasensitive) IU/mL 14.4 12.1 16.7 43.7 36.7 50.7 150 126 174 pmol/L 99.9 83.8 116 303 255 352 1041 874 1207

    Luteinizing Hormone (LH) (hLH) mIU/mL 1.06 0.900 1.22 14.8 12.5 17.2 37.0 31.1 42.9 IU/L 1.06 0.900 1.22 14.8 12.5 17.2 37.0 31.1 42.9

    Progesterone ng/mL 0.780 0.640 0.920 10.9 9.16 12.6 24.1 20.3 28.0 nmol/L 2.48 2.04 2.93 34.7 29.1 40.2 76.7 64.5 89.0

    Prolactin ng/mL 6.07 5.09 7.05 16.9 14.2 19.6 35.4 29.7 41.0 g/L 6.07 5.09 7.05 16.9 14.2 19.6 35.4 29.7 41.0

    Prostate Specic Antigen, Free (Hybritech) ng/mL 0.550 0.470 0.630 1.88 1.58 2.18 13.6 11.4 15.7 g/L 0.550 0.470 0.630 1.88 1.58 2.18 13.6 11.4 15.7

    Prostate Specic Antigen, Free (WHO 96/668) ng/mL 0.430 0.360 0.500 1.48 1.24 1.72 10.7 9.00 12.4 g/L 0.430 0.360 0.500 1.48 1.24 1.72 10.7 9.00 12.4

    Prostate Specic Antigen, Total (Hybritech) ng/mL 1.00 0.840 1.16 2.92 2.46 3.38 21.1 17.7 24.5 g/L 1.00 0.840 1.16 2.92 2.46 3.38 21.1 17.7 24.5

    Prostate Specic Antigen, Total (WHO 96/670) ng/mL 0.850 0.710 0.990 2.27 1.91 2.63 16.4 13.8 19.1 g/L 0.850 0.710 0.990 2.27 1.91 2.63 16.4 13.8 19.1

    T3 Uptake / T-Uptake % Uptake 41.9 35.0 48.3 44.6 37.5 51.8 51.8 43.5 60.0 % Uptake 41.9 35.0 48.3 44.6 37.5 51.8 51.8 43.5 60.0

    T3 Free pg/mL 2.46 1.96 2.96 4.77 3.81 5.73 9.00 7.20 10.8 pmol/L 3.79 3.02 4.56 7.35 5.87 8.82 13.9 11.1 16.6

    T3 Total ng/mL 0.880 0.740 1.02 1.71 1.43 1.99 2.86 2.37 3.29 nmol/L 1.36 1.14 1.57 2.63 2.20 3.06 4.41 3.65 5.07

    T4 Free (Modied) ng/dL 0.800 0.680 0.920 2.05 1.73 2.37 3.93 3.31 4.55 pmol/L 10.3 8.77 11.9 26.4 22.3 30.6 50.7 42.7 58.7

    T4 Total g/dL 4.47 3.75 5.19 9.49 7.97 11.0 13.8 11.6 16.1 nmol/L 57.7 48.4 67.0 122 103 142 178 150 207

    Testosterone ng/mL 1.18 1.00 1.38 5.17 4.35 5.99 8.12 6.82 9.42 nmol/L 4.09 3.47 4.79 17.9 15.1 20.8 28.2 23.7 32.7

    Thyroid Stimulating Hormone (TSH) (hTSH Fast) IU/mL 0.400 0.340 0.480 5.78 4.86 6.70 33.0 27.7 38.2 mIU/L 0.400 0.340 0.480 5.78 4.86 6.70 33.0 27.7 38.2

    Thyroid Stimulating Hormone (TSH) (hTSH HYPERsensitive) IU/mL 0.400 0.340 0.480 5.78 4.86 6.70 33.0 27.7 38.2 mIU/L 0.400 0.340 0.480 5.78 4.86 6.70 33.0 27.7 38.2

    Vitamin B12 pg/mL 339 280 398 530 446 615 1057 888 1226 pmol/L 250 207 294 391 329 454 780 655 905

    BECKMAN COULTER AU 400 / 600 / 640 / 680 / 2700 / 5400 Acetaminophen (Emit 2000) g/mL 50.8

    Quinidine (Emit 2000) g/mL 0.790 0.600 1.00 2.57 1.93 3.20 4.35 3.26 5.40 mol/L 2.43 1.85 3.08 7.92 5.94 9.86 13.4 10.0 16.6

    Salicylate (Emit) mg/dL 3.