METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

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RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME This document must be retained by participant RIQAS Please be aware that the RIQAS Instrument and reagent supplier codes are now in a separate booklet. Please ensure you have a copy of this in order to complete this document. METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

Transcript of METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

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RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME

This document must be retained by participant

RIQAS

Please be aware that the RIQAS Instrument and reagent supplier codes are now in a separate booklet. Please ensure you have a copy of this in order to complete this document.

METHOD QUESTIONNAIREIMMUNOASSAY PROGRAMME

RQ9125

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REGISTRATION INSTRUCTIONS & RIQAS POLICIESCRITERIA FOR PARTICIPATION

REGISTRATION INSTRUCTIONS

METHOD QUESTIONNAIRE:- To be retained by participant

F. RIQASNet

G. PDF REPORTS

B. GROUP REPORTS

Please be aware that it may take up to 3 weeks to process enrolment documents if you are not entering your own assay details.

IMPORTANT NOTE - AFP, FSH, GH, LH, PROLACTIN, TSHSome kits use reagent of manufacturer specific standards and factors to convert sample assay values obtained to the appropriate International units ofactivity. In these cases we recommend that you report your results in units of activity using the conversion factor quoted in your kit procedure sheet. Wecannot accept results for these parameters in anything other than International Units of Activity or their equivalent decimal multiple. No mass results will beaccepted with the exception of GH results run using assays which are standardised to WHO 98/574.

Please inform RIQAS of any change to contact details as soon as possible.

RIQASNet is a web-based online method for result entry / method changes and additions of parameters / viewing of released reports. To access RIQASnetgo to www.riqas.net. Internet access and login details are required for RIQASNet and Adobe Reader is required for viewing reports. If you wish to useRIQASNet please indicate this by ticking the box on the enrolment document. Your login information and password will be supplied by RIQAS. Your logininformation will be based on the 1st email address you supply on your enrolment document. A PDF copy of the report will be sent to this address and canalso be sent to 2 other email addresses. These addresses should be stated on your enrolment document.

Once your method questionnaire has been completed, you must transfer the information onto your enrolment document.

ENROLMENT DOCUMENT:- To be returned to RIQAS

A. LABORATORY REFERENCE NUMBEROn receipt of an enrolment document, each participant is assigned a laboratory reference number which consists of a participant number which isunique to your laboratory and a registration letter which is assigned for each new registration we receive from you. If you are a current or previousparticipant, please state your participant number on the enrolment document. If you do not have a Laboratory Reference Number, this will be generatedby RIQAS when you register for the first time and you will be sent RIQAS literature, which will enable you to understand the RIQAS process and interpretyour reports. Please quote this number on all correspondence with RIQAS.

INTRODUCTIONMethod questionnaires are available for all routine RIQAS Programmes and are reviewed and updated every month, as indicated by the issue date at the bottom of every page. They are designed to allow you to register for this RIQAS Programme and to inform you of RIQAS protocols and policies. It is important that you read and understand all the information in these introductory pages before completing the enrolment document, which forms the basis of your registration and contract with RIQAS. If you have any questions or concerns about any of the information presented in this document, please contact RIQAS either directly or through your local Randox Laboratories representative.

This method questionnaire should be completed and retained by you for your records. Please ensure that you complete the method questionnaire in full.Your details will help us to classify your results correctly and thus provide you with useful statistical data.

Following this introduction section, is the method questionnaire, which indicates the method codes available for each parameter along with the standard RIQAS unit. On the method questionnaire, for each parameter you wish to run, please tick the method appropriate to you, then state your instrument code, reagent code, and the units that you use in your laboratory if they are different from the RIQAS standard units. If codes are not available for your assay, please state the details of your method clearly in the section at the end of the enrolment document.

In order to fully complete this questionnaire you will also need a copy of the RIQAS Instruments and Reagent Suppliers which is available to download fromthe RIQAS website (www.riqas.com). Please ensure you have this list available when completing this questionnaire.

NOTE: IF A REGISTERED PARTICIPANT DOES NOT PARTICIPATE FOR A CYCLE, THEY WILL BE EXPECTED TO COMPLETE NEW ENROLMENT DOCUMENTS IN ORDER TO RE-JOIN THE PROGRAMME.

H. SUMMARY CSV FILES

Reports can now be sent as PDF files as an alternative to paper reports. These files can be sent to up to 3 email addresses. If you wish to receive PDFreports please indicate this by ticking the box on the enrolment document and include the email addresses to which the reports should be sent. AdobeReader is required to view the reports.

It is possible to enrol multiple instruments within your laboratory. Kindly complete separate enrolment documents for each instrument clearly identifying each instrument in the box provided. A complementary instrument group report is supplied if you have returned results for more than one registration of the sameprogramme. If you intend to enrol laboratories at different sites or if you are part of a group of laboratories, an inter-laboratory group report for each samplecan be supplied on receipt of a completed authorisation form from each registered laboratory. Please contact RIQAS for a copy of the official inter-laboratory authorisation form. C. ORDER NUMBERIf you are a UK or Irish participant, please state your official order number in the boxes provided. Other participants may order directly from their localRandox Laboratories representative.

It is important to state the name and full address details of the Quality Assessment Officer or contact person who will receive all correspondence and routine reports during the cycle. This is the address to which reports will be posted if you do not select an electronic correspondence method. Please also state thecompany name of the Randox representative who is supplying you with the RIQAS product under 'Randox Office/Distributor'

D. CYCLE/PRODUCT REQUIREMENTSPlease tick the cycles you wish to subscribe for. If there is more than one kit/product offered for the programme, please also tick the kit you wish tosubscribe for.E. PRIMARY CONTACT DETAILS

Labs can register to receive a csv file which contains a summary of your routine report statistics and performance indicators. This file mirrors the informationfound on the summary page of your report, except that we have included the calculated SD and SDPA. Also the PERFORMANCE column will show * inplace of the red triangle usually shown on the summary page of your routine report. This can be sent to the 3 email addresses registered to receive the pdfreports. If you wish to receive a summary csv file please indicate this by ticking the box on the enrolment document and include the email addresses towhich the reports should be sent. CSV files are also available for Instrument and Inter-Laboratory group reports. Please contact RIQAS for furtherinformation.

This programme is available to any laboratory running the assays listed in this document. Quantitative results will be accepted on this programme.

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If units other than the standard RIQAS units are used, please specify these in the boxes supplied.ONCE COMPLETED, THE ENROLMENT DOCUMENT SHOULD BE SENT TO RIQAS FOR REGISTRATION.

Please notify your local Randox representative immediately if any of these are incorrect.

Requests for the correction or removal of erroneous results must be accompanied by evidence that the error was non-analytical, as defined on form 9277-RQ. RIQAS is obliged to inform country-specific regulatory bodies of requests for correction of results (if they request such information for laboratorymonitoring purposes).

Participants who use RIQASNet: Method changes. These can be made in the Assay Details section of the Data Entry menu. A list of your registeredlaboratory reference numbers will appear on screen. Select the laboratory reference number for which you would like to change the assay details. A currentlist of assay details will appear, click on the appropriate parameter. To change the details click the arrow box on the appropriate details and select a newone. Save the changes and submit them to RIQAS. Changes will not be instantaneously updated on RIQASNet but will be uploaded onto RIQASNet usuallywithin 72 hours. It is possible to submit results and method changes together as method changes will be made before results are entered in to the RIQASdatabase.

Participants using RIQASNet will receive an email containing their login information. Once you have successfully logged in to RIQASNet you will see yourvarious laboratory reference numbers for each registered programme. If you have opted to add parameters/assay details using RIQASNet, please do so assoon as possible (see below).If no code is available for your assay, please state the details of your method clearly in the section at the end of the enrolment document or follow the instructions on RIQASNet.For Ortho-Clinical Diagnostics VITROS registrations, please state the 2 digit slide Generation number for each analyte.

Provided that you have ordered sufficiently in advance, your RIQAS kit(s) will be shipped to you to arrive before the analysis date of the first sample in thekit. If you do not receive your kit(s) before this time, please contact your local Randox representative.

L. ADDITION OF PARAMETERS / ASSAY DETAILS

NB Deletions of parameters cannot be made on RIQASNet. If you wish to delete a parameter please contact RIQAS directly on [email protected].

Participants who do not wish to use RIQASNet at all will be sent a master return sheet which is specific for your registered parameters and units. Youshould photocopy this sheet as required and use it to return results to RIQAS.

I. DECLARATION

Please ensure that your order is placed with your local Randox representative at least 6-8 weeks before the cycle starts. This will ensure sufficient time toprocess and despatch your kit(s) to you. Participants from UK or Ireland may order products directly from RIQAS with an official order number. Ordersreceived within 6 weeks of the start of the cycle will be processed, but RIQAS cannot guarantee delivery in time for the first sample. Current prices ofRIQAS products are available from your local Randox Laboratories representative.

Participants who use return sheets: Each Results Return Sheet has a section for method changes. Please state your new classification codes at thebottom of your next return sheet. We assume that your new classification will be in routine use from the date on the return sheet unless you tell usotherwise. If you have added or deleted a parameter, changed your unit or Vitros slide generation number, an updated return sheet will be forwarded toyou. It is important that you discard your old return sheet and use only your updated copy for future returns.

K. UPDATING ASSAY DETAILS

The declaration indicates that you have read and understood the RIQAS policies in the most recent method questionnaire associated with the programme. The submission of the enrolment document to RIQAS, either directly or via your local Randox representative, represents your agreement for RIQAS to proceed with your registration, based on your completed enrolment document. Note: Method questionnaires are updated every month and the issue date is stated on every questionnaire and enrolment document.J. REGISTRATION OF ASSAY DETAILS

Labs can register their assay details using RIQASNet or can complete the 'Registration of Assay Details' section of the enrolment document. Labs should tick the appropriate box under the 'Registration of Assay Details' section of the enrolment document. If a lab wishes RIQAS to register their assay details, they should complete the Registration of Assay Details section using the codes from this method questionnaire and the Instrument/Reagent Supplier Book.

It is possible to change your unit, method, instrument or reagent classification during a cycle.

ORDERING RIQAS PRODUCTS

Participants who use RIQASNet: Addition of Parameters. Parameters can be added using the Assay Details section of the Data Entry menu. A list ofyour registered laboratory reference numbers will appear on screen. Select the laboratory reference number for which you would like to add the assaydetails. At the top of the screen is 'Add Parameter'. Click on this and a list of parameters you are not registered for will appear. Select the parameter youwish to add and click the arrow box on the appropriate details and select your assay details. Save the changes and submit them to RIQAS. As above,additions will be available on RIQASnet usually within 72 hrs.

d) the samples have the appearance as indicated on the IFU and that none of them are damaged

Please ensure that the product is immediately stored according to the recommendations on the package labelling. ASSAY OF SAMPLES & RETURN OF RESULTSCarefully read the instructions stated on the Instructions for Use (IFU) prior to preparation and assay of RIQAS samples. The RIQAS samples should beassayed at the recommended time specified on the IFU. Following appropriate preparation, samples should be treated as routine, unless otherwise statedon the IFU. Please assay the samples on or before the recommended date for analysis and forward your results to RIQAS by no later than 17:00 GMT onthe FINAL DATE, as indicated in the IFU. We recommend using RIQASNet to return results. If returning results on return sheet, it is most important thatyour Laboratory Reference Number(s), cycle number, sample number and FINAL DATE for return of results are clearly written at the top of the return sheet.If you wish to fax your results please transmit them 3 working days before the FINAL DATE to + 44 (0) 28 9445 4398. You may also e-mail your results [email protected]. Please contact RIQAS for a RESULT RETURN SHEET template.

In keeping with the objectives of EQA schemes, participants should be aware that collusion and falsification of results is considered to be unethical andconstitutes scientific fraud. RIQAS policies must ensure that a laboratory is unaware of RIQAS means for comparison before submitting their own results.Where a result is not submitted by the final date, a report will be issued, but the missing results will be indicated as “No return” or “N” throughout the RIQASreports. RIQAS permits the submission of late or corrected results only under the circumstances described below. Requests for the submission of late orcorrected results must be submitted in writing and in English on RIQAS Form No. 9277-RQ (either by the participant or their local Randox Representative)and must be approved by RIQAS Management. The form is available on www.riqas.net.

New reports will be re-issued for late or corrected results only where there has been an error made by Randox Laboratories HQ, Randox representatives ordistributors.

c) the correct number of samples are present as indicated on the IFU

a) it is the product you orderedb) the kit contains detailed Instructions For Use (IFU), including material characteristics, preparation, stability, storage and safety

It may be possible to order RIQAS products during a cycle, subject to availability. Please ask your local Randox representative to check availability before SHIPPING AND RECEIPT OF RIQAS PRODUCTS

On receipt of your RIQAS kit, please check that:

LATE AND CORRECTED RESULTS

Requests for the submission of late results must be accompanied by evidence that an error has been made, and that the error has not been caused by the participant.

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END OF CYCLE REPORTS

CONFIDENTIALITY

CERTIFICATE OF ACCEPTABLE PERFORMANCE

THIS PROGRAMME IS ACCREDITED BY UKAS TO ISO/IEC 17043:2010

Please contact RIQAS at

Tel: +44 (0) 28 9445 4399Fax: +44 (0) 28 9445 4398E-Mail [email protected] Scheme Co-ordinator: Stephen DohertyRANDOX LABORATORIES LTD., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom

CORRECTED RESULTS

RIQAS is obligated to identify and report persistent poor performing UK labs to the National Quality Assessment Advisory Panel. Poor performers areidentified as those failing to meet performance criteria agreed with NQAAP. The performance criteria is specified in all performance surveillancecorrespondence with participants, and is also available on request. Participants are initially informed of poor performance by letter. Failure to improveperformance will prompt details to be forwarded to NQAAP. All information sent to participants and NQAAP is strictly confidential. Please contact RIQAS ifyou require further information on Performance Surveillance.

Should the need arise, participants may raise requests or enquiries through correspondence with the local Randox Laboratories representative or bycontacting RIQAS directly. Participants may appeal against the evaluation of their performance by completing a PARTICIPANT APPEALS FORM, 10770-RQ. Participants may raise a complaint in relation to the product or service provided by completing the PARTICIPANT COMPLAINTS FORM, 10772-RQ.These forms are available on RIQASNet, or on request from RIQAS.

LATE RESULTS

Laboratories may correct results only if it can be determined that the error was non-analytical and where the request for submission is within 4 weeks of theoriginal final date. A laboratory may correct a result under the following circumstances: � Reconstituting a sample in an incorrect volume before analysis� Assaying and/or submitting the results for the wrong sample� Making a transcription error - submission of an analyser print-out indicating that the analysis date was before the final date is required.

Results will normally be processed within 2 days of the FINAL DATE. PDF reports will be emailed the day after the results have been processed and forthose registered for RIQASNet the PDF reports will be available on RIQASNet shortly after. Printed reports usually take a further 1-3 days to print anddespatch.

At the end of a cycle, a summary report will be issued to all participants. This includes a summary page for each parameter, an Average Absolute SDIreport and a Cerificate of Acceptable performance (see below).

Participants are also provided with a Certificate of Acceptable Performance within their End-of-Cycle report. Acceptable performance is considered to be aCycle Average Absolute SDI of less than 2. While all participants receive an end-of-cycle report, participants (including those who enrol mid-cycle) are onlyeligible for Certificates of Performance if they have returned more than half of the samples in a full cycle.

DEVIATION FROM EXISTING POLICIES/SERVICEIf there is any deviation from the existing policies or service, participants will be notified either directly or via their local Randox representative.

SUB-CONTRACTINGRIQAS sub-contracts aspects of the scheme. RIQAS accepts responsibility for the sub-contractors' work and protocols are in place to ensure that sub-contractors are deemed competent.

OUR COMPETENCE AS A PROFICIENCY TESTING PROVIDEROn request, RIQAS is willing to co-operate with participants seeking evidence of our competence as a proficiency testing provider or information on thedesign and implementation of RIQAS Programmes.

RIQAS makes every effort to ensure that the samples provided are clinically challenging to as many laboratory systems as possible. For details, pleasecontact RIQAS either directly or through your local Randox representative.

PARTICIPANT FEEDBACK, COMPLAINTS & APPEALSIn order to ensure that RIQAS provides an appropriate and satisfying service, participants are invited to complete a feedback survey on RIQASNet. You may contact us at any time during the cycle, should you have any requests for additional programmes or parameters or comments regarding existing programmes.

DESPATCH OF REPORTS

In general, late results will not be accepted after the final date.Late results will only be accepted where there has been an error made by Randox Laboratories HQ, Randox representatives or distributors.

PERFORMANCE SURVEILLANCE OF UK LABS

USE OF RIQAS REPORTSParticipants have permission to make copies of their RIQAS reports for internal use and for regulatory purposes only. RIQAS reports must not be duplicatedfor external use without permission from the RIQAS Scheme Co-ordinator. Under no circumstances should information on RIQAS reports be taken out ofcontext or falsified in any way.

Participation in any RIQAS programme is considered to be strictly confidential. Any data transfer or correspondence with participants, either directly or vialocal Randox representative, will be deemed confidential. Participants should be aware that regulatory authorities have the right to request an assessmentof a participant's performance. Where regulatory authorities are to be provided with a participant's results, participants will be notified.

CERTIFICATES OF PARTICIPATIONComplimentary certificates of participation for each RIQAS programme are available to participants at the end of the current cycle, provided that at least 50% of results have been returned. Participants who enrol mid-cycle will be eligible for a Certificate for Participation if they have participated in at least 50% of samples available for the remainder of the cycle since enrolment. The certificate will specify the cycle, programme and the LABORATORY / HOSPITAL NAME which is detailed in the certificate section of RIQASNet. At the end of a cycle, a list of all eligible labs will be exported from RIQASNet and certificates will be printed according to these details. Please ensure all certificate details are up to date in your RIQASNet account.

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREACTH pmol/lCODE METHODACSAN Beckman Access / Lxi 725ACBME Biomerica ELISAACBRI Brahms RIAACCII CIS IRMAACLIA Diasorin LiaisonACLIX Diasorin Liaison XLACBYK Diasorin RIAACDRG DRG ELISAACBIE IBL International ELISAACMC2 Mindray CL-SeriesACMP MP Diagnostics RIAACC6 Roche Cobas 6000 / 8000ACRCE Roche Cobas 4000 / e411ACEYS Roche ElecsysACRME Roche Modular E170ACSCI Scantibodies IRMAACSCR Scantibodies RIAACCCP Siemens Centaur CPACCEN Siemens Centaur XP/XPT/ClassicACDPI Siemens/DPC Immulite 1000ACDP2 Siemens/DPC Immulite 2000/2500ACSNM SNIBE Maglumi analysersACTOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Alphafoetoprotein (AFP) U/ml*CODE METHODAFABE Abbott AFP-EIAAFARC Abbott ArchitectAFABX Abbott AxsymAFABB Abbott IMxAFARB Abbott RIAbeadAFAMP AMP ELISAAFSAN Beckman Access/LXi725AFOAU Beckman Coulter AU3000iAFDXI Beckman DxI 600 / 800AFBEH Behring RIA-gnostAFBCI Biocheck Inc ELISAAFBIV bioMerieux VIDASAFVIA bioMerieux VIDIAAFBMA Boditech Med Inc AFIA-6AFBMI Boditech Med Inc i-CHROMAAFBRR Brahms KryptorAFCBE Calbiotech ELISAAFCII CIS IRMAAFCA Clinical Assays GammaDabAFCLI Clinpro ELISAAFDSE Diagnostic Systems ELISAAFDIE DiaMetra ELISAAFLIA DiaSorin LiaisonAFLIX DiaSorin Liaison XLAFBYK Diasorin (RIA)AFDIS DIAsource IRMAAFDRG DRG ELISAAFELI ELISAAFFUJ Fujirebio ELISAAFFJL Fujirebio Lumipulse G SeriesAFGBE General Biologicals ELISAAFHUE Human ELISAAFHTE Hybritech Tandem-EAFHTR Hybritech Tandem-RAFIMI Immunotech IRMAAFIZO Izotop RIAAFMED MedgenixAFMC2 Mindray CL SeriesAFMOE Monobind Inc ELISA/CLIAAFVEC Ortho Vitros 3600/5600/ECiAFDEL Perkin Elmer DELFIA Xpress/AutoDELFIAAFPHA Pharmacia AFP RIAAFPHM Pharmacia AFP RIA (Mab)AFEV Randox EvidenceAFC6 Roche Cobas 6000 / 8000AFROC Roche Cobas CoreAFRCE Roche Cobas 4000 / e411AFEYS Roche ElecsysAFBOE Roche EnzymunAFRME Roche Modular E170

CONTINUED ON NEXT PAGE

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREAlphafoetoprotein (AFP) U/ml* (Continued)CODE METHODAFSRI SEAC Radim IRMAAFSB Serono AFP bridgeAFSS Serono Serozyme/SRiAFCC Siemens/Bayer ACS 180AFBAY Siemens/Bayer Immuno IAFCCP Siemens Centaur CPAFCEN Siemens Centaur XP/XPT/ClassicAFDDV Siemens/Dade Dimension/VistaAFDCI Siemens/DPC Coat-a-Count IRMAAFDDA Siemens/DPC Double AntibodyAFDPI Siemens/DPC Immulite 1000AFDP2 Siemens/DPC Immulite 2000/2500AFSNM SNIBE Maglumi analysersAFSF Stat Fax Elisa readersAFSHI Sysmex HISCL SeriesAFTSU Technosuma UMELISAAFTOS TOSOHAFVBE Vector Best ELISAAFVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

*WHO 1975 1st IS (IARC standard 72/225)

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Aldosterone pmol/lCODE METHODALAIR Adaltis IRMAALALP ALPCO ELISAALABC AutoBio CLIAALBCR Beckman Coulter Active RIAALBCS Biocrates SterolDQ KitALCIR CIS RIAALDBE Diagnostics Biochem Canada (DBC) ELISAALDME DiaMetra ELISAALDLIA Diasorin LiaisonALDLIX Diasorin Liaison XLALBYK Diasorin RIAALDIR DIAsource RIAALDRG DRG ELISAALDSL DSL RIAALELI ELISAALGER GenTech RIAALIBL IBL International ELISAALIDS IDS iSYSALICE Immunospec Corp. ELISAALIMM Immunotech RIAALLM LC / MSALNOV Novatech ELISAALRAA Radim AliseiALRAD Radim RIAALDP2 Siemens/DPC Immulite 2000ALSNM SNIBE Maglumi analysersALZEN ZenTech RIA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Amikacin µmol/l (PILOT)CODE METHODAMARC Abbott ArchitectAMABX Abbott AxsymAMDXC Beckman DxC 600/800AMEMI EMITAMIC6 Roche Cobas 6000 / 8000AMINT Roche IntegraAMTSQ Thermo Scientific QMS Amikacin

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREAndrostenedione nmol/l (PILOT)CODE METHODANBCR Beckman Coulter Active RIAANBCS Biocrates SterolDQ KitANBIE Bio-Line ELISAANBLK BLK ELISAANCIR CIS BIO RIAANDBC DBC ELISAANDME DiaMetra ELISAANLIX DiaSorin Liaison XLANDIE DIAsource ELISAANDIR DIAsource RIAANDRG DRG ELISAANDTD Dynex DS2 ELISAANHP HPLC/UPLCANIBE IBL International ELISAANIME Inter Medical EIAANLDE Labor Diagnostike Nord ELISAANLM LC/MSANMP MP Diagnostics RIAANNOV Novatec ELISAANRAA Radim AliseiANRAD Radim RIAANDPC Siemens/DPC Coat-a-CountANDPI Siemens/DPC Immulite 1000ANDP2 Siemens/DPC Immulite 2000

Other methods please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

Beta-2-microglobulin µg/mlCODE METHODB2ARC Abbott ArchitectB2ABX Abbott AxsymB2ABB Abbott IMxB2ADE Aesku Diagnostics ELISAB2BEK Beckman ArrayB2AU4 Beckman AU400/600/640/2700/5400B2BIM Beckman ImmageB2BLT Biolatex ImmunoassayB2BIV bioMerieux VIDASB2CLI Clinpro ELISAB2CDI Cortez Diagnostics ELISAB2DCP Dako Cytomation PET KitB2LIA DiaSorin LiaisonB2LIX DiaSorin Liaison XLB2BYK DiaSorin other instrumentsB2DRG DRG ELISAB2ELI ELISAB2FJL Fujirebio Lumipulse G SeriesB2GNN Goldsite Nephstar NephelometerB2IBQ ILab/Biokit QuantexB2IM Immunotec RIAB2DEL Perkin Elmer DELFIAB2RCE Roche Cobas 4000 / c311B2C6 Roche Cobas 6000 / 8000B2ROC Roche Cobas Core EIAB2EYS Roche ElecsysB2INT Roche IntegraB2RME Roche Modular PB2BOT Roche TinaquantB2CNS Siemens Advia 1200/1650/1800/2400B2CC Siemens/Bayer ACS 180B2CCP Siemens Centaur CPB2CEN Siemens Centaur XP/XPT/ClassicB2BN Siemens/Behring NephelometerB2DD Siemens/Dade DimensionB2DCI Siemens/DPC Coat-a-Count IRMAB2DPI Siemens/DPC Immulite 1000B2DP2 Siemens/DPC Immulite 2000/2500B2SNM SNIBE Maglumi analysersB2SF Stat Fax Elisa readersB2TOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECA 125 U/mlCODE METHODC5ARC Abbott ArchitectC5ABX Abbott AxsymC5ABB Abbott IMxC5AEE Adaltis EIAgen ELISAC5DXI Beckman DxI 600 / 800C5SAN Beckman Access/Lxi725C5BCI Biocheck Inc. ELISAC5BIV bioMerieux VIDASC5BRR Brahms KryptorC5CB CIS BIO Extended protocolC5CBS CIS BIO Short protocolC5CII CIS IRMAC5CLI Clinpro ELISAC5DSE Diagnostic Systems ELISAC5BYK DiaSorin (IRMA)C5LIA DiaSorin LiaisonC5LIX DiaSorin Liaison XLC5DIS DIAsource IRMAC5DRG DRG ELISAC5DSI DSI ELISAC5ELI ELISAC5HUE Human ELISAC5FUJ Fujirebio ELISAC5FJ Fujirebio IRMAC5FJL Fujirebio Lumipulse G SeriesC5GBE General Biologicals ELISAC5IMI Immunotech IRMAC5IME InterMedical EIAC5IZO IzotopC5MC2 Mindray CL-SeriesC5MOE Monobind Inc ELISA/CLIAC5NOV Novatec ELISAC5VEC Ortho Vitros 3600/5600/ECiC5EV Randox EvidenceC5C6 Roche Cobas 6000 / 8000C5ROC Roche Cobas CoreC5RCE Roche Cobas 4000 / e411C5EYS Roche ElecsysC5BOE Roche EnzymunC5RME Roche Modular E170C5CC Siemens/Bayer ACS 180C5BAY Siemens/Bayer Immuno IC5CP2 Siemens Centaur CP CA125 II KitC5CCP Siemens Centaur CP OV KitC5CN2 Siemens Centaur XP/XPT/Classic CA125 II KitC5CEN Siemens Centaur XP/XPT/Classic OV KitC5DD Siemens/Dade DimensionC5DDV Siemens/Dade Dimension VistaC5DPI Siemens/DPC Immulite 1000C5DP2 Siemens/DPC Immulite 2000/2500C5DIC Siemens/DPC IRMACountC5SNM SNIBE Maglumi analysersC5SF Stat Fax Elisa ReadersC5SHI Sysmex HISCL SeriesC5TOS TOSOHC5VB Vector Best Enzyme ImmunoassayC5VLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 8/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECA15-3 U/mlCODE METHODC3ARC Abbott ArchitectC3ABX Abbott AxsymC3ABB Abbott IMxC3AEC Adaltis EclecticaC3SAN Beckman Access/LXi725C3DXI Beckman DxI 600 / 800C3BIV BioMerieux VIDASC3BRR Brahms KryptorC3CB CIS BIO InternationalC3CII CIS IRMAC3CLI Clinpro ELISAC3BYK DiaSorin (IRMA)C3LIA DiaSorin LiaisonC3LIX DiaSorin Liaison XLC3DIS DIAsource IRMAC3DRG DRG ELISAC3ELI ELISAC3FUJ Fujirebio ELISAC3FJ Fujirebio IRMAC3FJL Fujirebio Lumipulse G SeriesC3HUE Human ELISAC3IMI Immunotech IRMAC3IME InterMedical EIAC3IZO IzotopC3MC2 Mindray CL-SeriesC3MOE Monobind Inc ELISA/CLIAC3NOV Novatec ELISAC3VEC Ortho Vitros 3600/5600/ECiC3EV Randox EvidenceC3C6 Roche Cobas 6000 / 8000C3ROC Roche Cobas CoreC3RCE Roche Cobas 4000 / e411C3EYS Roche ElecsysC3BOE Roche EnzymunC3RME Roche Modular E170C3CC Siemens/Bayer ACS 180C3CCP Siemens Centaur CPC3CEN Siemens Centaur XP/XPT/ClassicC3DD Siemens/Dade DimensionC3DDV Siemens/Dade Dimension VistaC3DPI Siemens/DPC Immulite 1000C3DP2 Siemens/DPC Immulite 2000/2500C3SNM SNIBE Maglumi analysersC3SF Stat Fax Elisa readersC3TOS TOSOHC3VBE Vector Best ELISAC3VB Vector Best Enzyme Immunoassay

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 9/43 Revised Dec 2017

Page 10: METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECA 19-9 U/mlCODE METHODC9ARC Abbott ArchitectC9AXR Abbott Architect XR/XR2/XRLC9ABX Abbott AxsymC9ABB Abbott IMxC9AEC Adaltis EclecticaC9SAN Beckman Access/LXi725C9DXI Beckman DxI 600 / 800C9BIV bioMerieux VIDASC9BRR Brahms KryptorC9CB CIS BIO InternationalC9CII CIS IRMAC9CLI Clinpro ELISAC9BYK DiaSorin (IRMA)C9LIA DiaSorin LiaisonC9LIX DiaSorin Liaison XLC9DIE Diametra ELISAC9DIS Diasource IRMAC9DRG DRG ELISAC9ELI ELISAC9FUJ Fujirebio ELISAC9FJ Fujirebio IRMAC9FJL Fujirebio Lumipulse G SeriesC9HUE Human ELISAC9IMI Immunotech IRMAC9IME InterMedical EIAC9IZO IzotopC9MC2 Mindray CL-SeriesC9MOE Monobind Inc ELISA/CLIAC9NOV Novatec ELISAC9VEC Ortho Vitros 3600/5600/ECiC9EV Randox EvidenceC9C6 Roche Cobas 6000 / 8000C9ROC Roche Cobas CoreC9RCE Roche Cobas 4000 / e411C9EYS Roche ElecsysC9BOE Roche EnzymunC9RME Roche Modular E170C9CC Siemens/Bayer ACS 180C9BAY Siemens/Bayer Immuno 1C9CCP Siemens Centaur CPC9CEN Siemens Centaur XP/XPT/ClassicC9DD Siemens/Dade DimensionC9DDV Siemens/Dade Dimension VistaC9DPI Siemens/DPC Immulite 1000C9DP2 Siemens/DPC Immulite 2000/2500C9SNM SNIBE Maglumi analysersC9SF Stat Fax Elisa ReadersC9SHI Sysmex HISCL SeriesC9TOS TOSOHC9VBE Vector Best ELISAC9VB Vector Best Enzyme Immunoassay

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 10/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECarbamazepine µmol/lCODE METHODCAAER Abbott AerosetCAARC Abbott Architect (CMIA)CAARP Abbott Architect (PETINIA)CAABX Abbott AxsymCAABT Abbott TDxCASAN Beckman Access/LXi725CAOAD Beckman Coulter AU400/600/640/2700/5400CADXC Beckman DxCCADXI Beckman DxI 600 / 800CABEK Beckman ArrayCABIM Beckman ImmageCASYN Beckman Synchron CX / LXCABEO Behring OpusCABIV bioMerieux VIDASCACLI Clinpro ELISACAELI ELISACAEMI EMITCAHIT Hitachi 911/912/917CAHP HPLCCAH9 Hydra 09CAMMI Merck MicrolabCAMIE Microgenics CEDIA assayCAVIT Ortho-Clinical Diagnostics VitrosCADAY Randox Daytona / ImolaCAINT Roche IntegraCARME Roche Modular E170CAC6 Roche Cobas 6000 / 8000CARCE Roche Cobas 4000 / c311CACNS Siemens ADVIA 1200/1650/1800/2400CACC Siemens/Bayer ACS 180CABAY Siemens/Bayer Immuno ICACCP Siemens Centaur CPCACEN Siemens Centaur XP/XPT/ClassicCADD Siemens DimensionCADPI Siemens/DPC Immulite 1000CADP2 Siemens/DPC Immulite 2000/2500CABEM Siemens Syva / EMITCASF Stat Fax Elisa readersCATKO Thermo Konelab

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Carcinoembryonic Antigen (CEA) ng/mlCODE METHODCEARC Abbott ArchitectCEABX Abbott AxsymCEABB Abbott IMxCEAEC Adaltis EclecticaCEAMP AMP ELISACESAN Beckman Access/LXi725CEOAU Beckman Coulter AU3000iCEDXI Beckman DxI 600 / 800CEBEH Behring (IRMA)CEBIV bioMerieux VIDASCEVIA bioMerieux VIDIACEBMA Boditech Med Inc AFIA-6CEBMI Boditech Med Inc i-CHROMACEBRR Brahms KryptorCECII CIS IRMACECIR CIS RIA Coated tubeCECLI Clinpro ELISACEBYK DiaSorin (IRMA)CELIA DiaSorin LiaisonCELIX DiaSorin Liaison XLCEDIS DIAsource IRMACEDRG DRG ELISACEELI ELISACEFUJ Fujirebio ELISACEFJL Fujirebio Lumipulse G SeriesCEHUE Human ELISACEHTE Hybritech Tandem-ECEHTR Hybritech Tandem-RCEIMI Immunotech IRMACEIME InterMedical EIACEIZO Izotop RIA

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RQ9125 Method Questionnaire 11/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECarcinoembryonic Antigen (CEA) ng/ml (Continued)CODE METHODCEMM Merck MagiaCEMC2 Mindray CL-SeriesCEMOE Monobind Inc. ELISA / CLIACEVEC Ortho Vitros 3600/5600/ECiCEDEL Perkin Elmer DELFIACEPHA Pharmacia CEA RIACEC6 Roche Cobas 6000 / 8000CEROC Roche Cobas CoreCERCE Roche Cobas 4000 / e411CEEYS Roche ElecsysCEBOE Roche EnzymunCERME Roche Modular E170CESB Serono CEA bridgeCECC Siemens/Bayer ACS 180CEIMS Siemens/Bayer ADVIA IMS 800iCEBAY Siemens/Bayer Immuno ICECCP Siemens Centaur CPCECEN Siemens Centaur XP/XPT/ClassicCEDDV Siemens/Dade Dimension VistaCEDCI Siemens/DPC Coat-a-count IRMACEDDA Siemens/DPC Double AntibodyCEDPI Siemens/DPC Immulite 1000CEDP2 Siemens/DPC Immulite 2000/2500CESNM SNIBE Maglumi analysersCESF Stat Fax Elisa readersCESHI Sysmex HISCL SeriesCETOS TOSOHCEVBE Vector Best ELISACEVB Vector Best Enzyme ImmunoassayCEVLE Veda.Lab Easy ReaderCEXME Xema Medical EIA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Cortisol nmol/lCODE METHODC2ARC Abbott ArchitectC2ABX Abbott AxsymC2ABB Abbott TDx/FLxC2SAN Beckman Access/LXi725C2DXI Beckman DxI 600 / 800C2BD Beckton DickinsonC2BCS Biocrates SterolDQ KitC2BIV bioMerieux VIDASC2BMA Boditech Med Inc AFIA-6C2BMI Boditech Med Inc i-CHROMAC2CIR CIS RIAC2CA Clinical Assays GammacoatC2CLI Clinpro ELISAC2DEE Demeditec ELISAC2DIA Dialab ELISAC2DIE DiaMetra ELISAC2BYK DiaSorin RIAC2LIA DiaSorin LiaisonC2LIX DiaSorin Liaison XLC2DIR DIASource RIAC2DSI DSI EIAC2DSL DSL RIAC2ELI ELISAC2HUE Human ELISAC2RIA Immunotech RIAC2KQ Kallestad QuanticoatC2LM LC/MSC2MC2 Mindray CL SeriesC2MOE Monobind Inc. ELISA / CLIAC2NOV Novatec ELISAC2ORI OrionC2VEC Ortho Vitros 3600/5600/ECiC2DEL Perkin Elmer DELFIAC2WW Perkin Elmer Wizard/wallacC2RAA Radim AliseiC2RCE Roche Cobas 4000 / e411C2RC2 Roche Cobas 4000 /e411 Gen IIC2C6 Roche Cobas 6000 / 8000C2C62 Roche Cobas 6000 / 8000 Gen II

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RQ9125 Method Questionnaire 12/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRECortisol nmol/l (Continued)CODE METHODC2EYS Roche ElecsysC2EY2 Roche Elecsys Gen IIC2BOE Roche EnzymunC2RME Roche Modular E170C2RM2 Roche Modular E170 Gen IIC2SCB Serono Cortisol BridgeC2SS Serono Serozyme/SRIC2CC Siemens/Bayer ACS 180C2BAY Siemens/Bayer Immuno IC2CCP Siemens Centaur CPC2CEN Siemens Centaur XP/XPT/ClassicC2DPC Siemens/DPC Coat-a-CountC2DDA Siemens/DPC Double AntibodyC2DPI Siemens/DPC Immulite 1000C2DP2 Siemens/DPC Immulite 2000/2500C2SNM SNIBE Maglumi analysersC2SF Stat Fax Elisa readersC2TOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

C-Peptide nmol/lCODE METHODCPARC Abbott ArchitectCPAIR Adaltis IRMACPCIR CIS. RIACPCII CIS BIO IRMACPLIA Diasorin LiaisonCPLIX Diasorin Liaison XLCPDIR DIAsource RIACPDRG DRG ELISACPDSL DSL RIACPELI ELISACPFJL Fujirebio Lumipulse G SeriesCPILM ILMACPIRM Immunotech IRMACPIEL Inova MicroelisaCPLDE Labor Diagnostike Nord ELISACPMC2 Mindray CL SeriesCPMOE Monobind Inc. ELISA / CLIACPRAA Radim AliseiCPRAD Radim RIACPEV Randox Evidence / InvestigatorCPC6 Roche Cobas 6000 / 8000CPRCE Roche Cobas 4000 / e411CPEYS Roche ElecsysCPRME Roche Modular E170CPCCP Siemens Centaur CPCPCEN Siemens Centaur XP/XPT/ClassicCPDPI Siemens/DPC Immulite 1000CPDP2 Siemens/DPC Immulite 2000/2500CPSNM SNIBE Maglumi analysersCPTOS TOSOHCPVBE Vector Best ELISA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 13/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREDHEA-S (dihydroepiandosterone sulphate) µmol/lCODE METHODDHARC Abbott ArchitectDHABX Abbott AxsymDHSAN Beckman Access/LXi725DHDXI Beckman DxI 600 / 800DHBCS Biocrates SterolDQ KitDHBT bioMerieux TektimeDHCLI Clinpro ELISADHDIM DiaMetraDHLIA DiaSorin LiaisonDHLIX DiaSorin Liaison XLDHBYK DiaSorin (RIA)DHDIE DIASource ELISADHDIR DIASource RIADHDRG DRG ELISADHDSL DSL RIADHELI ELISADHHUE Human ELISADHIBE IBL ELISADHIMR Immunotech RIADHLM LC/MSDHMED Meditec ELISADHMC2 Mindray CL SeriesDHMOE Monobind Inc. ELISA / CLIADHNOV Novatec ELISADHORI OrionDHVEC Ortho Vitros 3600/5600/ECiDHRAA Radim AliseiDHC6 Roche Cobas 6000 / 8000DHRCE Roche Cobas 4000 / e411DHEYS Roche ElecsysDHRME Roche Modular E170DHSRI SEAC RADIM IRMADHCCP Siemens Centaur CPDHCEN Siemens Centaur XP/XPT/ClassicDHDPC Siemens/DPC Coat-a-CountDHDPI Siemens/DPC Immulite 1000DHDP2 Siemens/DPC Immulite 2000/2500DHSNM SNIBE Maglumi analysersDHSF Stat Fax Elisa readersDHTOS TOSOHDHTMS Tecan Miniswift

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS , SPECIFY

DHEA-unconjugated nmol/lCODE METHODDHDSL Beckman/DSL RIADHBET Beta-counterDHBCS Biocrates SterolDQ KitDHDEE Demeditec ELISADHDRG DRG ElisaDHELI ELISADHIRA Immunotech RIADHWG Perkin Elmer Gamma counterDHSF Stat Fax Elisa readers

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS , SPECIFY

RQ9125 Method Questionnaire 14/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREDigoxin nmol/lCODE METHODDIAER Abbott AerosetDIARC Abbott ArchitectDIABX Abbott AxsymDIABB Abbott IMxDIABT Abbott TDxDISAN Beckman Access/LXi725DIOAD Beckman Coulter AU400/600/640/2700/5400DIDXC Beckman DxCDIDXI Beckman DxI 600 / 800DIBIM Beckman ImmageDISYN Beckman Synchron CX / LXDIBEM Behring EmitDIBIV bioMerieux VIDASDIBT Biotecnica TargaDICLI Clinpro ELISADIELI ELISADIEMI EMITDIHIT Hitachi 911/912/917DIH9 Hydra 09DIVIT Ortho-Clinical Diagnostics VitrosDIVEC Ortho Vitros 3600/5600/ECiDIDAY Randox DaytonaDIC5 Roche Cobas c501 / 502 / 701DIC6 Roche Cobas e601 / 602 / 801DIRCE Roche Cobas 4000 / c311DIRC4 Roche Cobas 4000/e411DIEYS Roche ElecsysDIBOE Roche EnzymunDIINT Roche IntegraDIRME Roche Modular E170DICNS Siemens ADVIA 1200/1650/1800/2400DICC Siemens/Bayer ACS 180DIBAY Siemens/Bayer Immuno IDICCP Siemens Centaur CPDICEN Siemens Centaur XP/XPT/ClassicDIDD Siemens/Dade DimensionDIDDV Siemens/Dade Dimension Vista / ExL LOCIDIDPC Siemens/DPC Coat-a-CountDIDPI Siemens/DPC Immulite 1000DIDP2 Siemens/DPC Immulite 2000/2500DISNM SNIBE Maglumi analysersDISF Stat Fax Elisa readersDIMIE Thermo Scientific/Microgenics DRI assay

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Estriol, Total nmol/l (PILOT)CODE METHODESARC Abbott ArchitectESAEE Adaltis ElAgenESSAN Beckman Access/DxI600/800ESLIA Diasorin LiaisonESLIX Diasorin Liaison XLESDRG DRG ELISAESHUE Human ELISAESMC2 Mindray CL SeriesESNOV NovatecESDPC Siemens/DPC Coat-a-CountESDPI Siemens/DPC Immulite 1000ESDP2 Siemens/DPC Immulite 2000

Other methods please specify on enrolment documentINSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 15/43 Revised Dec 2017

Page 16: METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREEthosuximide µmol/l (PILOT)CODE METHODETHEMI EMITETHHP HPLC

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Ferritin ng/mlCODE METHODFEARC Abbott Architect ChemiluminescenceFEARQ Abbott Architect QuantiaFEABX Abbott AxsymFEABB Abbott IMxFEAEC Adaltis EclecticaFEAMP AMP ELISAFESAN Beckman Access/LXi725FEAU4 Beckman Coulter AU400/600/640/2700/5400FEDXI Beckman DxI 600 / 800FEBDD Beckton Dick. Double AntibodyFEBDM Beckton Dickinson MabFEBIC Bioclone (IRMA)FEBLC Biolatex CRM Diagnostic SystemsFEBIV bioMerieux VIDASFEVIA bioMerieux VIDIAFEBRQ Bio-Rad QuantimuneFEBMI Boditech Med Inc i-CHROMAFECBE Calbiotech ELISAFECII CIS IRMAFECA Clinical Assays GammaDabFECLI Clinpro ELISAFEDLC Delta Chemie ImmunoturbidimetricFEDGG Diagam (Gold Colloidal)FEDSE Diagnostic Systems ELISAFEDIE DiaMetra ELISAFEBYK DiaSorin IRMAFELIA DiaSorin LiaisonFELIX DiaSorin Liaison XLFEELI ELISAFEELD Eurolyser DiagnostikaFEFJL Fujirebio Lumipulse G SeriesFEGSP Gesan ProductionFEHTE Hybritech Tandem-EFEHTR Hybritech Tandem-RFEIBQ ILab / Biokit QuantixFEIMI Immunotech IRMAFEMC2 Mindray CL SeriesFEMOE Monobind Inc ELISAFENOV Novatec ELISAFEKD Ortho-Clinical Diagnostics Double AntibodyFEVEC Ortho Vitros 3600/5600/ECiFEDEL Perkin Elmer DELFIAFERAA Radim AliseiFEDAY Randox DaytonaFEEV Randox Evidence / InvestigatorFEBOE Roche Enzymun(ES300600700)FEC5 Roche Cobas c501 / 502 / 701FEROC Roche Cobas CoreFERCE Roche Cobas 4000 / c311FEEYS Roche Elecsys/Cobas e411FEINT Roche IntegraFERME Roche Modular E170 / Cobas e601 / 602 / 801FEBOT Roche TinaquantFECC Siemens/Bayer ACS 180FEBAY Siemens/Bayer Immuno IFECCP Siemens Centaur CPFECEN Siemens Centaur XP/XPT/ClassicFEBN Siemens/Dade Behring NephelometerFEDD Siemens/Dade DimensionFEDDV Siemens/Dade Dimension VistaFEDCI Siemens/DPC Coat-a-Count IRMAFEDDA Siemens/DPC Double AntibodyFEDPI Siemens/DPC Immulite 1000FEDP2 Siemens/DPC Immulite 2000/2500FESNM SNIBE Maglumi analysersFESF Stat Fax Elisa readers

CONTINUED ON NEXT PAGE

RQ9125 Method Questionnaire 16/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREFerritin ng/ml (Continued)CODE METHOD

FETOS TOSOHFEVBE Vector Best ELISAFEVB Vector Best Enzyme ImmunoassayFEVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Folate nmol/lCODE METHODFOARC Abbott ArchitectFOABX Abbott AxsymFOABB Abbott IMxFOSAN Beckman Access/LXi725FODXI Beckman DxI 600 / 800 - A14208FODXA Beckman DxI 600 / 800 - A98032FOBSL Beckton Dickinson S'TRAC Liquid phaseFOBSN Beckton Dickinson S'TRAC Solid Phase no boilFOBSB Beckton Dickinson S'TRAC Solid Phase boilFOBRQ Bio-Rad QuantaphaseFOCLI Clinpro ELISAFOBYK Diasorin LiaisonFOLIX Diasorin Liaison XLFOELI ELISAFOMC2 Mindray CL SeriesFOMP MP Biomedicals RIAFOVEC Ortho Vitros 3600/5600/ECiFODEL Perkin Elmer DELFIAFOREF Roche Elecsys FolateFORF3 Roche Folate III - 04476433FORF3S Roche Folate III - 07559992FOCC2 Siemens/Bayer ACS 180 (enhanced kit)FOCC Siemens/Bayer ACS 180 (old kit)FOBAY Siemens/Bayer Immuno IFOCCP Siemens Centaur CP (enhanced kit)FOCN2 Siemens Centaur XP/XPT/Classic (enhanced kit)FODD Siemens/Dade DimensionFODDV Siemens/Dade Dimension VistaFODDC Siemens/DPC Dualcount boilFODPI Siemens/DPC Immulite 1000FODP2 Siemens/DPC Immulite 2000FODP5 Siemens/DPC Immulite 2500FODSB Siemens/DPC Solid Phase boilFODSN Siemens/DPC Solid Phase no boilFOSF Stat Fax Elisa readersFOTOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Follicle Stimulating Hormone (FSH) mU/ml*CODE METHODFSARC Abbott ArchitectFSABX Abbott AxsymFSABB Abbott IMxFSAEC Adaltis EclecticaFSAEE Adaltis ElAgenFSAIR Adaltis IRMAFSSAN Beckman Access/LXi725FSOAU Beckman Coulter AU3000iFSDXI Beckman DxI 600 / 800FSBD Beckton Dickinson SimulTRACFSBEH Behring RIA-gnostFSBCI Biocheck Inc ELISAFSBCL Bioclone IRMAFSBIO bioMerieux CoatriaFSBIV bioMerieux VIDASFSVIA bioMerieux VIDIAFSBIN Bioneovan ELISA

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RQ9125 Method Questionnaire 17/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREFollicle Stimulating Hormone (FSH) mU/ml* (Continued)CODE METHODFSBMA Boditech Med Inc AFIA-6FSBMI Boditech Med Inc i-CHROMAFSCBE Calbiotech ELISAFSCHE ChelseaFSCII CIS IRMAFSCIR CIS RIA Coated tubeFSCLI Clinpro ELISAFSDAE Diagnostic Automation ELISAFSDSE Diagnostic Systems ELISAFSBYK DiaSorin IRMAFSLIA DiaSorin LiaisonFSLIX DiaSorin Liaison XLFSDIR DIAsource IRMAFSDIA Dialab ELISAFSDIE DiaMetra ELISAFSDRG DRG ELISAFSELI ELISAFSFJL Fujirebio Lumipulse G SeriesFSGBE General Biologicals ELISAFSHUE Human ELISAFSIMI Immunotech IRMAFSLDE Labor Diagnostika Nord ELISAFSMED Medgenix (IRMA)FSMM Merck MagiaFSMC2 Mindray CL-SeriesFSMOE Monobind Inc. ELISA / CLIAFSMPI MP Biomedicals IRMAFSMPR MP Biomedicals RIAFSNIC Nichols (IRMA)FSVEC Ortho Vitros 3600/5600/ECiFSDEL Perkin Elmer DELFIAFSWW Perkin Elmer Wizard/wellacFSRAE Radim IEMA wellFSRAD Radim IRMA CTFSRRD Radim RAD120FSRAN Randox ELISAFSC6 Roche Cobas 6000 / 8000FSROC Roche Cobas Core EIAFSRCE Roche Cobas 4000 / e411FSEYS Roche ElecsysFSBOE Roche EnzymunFSRME Roche Modular E170FSSM Serono MAIAFSSMC Serono MAIAcloneFSSS Serono Serozyme/SRIFSCC Siemens/Bayer ACS 180FSBAY Siemens/Bayer Immuno IFSCCP Siemens Centaur CPFSCEN Siemens Centaur XP/XPT/ClassicFSDDV Siemens/Dade Dimension VistaFSDCI Siemens/DPC Coat-a-Count IRMAFSDDA Siemens/DPC Double AntibodyFSDPI Siemens/DPC Immulite 1000FSDP2 Siemens/DPC Immulite 2000/2500FSSNM SNIBE Maglumi analysersFSSF Stat Fax Elisa readersFSTOS TOSOHFSVEB Vector Best ELISAFSVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

*WHO 1980 2nd IRP (NIBSC standard 78/549)

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Gentamycin µmol/lCODE METHODGEARC Abbott Architect (CMIA)GEARP Abbott Architect (PETINIA)GEABX Abbott AxsymGEABT Abbott TDxGEBCA Beckman Coulter AnalyzersGEDXC Beckman DxC 600/800GEEMI EMITGERDX Randox RX Daytona / ImolaGEC6 Roche Cobas 6000 / 8000 Online KIMSGEC6C Roche Cobas 6000 / 8000 CEDIA

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RQ9125 Method Questionnaire 18/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREGentamycin µmol/l (Continued)CODE METHODGEINT Roche IntegraGEMOD Roche Modular P/D Online KIMSGEMOC Roche Modular P/D CEDIAGECNS Siemens ADVIA 1200/1650/1800/2400GECCP Siemens Centaur CPGECEN Siemens Centaur XP/XPT/ClassicGEDD Siemens/Dade Dimension/VistaGEBEM Siemens Syva/EMITGEQMS Thermo QMS

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Growth Hormone (GH) µU/mlCODE METHODGHABX Abbott AxsymGHSAN Beckman Access/LXi725GHDXI Beckman DxI 600 / 800GHBCL Bioclone (IRMA)GHBCI Biocheck Inc ELISAGHBIO bioMerieux CoatriaGHBIV bioMerieux VIDASGHCII CIS IRMAGHCLI Clinpro ELISAGHDME DiaMetra ELISAGHBYK DiaSorin IRMAGHLIA DiaSorin LiaisonGHLIX DiaSorin Liaison XLGHDIR DIAsource IRMAGHDSL DSLGHDRG DRG ELISAGHELI ELISAGHHTE Hybritech Tandem-EGHHTR Hybritech Tandem-RGHIBL IBL InternationalGHIDS IDS iSYSGHIZO IzotopGHIMI Immunotech IRMAGHKQ Kallestad QuantitopeGHLDE Labor Diagnostika Nord ELISAGHMED Medgenix (IRMA)GHMOE Monobind Inc. ELISA / CLIAGHNET Netria (IRMA)GHNIC Nichols (IRMA)GHORS Orion SpectriaGHVEC Ortho Vitros 3600/5600/ECiGHPEE Padtan Elm ELISAGHDEL Perkin Elmer DELFIAGHWW Perkin Elmer Wizard/wallacGHPHA Pharmacia hGH RIAGHC6 Roche Cobas 6000 / 8000GHRCE Roche Cobas 4000 / e411GHEYS Roche ElecsysGHRME Roche Modular E170GHCC Siemens/Bayer ACS 180GHCCP Siemens Centaur CPGHCEN Siemens Centaur XP/XPT/ClassicGHDDA Siemens/DPC Double AntibodyGHDPI Siemens/DPC Immulite 1000GHDP2 Siemens/DPC Immulite 2000/2500GHSNM SNIBE Maglumi analysersGHSF Stat Fax Elisa readersGHTOS TOSOH

Other methods please specify on enrolment document

Results from assays which are standardised to WHO IS 98/574 may be submitted in ng/ml or ug/l. Results returned in mass units from assays based on other standards must be converted to mU/l or uU/ml before submission to RIQAS

INSTRUMENT CODEREAGENT CODE

OTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 19/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREChorionic Gonadotrophin (hCG) mU/ml*CODE METHODHCARC Abbott ArchitectHCABX Abbott AxsymHCABE Abbott hCG-EIAHCABI Abbott IMx (intact hCG)HCABT Abbott IMx (total hCG)HCAEC Adaltis EclecticaHCAEE Adaltis ElAgenHCSAN Beckman Access/LXi725HCSA5 Beckman Access Total BhCG (5th IS)HCOAU Beckman Coulter 3000iHCDXI Beckman DxI 600 / 800HCDX5 Beckman DXI Total BhCG (5th IS)HCBDD Beckton Dickinson Double AntibodyHCBDM Beckton Dickinson MabHCBEH Behring (IRMA)HCBEO Behring OpusHCBIC Bioclone Double AntibodyHCBIV bioMerieux VIDAS / mini VIDASHCVIA bioMerieux VIDIAHCBMA Boditech Med Inc AFIA-6HCBMI Boditech Med Inc i-CHROMAHCBRR Brahms KryptorHCCIR CIS RIA Coated tubeHCCLI Clinpro ELISAHCLIA DiaSorin LiaisonHCLIX DiaSorin Liaison XLHCBYK DiaSorin other instrumentsHCDRG DRG ELISAHCSDSL DSL RIAHCELI ELISAHCFJL Fujirebio Lumipulse G SeriesHCHUE Human ELISAHCIMI Immunotech IRMAHCIME InterMedical EIAHCIZO Izotop IRMAHCMED Medgenix (IRMA)HCMC2 Mindray CL SeriesHCMP Mitsubishi PathfastHCMOE Monobind Inc. ELISA / CLIAHCNOV Novatec ELISAHCVEC Ortho Vitros 3600/5600/ECiHCDEL Perkin Elmer DELFIAHCWW Perkin Elmer Wizard/wallacHCPHA Pharmacia IRMA (CT)HCAQT Radiometer AQT90 FlexHCC6 Roche hCG + BetaHCROC Roche Cobas Core EIAHCEYI Roche hCG STAT (Intact)HCBOE Roche EnzymunHCSRE Seac Radim IEMAHCSD Serono Double AntibodyHCSMC Serono MAIAcloneHCSS Serono Serozyme/SRIHCCC Siemens/Bayer ACS 180HCBAY Siemens/Bayer Immuno IHCCCP Siemens Centaur CPHCCEN Siemens Centaur XP/XPT/ClassicHCDD Siemens/Dade DimensionHCDDV Siemens/Dade Dimension VistaHCDPC Siemens/DPC Coat-a-CountHCDDA Siemens/DPC Double AntibodyHCDPI Siemens/DPC Immulite 1000HCDP2 Siemens/DPC Immulite 2000HCDP5 Siemens/DPC Immulite 2500HCSCS Siemens Stratus CSHCSII Siemens/Dade Stratus Immunoassay Syst. (intact hCG)HCSIT Siemens/Dade Stratus Immunoassay Syst. (total hCG)HCSNM SNIBE Maglumi analysersHCSF Stat Fax Elisa readersHCTSU Tecnosuma UMELISAHCTOS TOSOHHCVLE Veda.Lab Easy ReaderHCXME Xema Medical EIA

Other methods please specify on enrolment document

*WHO 1975 3rd IS (NIBSC standard 75/537)

INSTRUMENT CODEREAGENT CODE

OTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 20/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREIgE U/mlCODE METHODIGARC Abbott ArchitectIGABX Abbott AxsymIGABB Abbott IMxIGAMI Agappe Mispa i2IGABE Alkor-Bio ELISAIGSAN Beckman Access/LXi725IGDXI Beckman DxI 600 / 800IGBIM Beckman ImmageIGBAD Bioanalytic DiagnosticIGBCI Biocheck Inc. ELISAIGBLC Biolatex CRM Diagnostic Systems IGBIL Bioline ELISAIGBIV bioMerieux VIDASIGCBE Calbiotech ELISAIGCLI Clinpro ELISAIGDIE DiaMetra ELISAIGLIA DiaSorin LiaisonIGLIX DiaSorin Liaison XLIGDRG DRG ELISAIGDSI DSI EIAIGELI ELISAIGEUE Euroimmun ELISAIGFJL Fujirebio Lumipulse G SeriesIGHUE Human ELISAIGIBQ ILab/Biokit QuantexIGINE Intermedical ELISAIGMM Merck MagiaIGMBS Mindray BS-120/200/300/400IGMOE Monobind Inc. ELISA / CLIAIGPEE Padtan Elm ELISAIGPHU Phadia Immunocap InstrumentsIGRAA Radim AliseiIGRAD Radim IRMA CTIGRAN Randox Immunoturbidimetric assayIGDAY Randox RX series InstrumentsIGC6 Roche Cobas 6000 / 8000IGROC Roche Cobas CoreIGRCE Roche Cobas 4000 / e411IGEYS Roche ElecsysIGBOE Roche EnzymunIGRME Roche Modular E170IGCC Siemens/Bayer ACS 180IGCNS Siemens/Bayer Advia 1200/1650/1800/2400IGCML Siemens/Bayer MagicLiteIGCCP Siemens Centaur CPIGCEN Siemens Centaur XP/XPT/ClassicIGBN Siemens/Dade Behring NephelometerIGDD Siemens/Dade DimensionIGDCI Siemens/DPC Coat-a-Count IRMAIGDPI Siemens/DPC Immulite 1000IGDP2 Siemens/DPC Immulite 2000/2500IGSNM SNIBE Maglumi analysersIGST Stat Fax Elisa ReadersIGPR Tokyo Boeki Prestige IGTOS TOSOHIGVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 21/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREInsulin µU/mlCODE METHODINARC Abbott ArchitectINABX Abbott AxsymINABB Abbott IMxINAPE Alfa Prime ELISAINSAN Beckman Access/LXi725INDXI Beckman DxI 600 / 800INBIG Biosource Gamma counterINCIS CIS IRMAINCIR CIS RIA coated tubeINCLI Clinpro ELISAINDAE Diagnostic AutomationINLIA DiaSorin LiasonINLIX DiaSorin Liason XLINDSE Diasource ELISAINDIA Diasource IRMAINDRG DRG ELISAINELI ELISAINFJL Fujirebio Lumipulse G SeriesINIMI Immunotech IRMAINIVL Invitron LuminescenceINIZG Izotop Gamma CounterINLIR Linco RIAINMC2 Mindray CL SeriesINMOE Monobind Inc. ELISAINNOV Novatec ELISAINVEC Ortho Vitros 3600/5600/ECiINDEL Perkin Elmer DelfiaINWW Perkin Elmer WizardINRAA Radim AliseiINEV Randox Evidence / InvestigatorINC6 Roche Cobas 6000 / 8000INRCE Roche Cobas 4000 / e411INEYS Roche ElecsysINRME Roche Modular E170INCC Siemens/Bayer ACS180INCCP Siemens Centaur CPINCEN Siemens Centaur XP/XPT/ClassicINDPC Siemens/DPC Coat-a-countINDPI Siemens/DPC Immulite 1000INDP2 Siemens/DPC Immulite 2000INDP5 Siemens/DPC Immulite 2500INSNM SNIBE Maglumi analysersINSF Stat Fax Elisa readersINTOS TosohINVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Luteinising Hormone (LH) mU/ml*CODE METHODLHARC Abbott ArchitectLHABX Abbott AxsymLHABB Abbott IMxLHAEC Adaltis EclecticaLHAEE Adaltis ElAgenLHAIR Adaltis IRMALHABE Alkor-Bio ELISALHSAN Beckman Access/LXi725LHOAU Beckman Coulter AU3000iLHDXI Beckman DxI 600 / 800LHBD Beckton Dickinson SimulTRACLHBEH Behring RIA-gnostLHBCI Biocheck Inc ELISALHBCL Bioclone IRMALHBIO bioMerieux CoatriaLHBIV bioMerieux VIDASLHVIA bioMerieux VIDIALHBIN Bioneovan ELISALHBMA Boditech Med Inc AFIA-6LHBMI Boditech Med Inc i-CHROMALHCBE Calbiotech ELISALHCHE ChelseaLHCII CIS IRMA

CONTINUED ON NEXT PAGE

RQ9125 Method Questionnaire 22/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRELuteinising Hormone (LH) mU/ml* (continued)CODE METHODLHCIR CIS RIA Coated tubeLHCLI Clinpro ELISALHDAE Diagnostic Automation ELISALHDSE Diagnostic Systems ELISALHDIA Dialab ELISALHDIE DiaMetra ELISALHBYK DiaSorin IRMALHLIA DiaSorin LiaisonLHLIX DiaSorin Liaison XLLHDIR DIAsource IRMALHELI ELISALHFJL Fujirebio Lumipulse G SeriesLHGBE General Biologicals ELISALHHUE Human ELISALHIMI Immunotech IRMALHLDE Labor Diagnostika Nord ELISALHMED Medgenix (IRMA)LHMM Merck MagiaLHMC2 Mindray CL-SeriesLHMOE Monobind Inc. ELISA / CLIALHMPI MP Biomedicals IRMALHMPR MP Biomedicals RIALHNOV Novatec ELISALHNIC Nichols (IRMA)LHVEC Ortho Vitros 3600/5600/ECiLHDEL Perkin Elmer DELFIALHDES Perkin Elmer DELFIA (Specific)LHWW Perkin Elmer Wizard/wallacLHRAE Radim IEMA wellLHRAD Radim IRMA CTLHRRD Radim RAD120LHRAN Randox ELISALHEV Randox EvidenceLHC6 Roche Cobas 6000 / 8000LHROC Roche Cobas Core EIALHRCE Roche Cobas 4000 / e411LHEYS Roche ElecsysLHBOE Roche EnzymunLHRME Roche Modular E170LHSM Serono MAIALHSMC Serono MAIAcloneLHSS Serono Serozyme/SRILHCC Siemens/Bayer ACS 180LHBAY Siemens/Bayer Immuno ILHCCP Siemens Centaur CPLHCEN Siemens Centaur XP/XPT/ClassicLHDDV Siemens/Dade Dimension VistaLHDCI Siemens/DPC Coat-a-Count IRMALHDDA Siemens/DPC Double AntibodyLHDPI Siemens/DPC Immulite 1000LHDP2 Siemens/DPC Immulite 2000LHDP5 Siemens/DPC Immulite 2500LHSNM SNIBE Maglumi analysersLHSF Stat Fax Elisa readersLHTOS TOSOHLHVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

*WHO 1988 2nd IS (NIBSC standard 80/552)INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 23/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREOestradiol pmol/lCODE METHODOEARC Abbott ArchitectOEABX Abbott AxsymOEABB Abbott IMxOEAIR Adaltis IRMAOESAN Beckman Access/LXi725OEDXI Beckman DxI 600 / 800OEBCI Biocheck Inc ELISAOEBCS Biocrates SterolDQ KitOEBIO bioMerieux CoatriaOEBIV bioMerieux VIDASOEVIA bioMerieux VIDIAOECIR CIS RIAOECLI Clinpro ELISAOEDIA Dialab ELISAOEDIE DiaMetra ELISAOEDAE Diagnostic Automation ELISAOEBYK DiaSorin IRMAOELIA Diasorin LiaisonOELIX Diasorin Liaison XLOEDIR DIAsource RIAOEDSL DSL RIAOEDTD Dynex DS2 ELISAOEELI ELISAOEFLG Fujirebio Lumipulse G SeriesOEGBE General Biologicals ELISAOEHUE Human ELISAOEIMR Immunotech RIAOEIMRS Immunotech RIA Ultra-SensitiveOEIME InterMedical EIAOELDE Labor Diagnostika Nord ELISAOEMOE Monobind Inc ELISA / CLIAOEMC2 Mindray CL-SeriesOEMPR MP Biomedicals RIAOENOV Novatec ELISAOEORS Orion SpectriaOEVEC Ortho Vitros 3600/5600/ECiOEDEL Perkin Elmer DELFIAOEWW Perkin Elmer Wizard/wallacOERAD Radim RIAOEEV Randox EvidenceOEC6 Roche Cobas 6000 / 8000 (Estradiol II)OEC63 Roche Cobas 6000 / 8000 (Estradiol III)OEROC Roche Cobas CoreOERCE Roche Cobas 4000 / e411 (Estradiol II)OERC3 Roche Cobas 4000 / e411 (Estradiol III)OEEYS Roche Elecsys (Estradiol II)OEEY3 Roche Elecsys (Estradiol III)OEBOE Roche EnzymunOERME Roche Modular E170 (Estradiol II)OERM3 Roche Modular E170 (Estradiol III)OERSL RSL Double Antibody directOESM Serono MAIAOESS Serono Serozyme/SRIOECC Siemens/Bayer ACS 180OEBAY Siemens/Bayer Immuno IOECCP Siemens Centaur CPOECP2 Siemens Centaur CP Enhanced (eE2)OECP3 Siemens Centaur CP (E26 III)OECEN Siemens Centaur XP/XPT/ClassicOECE2 Siemens Centaur XP/XPT/Classic Enhanced (eE2)OECE3 Siemens Centaur XP/XPT/Classic (E26 III)OEDDV Siemens/Dade Dimension VistaOEDPC Siemens/DPC Coat-a-CountOEDDA Siemens/DPC Double Antibody directOEDPI Siemens/DPC Immulite 1000OEDP2 Siemens/DPC Immulite 2000/2500OESNM SNIBE Maglumi analysersOESF Stat Fax Elisa ReadersOESRB Steranti RIS BaxterOETOS TOSOH (E2)OETO2 TOSOH (iE2-hsE2)OEXME Xema Medical EIA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 24/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRE17-OH-Progesterone nmol/lCODE METHODPHARC Abbott ArchitectPHABX Abbott AxsymPHAEE Adaltis ElAgenPHBR Beckman Coulter RIAPHBCS Biocrates SterolDQ KitPHBIL Bioline ELISAPHBCE Biorad Coda ELISAPHBIE Biosource ELISAPHBCT Biosource RIA-CTPHCIR CIS RIA Coated TubePHCLI Clinpro ELISAPHCDI Cortez Diagnostics ELISAPHDEE Demeditec ELISAPHDME DiaMetra ELISAPHDIE DIAsource ELISAPHDIR DIASource RIAPHDRG DRG ELISAPHDSL DSL gamma-counterPHDTD Dynex DS2 ELISAPHELI ELISAPHIBL IBL ELISAPHRIA Immunotech RIAPHLDE Labor Diagnostika Nord ELISAPHLM LC/MSPHMED Medgenix Single antibody directPHMOE Monobind Inc ELISA/CLIAPHMPR MP Biomedicals RIAPHNOV Novatec ELISAPHVEC Ortho Vitros 3600/5600/ECiPHDEL Perkin Elmer DELFIAPHRAA Radim AliseiPHRCE Roche Cobas 4000 / e411PHC6 Roche Cobas 6000 / 8000PHEYS Roche ElecsysPHRME Roche Modular E170PHRSL RSL Double Antibody directPHSRR SEAC RADIM RIAPHCCP Siemens Centaur CPPHCEN Siemens Centaur XP/XPT/ClassicPHDPC Siemens/DPC Coat-a-CountPHDPI Siemens/DPC Immulite 1000PHDP2 Siemens/DPC Immulite 2000/2500PHSNM SNIBE Maglumi AnalysersPHSF Stat Fax Elisa Readers

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Paracetamol (Acetaminophen) mmol/lCODE METHODPAARC Abbott ArchitectPAABX Abbott AxsymPAOAD Beckman AU instrumentsPADXC Beckman DxCPACLS Cambride Life Sciences AssayPAEMI EMITPAH HPLCPADC Ortho Vitros MicroSlide SystemsPARX Randox RXPAC6 Roche Cobas c501/c502/c701/c702PAINT Roche IntegraPARME Roche Modular E170PACCP Siemens Centaur CPPACEN Siemens Centaur XP/XPT/ClassicPADD Siemens/Dade Dimension / Vista

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 25/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREPhenobarbital µmol/l CODE METHODPHBARC Abbott Architect (CMIA)PHARP Abbott Architect (PETINIA)PHBABX Abbott AxsymPHBOAD Beckman AU400 / 600 / 640 / 2700 / 5400PHBLXD Beckman Synchron LX Systems / Unicel DxCPHBEMI EMITPHBHP HPLCPHBMIE Microgenics CEDIA assayPHBDC Ortho Vitros Microslide SystemsPHBDAY Randox DaytonaPHBRCE Roche Cobas 4000 / c311PHBC5 Roche Cobas c501 / 502 / 701PHBC6 Roche Cobas e601/602/801PHBINT Roche IntegraPHBMOD Roche Modular P / DPHBCNS Siemens Advia 1200/1650/1800/2400PHBCCP Siemens Centaur CPPHBCEN Siemens Centaur XP/XPT/ClassicPHBDDV Siemens Dade Dimension/VistaPHBDPI Siemens/DPC Immulite 1000PHBDP2 Siemens/DPC Immulite 2000 / 2500PHBEM Siemens Syva/EMIT

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Phenytoin µmol/lCODE METHODPHAER Abbott AerosetPHARC Abbott ArchitectPHABX Abbott AxsymPHABT Abbott TDxPHAEC Adaltis EclecticaPHDXC Beckman DxCPHBEK Beckman ArrayPHBIM Beckman ImmagePHSYN Beckman Synchron CX / LXPHBEM Behring EmitPHBIV bioMerieux VIDASPHCLI Clinpro ELISAPHELI ELISAPHEMI EMITPHGM GCMSPHHIT Hitachi 911/912/917PHHP HPLCPHMMI Merck MicrolabPHMIE Microgenics CEDIA assayPHVIT Ortho-Clinical Diagnostics VitrosPHDAY Randox DaytonaPHEYS Roche ElecsysPHINT Roche IntegraPHMOD Roche Modular D/PPHRME Roche Modular E170PHC6 Roche Cobas 6000 / 8000PHRCE Roche Cobas 4000 / c311PHCNS Siemens ADVIA 1200/1650/1800/2400PHCC Siemens/Bayer ACS 180PHBAYI Siemens/Bayer Immuno 1PHCCP Siemens Centaur CPPHCEN Siemens Centaur XP/XPT/ClassicPHDD Siemens/Dade Dimension VistaPHDPI Siemens/DPC Immulite 1000PHDP2 Siemens/DPC Immulite 2000/2500PHSF Stat Fax Elisa Readers

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Primidone µmol/lCODE METHODPIEMT EMITPIHP HPLCPIINT Roche Integra

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 26/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREProgesterone nmol/lCODE METHODPGARC Abbott ArchitectPGABX Abbott AxsymPGABB Abbott IMxPGAEC Adaltis EclecticaPGAIR Adaltis IRMAPGSAN Beckman Access Prog. Cal 33555PGSAS Beckman Access Prog. DE Cal. A80773PGOAU Beckman Coulter AU3000iPGDXI Beckman DXI Prog. Cal 33555PGDXS Beckman DXI Prog. DE Cal. A80773PGBCI Biocheck Inc ELISAPGBCS Biocrates SterolDQ KitPGBIO bioMerieux CoatriaPGBIV bioMerieux VIDASPGVIA bioMerieux VIDIAPGBIN Bioneovan ELISAPGBMA Boditech Med Inc AFIA-6PGCBE Calbiotech ELISAPGCIR CIS-RIA Coated tubePGCLI Clinpro ELISAPGDSE Diagnostic Systems ELISAPGDIA Dialab ELISAPGDIE DiaMetra ELISAPGBYK DiaSorin (RIA)PGLIA DiaSorin LiaisonPGLIX DiaSorin Liaison XLPGDRG DRG ELISAPGDSL DSL RIAPGELI ELISAPGFJL Fujirebio Lumipulse G SeriesPGGBE General Biologicals ELISAPGHUE Human ELISAPGIMR Immunotech RIAPGIME InterMedical EIAPGLDE Labor Diagnostika Nord ELISAPGMC2 Mindray CL-SeriesPGMOE Monobind Inc. ELISA / CLIAPGNOV Novatec ELISAPGORD Orion Double Antibody DirectPGORS Orion SpectriaPGVEC Ortho Vitros 3600/5600/ECiPGDEL Perkin Elmer DELFIAPGDEM Perkin Elmer DELFIA MabPGWW Perkin Elmer Wizard/wallacPGRRD Radim RAD120PGRAD Radim RIAPGEV Randox EvidencePGRAN Randox ELISAPGC6 Roche Cobas 6000 / 8000 (Prog. II)PGC63 Roche Cobas 6000 / 8000 (Prog. III)PGROC Roche Cobas CorePGRCE Roche Cobas 4000 / e411 (Prog. II)PGRC3 Roche Cobas 4000 / e411 (Prog. III)PGEYS Roche Elecsys (Prog. II)PGEY3 Roche Elecsys (Prog. III)PGBOE Roche EnzymunPGRME Roche Modular E170 (Prog. II)PGRM3 Roche Modular E170 (Prog. III)PGRSL RSL Double Antibody directPGSS Serono Serozyme/SRIPGSEC Serono solid phase second AntibodyPGCC Siemens/Bayer ACS 180PGBAY Siemens/Bayer Immuno IPGCCP Siemens Centaur CPPGCEN Siemens Centaur XP/XPT/ClassicPGDDV Siemens/Dade Dimension VistaPGDPC Siemens/DPC Coat-a-CountPGDPI Siemens/DPC Immulite 1000PGDP2 Siemens/DPC Immulite 2000/2500PGSNM SNIBE Maglumi analysersPGSF Stat Fax Elisa readersPGTOS TOSOH

Other methods please specify on enrolment documentINSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 27/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREProlactin (PRL) µU/ml*CODE METHODPLARC Abbott ArchitectPLARN Abbott Architect (Re-standardised)PLABX Abbott AxsymPLABB Abbott IMxPLARB Abbott RIAbead IIPLAEC Adaltis EclecticaPLAEE Adaltis ElAgenPLAIR Adaltis IRMAPLSAN Beckman Access/LXi725PLOAU Beckman Coulter AU3000iPLDXI Beckman DxI 600 / 800PLBEH Behring RIA-gnostPLBCI Biocheck Inc ELISAPLBCL Bioclone IRMAPLBIL Bioline IRMAPLBIO bioMerieux CoatriaPLBIV bioMerieux VIDASPLVIA bioMerieux VIDIAPLBMA Boditech Med Inc AFIA-6PLBMI Boditech Med Inc i-CHROMAPLBRR Brahms KryptorPLCBE Calbiotech ELISAPLCHE ChelseaPLCII CIS IRMAPLCIR CIS RIA coated tubePLCLI Clinpro ELISAPLDAE Diagnostic Automation ELISAPLDSE Diagnostic Systems ELISAPLDIA Dialab ELISAPLDIE Diametra ELISAPLBYK DiaSorin IRMAPLLIA DiaSorin LiaisonPLLIX DiaSorin Liaison XLPLDIR DIAsource IRMAPLDSL DSL RIAPLELI ELISAPLFJL Fujirebio Lumipulse G SeriesPLGBE General Biologicals ELISAPLHUE Human ELISAPLHTE Hybritech Tandem-EPLHTR Hybritech Tandem-RPLIMI Immunotech IRMAPLIZO Izotop IRMAPLLDE Labor Diagnostika Nord ELISAPLMED Medgenix (IRMA)PLMM Merck MagiaPLMC2 Mindray CL-SeriesPLMOE Monobind Inc. ELISA / CLIAPLMPI MP Biomedicals IRMAPLNOV Novatec ELISAPLORS Orion Spectria (CT)PLKD Ortho-Clinical Diagnostics Double AntibodyPLVEC Ortho Vitros 3600/5600/ECiPLDEL Perkin Elmer DELFIAPLWW Perkin Elmer Wizard/wallacPLPHA Pharmacia PRL RIAPLRAE Radim IEMA wellPLRAD Radim IRMA CTPLRRD Radim RAD120PLEV Randox EvidencePLRAN Randox ELISAPLEY2 Roche Elecsys/E170/Cobas 6000/8000 (PROLACTIN II)PLC6 Roche Cobas 6000 / 8000PLROC Roche Cobas Core EIAPLRCE Roche Cobas 4000 / e411PLEYS Roche ElecsysPLBOE Roche EnzymunPLRME Roche Modular E170PLSM Serono MAIAPLSMC Serono MAIAclonePLSS Serono Serozyme/SRIPLCC Siemens/Bayer ACS 180PLBAY Siemens/Bayer Immuno IPLCCP Siemens Centaur CPPLCEN Siemens Centaur XP/XPT/ClassicPLDDV Siemens/Dade Dimension VistaPLDCI Siemens/DPC Coat-a-Count IRMAPLDDA Siemens/DPC Double AntibodyPLDPI Siemens/DPC Immulite 1000PLDP2 Siemens/DPC Immulite 2000/2500PLSNM SNIBE Maglumi analysersPLSF Stat Fax Elisa ReaderPLTOS TOSOHPLVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

*WHO 1986 2nd IS (NIBSC standard (83/562) WHO 3rd IS (NIBSC standard 84/500)

INSTRUMENT CODEREAGENT CODE

RQ9125 Method Questionnaire 28/43 Revised Dec 2017

Page 29: METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREPSA, Free ng/mlCODE METHODPFARC Abbott ArchitectPFABX Abbott Axsym monoclonalPFABB Abbott IMxPFAEC Adaltis EclecticaPFDXI Beckman DXI standardised to HybritechPFDXS Beckman DXI standardised to WHO IRP96/670PFSA2 Beckman Access standardised to HybritechPFSAS Beckman Access standardised to WHO IRP96/670PFBIV BioMerieux VIDASPFVIA bioMerieux VIDIAPFBMA Boditech Med Inc AFIA-6PFBRR Brahms KryptorPFCIR CIS RIA coated tubePFCLI Clinpro ELISAPFDSE Diagnostic Systems ELISAPFDIA Dialab ELISAPFDIE DiaMetra ELISAPFBYK DiaSorin (IRMA)PFLIA DiaSorin LiaisonPFLIX DiaSorin Liaison XLPFDRG DRG ELISAPFDSI DSI ELISAPFELI ELISAPFFJL Fujirebio Lumipulse G SeriesPFIMI Immunotech IRMAPFMC2 Mindray CL SeriesPFMOE Monobind Inc. ELISA / CLIAPFVE2 Ortho Vitros 3600 / 5600 / Eci PSA IIPFDEL Perkin Elmer DELFIAPFPTE Pishtaz Teb ELISAPFRAA Radim AliseiPFRRD Radim RAD120PFEV Randox EvidencePFC6 Roche Cobas 6000 / 8000PFRCE Roche Cobas 4000 / e411PFRME Roche Modular E170PFROC Roche Cobas CorePFEYS Roche ElecsysPFCC Siemens/Bayer ACS 180PFCCP Siemens Centaur CPPFCEN Siemens Centaur XP/XPT/ClassicPFDD Siemens/Dade DimensionPFDDV Siemens/Dade Dimension VistaPFDPC Siemens/DPC Coat-a-CountPFDPI Siemens/DPC Immulite 1000PFDP2 Siemens/DPC Immulite 2000/2500PFSNM SNIBE Maglumi analysersPFSF Stat Fax Elisa ReadersPFTSU Tecnosuma UMELISAPFTOS TOSOHPFVLE Veda.Lab Easy ReaderPFXME Xema Medical EIA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 29/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREPSA, total ng/mlCODE METHODPSARC Abbott ArchitectPSAX2 Abbott Axsym monoclonalPSABX Abbott Axsym polyclonalPSAB2 Abbott IMx monoclonalPSABB Abbott IMx polyclonalPSAEC Adaltis EclecticaPSABE Alkor-Bio ELISAPSAMP AMP ELISAPSSA2 Beckman Access standardised to HybritechPSSAS Beckman Access standardised to WHO IRP96/670PSDXS Beckman DXI standardised to WHO IRP96/670 PSDXI Beckman DXI standardised to HybritechPSBCI Biocheck Inc ELISAPSBV2 bioMerieux Vidas TPSAPSVIA bioMerieux VIDIAPSBMI Boditech Med Inc i-CHROMAPSBRR Brahms KryptorPSCBE Calbiotech ELISAPSCIS CIS ELISA 2PSCIR CIS RIA coated tubePSCLI Clinpro ELISAPSDSE Diagnostic Systems ELISAPSDIA Dialab ELISAPSDIE DiaMetra ELISAPSBYK DiaSorin (IRMA)PSLIA DiaSorin LiaisonPSLIX DiaSorin Liaison XLPSDRG DRG ELISAPSDSI DSI ELISAPSELI ELISAPSFUJ Fujirebio ELISAPSFJL Fujirebio Lumipulse G SeriesPSHUE Human ELISAPSHS Hybritech StratusPSHTE Hybritech Tandem-EPSHTR Hybritech Tandem-RPSIMI Immunotech IRMAPSIZO Izotop RIAPSMC2 Mindray CL SeriesPSMOE Monobind Inc. ELISA / CLIAPSVEC Ortho Vitros 3600 / 5600 / ECiPSVE2 Ortho Vitros 3600 / 5600 / ECi PSA IIPSDEL Perkin Elmer DELFIAPSPTE Pishtaz Teb ELISAPSRAA Radim AliseiPSRRD Radim RAD120PSEV Randox EvidencePSC6 Roche Cobas 6000 / 8000PSROC Roche Cobas Core EIAPSRCE Roche Cobas 4000 / e411PSEYS Roche ElecsysPSBOE Roche EnzymunPSRME Roche Modular E170PSSMC Serono MAIAclonePSIMS Siemens/Bayer ADVIA IMS 800iPSCC2 Siemens/Bayer ACS 180 (equimolar)PSBAY Siemens/Bayer Immuno IPSCCP Siemens Centaur CPPSCN2 Siemens Centaur XP/XPT/ClassicPSDDV Siemens/Dade Dimension VistaPSDD2 Siemens/Dade Dimension equimolarPSDPC Siemens/DPC Coat-a-CountPSDPI Siemens/DPC Immulite 1000 Total PSAPSDP3 Siemens/DPC Immulite 1000 3rd GenerationPSDP2 Siemens/DPC Immulite 2000/2500 Total PSAPSDP4 Siemens/DPC Immulite 2000/2500 3rd generationPSDIC Siemens/DPC IRMA-CountPSSNM SNIBE Maglumi analysersPSSF Stat Fax Elisa ReadersPSSHI Sysmex HISCL SeriesPSTSU Tecnosuma UMELISAPSTOS TOSOHPSVB Vector Best Enzyme ImmunoassayPSVLE Veda.Lab Easy ReaderPSXME Xema Medical EIA

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 30/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREParathyroid Hormone (PTH) pmol/l CODE METHODPTARC Abbott ArchitectPTABX Abbott AxsymPTSAN Beckman Access/LXi725PTDXI Beckman DxI 600 / 800PTHBLE Bioline ELISAPTBME Biomerica ELISAPTBIG Biosource Gamma counterPTCIS CIS IRMAPTCLI Clinpro ELISAPTBYK DiaSorin (RIA)PTLIA DiaSorin Liaison 1-84 PTHPTLIX DiaSorin Liaison XL 1-84 PTHPTLIAN DiaSorin Liaison N-TACT PTH IIPTLIXN DiaSorin Liaison XL N-TACT PTH IIPTDSE Diasource ELISAPTDRG DRG ELISAPTDSL DSL Gamma counterPTELI ELISAPTFJL Fujirebio Lumipulse G SeriesPTIDS IDS-iSYS PTHPTIMI Immunotech IRMAPTMC2 Mindray CL SeriesPTVEC Ortho Vitros 3600/5600/EciPTWW Perkin Elmer WizardPTRCEB Roche Cobas 4000 / e411 PTH (1-84)PTRCE Roche Cobas 4000 / e411 PTH/PTH STATPTC6B Roche Cobas 6000 / 8000 PTH (1-84)PTC6 Roche Cobas 6000 / 8000 PTH/PTH STATPTEYS6 Roche Elecsys PTH (1-84)PTEYS Roche Elecsys PTH/PTH STATPTRMEB Roche Modular E170 PTH (1-84)PTRME Roche Modular E170 PTH/PTH STATPTSC Scantibodies RIAPTCCP Siemens Centaur CPPTCEN Siemens Centaur XP/XPT/ClassicPTCC Siemens/Bayer ACS 180PTDPC Siemens/DPC coated tube IRMAPTDPI Siemens/DPC Immulite 1000PTDP2 Siemens/DPC Immulite 2000PTDP5 Siemens/DPC Immulite 2500PTSNM SNIBE Maglumi analysersPTSF Stat Fax Elisa ReadersPTTOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 31/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRESalicylate mmol/l (PILOT)CODE METHODSAARC Abbott ArchitectSAABX Abbott AxsymSADXC Beckman DxC 600/800SAEMI EMITSADC Ortho Vitros MicroSlide SystemsSAC6 Roche Cobas c501/502SAINT Roche IntegraSARME Roche Modular E170SACNS Siemens/Bayer ADVIA 1200/1650/1800/2400SACCP Siemens Centaur CPSACEN Siemens Centaur XP/XPT/ClassicSADD Siemens/Dade Dimension / Vista

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Sex Hormone Binding Globulin (SHBG) nmol/l CODE METHODSHABG Abbott ANSR gamma counterSHARC Abbott ArchitectSHSAN Beckman AccessSHDXI Beckman DxI 600 / 800SHBET Beta-counterSHCIS CIS IRMASHCLI Clinpro ELISASHRAD CT RadimSHDEE Demeditec ELISASHDRG DRG ELISASHDSL DSL gamma counterSHELI ELISASHIBE IBL ELISASHIMM Immunotech IRMASHIZO Izotop IRMASHORI Orion Gamma counterSHWW Perkin Elmer WizardSHRCE Roche Cobas 4000 / e411SHC6 Roche Cobas 6000 / 8000SHEYS Roche ElecsysSHRME Roche Modular E170SHCCP Siemens Centaur CPSHCEN Siemens Centaur (Ref 06520781)SHCE2 Siemens Centaur (Ref 10997191)SHDPC Siemens/DPC coated tube IRMASHDPI Siemens/DPC Immulite 1000SHDP2 Siemens/DPC Immulite 2000/2500SHZEN Zentech gamma counter

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 32/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREFree Triiodothyronine (Free T3) pmol/lCODE METHODF3ARC Abbott ArchitectF3ABX Abbott AxsymF3ABB Abbott IMxF3AEC Adaltis EclecticaF3AMP AMP ELISAF3SAN Beckman Access/LXi725F3OAU Beckman Coulter AU3000iF3DXI Beckman DxI 600 / 800F3BD Beckton DickinsonF3BEH BehringF3BCI Biocheck Inc ELISAF3BIV bioMerieux VIDASF3VIA bioMerieux VIDIAF3BMA Boditech Med Inc AFIA-6F3BRR Brahms RIAF3CII CIS IRMAF3CLI Clinpro ELISAF3DSE Diagnostic Systems ELISAF3DIE DiaMetra ELISAF3BYK DiaSorin (RIA)F3LIA DiaSorin LiaisonF3LIX DiaSorin Liaison XLF3ELI ELISAF3EQE Equipar ELISAF3FJL Fujirebio Lumipulse G SeriesF3HUE Human ELISAF3IMR Immunotech RIAF3L LisophaseF3MC2 Mindray CL-SeriesF3MOE Monobind Inc. ELISAF3NTE NovaTec EIAF3VEC Ortho Vitros 3600/5600/ECiF3DEL Perkin Elmer DELFIAF3WW Perkin Elmer Wizard/wallacF3RRD Radim RAD 120F3EV Randox EvidenceF3RCE Roche Cobas 4000 / e411F3C6 Roche Cobas 6000 / 8000F3ROC Roche Cobas Core EIAF3EYS Roche ElecsysF3BOE Roche EnzymunF3RME Roche Modular E170F3SRR SEAC Radim RIAF3SS Serono Serozyme/SRIF3CCP Siemens Centaur CPF3CEN Siemens Centaur XP/XPT/ClassicF£DDE Siemens Dimension Exl LOCIF3DDV Siemens Dimension Vista LOCIF3CC Siemens/Bayer ACS 180F3BAY Siemens/Bayer Immuno IF3DD Siemens/Dade DimensionF3DPC Siemens/DPC Coat-a-CountF3DPI Siemens/DPC Immulite 1000F3DP2 Siemens/DPC Immulite 2000/2500F3SNM SNIBE Maglumi analysersF3SF Stat Fax Elisa ReadersF3SHI Sysmex HISCL SeriesF3TOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 33/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRETriiodothyronine (Total T3) nmol/lCODE METHODT3ARC Abbott ArchitectT3ABX Abbott AxsymT3ABB Abbott IMxT3SAN Beckman Access/LXi725T3OAU Beckman Coulter AU3000iT3DXI Beckman DxI 600 / 800T3BEH Behring coated tubeT3BEO Behring OpusT3BIV bioMerieux VIDAST3BMA Boditech Med Inc AFIA-6T3BMI Boditech Med i-ChromaT3CBE Calbiotech ELISAT3CIR CIS RIA coated tubeT3CA Clinical Assays GammacoatT3CLI Clinpro ELISAT3DSEL Diagnostic Systems ELISAT3DIE DiaMetra ELISAT3DSE Diasource ELISAT3LIA DiaSorin LiaisonT3LIX DiaSorin Liaison XLT3BYK DiaSorin RIAT3DSI DSI EIAT3DSL DSL RIAT3ELI ELISAT3FJL Fujirebio Lumipulse G SeriesT3HUE Human ELISAT3IMI Immunotech IRMAT3IMR Immunotech RIAT3IZO Izotop RIAT3KQ Kallestad QuanticoatT3MM Merck MagiaT3MC2 Mindray CL-SeriesT3MOE Monobind Inc. ELISAT3MP MP Biomedicals RIAT3ODE Omega Diagnostics ELISAT3OSA Orion Single AntibodyT3ORS Orion SpectriaT3VEC Ortho Vitros 3600/5600/ECiT3DEL Perkin Elmer DELFIAT3PEW Perkin Elmer Wizard RIAT3WW Perkin Elmer Wizard/wallacT3EV Randox EvidenceT3RAN Randox ELISAT3C6 Roche Cobas 6000 / 8000T3ROC Roche Cobas Core EIAT3RCE Roche Cobas 4000 / e411T3EYS Roche ElecsysT3BOE Roche EnzymunT3RME Roche Modular E170T3SRR SEAC Radim RIAT3SS Serono Serozyme/SRIT3CC Siemens/Bayer ACS 180T3BAY Siemens/Bayer Immuno IT3CCP Siemens Centaur CPT3CEN Siemens Centaur XP/XPT/ClassicT3DD Siemens/Dade DimensionT3DPC Siemens/DPC Coat-a-CountT3DDA Siemens/DPC Double AntibodyT3DPI Siemens/DPC Immulite 1000T3DP2 Siemens/DPC Immulite 2000/2500T3SNM SNIBE Maglumi analysersT3SF Stat Fax Elisa ReadersT3TOS TOSOHT3VLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 34/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREFree Thyroxine (Free T4) pmol/lCODE METHODF4ARC Abbott ArchitectF4ABX Abbott AxsymF4ABB Abbott IMxF4AEC Adaltis EclecticaF4AEE Adaltis ElAgenF4AMP AMP ELISAF4SAN Beckman Access/LXi725F4OAU Beckman Coulter AU3000iF4DXI Beckman DxI 600 / 800F4BD Beckton Dickinson SimulTRACF4BEH Behring RIA gnost 2-stepF4BCI Biocheck Inc ELISAF4BIVN BiomerieuxVIDAS-FT4N KitF4VIA bioMerieux VIDIAF4BMA Boditech Med Inc AFIA-6F4BRR Brahms RIAF4CBE Calbiotech ELISAF4CII CIS IRMAF4CIR CIS RIA coated tubeF4CA Clinical Assays Gammacoat directF4CA2 Clinical Assays 2-stepF4CLI Clinpro ELISAF4DSE Diagnostic Systems ELISAF4DIA Dialab ELISAF4DIE DiaMetra ELISAF4LIA DiaSorin LiaisonF4LIX DiaSorin Liaison XLF4BYK DiaSorin (RIA)F4DSR DiaSource RIAF4ELI ELISAF4FJL Fujirebio Lumipulse G SeriesF4GB General Biologicals ELISAF4HUE Human ELISAF4IMI Immunotech IRMAF4IMR Immunotech RIAF4IZO Izotop RIAF4LDE Labor Diagnostika Nord ELISAF4L LisophaseF4MM Merck MagiaF4MC2 Mindray CL-SeriesF4MOE Monobind Inc. ELISA / CLIAF4NOV Novatec ELISAF4VEC Ortho Vitros 3600/5600/ECiF4DEL Perkin Elmer DELFIAF4WW Perkin Elmer Wizard/wallacF4RRD Radim RAD 120F4EV Randox EvidenceF4RAN Randox ELISAF4C6 Roche Cobas 6000 / 8000F4ROC Roche Cobas Core EIAF4RCE Roche Cobas 4000 / e411F4EYS Roche ElecsysF4BOE Roche EnzymunF4RME Roche Modular E170F4SRR SEAC Radim RIAF4SS Serono Serozyme/SRIF4IMS Siemens/Bayer ADVIA IMS 800iF4CC Siemens/Bayer ACS 180F4BAY Siemens/Bayer Immuno IF4CCP Siemens Centaur CPF4CEN Siemens Centaur XP/XPT/ClassicF4DD Siemens/Dade DimensionF4DDE Siemens Dimension Exl LOCIF4DDV Siemens Dimension Vista LOCIF4DPC Siemens/DPC Coat-a-CountF4DPI Siemens/DPC Immulite 1000F4DP2 Siemens/DPC Immulite 2000/2500F4SNM SNIBE Maglumi analysersF4SF Stat Fax Elisa ReaderF4SHI Sysmex HISCL SeriesF4TMS Tecan MiniswiftF4TOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 35/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREThyroxine (Total T4) nmol/lCODE METHODT4ARC Abbott ArchitectT4ABX Abbott AxsymT4ABB Abbott IMx/FLx/TDxT4SAN Beckman Access/LXi725T4OAU Beckman Coulter AU3000iT4DXI Beckman DxI 600 / 800T4BD Beckton DickinsonT4BEO Behring OpusT4BCI Biocheck Inc ELISAT4BIV bioMerieux VIDAST4BMA Boditech Med Inc AFIA-6T4BMI Boditech Med Inc i-CHROMAT4BRR Brahms RIAT4CIR CIS RIA coated tubeT4CA Clinical Assays GammacoatT4CLI Clinpro ELISAT4DSEL Diagnostic Systems ELISAT4DIE DiaMetra ELISAT4DSE Diasource ELISAT4LIA DiaSorin LiaisonT4LIX DiaSorin Liaison XLT4BYK DiaSorin RIAT4DSL DSL RIAT4ELI ELISAT4FJL Fujirebio Lumipulse G SeriesT4HUE Human ELISAT4IMI Immunotech RIAT4IZO Izotop IRMAT4IZR Izotop RIAT4KQ Kallestad QuanticoatT4MM Merck MagiaT4MIE Microgenics DRI assayT4MC2 Mindray CL-SeriesT4MOE Monobind Inc. ELISAT4MP MP Biomedicals RIAT4ODE Omega Diagnostics ELISAT4OSA Orion Single AntibodyT4ORS Orion SpectriaT4VEC Ortho Vitros 3600 / 5600 / ECiT4DEL Perkin Elmer DELFIAT4PEW Perkin Elmer Wizard RIAT4WW Perkin Elmer Wizard/wallacT4EV Randox EvidenceT4RAN Randox ELISAT4C6 Roche Cobas 6000 / 8000T4ROC Roche Cobas Core EIAT4RCE Roche Cobas 4000 / e411T4EYS Roche ElecsysT4BOE Roche EnzymunT4RME Roche Modular E170T4SRR SEAC Radim RIAT4SS Serono Serozyme/SRIT4STB Serono T4 BridgeT4CC Siemens/Bayer ACS 180T4BAY Siemens/Bayer Immuno IT4CCP Siemens Centaur CPT4CEN Siemens Centaur XP/XPT/ClassicT4DD Siemens/Dade DimensionT4DPC Siemens/DPC Coat-a-CountT4DPI Siemens/DPC Immulite 1000T4DP2 Siemens/DPC Immulite 2000 / 2500T4SNM SNIBE Maglumi analysersT4SF Stat Fax Elisa ReadersT4SY SyvaT4TSU Technosuma UMELISAT4TS Thermo Scientific - DRIT4TOS TOSOHT4VLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 36/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREFree Testosterone pmol/l (PILOT)CODE METHODTFARC Abbott ArchitectTFAEE Adaltis ElAgenTFBIV bioMerieux Vidas/Mini VidasTFBCE Biorad Coda ELISATFCAL CalculatedTFCDI Cortez Diagnostics ELISATFDEE Demeditec ELISATFDBE Diagnostics Biochem Canada (DBC) ELISATFDIE DiaMetra ELISATFBYK Diasorin RIATFDIS DIAsource ELISATFDIR DIAsource RIATFDRG DRG ELISATFDSL DSL / Beckman Coulter RIATFIBL IBL ELISATFIMM Immunotech RIATFLDE Labor Diagnostika Nord ELISATFMOE Monobind Inc. ELISA/CLIATFNOV Novatech ELISATFRAA Radim AliseiTFRAD Radim RIATFC6 Roche Cobas 6000 / 8000TFRCE Roche Cobas 4000 / e411TFRME Roche Modular E170TFDPC Siemens/DPC Coat-a-CountTFSNM SNIBE Maglumi analysers

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Testosterone nmol/lCODE METHODTEARC Abbott ArchitectTEAR2 Abbott Architect 2nd GenTEABX Abbott AxsymTEABB Abbott IMxTESAN Beckman Access/LXi725TEDXI Beckman DxI 600 / 800TEBCI Biocheck Inc ELISATEBCS Biocrates SterolDQ KitTEBIE bioMerieux Single Ab. with extractionTEBIO bioMerieux Single Ab. directTEBIV bioMerieux VIDASTEBV2 bioMerieux VIDAS Testosterone IITEBMA Boditech Med Inc AFIA-6TEBMI Boditech Med Inc i-CHROMATECBE Calbiotech ELISATECIR CIS RIA Coated tubeTECLI Clinpro ELISATEDSE Diagnostic Systems ELISATEDIE DiaMetra ELISATELIA DiaSorin LiaisonTELIX DiaSorin Liaison XLTEBYK DiaSorin RIA-matTEDRG DRG ELISATEDSL DSL RIATEELI ELISATEFJL Fujirebio Lumipulse G SeriesTEGBE General Biologicals ELISATEHUE Human ELISATEIBE IBL International ELISATEIMR Immunotech RIATEIME InterMedical EIATEMED Medgenix Single Antibody directTEMC2 Mindray CL-SeriesTEMOE Monobind Inc. ELISA / CLIATEOSP Orion Solid Phase second AntibodyTEORS Orion SpectriaTEVEC Ortho Vitros 3600/5600/ECiTEDEL Perkin Elmer DELFIATEWW Perkin Elmer Wizard/wallacTEEV Randox EvidenceTEC62 Roche Cobas 6000 / 8000 Test IITEROC Roche Cobas CoreTERCE2 Roche Cobas 4000 / e411 Test IITEEYS2 Roche Elecsys Test IITEBOE Roche EnzymunTERME2 Roche Modular E170 Test II

CONTINUED ON NEXT PAGE

RQ9125 Method Questionnaire 37/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRETestosterone nmol/l (Continued)CODE METHODTERSL RSL Double Antibody directTESM Serono MAIATESS Serono Serozyme/SRITECC Siemens/Bayer ACS 180TEBAY Siemens/Bayer Immuno ITECCP Siemens Centaur CPTECEN Siemens Centaur XP/XPT/Classic TSTOTECE2 Siemens Centaur XP/XPT/Classic TSTIITEDDV Siemens/Dade Dimension VistaTEDPC Siemens/DPC Coat-a-CountTEDDA Siemens/DPC Double Antibody with extractionTEDPI Siemens/DPC Immulite 1000TEDP2 Siemens/DPC Immulite 2000/2500TESNM SNIBE Maglumi analysersTESF Stat Fax Elisa ReadersTETOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Thyroglobulin ng/ml CODE METHODTGARC Abbott Architect 2000iTGDXI Beckman DxI 600 / 800TGSAN Beckman AccessTGBRG Brahms gamma counterTGBRI Brahms IRMATGBRR Brahms RIATGCIR CIS RIA coated tubeTGCLI Clinpro ELISATGDME DiaMetra ELISATGLIA DiaSorin LiaisonTGLIX DiaSorin Liaison XLTGDIC Diesse ChorusTGDRG DRG ELISATGELI ELISATGGDE Genesis Diagnostics ELISATGGEN Genesys gamma counterTGGT Grifols Triturus EIATGIEM IEMA WellTGIME Intermedical ELISATGIDE IVAX Diagnostics Inc ELISATGIZG Izotop Gamma counterTGKRO Kronus IRMATGMED Medipan IRMATGMOE Monobind Inc. ELISA / CLIATGORG Orgentec ELISATGNOV NovaTec ELISATGDEL Perkin Elmer DELFIATGRAA Radim AliseiTGRAE Radim IEMA well TGRRD Radim RAD 120TGC6 Roche Cobas 6000 / 8000TGC62 Roche Cobas 6000/8000 Tg IITGRCE Roche Cobas 4000 / e411TGRCE2 Roche Cobas 4000/e411 Tg IITGEYS Roche ElecsysTGEYS2 Roche Elecsys Tg IITGRME Roche Modular E170TGRME2 Roche Modular E170 Tg IITGRSR RSR double antibodyTGSRE Seac Radim IEMATGCC Siemens/Bayer ACS 180TGDPI Siemens/DPC Immulite 1000TGDP2 Siemens/DPC Immulite 2000/2500TGDPC Siemens/DPC IRMATGSNM SNIBE Maglumi analysersTGSF Stat Fax Elisa readersTGTOS TosohTGKRY Trace Kryptor

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 38/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRETheophylline µmol/lCODE METHODTHAER Abbott AerosetTHARC Abbott ArchitectTHABX Abbott AxsymTHABT Abbott TDxTHSAN Beckman Access/LXi725THOAD Beckman AU400/600/640/2700/5400THDXC Beckman DxCTHDXI Beckman DxI 600 / 800THBEK Beckman ArrayTHBIM Beckman ImmageTHSYN Beckman Synchron CX / LXTHBEM Behring EmitTHBIV bioMerieux VIDASTHCLI Clinpro ELISATHELI ELISATHEMI EMITTHGM GCMSTHHIT Hitachi 911/912/917THHP HPLCTHMIE Microgenics CEDIA assayTHVIT Ortho-Clinical Diagnostics VitrosTHDAY Randox DaytonaTHC6 Roche Cobas 6000 / 8000THRCE Roche Cobas 4000 / c311THINT Roche IntegraTHMOD Roche Modular D/PTHCNS Siemens Advia 1200/1650/1800/2400THCC Siemens/Bayer ACS 180THCCP Siemens Centaur CPTHCEN Siemens Centaur XP/XPT/ClassicTHDD Siemens/Dade Dimension VistaTHDPI Siemens/DPC Immulite 1000THDP2 Siemens/DPC Immulite 2000/2500THSF Stat Fax Elisa Readers

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Tobramycin µmol/l (PILOT)CODE METHODTBARE Abbott Architect / AxsymTBABX Abbott AxsymTBDXC Beckman DXC 600 / 800TBEMI EMITTBINT Roche IntegraTBCNS Siemens ADVIA 1200/1650/1800/2400TBCCP Siemens Centaur CPTBCEN Siemens Centaur XP/XPT/ClassicTBDD Siemens Dimension

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Thyroid Stimulating Hormone (TSH) µU/mlCODE METHODTSARC Abbott ArchitectTSABX Abbott Axsym Ultrasensitive hTSH IITSAX3 Abbott Axsym 3rd generationTSABB Abbott IMx Ultrasensitive hTSH IITSABI Abbott IRMATSABE Abbott TSH-EIATSAEC Adaltis EclecticaTSAEE Adaltis ElAgenTSAIR Adaltis IRMATSAKE Alkor-Bio ELISATSAMP AMP ELISATSSAF Beckman Access / LXi725 FastTSH 2nd generationTSSAN Beckman Access / LXi725 hyperTSH 3rd genTSOAU Beckman Coulter AU3000iTSDXI Beckman DxI 600 / 800 1st generationTSDX3 Beckman DxI 600 / 800 / Access 2 (3rd IS)TSDXF Beckman DxI 600 / 800 Fast TSHTSDXH Beckman DxI 600 / 800 Hyper TSHTSBD Beckton Dickinson SimulTRAC IRMATSBEH Behring (IRMA)TSBEO Behring Opus

CONTINUED ON NEXT PAGE

RQ9125 Method Questionnaire 39/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREThyroid Stimulating Hormone (TSH) µU/ml (Continued)CODE METHODTSBCI Biocheck Inc ELISATSBIV bioMerieux VIDAS TSHTSBV3 bioMerieux VIDAS TSH3 (ultrasensitive)TSVIA bioMerieux VIDIATSBMA Boditech Med Inc AFIA-6TSBMI Boditech Med Inc i-CHROMATSBRI Brahms IRMATSCII CIS IRMATSCA Clinical Assays GammacoatTSCLI Clinpro ELISATSDSE Diagnostic Systems ELISATSDIA Dialab ELISATSDME DiaMetra ELISATSBYK DiaSorin (IRMA)TSLIA DiaSorin LiaisonTSLIX DiaSorin Liaison XLTSDIR DiaSource IRMATSDRG DRG ELISATSDSI DSI ELISATSELI ELISATSFJL Fujirebio Lumipulse G SeriesTSGB General Biologicals ELISATSHUE Human ELISATSICT Iason coaTube TSHTSIMI Immunotech IRMATSIZO Izotop IRMATSKQ Kallestad QuanticloneTSMED Medgenix (IRMA)TSMM Merck MagiaTSMC2 Mindray CL-SeriesTSMOE Monobind Inc. ELISATSMPR MP Biomedicals RIATSNIC Nichols (IRMA)TSNOV Novatec ELISATSORS Orion SpectriaTSVEC Ortho Vitros 3600/5600/ECiTSDEL Perkin Elmer DELFIATSDEU Perkin Elmer DELFIA UltraTSWW Perkin Elmer Wizard/wallacTSPRI Pharmacia RIACTTSRRD Radim RAD 120TSEV Randox EvidenceTSRAN Randox ELISATSC6 Roche Cobas 6000 / 8000TSROC Roche Cobas Core EIATSRCE Roche Cobas 4000 / e411TSEYS Roche ElecsysTSBOE Roche EnzymunTSRME Roche Modular E170TSSRR SEAC Radim RIATSSM Serono MAIATSSMC Serono MAIAcloneTSSS Serono Serozyme/SRITSCC Siemens/BayerACS 180TSCC3 Siemens/Bayer ACS-180 3rd generationTSIMS Siemens/Bayer ADVIA IMS 800iTSBAY Siemens/Bayer Immuno ITSCCP Siemens Centaur CPTSCP3 Siemens Centaur CP 3rd GenerationTSCCU Siemens Centaur CP TSH3-UltraTSCEN Siemens Centaur XP/XPT/ClassicTSCN3 Siemens Centaur XP/XPT/Classic 3rd GenerationTSCNU Siemens Centaur XP/XPT/Classic TSH3-UltraTSDD Siemens/Dade DimensionTSDDE Siemens Dimension Exl LOCITSDDV Siemens Dimension Vista LOCITSDCI Siemens/DPC Coat-a-Count IRMATSDDA Siemens/DPC Double AntibodyTSDPI Siemens/DPC Immulite 1000TSDP2 Siemens/DPC Immulite 2000/2500TSSNM SNIBE Maglumi analysersTSSF Stat Fax Elisa ReadersTSSHI Sysmex HISCL SeriesTSTSU Technosuma UMELISATSTOS TOSOHTSVLE Veda.Lab Easy Reader

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 40/43 Revised Dec 2017

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RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREValproic Acid µmol/lCODE METHODVAARC Abbott Architect (CMIA)VAARP Abbott Architect (PETINIA)VAABX Abbott AxsymVAABT Abbott TDxVASAN Beckman Access/LXi725VAOAD Beckman Coulter AU400/600/640/2700/5400VADXC Beckman DxCVADXI Beckman DxI 600 / 800VABEK Beckman ArrayVABIM Beckman ImmageVASYN Beckman Synchron CX / LXVABEO Behring OpusVABIV bioMerieux VIDASVACLI Clinpro ELISAVAELI ELISAVAEMI EMITVAHIT Hitachi 911/912/917VAHP HPLCVAH9 Hydra 09VAIL ILab 600/650 CEDIAVAMMI Merck MicrolabVAVIT Ortho Vitros 4600/5600/5.1VADAY Randox DaytonaVARX Randox RX SeriesVAC6 Roche Cobas 6000 / 8000VARCE Roche Cobas 4000 / c311VAINT Roche IntegraVAMOD Roche Modular P / DVARME Roche Modular E170VACNS Siemens ADVIA 1200/1650/1800/2400VACC Siemens/Bayer ACS 180VABAY Siemens/Bayer Immuno IVACCP Siemens Centaur CPVACEN Siemens Centaur XP/XPT/ClassicVADD Siemens DimensionVADPI Siemens/DPC Immulite 1000VADP2 Siemens/DPC Immulite 2000/2500VABEM Siemens Syva / EMITVASF Stat Fax Elisa readersVATKO Thermo KonelabVASEL Vitalab Selectra

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

Vancomycin µmol/lCODE METHODVAARC Abbott Architect (CMIA)VAARP Abbott Architect (PETINIA)VAABX Abbott AxsymVABSU Beckman Coulter Synchron LX / UnicelVADXC Beckman DxC 600/800VAEMI EMITVADC Ortho Vitros MicroSlide SystemsVAC6 Roche Cobas 6000 / 8000VAINT Roche IntegraVAMOD Roche Modular P/DVACNS Siemens ADVIA 1200/1650/1800/2400VACCP Siemens Centaur CPVACEN Siemens Centaur XP/XPT/ClassicVADD Siemens/Dade Dimension/VistaVABEM Siemens Syva/EMITVATSQ Thermo Scientific QMS Vancomycin

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 41/43 Revised Dec 2017

Page 42: METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIREVitamin B12 pmol/lCODE METHODVBARC Abbott ArchitectVBABX Abbott AxsymVBABB Abbott IMxVBSAN Beckman Access/LXi725VBDXI Beckman DxI 600 / 800VBBSB Beckton Dickinson Solid Phase boilVBBSN Beckton Dickinson Solid Phase no boilVBBSL Beckton Dickinson S'TRAC Liquid PhaseVBBRQ Bio-Rad QuantaphaseVBCLI Clinpro ELISAVBBYK Diasorin LiaisonVBLIX Diasorin Liaison XLVBELI ELISAVBMC2 Mindray CL SeriesVBMOE Monobind Inc. ELISAVBMP MP Biomedicals RIAVBVEC Ortho Vitros 3600/5600/ECiVBDEL Perkin Elmer DELFIAVBRCE Roche Cobas 4000 / e411VBRC2 Roche Cobas 4000 / e411 Gen IIVBC6 Roche Cobas 6000 / 8000VBC62 Roche Cobas 6000/8000 Gen IIVBEYS Roche ElecsysVBRME Roche Modular E170VBRM2 Roche Modular E170 Gen IIVBCC Siemens/Bayer ACS 180VBBAY Siemens/Bayer Immuno IVBCCP Siemens Centaur CPVBCEN Siemens Centaur XP/XPT/ClassicVBDD Siemens/Dade DimensionVBDDV Siemens/Dade Dimension VistaVBDPC Siemens/DPC Coat-a-CountVBDDC Siemens/DPC Dualcount boilVBDPI Siemens/DPC Immulite 1000VBDP2 Siemens/DPC Immulite 2000VBDP5 Siemens/DPC Immulite 2500VBDSB Siemens/DPC Solid Phase boilVBDSN Siemens/DPC Solid Phase no boilVBSNM SNIBE Maglumi analysersVBSF Stat Fax Elisa ReadersVBTOS TOSOHVBYH YHLO Union Immune Analyser

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

1-25-(OH)2-Vitamin D pmol/l (PILOT)CODE METHODVDLIA DiaSorin LiaisonVDLIX DiaSorin Liaison XLVDBYK DiaSorin RIAVDDRG DRG ELISAVDHPLC HPLCVDIDE IDS ELISAVDIDR IDS RIAVDIDS IDS iSYS

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 42/43 Revised Dec 2017

Page 43: METHOD QUESTIONNAIRE IMMUNOASSAY PROGRAMME RQ9125

RQ9125 - IMMUNOASSAY PROGRAMMEMETHOD QUESTIONNAIRE25-OH-Vitamin D nmol/lCODE METHOD VDARC Abbott Architect (3L52)VDARC2 Abbott Architect (5P02)VDSAN Beckman Access 25 OH Vitamin D TotalVDDXI Beckman DxI 600 / 800VDBIV BioMerieux VidasVDBRI Brahms IRMAVDDEE Demeditec ELISAVDLIA Diasorin LiaisonVDLIX DiaSorin Liaison XLVDBYK Diasorin RIAVDDIE DIAsource ELISAVDDIR DIAsource RIAVDDLD DLD DiagnostikaVDDRG DRG ELISAVDELI ELISAVDEUE Euroimmun ELISAVDFJL Fujirebio Lumipulse G SeriesVDHP HPLC / UPLCVDIBL IBL ELISAVDIDR IDS RIAVDLCMS LC/MSVDMC2 Mindray CL SeriesVDMOE Monobind Inc. ELISAVDORA Orgentec Alegria ElisaVDVEC Ortho Vitros 3600/5600/EciVDC6 Roche Vitamin D TotalVDR2 Roche Vitamin D Total IIVDCCP Siemens Centaur CPVDCEN Siemens Centaur XP/XPT/ClassicVDSDE Siemens Dimension EXL Vitamin D TotalVDDPI Siemens/DPC Immulite 1000VDTOS TOSOH

Other methods please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9125 Method Questionnaire 43/43 Revised Dec 2017