Clinical Chemistry Method Questionnaire

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RIQAS RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME This document must be retained by participant 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 GENERAL CLINICAL CHEMISTRY PROGRAMME RQ9112/9113

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Transcript of Clinical Chemistry Method Questionnaire

Page 1: Clinical Chemistry Method Questionnaire

RIQASRANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME

This document must be retained by participant

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 QUESTIONNAIREGENERAL CLINICAL

CHEMISTRY PROGRAMMERQ9112/9113

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REGISTRATION INSTRUCTIONS & RIQAS POLICIESCRITERIA FOR PARTICIPATION

REGISTRATION INSTRUCTIONS

METHOD QUESTIONNAIRE:- To be retained by participant

NB For enzymes, it is important for you to record the temperature at which the assay is performed.

F. RIQAS Net

G. PDF REPORTS

RIQAS Net is a web-based online method for result entry / method changes and additions of parameters / viewing of released reports. To access RIQAS nego to www.riqas.net. Internet access and login details are required for RIQAS Net and Adobe Reader is required for viewing reports. If you wish to useRIQAS Net 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.

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. H. SUMMARY CSV FILES

The declaration indicates that you have read and understood the RIQAS policies. Your signature represents your agreement for RIQAS to process with your registration based on your completed enrolment document.

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. Summary csv files will also be sentretrospectively for any parameters for which results are not returned by the original final date. These are sent 4 weeks after the original final date. In order toreceive these retrospective summary csv files you must tick the box on the enrolment document. Please contact RIQAS for further information.

I. DECLARATION

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

If 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.

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. 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.

Once your method questionnaire has been completed, you must transfer the information onto your enrolment document.ENROLMENT DOCUMENT:- To be returned to RIQASPlease be aware that it may take up to 3 weeks to process enrolment documents if you wish RIQAS to complete the full registration of assay details.

On 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 generated byRIQAS when you register for the first time and you will be sent RIQAS literature, which will enable you to understand the RIQAS process and interpret yourreports. Please quote this number on all correspondence with RIQAS .

B. GROUP REPORTS

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 DETAILSIt is important to state the name and full address details of the Quality Assessment Officer or contact person who will receive all correspondence and routinereports 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'

A. LABORATORY REFERENCE NUMBER

This programme is available to any laboratory running the assays listed in this document. Quantitative results will be accepted on this programme.INTRODUCTIONMethod questionnaires are available for all routine RIQAS Programmes. They are designed to allow you to register for this RIQAS Programme and toinform you of RIQAS protocols and policies. It is important that you read and understand all the information in these introductory pages. If you have anyquestions or concerns about any of the information presented in this document, please contact RIQAS either directly or through your local RandoxLaboratories 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.

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.

It is possible to enrol multiple instruments within your laboratory. Kindly complete separate enrolment documents for each instrument clearly identifying eachinstrument 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 NUMBER

RQ9112 9113 Method Questionnaire 2/20 Revised Feb 2014

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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.

K. UPDATING ASSAY DETAILSIt is possible to change your unit, method, instrument or reagent classification during a cycle. Participants who use RIQAS Net: 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 RIQAS Net but will be uploaded onto RIQAS Net usually within 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 RIQAS database.

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 to you.It is important that you discard your old return sheet and use only your updated copy for future returns.L. ADDITION OF PARAMETERS / ASSAY DETAILSParticipants 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.

Please ensure that the product is immediately stored according to the recommendations on the package labelling.

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

Carefully 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.

LATE AND CORRECTED RESULTSIn 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, and it will not be possible to view mean for comparison statistics of other labs. RIQAS permits the submission of late or corrected results only underthe circumstances described below. Requests for the submission of late or corrected results must be submitted in writing and in English on RIQAS FormNo. 9277-RQ (either by the participant or their local Randox Representative) and must be approved by RIQAS Management. The form is available onwww.riqas.net.

b) the kit contains detailed Instructions For Use (IFU), including material characteristics, preparation, stability, storage and safety c) the correct number of samples are present as indicated on the IFU

For Ortho-Clinical Diagnostics VITROS registrations, please state the 2 digit slide Generation number for each analyte.

J. REGISTRATION OF ASSAY DETAILS

Labs can register their assay details using RIQAS Net 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.

Participants who do not wish to use RIQAS Net 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 .

Participants using RIQAS Net will receive an email containing their login information. Once you have successfully logged in to RIQAS Net 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 RIQAS Net.

ORDERING RIQAS PRODUCTSPlease 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.It may be possible to order RIQAS products during a cycle, subject to availability. Please contact your local Randox representative for more information.

ASSAY OF SAMPLES & RETURN OF RESULTS

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

SHIPPING AND RECEIPT OF RIQAS PRODUCTSProvided 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.On receipt of your RIQAS kit, please check that:

a) it is the product you ordered

Requests for the correction or deletion 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).New reports will be re-issued for late or corrected results only where there has been a shipping or administration error by Randox Laboratories HQ.

RQ9112 9113 Method Questionnaire 3/20 Revised Feb 2014

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END OF CYCLE REPORTS

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 Doherty

RANDOX LABORATORIES LTD., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY

If there is any deviation from the existing policies or service, participants will be notified either directly or via their local Randox representative.

RIQAS 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.

Results will normally be processed within 2 days of the FINAL DATE. PDF reports will be emailed as soon as the results have been processed and for thoseregistered for RIQAS Net the PDF reports will be available on RIQAS Net shortly after. Printed reports usually take a further 1-3 days to print and despatch.

CERTIFICATES OF PARTICIPATION

USE OF RIQAS REPORTS

In order to ensure that RIQAS provides an appropriate and satisfying service, all participants will be provided with a feed-back questionnaire towards theend of a cycle. We would invite you to contact us at any time during the cycle, should you have any requests for additional programmes or parameters orcomments regarding existing programmes.

PERFORMANCE SURVEILLANCE OF UK LABS

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 SDI reportand a Cerificate of Acceptable performance (see below).

Complimentary certificates of participation for each RIQAS programme are available to participants at the end of the current cycle, provided that at least50% 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 / HOSPITALNAME specified in the address details of the enrolment document. Modified certificates may be requested through your local Randox representative. At theend of a cycle, a list of all eligible labs will be sent to the local Randox representative who will confirm the Laboratory/Hospital Name. This list will bereturned to the RIQAS department and certificates printed according to the details sent by the local Randox representative. If any modifications or additionsare required after this list has been finalised an adminstration fee will be charged.

DEVIATION FROM EXISTING POLICIES/SERVICE

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.

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.Should the need arise, participants may appeal against the interpretation of their results or assessment of their performance through correspondence withthe local Randox Laboratories representative or by contacting RIQAS directly.

SUB-CONTRACTING

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.

PARTICIPANT FEEDBACK & RIGHT TO APPEAL

Participants 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.CONFIDENTIALITYParticipation 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 their laboratory accreditation bodies have the right to request anassessment of a participant's performance. Where regulatory authorities are to be provided with a participant's results, participants will be notified.

DESPATCH OF REPORTS

LATE RESULTS

CORRECTED RESULTSLate results will only be accepted where there has been a shipping error or administration error by Randox Laboratories HQ

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

In general, late results will not be accepted after the final date, and particularly not if a report has already been issued.

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RQ9112 9113 Method Questionnaire 4/20 Revised Feb 2014

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREACID PHOSPHATASE, PROSTATIC U/lCODE METHODAPP2 Naphthyl phosphate substrate, end pointAPP1 Naphthyl phosphate substrate, kineticAPP6 Naphthyl phosphate with pentane diolAPP3 p-Nitrophenyl phosphate substrateAPP4 Thymolphthalein phosphate substrateAPPDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberAPPO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

ACID PHOSPHATASE, TOTAL U/lCODE METHODACP2 Naphthyl phosphate substrate, end pointACP1 Naphthyl phosphate substrate, kineticACP6 Naphthyl phosphate with pentane diolACP3 p-Nitrophenyl phosphate substrateACP4 Thymolphthalein phosphate substrateACPDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberACP5 Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

ALBUMIN g/lCODE METHODALB1 Bromocresol Green (BCG)ALB2 Bromocresol Purple (BCP)ALBNP Nephelometric AssaysALBT Turbidimetric AssaysALBDC Ortho Vitros Microslide SystemsALBDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberALBOD Other Dry ChemistryALBO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

ALKALINE PHOSPHATASE U/lCODE METHODAPNON AMP, non-optimisedAPIF AMP, optimised to IFCCAPNS AMP, optimised to NVKC/SFBCAPRED AMP, reduced interferenceAPINT Roche AMP Buffer IFCCAPDB Siemens/Dade Dimension, AMP bufferAPAMP Other AMP kitsAPC ColorimetricAPDEA Diethanolamine buffer, DEAAPTRI Tris/carbonate bufferAPDC Ortho Vitros Microslide SystemsAPDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberAPOD Other Dry ChemistryAPO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 5/20 Revised Feb 2014

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREALANINE TRANSAMINASE, ALT U/lCODE METHODALTC ColorimetricALTP Phosphate buffer, DGKCALTDB Siemens/Dade standard non IFCC correlatedALTNP Tris buffer without pyridoxal - 5 - phosphateALTIF Tris buffer with pyridoxal - 5 - phosphateALTP5 Tris buffer with pyridoxal - 5 - phosphate, NVKCALTT Tris buffer, SCEALTDC Ortho Vitros Microslide SystemsALTDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberALTOD Other Dry Chemistry

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

AMYLASE, PANCREATIC U/lCODE METHODPAMBK Beckman Synchron CX/LXi/DxCPAM2 Roche & Randox Liquid Stable pNPG7PAM1 Immunoinhibition, EPS substratePAM3 Other Dry ChemistryPAMO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

AMYLASE, TOTAL U/lCODE METHODBLOCKED MALTOHEPTAOSIDE SUBSTRATESAM1T Beckman Synchron AMY7AM1C bioMerieuxAM1D BiotrolAM1P DCLAM1F HumanAM1G Instrumentation Laboratory (IL)AM1H Medical Analysis Systems (MAS)AM1S OlympusAM1N Other blocked Maltoheptaoside substratesAM1K RAIchemAM1I Randox - Benzylidene blocked pNPG7AM1J Randox - Ethylidene blocked pNPG7AM1Q Randox Liquid stable pNPG7AM1R Roche liquid stable pNPG7AM1B Siemens/BayerAM1L SigmaAM1M Trace

NON-BLOCKED pNP MALTOHEPTAOSIDE SUBSTRATESAM2B Other non-blocked pNPG7

MALTOTETRAOSE SUBSTRATESAM3A Beckman Synchron CX4/CX5/CX7AM3B Other Maltotetraose substrates

pNP MALTOPENTA/HEXA OSIDE SUBSTRATESAM4A Siemens/BayerAM4B Siemens/DadeAM4C Other Maltopenta/hexaoside substrates

CONTINUED ON NEXT PAGE

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREAMYLASE, TOTAL U/l (Continued)CODE METHODOTHER SUBSTRATESAM8F 2-chloro-pNPG3 - bioMerieuxAM8E 2-chloro-pNPG3 - Siemens/Dade BehringAM8G 2-chloro-pNPG3 - Other AM8B 2-chloro-pNP-linked substrate - Siemens/BayerAM8C 2-chloro-pNP-linked substrate - Roche Integra AM8D 2-chloro-pNP-linked substrate - Other RocheAM8A 2-chloro-pNP-linked substrate - Other

AM5A Beckman Synchron AS - dyed amylopectinAM7A Phadebas TabletAM10 pNP Maltotrioside substratesAM6A Saccharogenic methods

AYDC Ortho Vitros Microslide SystemsAYDT Vitros DT60/DT60 II

Vitros Slide Generation NumberAYOD Other Dry ChemistryAM9A Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

ASPARTATE TRANSAMINASE, AST U/lCODE METHODASTC ColorimetricASTP Phosphate buffer, DGKCASTDB Siemens/Dade standard non IFCC correlatedASTIF Tris buffer with pyridoxal - 5 - phosphateASTP5 Tris buffer with pyridoxal - 5 - phosphate, NVKCASTNP Tris buffer without pyridoxal - 5 - phosphateASTT Tris buffer, SCEASTDV Ortho Vitros Microslide visible slideASTDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberASTOD Other Dry Chemistry

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

BICARBONATE mmol/lCODE METHODBICOL ColorimetricBIDIF Differential rate pH changeBIENZ EnzymaticBIISE Ion selective electrodeBIMAN ManometricBIDC Ortho Vitros Microslide SystemsBIDT Vitros DT60/DT60 II/DTE II

Vitros Slide Generation NumberBICOD Other Dry ChemistryBICO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

BILE ACIDS µmol/lCODE METHODBIAE Enzymatic ColorimetricBIOM Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRE BILIRUBIN, DIRECT µmol/lCODE METHODBDDI Diazo with DichloroanalineBDSA Diazo with Sulphanilic AcidBDDD Dichlorophenyl DiazoniumBDVER Oxidation to BiliverdinBDRJG Roche JG factoredBDDU Ortho Vitros Microslide Systems conjugated from BUBCBDTB Ortho Vitros Microslide Systems Total Bil-BU (from BUBC)

Vitros Slide Generation NumberBDOD Other Dry ChemistryBDO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

BILIRUBIN, TOTAL µmol/lCODE METHODBIDI Diazo with DichloroanilineBISA Diazo with Sulphanilic AcidBIION Diazonium ionBDD Dichclorophenyl DiazoniumBINBD Nitrobenzenediazonium SaltBIVER Oxidation to BiliverdinBICAL Roche calibrator (US set point only)BIBL Ortho Vitros Microslide Systems Total BilBIBU Ortho Vitros Microslide Systems Total BUBCBIBT Vitros DT60/DT60 II Total Bil

Vitros Slide Generation NumberBIOD Other Dry ChemistryBIO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

CALCIUM mmol/lCODE METHODCAZO ArsenazoCAAA Atomic absorptionCACPC Cresolphthalein complexoneCAISE Ion selective electrodeCAMB Methylthymol blueCABAP NM-BAPTACADC Ortho Vitros Microslide SystemsCAPO PhosphonazoCADT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberCAOD Other Dry ChemistryCAO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

CALCIUM, IONISED mmol/lCODE METHODCIISE Ion Selective Electrode - ISECIOF Optical FluorescenceCIIO Other methods (non calculated)

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

Please note that Ionised Calcium results should not be pH adjusted

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRECHOLINESTERASE (PILOT) U/lCODE METHODCHEAT Colorimetric - AcetylthiocholineCHECBC Colorimetirc - BenzoylcholineCHECBT Colorimetric - ButyrylthiocholineCHEPT Colorimetric - PropionylthiocholineCHEDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberCHEO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

CHLORIDE mmol/lCODE METHODCLCOL ColorimetricCLCOU CoulometricCLSED Ion Selective Electrode, directCLISE Ion Selective Electrode, indirectCLTIT TitrimetricCLOF Optical FluorescenceCLDC Ortho Vitros Microslide SystemsCLDT Vitros DT60/DT60 II/DTE II

Vitros Slide Generation NumberCLOD Other Dry ChemistryCLO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

CHOLESTEROL mmol/lCODE METHODCHOL Cholesterol OxidaseCHODB Siemens/Dade Behring reagentsCHODC Ortho Vitros Microslide SystemsCHODT Vitros DT60/DT60 II

Vitros Slide Generation NumberCHOOD Other Dry ChemistryCHOLO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

CREATINE KINASE, TOTAL U/lCODE METHODCKCP Creatine phosphate substrate startCKTD Dithioerythritol (DTE)CKDIF Dithioerythritol (DTE) IFCC correlatedCKTM Monothioglycerol CKIFF CK-NAC (IFCC)CKACT CK-NAC serum start (DGKC)CKNAC CK-NAC substrate start (DGKC)CKDC Ortho Vitros Microslide SystemsCKDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberCKOD Other Dry Chemistry

CKO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

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RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRECOPPER µmol/lCODE METHODCUAA Atomic absorptionCUCOL ColorimetricCUMS Mass SpectrometryCUO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

CREATININE µmol/lCODE METHODCREAP Alkaline picrate without deproteinisationCRDEP Alkaline picrate with deproteinisationCRPAP Creatinine PAP methodCREUV Enzymatic UV methodCRIDM IDMS traceableCRERB Jaffe rate blankedCREJC Jaffe rate blanked comp. for serum (-18umol/l)CRERC Jaffe rate blanked compensated (subtract 26umol/l)CRECP Roche Creatinine PlusCREDD Ortho Vitros Microslide Double SlideCREDC Ortho Vitros Microslide Single SlideCREDT Vitros DT60/DT60 II/DTSC IICREID Vitros, IDMS traceable

Vitros Slide Generation NumberCREOD Other Dry ChemistryCREAO Other enzymatic methods

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

D-3-HYDROXYBUTYRATE mmol/lCODE METHODD3HPB Phosphate buffer 20mmol pH7.0D3HRD Randox - Tris buffer 100mmol pH 8.5D3H0 Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

FRUCTOSAMINE (PILOT) umol/lCODE METHODFRNBT Nitrotetrazolium blue colorimetric assayFRRDE Randox enzymatic assay

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

GAMMA GLUTAMYL TRANSFERASE, GGT U/lCODE METHODGGTCL DCL gamma glutamyl-3-carboxy-4-nitroanalideGGTCN Gamma glutamyl-3-carboxy-4-nitroanalideGGTIF Gamma glutamyl-3-carboxy-4-nitroanalide (IFCC)GGTN Gamma glutamyl-4-nitroanilideGGTDB Siemens/Dade standard non IFCC correlatedGGTDC Ortho Vitros Microslide SystemsGGTDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberGGTOD Other Dry ChemistryGGTO Other methods, please specify on enrolment document

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RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 10/20 Revised Feb 2014

Page 11: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREGLUTAMATE DEHYDROGENASE U/lCODE METHODGLDRX α-oxoglutarate Triethanolamine buffer 50 mmol/lGLDDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberGLDO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

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GLUCOSE mmol/lCODE METHODGLUDH Glucose dehydrogenaseGLUOX Glucose oxidaseGLBEK GOD/02-Beckman methodGLUHX HexokinaseGLUOE Oxygen electrodeGLDC Ortho Vitros Microslide SystemsGLUDT Vitros DT60/DT60 II

Vitros Slide Generation NumberGLUOD Other Dry ChemistryGLUO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

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HYDROXYBUTYRATE DEHYDROGENASE U/lCODE METHODHBDH2 Oxobutyrate < 10 mmol/lHBDH1 Oxobutyrate > 10mmol/lHBDDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberHBDHO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

HDL-CHOLESTEROL mmol/lCODE METHOD

DIRECT METHODSHDL12 Direct HDL, Clearance methodHDL10 Direct HDL, ImmunoseparationHDL11 Direct HDL, PEGMEHDL9 Direct HDL, PPD (Polymer/Polyanion detergent)HDR3 Direct HDL, Roche 3rd gen.HDLUL HDL, Ultra/Accel Selective DetergentHDLDP Vitros dHDL, PTA/MgCl2 direct precip.HDLMT Vitros 5.1 FS Microtip assayHDVIM Vitros, Magnetic HDL

Vitros Slide Generation Number

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 11/20 Revised Feb 2014

Page 12: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREIRON µmol/lCODE METHODFE1 Colorimetric with precipitationFE2 Colorimetric without precipitationFEDC Ortho Vitros Microslide SystemsFEDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberFEOD Other Dry ChemistryFEO1 Other methods, please specify on enrolment document

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REAGENT CODE

OTHER UNITS, SPECIFY

LACTATE (PILOT) mmol//lCODE METHODLACCLO Colorimetric - Lactate oxidaseLACDC Ortho Vitros MicroSlide SystemsLACEE Enzymatic ElectrodeLACISE Ion Selective ElectrodeLACOD Other Dry ChemistryLACUV UV - LDHLACDT Vitros DT60/DT60 II

INSTRUMENT CODE

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LACTATE DEHYDROGENASE, LD U/lCODE METHODLACTATE TO PYRUVATE METHODSLDIF L to P, IFCCLDDB L to P Siemens/Dade,non-IFCCLDLP Other Lactate to Pyruvate methods

PYRUVATE TO LACTATE METHODSLDPL2 P to L German methodsLDPL1 P to L Scandinavian & Dutch methodsLDPL3 P to L SFBCLDPL4 Pyruvate 1.4 mM - Beckman LD-P

DRY CHEMISTRYLDDC Ortho Vitros Microslide SystemsLDDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberLDOD Other Dry Chemistry

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 12/20 Revised Feb 2014

Page 13: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRELIPASE U/lCODE METHODLIP10 Colorimetric, RandoxLIP6 Colorimetric, RocheLIP5 Colorimetric, Siemens/Dade Dimension (LIP kit)LIP5A Colorimetric, Siemens/Dade Dimension (LIPL kit)LIP7 Colorimetric, SigmaLIP2 Other Colorimetric

LIP9 Randox, Turbidimetric with colipaseLIP8 Roche,Turbidimetric with colipaseLIP1 Other Turbidimetric with colipaseLIP4 Turbidimetric without colipase

LIP3 Titrimetric

LIPDC Ortho Vitros Microslide SystemsLIPDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberLIPOD Other Dry Chemistry

INSTRUMENT CODE

REAGENT CODE

RESULTS REPORTED AT 25oC 30oC 37oC

OTHER UNITS, SPECIFY

LITHIUM mmol/lCODE METHODLIAA Atomic absorptionLIFP Flame photometryLISE Ion selective electrodeLISP SpectrophotometryLIDC Ortho Vitros Microslide SystemsLIDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberLIOD Other Dry ChemistryLIO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

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MAGNESIUM mmol/lCODE METHODMGAZO ArsenazoMGAA Atomic absorptionMGCA CalmagiteMGCP Chlorphosphonazo IIIMGEN EnzymaticMGMB Methylthymol blueMGXY Xylidyl BlueMAGDC Ortho Vitros Microslide SystemsMGDT Vitros DT60/DT60 II

Vitros Slide Generation NumberMAGOD Other Dry ChemistryMGMD Other magnesium dyesMGO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 13/20 Revised Feb 2014

Page 14: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRENON-ESTERIFIED FATTY ACIDS (NEFA) mmol/l (PILOT)CODE METHODNFACSM ACS-ACOD-MEHA Method (inc. Maleimide)NFCOL Colorimetric EndpointNFGC GC/MSNFHPL HPLCNFMIC Micro Method - FACL 50

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

OSMOLALITY mOsm/KgCODE METHODOSC CalculatedOSFPD Freezing point depressionOSVP Vapour pressure

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

PHOSPHATE, INORGANIC mmol/lCODE METHODPHBK Beckman PHOSm kit (365nm)PHENZ Phosphomolybdate enzymaticPHMD Phosphomolybdate UVPHDC Ortho Vitros Microslide SystemsPHDT Vitros DT60/DT60 II/DTSC II

Vitros Slide Generation NumberPHOD Other Dry ChemistryPHOP Other methods, no protein ppt, please specifyPHOPT Other methods, with protein ppt, please specify

INSTRUMENT CODE

REAGENT CODE

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POTASSIUM mmol/lCODE METHODKCHR ChromolyteKCOL ColorimetricKEN EnzymaticKFP Flame photometryKISE Ion Selective Electrode method - directKISE1 Ion Selective Electrode method - indirectKOF Optical FluorescenceKDC Ortho Vitros Microslide SystemsKDT Vitros DT60/DT60 II/DTE II

Vitros Slide Generation NumberKOD Other Dry ChemistryKOM Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 14/20 Revised Feb 2014

Page 15: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREPROTEIN, TOTAL g/lCODE METHODPRCX Biuret reaction, CX4/CX5/CX7PREP Biuret reaction, end pointPRKE Biuret reaction, kineticPRDC Ortho Vitros Microslide SystemsPRDT Vitros DT60/DT60 II

Vitros Slide Generation NumberPROD Other Dry ChemistryPRO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

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PSA, TOTAL µg/lCODE METHODPSA31 Abbott ArchitectPSA18 Abbott Axsym - monoclonalPSA15 Abbott Axsym - polyclonalPSA21 Abbott IMx - monoclonalPSA1 Abbott IMx - polyclonalPSA26 Beckman Access Hybritech TPSAPSA36 Beckman Coulter AU 3000iPSA20 bioMerieux VIDAS TPSAPSA46 Boditech Med Inc i-CHROMAPSA2 CIS ELISA 2PSA38 DSI ELISAPSA40 Diasorin LiaisonPSA41 DRG ELISAPSA37 ELISAPSA43 Fujirebio Lumipulse GPSA39 Monobind Inc ELISA/CLIAPSA32 Ortho Vitros 3600 / 5600 / ECiPSA44 Ortho Vitros 3600 / 5600 / ECi PSA IIPSA8 Perkin Elmer DELFIAPSA47 Radim AliseiPSA35 Roche Cobas 6000 / 8000PSA6 Roche Cobas Core EIAPSA34 Roche Cobas 4000 / e411PSA19 Roche Elecsys, Modular E170PSA16 Roche EnzymunPSA7 Serono MAIA ClonePSA42 SNIBE Maglumi analysersPSA17 Siemens/Bayer ACS 180 - PSA II kitPSA27 Siemens/Bayer ACS180 (equimolar)PSA24 Siemens/Bayer ADVIA CentaurPSA28 Siemens/Bayer ADVIA Centaur (equimolar)PSA14 Siemens/Bayer Immuno 1PSA22 Siemens/Dade Behring OpusPSA33 Siemens/Dade, DimensionPSA29 Siemens Immulite 2000/2500 Total PSAPSA30 Siemens Immulite 2000/2500 3rd GenerationPSA13 Siemens Immulite 1000 Total PSAPSA25 Siemens Immulite 1000 3rd GenerationPSA3 Siemens/DPC IRMA countPSA12 TOSOHPSA45 Xema Medical EIAPSA9 Other methods, please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

SODIUM mmol/lCODE METHODNACH ChromolyteNACOL ColorimetricNAEN EnzymaticNAFP Flame photometryNAISE Ion Selective Electrode method - directNISE1 Ion Selective Electrode method - indirectNAOF Optical FluorescenceNADC Ortho Vitros Microslide SystemsNADT Vitros DT60/DT60 II/DTE II

Vitros Slide Generation NumberNAOD Other Dry ChemistryNAOM Other methods, please specify on enrolment document

INSTRUMENT CODEREAGENT CODE

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RQ9112 9113 Method Questionnaire 15/20 Revised Feb 2014

Page 16: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREFREE TRIIODOTHYRONINE (FREE T3) pmol/lCODE METHODF3ARC Abbott, ArchitectF3ABX Abbott, AxSymF3ABB Abbott, IMxF3SAN Beckman, AccessF3DXI Beckman, DxI800F3BCI Biocheck Inc ELISAF3BIV Biomerieux, VIDASF3VIA Biomerieux, VIDIAF3CII CIS, IRMAF3BYK Diasorin (RIA)F3LIA Diasorin LiaisonF3ELI ELISAF3MOE Monobind Inc ELISA/CLIAF3VEC Ortho Vitros, 3600/5600/ECiF3DEL Perkin Elmer DelfiaF3RRD Radim RAD 120F3C6 Roche Cobas 6000 / 8000F3RCE Roche Cobas 4000 / e411F3ROC Roche, Cobas CoreF3EYS Roche, ElecsysF3BOE Roche, EnzymunF3RME Roche, Modular E170F3CC Siemens/Bayer, ACS 180F3CEN Siemens/Bayer, ADVIA CentaurF3BAY Siemens/Bayer, Immuno IF3DDE Siemens Dimension Exl LOCIF3DDV Siemens Dimension Vista LOCIF3DPC Siemens/DPC, Coat-a-CountF3DPI Siemens/DPC, Immulite 1000F3DP2 Siemens/DPC, Immulite 2000/2500F3SNM SNIBE Maglumi AnalysersF3TOS TOSOHF3O Other methods

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

TRIIODOTHYRONINE (TOTAL T3 ) nmol/lCODE METHODT3ARC Abbott, ArchitectT3ABX Abbott, AxsymT3ABB Abbott, IMxT3SAN Beckman, Access/LXi725T3DXI Beckman, DxI800T3BIV bioMerieux, VIDAST3CIR CIS, RIA coated tubeT3BYK Diasorin (RIA)T3LIA Diasorin LiaisonT3DIA DiaSource RIAT3DSL DSL, RIAT3ELI ELISAT3IMI Immunotech, IRMAT3MOE Monobind Inc ELISA/CLIAT3MP MP Biomedicals, RIAT3VEC Ortho Vitros, 3600/5600/ECiT3PEW Perkin Elmer Wizard RIAT3C6 Roche Cobas 6000 / 8000T3RCE Roche Cobas 4000 / e411T3ROC Roche, Cobas CoreT3EYS Roche, ElecsysT3BOE Roche, EnzymunT3RME Roche, Modular E170T3CC Siemens/Bayer, ACS 180T3CEN Siemens/Bayer, ADVIA CentaurT3BAY Siemens/Bayer, Immuno IT3DDV Siemens/Dade Dimension VistaT3DPC Siemens/DPC, Coat-a-countT3DPI Siemens/DPC, Immulite 1000T3DP2 Siemens/DPC, Immulite 2000/2500T3SNM SNIBE Maglumi AnalysersT3TOS TOSOHT3O Other methods

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 16/20 Revised Feb 2014

Page 17: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREFREE THYROXINE (FREE T4) pmol/lCODE METHODF4ARC Abbott, ArchitectF4ABX Abbott, AxSymF4ABB Abbott, IMxF4SAN Beckman, Access/LXi725F4DXI Beckman, DxI800F4BCI Biocheck Inc ELISAF4BIV Biomerieux, VIDASF4VIA Biomerieux, VIDIAF4BIVN Biomerieux,VIDAS-FT4N KitF4BYK DiaSorin (RIA)F4LIA Diasorin LiaisonF4DIA DiaSource RIAF4ELI ELISAF4GB General Biologicals ELISAF4IMI Immunotech, IRMAF4MOE Monobind Inc ELISA/CLIAF4VEC Ortho Vitros, 3600/5600/ECiF4DEL Perkin Elmer DelfiaF4RRD Radim RAD 120F4C6 Roche Cobas 6000 / 8000F4ROC Roche Cobas CoreF4RCE Roche Cobas 4000 / e411F4EYS Roche, ElecsysF4RME Roche, Modular E170F4CC Siemens/Bayer, ACS 180F4CEN Siemens/Bayer, ADVIA CentaurF4IMS Siemens/Bayer, ADVIA IMS 800iF4BAY Siemens/Bayer, Immuno IF4DD 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 AnalysersF4TOS TOSOHF4O Other methods

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

THYROXINE (TOTAL T4) nmol/lCODE METHODT4ARC Abbott, ArchitectT4ABX Abbott, AxSymT4ABB Abbott, IMx/FLx/TDxT4DXI Beckman DxI800T4SAN Beckman, Access/LXi725T4BCI Biocheck Inc ELISAT4BIV Biomerieux, VIDAST4BRR Brahms RIAT4CIR CIS, RIA coated tubeT4LIA Diasorin, LiaisonT4DIA DiaSource RIAT4DSL DSL, RIAT4ELI ELISAT4IMI Immunotech RIAT4MIE Microgenics DRI assayT4MOE Monobind Inc ELISA/CLIAT4MP MP Biomedicals, RIAT4VEC Ortho Vitros, 3600/5600/ECiT4DEL Perkin Elmer DelfiaT4PEW Perkin Elmer Wizard RIAT4C6 Roche Cobas 6000 / 8000T4ROC Roche Cobas CoreT4RCE Roche Cobas 4000 / e411T4EYS Roche, ElecsysT4RME Roche, Modular E170T4CC Siemens/Bayer, ACS 180T4CEN Siemens/Bayer, ADVIA CentaurT4BAY Siemens/Bayer, Immuno IT4DDV Siemens/Dade Dimension VistaT4DPC Siemens/DPC, Coat-a-CountT4DPI Siemens/DPC, Immulite 1000T4DP2 Siemens/DPC, Immulite 2000/2500T4SNM SNIBE Maglumi AnalysersT4TOS TOSOHT4O Other methods

INSTRUMENT CODE

REAGENT CODE

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RQ9112 9113 Method Questionnaire 17/20 Revised Feb 2014

Page 18: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRETOTAL IRON BINDING CAPACITY µmol/lCODE METHODTIBCD Direct ColorimetricUIBC FE+UIBC(saturation with fixed amount of iron)TIBC Removal of excess free ironIBCDC Ortho Vitros Microslide Systems

Vitros Slide Generation NumberIBCOD Other Dry ChemistryTIBCO Other methods, please specify on enrolment document

INSTRUMENT CODE

REAGENT CODE

OTHER UNITS, SPECIFY

TRIGLYCERIDESIMPORTANT NOTETriglycerides can be analysed and reported using several techniques

a) TOTAL GLYCEROLThe Total Glycerol in the sample is measured and reported . With thismethod only one measurement is required. Participants using thistechnique should select a method code from the TRIGLYCERIDES, TOTAL GLYCEROL section below.

b) TOTAL GLYCEROL WITH ESTIMATED FREE GLYCEROL CORRECTIONThe Total Glycerol is measured as in a) and 0.11 mmol/l (10 mg/dl) is subtracted from this to give a corrected result. Participants using this technique should select a method code from the TRIGLYCERIDES, TOTAL GLYCEROL section below.

c) TOTAL GLYCEROL WITH TRUE FREE GLYCEROL CORRECTIONTwo measurements are made: one for Total Gylcerol and one for Free Glycerol and the difference between the two is reported. RIQAS participants using this method should choose a method code from the TRIGLYCERIDES, TOTAL GLYCEROL WITH TRUE FREE GLYCEROL CORRECTION section.If you are in any doubt which method you use, please contact RIQAS

TRIGLYCERIDES, TOTAL GLYCEROL mmol/lCODE METHOD

METHOD 1 - LIPASE/GPO-PAPTG1A Colorimetric without glycerol correctionTG1B Colorimetric with 0.11 mmol/l (10 mg/dl) glycerol correction

METHOD 2 - LIPASE/GLYCEROL KINASE UVTG2A End-point without glycerol correctionTG2B End-point with 0.11 mmol/l (10 mg/dl) glycerol correction

METHOD 3 - LIPASE/GLYCEROL DEHYDROGENASETG3 Lipase/Glycerol Dehydrogenase

METHOD 4 - DRY CHEMISTRYTRIDC Ortho Vitros Microslide SystemsTRIDT Vitros DT60/DT60 II

Vitros Slide Generation NumberTRIOD Other Dry Chemistry

TRIGLYCERIDES, TOTAL GLYCEROL WITH TRUE FREE GLYCEROL CORRECTION mmol/lCODE METHOD

METHOD 1 - LIPASE/GPO-PAPTG1C Colorimetric 'free' glycerol blank correction

METHOD 2 - LIPASE/GLYCEROL KINASE UVTG2C End-point 'free' glycerol blank correction

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 18/20 Revised Feb 2014

Page 19: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIRETHYROID STIMULATING HORMONE (TSH) uU/mlCODE METHODTSARC Abbott ArchitectTSAX3 Abbott AxSym 3rd generationTSABX Abbott AxSym Ultrasensitive hTSH IITSABB Abbott IMx Ultrasensitive hTSH IITSAEC Adaltis EclecticaTSAIR Adaltis IRMATSSAF Beckman Access / LXi725 Fast TSH 2nd genTSSAN Beckman Access / LXi725 hyper TSH 3rd genTSDXI Beckman DXI800 1st generationTSDXF Beckman DXI800 fast TSHTSDXH Beckman DXI800 Hyper TSHTSBCI Biocheck Inc ELISATSVIA Biomerieux VIDIATSBV3 Biomerieux VIDAS TSH3 (ultrasensitive)TSBIV Biomeriuex VIDAS TSHTSDME DiaMetra ELISATSLIA Diasorin LiaisonTSDIR DiaSource IRMATSDSE DSI ELISATSELI ELISATSGB General Biologicals ELISATSICT Iason coaTube TSHTSIMI Immunotech IRMATSMOE Monobind Inc ELISA/CLIATSMPR MP Biomedicals RIATSVEC Ortho Vitros 3600 / 5600 / ECiTSDEL Perkin Elmer DelfiaTSDEU Perkin Elmer Delfia UltraTSRRD Radim RAD 120TSC6 Roche Cobas 6000 / 8000TSROC Roche Cobas CoreTSRCE Roche Cobas 4000 / e411TSEYS Roche ElecsysTSRME Roche Modular E170TSCEN Siemens/Bayer ADVIA CentaurTSCN3 Siemens/Bayer ADVIA Centaur 3rd generationTSCNU Siemens/Bayer ADVIA Centaur TSH3-UltraTSCC Siemens/Bayer ACS 180TSCC3 Siemens/Bayer ACS 180, 3rd generationTSDD Siemens/Dade DimensionTSDDE Siemens Dimension Exl LOCITSDDV Siemens Dimension Vista LOCITSDPI Siemens/DPC Immulite 1000TSDP2 Siemens/DPC Immulite 2000/2500TSSNM SNIBE Maglumi AnalysersTSTOS TOSOHTSO Other methods

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

UREA mmol/lCODE METHODURAC Beckman-ConductivityURDM Diacetyl monoximeURPHT O-PhthalaldhydeURUEP Urease, end pointURURH Urease, hypochloriteURUK Urease, kineticURDC Ortho Vitros Microslide SystemsURDT Vitros DT60/DT60 II

Vitros Slide Generation NumberUROD Other Dry Chemistry

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 19/20 Revised Feb 2014

Page 20: Clinical Chemistry Method Questionnaire

RQ9112/9113 - GENERAL CLINICAL CHEMISTRYMETHOD QUESTIONNAIREURIC ACID mmol/lCODE METHODURED Reduction methodsURSP Spectrophotometric at 280-290 nmURPER Uricase peroxidase without ascorbate oxidaseURPA2 Uricase peroxidase with ascorbate oxidase @ 546nmURPAS Uricase peroxidase with ascorbate oxidaseURCAT Uricase - catalase 340nm.UACDC Ortho Vitros Microslide SystemsUADT Vitros DT60/DT60 II

Vitros Slide Generation NumberUACOD Other Dry ChemistryURICO Other methods, please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

ZINC µmol/lCODE METHODZAA Atomic absorptionZCOL Colorimetric with deprot.ZNMS Mass SpectrometryZO Other methods, please specify on enrolment document

INSTRUMENT CODEREAGENT CODEOTHER UNITS, SPECIFY

RQ9112 9113 Method Questionnaire 20/20 Revised Feb 2014