Report External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus September INSTAND e.v. in cooperation with:

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1 Report External Quality Assessment Scheme Group 346 Virus Immunology - Hepatitis C Virus September 2014 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Prof. Dr. Heinz Zeichhardt doc. Dr. Oliver Donoso Mantke Issued by: INSTAND e.v. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.v. Düsseldorf/Berlin,

2 346 Hepatitis C Virus September 2014 Report doc EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt doc. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.v. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, Düsseldorf Hindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) /23; Fax: +49-(0) donoso@instand-ev.de Heinz.Zeichhardt@charite.de INSTAND Target Value Laboratories Universität Duisburg-Essen, Universitätsklinikum Essen, Institut für Virologie, Nationales Referenzzentrum für Hepatitis- C-Viren, Nationales Konsiliarlaboratorium für Tollwut: Prof. Dr. U. Dittmer, Prof. Dr. S. Ross, Prof. Dr. M. Roggendorf DRK Blutspendedienst Ost ggmbh, Institut f. Transfusionsmedizin Plauen: Dr. A. Karl, DBC K. Frank, Dr. K. Gubbe Justus-Liebig-Universität Gießen, Institut für Medizinische Virologie, Nationales Referenzzentrum für Hepatitis-B-Virus und Hepatitis-D-Virus: PD Dr. D. Glebe, Dr. C. Schüttler, Prof. Dr. W. Gerlich, Prof. Dr. J. Ziebuhr Labor Enders, Institut für Virologie, Infektiologie und Epidemiologie, Stuttgart: Prof. Dr. Gisela Enders & Partner Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Prüflabor für IVD, Langen: Dr. S. Nick, Dr. H. Scheiblauer Universität Regensburg, Institut für Medizinische Mikrobiologie und Hygiene, Bereich Klinische Virologie und Infektionsimmunologie, Nationales Konsiliarlaboratorium für HAV und HEV: Prof. Dr. Dr. A. Gessner, Prof. Dr. B. Schmidt, Dr. J. Wenzel Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar: Prof. Dr. S. Smola, Prof. Dr. N. Müller-Lantzsch, Dr. J. Rissland Universitätsklinikum Frankfurt, Institut für Medizinische Virologie, Frankfurt/Main, Nationales Referenzzentrum für Retroviren: Prof. Dr. O. T. Keppler, Prof. Dr. H. Rabenau, PD Dr. A. Berger, PD Dr. M. Stürmer Universitätsklinikum Freiburg, Institut für Medizinische Mikrobiologie und Hygiene, Abteilung Virologie: Dr. D. Huzly, PD Dr. M. Panning, Prof. Dr. D. Neumann-Haefelin Carried out by: INSTAND e.v. Ubierstr Düsseldorf Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: Report about INSTAND e.v. EQAS September of 8

3 346 Hepatitis C Virus September 2014 Report doc Notes to the evaluation Guideline of the German Medical Association (RiliBÄK) The INSTAND External Quality Assessment (EQA) scheme "Virus Immunology - Hepatitis C Virus" (346) includes measurands / tests, which are subject to the new Guideline of the German Medical Association (Bundesärztekammer/ RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen). Measurands / tests Hepatitis C virus, antibodies against (anti-hcv) Hepatits C virus, HCV antigen detection (HCV-Ag) Specified RiliBÄK Section B 2 "Qualitative determinations in laboratory medicine = Qualitative laboratoriumsmedizinische Untersuchungen" B 3 "Direct detection and characterization of infectious pathogens = Direkter Nachweis und Charakterisierung von Infektionserregern" Information on changes as to the INSTAND External Quality Assessment (EQA) schemes in virus diagnostics have already been published in recent EQA scheme reports and postal mailing. For details, please refer to the information on the INSTAND EQA schemes in virus diagnostics and the new RiliBÄK (as of 24 January 2014) Release of final reports of EQA schemes in virus diagnostics Each participant of this EQA scheme receives an with a table allowing to directly open and/or save the report of the corresponding EQA scheme by clicking the respective download button. Furthermore, each report of a defined EQA scheme will be released on the INSTAND homepage immediately after completion as PDF file under "EQAS / Reports / Year and Category (Virus immunology)" in English language ( and in German language ( Certificate Participation documents are sent out by post for this EQA scheme "Virus Immunology - Hepatitis C Virus" (346) as follows: certificate of successful participation, statement of participation, statement of individual results. The certificate of successful participation of this EQA scheme lists the respective measurands/tests, assigned to defined test categories, for which the requirements of the EQA scheme are met. Each test category is individually evaluated for the certificate of successful participation and separately listed in all participation and evaluation documents. The EQA scheme "Virus Immunology - Hepatitis C Virus" (346) comprises the following test categories: Test categories (10) Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen* (15) Tests for the isolated detection of HCV antigen** (20) Complementary tests for the detection of anti-hcv* * measurand / test subject to RiliBÄK, Specified Section B 2 ** test subject to RiliBÄK, Specified Section B 3 Report about INSTAND e.v. EQAS September of 8

4 346 Hepatitis C Virus September 2014 Report doc Receiving a certificate of successful participation The evaluation criteria for the results of EQA schemes for the detection of virus specific antibodies follow the new Guideline of the German Medical Association, RiliBÄK, Specified Section E 2 (specific requirements on EQA schemes for qualitative laboratory medical analyses = Spezielle Anforderungen an Ringversuche bei qualitativen laboratoriumsmedizinischen Untersuchungen). For receiving a certificate of successful participation for a defined EQA scheme it is required that you analyzed all samples of the sample set correctly with the same method in the corresponding test categories (100% correct results according to the target values). Please note: A corresponding proceeding has been applied for tests for virus antigen and genome detection. Specifications will follow. Example - Program "Virus Immunology - Hepatitis C Virus" (346): All 4 samples of the sample set have to be tested correctly with the same method in test category 10 "Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen". The same applies for test categories 15 and 20 of this EQA scheme. Frequency of mandatory participation to this EQA scheme and validity of the certificates The RiliBÄK defines the validity period of a certificate of successful participation for each of the EQA schemes stated in the Tables B 2-2 and B 3-2 (external quality assurance = Externe Qualitätssicherung/Ringversuche) of the Specified RiliBÄK Sections B 2 and B 3, respectively, as twice as long as the frequency for mandatory participation. This means that the validity period of the certificates of successful participation for this INSTAND EQA scheme will be one year. The validity of the certificates starts with the closing date of the EQA scheme (deadline for receipt of data). This date is printed on top of the certificates. Tests which are subject to the RiliBÄK are indicated in the certificate of successful participation by "R" with reference to the corresponding Specified Section of the RiliBÄK. Statement of individual results For this EQA scheme "Virus Immunology - Hepatitis C Virus" (346) a statement of individual results is sent out by post together with the certificate of successful participation and statement of participation. The statement of individual results lists for each measurand/test, assigned to defined test categories, the "correct result" with the target value as "valid result" as well as the reported result of the laboratory as "your results". This information is given line by line for each sample analyzed. In addition a "+"-symbol indicates that a certificate of successful participation is issued for a given test category if the laboratory reached 100% correct results for all 4 samples according to the target values. Overview of results A summary of results is given for each of the samples in a table with a specification by test categories. A success rate is depicted for each of the samples reflecting the portion of "correct" results (expressed as "percent" correct results and as "number of correct results per number of total results reported"). In addition an overall success rate - based on the results for all samples of a sample set - is given for each of the test categories. See Table 2 of the annotation to this report. Report about INSTAND e.v. EQAS September of 8

5 346 Hepatitis C Virus September 2014 Report doc Deployed EQA samples Sera from patients with characteristic parameters of an acute or chronic or past hepatitis C are deployed in this EQA scheme "Virus Immunology - Hepatitis C Virus" (346). The positive samples are diluted in a negative serum pool of healthy blood donors. Negative samples are from a negative serum pool of healthy blood donors. Target values The evaluation of this EQA scheme is based on the determination of target values for each of the samples analyzed. Please note: Reference measurement methods for the determination of target values are not applicable for virus diagnostics. The target value of a given EQA scheme sample - preset by the EQA scheme adviser - is confirmed by the INSTAND Target Value Laboratories prior to the distribution of the samples to the participants of this EQA scheme. The above mentioned INSTAND Target Value Laboratories test the samples for a second time during the course of the EQA scheme as regular participants. The final target value for a given sample is derived from the consensus value from all qualitative results. For this the results reported by the INSTAND Target Value Laboratories before and during the EQA scheme are considered. Accepted statements of results according to the respective sample property Qualitative results - "reactive/positive", "negative" or "borderline/indeterminate" (nominal characteristics) for anti-hcv and HCV-Ag The statement "not done" is allowed, when an analysis was not required for a given sample. In case the results of a given EQA scheme deviate from the preset target value, it will be investigated whether the deviating results are due to the test performance in the laboratory or to test immanent problems of commercial or in-house-tests. This investigation is performed together with the INSTAND Target Value Laboratories under the auspices of the EQA scheme adviser and in cooperation with the Joint Diagnostic Council of DVV and GfV. Determination of evaluation intervals Not applicable Report about INSTAND e.v. EQAS September of 8

6 346 Hepatitis C Virus September 2014 Report doc Annotation of the EQAS Adviser Dear colleagues, Below please find a detailed comment on this EQA scheme "Virus Immunology - Hepatitis C Virus" (346) September 2014 with: Information about test categories, statement of results and evaluation criteria, Summary of sample properties, target values, results and success rates, Annex with detailed description of all reported qualitative results including differentiation according to test formats, manufacturers and names of test kits. Number of participants in this EQA scheme: 400 laboratories 1 Test categories, statement of results and evaluation criteria for this EQA scheme The following statements of results were requested for each of the test categories in this EQA scheme which were the basis of evaluation (see Table 1): Test categories (10) Screening tests for the detection of anti-hcv or combined detection of anti-hcv and HCV antigen (15) Tests for the isolated detection of HCV antigen (20) Complementary tests for the detection of anti-hcv Table 1: Test categories, statement of results and evaluation criteria Statement of results the following statements of results were requested reactive or negative or borderline reactive or negative or borderline positive or negative or indeterminate or not done Evaluation criteria no. of correctly determined samples for receiving a certificate of successful participation 4 of 4 samples 4 of 4 samples 4 of 4 samples Reporting of results in the protocol sheets The simultaneous reporting of different results obtained with one and the same test cannot be accepted and will be evaluated as a missing value, e.g. the simultaneous reporting of a "reactive/positive" and "borderline/indeterminate" result for one and the same sample will not be accepted. A result has not been considered for evaluation in case you had specified that this result should only be taken as additional information and ignored as valid result. We ask you to report also the raw data of your test results (e.g. s/co, index etc.). We will start to show the evaluations of these raw data in due time. Please note for future EQA schemes that it is required to report complete results for all of the 4 samples for screening tests and complementary tests, respectively. In case of samples determined "negative" in screening tests please fill in at least "nd = not done", when you have not performed confirmation testing with such samples. Report about INSTAND e.v. EQAS September of 8

7 346 Hepatitis C Virus September 2014 Report doc 2 Summary of sample properties, target values, results and success rates Sample No. Table 2: Summary of sample properties, target values, results and success rates - testing for anti HCV and HCV-antigen Considered as Success rates for Sample properties "correct" results all methods per sample (target values) Sample source Dilutio n Screening tests Test category 10 HCV antigen tests Test category 15 Complementary tests Test category 20 An anti-hcv positive serum * of a patient with past hepatitis C (HCV PCR negative) * was diluted with negative sera of healthy blood donors 1 : 130* 1 : 65* reactive reactive negative # negative # positive positive Pool serum; negative sera of healthy blood donors ---- negative negative/ nd negative/ nd An anti-hcv positive serum of a patient with chronic hepatitis C (HCV PCR positive) was diluted with negative sera of healthy blood donors 1 : 20 reactive reactive # positive Success rates for all 4 samples in test categories 10, 15 and 20, respectively& Test category % (427/427) 100% (427/427) 99.8% (426/427) 100% (427/427) 99.7% & (395/396) & HCV antigen tests Test category % # (13/13) # 100% (13/13) 100% # (13/13) # 92.3% # (12/13) # Screeningtests Complementary tests Test category % (131/131) 100% (131/131) 99.2% (118/119) 99.2% (130/131) 92.3% & (12/13) & 98.4% & (125/127) & & The success rates for all 4 samples in test categories 10, 15 and 20, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods in the corresponding test category are recorded only once. * The samples and were the same dilutions of the same serum of the anti-hcv positive patient mentioned above. The dilution sera were identical. # The anti-hcv positive samples and were confirmed as HCV RNA negative by quantitative HCV-PCR. The anti-hcv positive sample was confirmed as HCV RNA positive by quantitative HCV-PCR. nd = not done Report about INSTAND e.v. EQAS September of 8

8 346 Hepatitis C Virus September 2014 Report doc A detailed description of the results for all samples including a differentiation according to the test formats, manufacturers and names of test kits is given in the annex to this report: 3 Annex - Tables including differentiation according to test formats, manufacturers and names of test kits 3.1 Qualitative testing for anti-hcv and HCV-Ag (Test categories 10, 15 and 20) We thank our colleagues of the above-mentioned INSTAND-Target Value Laboratories for their cooperation. Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND e.v. for details. Thank you very much for your kind cooperation. Sincerely yours, Prof. Dr. H. Zeichhardt P.S. We would like to inform you about the new virological INSTAND EQA schemes that are performed on a regular basis starting in 2014 and 2015, respectively: information on new virological EQA schemes (as of 10 November 2014) Report about INSTAND e.v. EQAS September of 8

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10 INSTAND e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) - in cooperation with Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Annex 3.1 Qualitative testing for anti-hcv and HCV-Ag Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen (test category 10) Tests for the exclusive detection of HCV antigen (test category 15) Complementary tests for the detection of anti-hcv (test category 20) Differentiation according to method, manufacturer and test name 346 HCV Deckblatt qual EN.doc

11 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (INSTAND) in cooperation with Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virus immunology Hepatitis C (346) EQAS Virology Sept Qualitative results for sample Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen : reactive Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate ELISA-anti-HCV (10) % Siemens - Ezygnost Anti-HCV % Bio-Rad - Monolisa Anti-HCV PLUS % Ortho - Ortho HCV 3.0 ELISA-Test % Fujirebio - INNOTEST HCV Ab IV % Human - anti-hcv % DiaSorin - Murex anti-hcv (version 4.0) % ELISA-anti-HCV+HCV Ag (11) % Bio-Rad - Monolisa HCV Ag-Ab Ultra % MEIA-anti-HCV AxSYM (20) % Abbott - AxSYM HCV Version % ChLIA-anti-HCV (30) % Siemens - ADVIA Centaur HCV % Bio-Rad - Access HCV Ab plus % Abbott - PRISM HCV % DiaSorin - LIAISON XL Murex HCV Ab % Ortho - VITROS Anti-HCV % ECLIA-anti-HCV (50) % Roche - Elecsys Anti-HCV II % CMIA-anti-HCV (60) % Abbott - ARCHITECT Anti-HCV % other anti-hcv (98) % biomerieux - VIDAS Anti-HCV % OraSure - OraQuick HCV Rapid Antibody Test % CvirG / LgesQ Rv= :18h Bl. 44

12 Grp. 346 Qualitative results for sample Tests for the isolated detection of HCV antigen : negative Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate CMIA HCV Ag (33) % Abbott - ARCHITECT HCV Ag % Qualitative results for sample Complementary tests for the detection of anti-hcv : positive Total test total positive indet. negative Success rate % Method / Manufacturer total positive indet. negative Success rate Dot IA anti-hcv (20) % Bio-Rad - Deciscan HCV plus % Line IA (21) % Fujirebio - INNO-LIA HCV Score % Mikrogen - recomline HCV IgG % Western Blot (30) % MP Biomedicals - HCV BLOT Version % CvirG / LgesQ Rv= :18h Bl. 45

13 Grp. 346 Qualitative results for sample Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen : reactive Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate ELISA-anti-HCV (10) % Siemens - Ezygnost Anti-HCV % Bio-Rad - Monolisa Anti-HCV PLUS % Ortho - Ortho HCV 3.0 ELISA-Test % Fujirebio - INNOTEST HCV Ab IV % DiaSorin - Murex anti-hcv (version 4.0) % Human - anti-hcv % ELISA-anti-HCV+HCV Ag (11) % Bio-Rad - Monolisa HCV Ag-Ab Ultra % MEIA-anti-HCV AxSYM (20) % Abbott - AxSYM HCV Version % ChLIA-anti-HCV (30) % Siemens - ADVIA Centaur HCV % Bio-Rad - Access HCV Ab plus % Abbott - PRISM HCV % Ortho - VITROS Anti-HCV % DiaSorin - LIAISON XL Murex HCV Ab % ECLIA-anti-HCV (50) % Roche - Elecsys Anti-HCV II % CMIA-anti-HCV (60) % Abbott - ARCHITECT Anti-HCV % other anti-hcv (98) % biomerieux - VIDAS Anti-HCV % OraSure - OraQuick HCV Rapid Antibody Test % Qualitative results for sample Tests for the isolated detection of HCV antigen : negative Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate CMIA HCV Ag (33) % Abbott - ARCHITECT HCV Ag % CvirG / LgesQ Rv= :18h Bl. 46

14 Grp. 346 Qualitative results for sample Complementary tests for the detection of anti-hcv : positive Total test total positive indet. negative Success rate % Method / Manufacturer total positive indet. negative Success rate Dot IA anti-hcv (20) % Bio-Rad - Deciscan HCV plus % Line IA (21) % Fujirebio - INNO-LIA HCV Score % Mikrogen - recomline HCV IgG % Western Blot (30) % MP Biomedicals - HCV BLOT Version % CvirG / LgesQ Rv= :18h Bl. 47

15 Grp. 346 Qualitative results for sample Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen : negative Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate ELISA-anti-HCV (10) % Siemens - Ezygnost Anti-HCV % Ortho - Ortho HCV 3.0 ELISA-Test % Bio-Rad - Monolisa Anti-HCV PLUS % Fujirebio - INNOTEST HCV Ab IV % DiaSorin - Murex anti-hcv (version 4.0) % Human - anti-hcv % ELISA-anti-HCV+HCV Ag (11) % Bio-Rad - Monolisa HCV Ag-Ab Ultra % MEIA-anti-HCV AxSYM (20) % Abbott - AxSYM HCV Version % ChLIA-anti-HCV (30) % Siemens - ADVIA Centaur HCV % Bio-Rad - Access HCV Ab plus % Abbott - PRISM HCV % Ortho - VITROS Anti-HCV % DiaSorin - LIAISON XL Murex HCV Ab % ECLIA-anti-HCV (50) % Roche - Elecsys Anti-HCV II % CMIA-anti-HCV (60) % Abbott - ARCHITECT Anti-HCV % other anti-hcv (98) % biomerieux - VIDAS Anti-HCV % OraSure - OraQuick HCV Rapid Antibody Test % Qualitative results for sample Tests for the isolated detection of HCV antigen : negative Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate CMIA HCV Ag (33) % Abbott - ARCHITECT HCV Ag % CvirG / LgesQ Rv= :18h Bl. 48

16 Grp. 346 Qualitative results for sample Complementary tests for the detection of anti-hcv : negative Total test total positive indet. negative Success rate % Method / Manufacturer total positive indet. negative Success rate Dot IA anti-hcv (20) % Bio-Rad - Deciscan HCV plus % Line IA (21) % Fujirebio - INNO-LIA HCV Score % Mikrogen - recomline HCV IgG % Western Blot (30) % MP Biomedicals - HCV BLOT Version % CvirG / LgesQ Rv= :18h Bl. 49

17 Grp. 346 Qualitative results for sample Screening tests for the detection of anti-hcv and combined detection of anti-hcv and HCV antigen : reactive Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate ELISA-anti-HCV (10) % Siemens - Ezygnost Anti-HCV % Ortho - Ortho HCV 3.0 ELISA-Test % Bio-Rad - Monolisa Anti-HCV PLUS % Fujirebio - INNOTEST HCV Ab IV % DiaSorin - Murex anti-hcv (version 4.0) % Human - anti-hcv % ELISA-anti-HCV+HCV Ag (11) % Bio-Rad - Monolisa HCV Ag-Ab Ultra % MEIA-anti-HCV AxSYM (20) % Abbott - AxSYM HCV Version % ChLIA-anti-HCV (30) % Siemens - ADVIA Centaur HCV % Bio-Rad - Access HCV Ab plus % Abbott - PRISM HCV % Ortho - VITROS Anti-HCV % DiaSorin - LIAISON XL Murex HCV Ab % ECLIA-anti-HCV (50) % Roche - Elecsys Anti-HCV II % CMIA-anti-HCV (60) % Abbott - ARCHITECT Anti-HCV % other anti-hcv (98) % biomerieux - VIDAS Anti-HCV % OraSure - OraQuick HCV Rapid Antibody Test % Qualitative results for sample Tests for the isolated detection of HCV antigen : reactive Total test total reactive borderline negative Success rate % Method / Manufacturer total reactive borderline negative Success rate CMIA HCV Ag (33) % Abbott - ARCHITECT HCV Ag % CvirG / LgesQ Rv= :18h Bl. 50

18 Grp. 346 Qualitative results for sample Complementary tests for the detection of anti-hcv : positive Total test total positive indet. negative Success rate % Method / Manufacturer total positive indet. negative Success rate Dot IA anti-hcv (20) % Bio-Rad - Deciscan HCV plus % Line IA (21) % Fujirebio - INNO-LIA HCV Score % Mikrogen - recomline HCV IgG % Western Blot (30) % MP Biomedicals - HCV BLOT Version % CvirG / LgesQ Rv= :18h Bl. 51