Hindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0)

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1 I S T A D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) ISTAD-Geschäftsstelle Ubierstr Düsseldorf Telefon: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt doc. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o ISTAD e.v. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, Düsseldorf Hindenburgdamm 27, 2203 Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) /23; Fax: +49-(0) donoso@instand-ev.de Heinz.Zeichhardt@charite.de 0 February 204 Final Report External Quality Assessment Scheme (EQAS) - September 203 Virus Immunology - Hepatitis A Virus (343) (Tests for anti-hav and anti-hav-igm) ISTAD-Target Value Laboratories: Universität Regensburg, Institut für Medizinische Mikrobiologie und Hygiene, Bereich Klinische Virologie und Infektionsimmunologie, ationales Konsiliarlaboratorium für HAV und HEV: Prof. Dr. W. Jilg, Dr. J. Wenzel Justus-Liebig-Universität Gießen, Institut für Medizinische Virologie, ationales 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 Universität Duisburg-Essen, Universitätsklinikum Essen, Institut für Virologie, ationales Referenzzentrum für Hepatitis-C-Viren, ationales Konsiliarlaboratorium für Tollwut: Prof. Dr. U. Dittmer, Prof. Dr. S. Ross, Prof. Dr. M. Roggendorf Uniklinik Köln, Institut für Virologie, ationales Referenzzentrum für Papillom- und Polyomaviren: Prof. Dr. H. Pfister, Prof. Dr. U. Wieland, Dr. R. Kaiser Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar; Prof. Dr. S. Smola, Prof. Dr.. Müller-Lantzsch Universitätsklinikum Frankfurt, Institut für Medizinische Virologie, Frankfurt/Main, ationales 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. eumann-haefelin 343 Hepatitis A Virus ovember December 203 Letter doc

2 Dear colleagues, Together with the final report of the ISTAD External Quality Assessment (EQA) scheme "Virus Immunology - Hepatitis A Virus" (343) ovember/december 203 we would like to inform you again about the new virological ISTAD EQA schemes that are performed on a regular basis from 204 on: Four additional training programs for virus genome detection of CMV, HBV, HCV and HIV- (RA), respectively, containing low virus concentrations 5 new EQA schemes Survey for planned EQA schemes We refer for more details to the attached information on new virological EQA schemes (as of 03 February 204) the ISTAD ordering documents 204 For the EQA scheme "Virus Immunology - Hepatitis A Virus " (343) ovember/december 203 you received the following participation documents by mail: certificate of successful participation, statement of participation, statement of individual results. Release of final reports of EQA schemes in virus diagnostics Each final report of a defined EQA scheme will be released on the ISTAD homepage immediately after completion as PDF file under "EQAS / Reports / Year and Category (Virus immunology)" in English language ( and in German language ( Information on new RiliBÄK (Guideline of the German Medical Association) You have already been informed about changes as to the ISTAD External Quality Assessment (EQA) schemes in virus diagnostics in recent final EQA scheme reports and postal mailings. We refer for more details to the information ISTAD EQA schemes in virus diagnostics and the new RiliBÄK (as of 24 January 204) 343 Hepatitis A Virus ovember December 203 Letter doc 2

3 Evaluation criteria for the results of this EQA scheme The certificate of successful participation of a defined EQA scheme in virus diagnostics is assigned to a defined test category. This EQA scheme comprises the following test categories: 0. Testing for anti-hav-igg or anti-hav total (qualitative reporting and reporting as miu/ml)* 20. Qualitative testing for anti-hav-igm* * RiliBÄK parameter subject to section B 2 These test categories are individually evaluated in the certificate of successful participation and listed in all participation documents and final reports. 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 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 (00% correct results according to the target values). Please note: A corresponding proceeding is applied for tests for virus antigen and genome detection. Specifications will follow. Example - Program "Virus Immunology - Hepatitis A Virus" (343): Both samples of have to be tested correctly with the same method in test category 0 "Testing for anti-hav- IgG or anti-hav total". The same applies for test category 20 of this EQA scheme. 2 Sample properties, target values, results and success rates Test category 0: You were requested to report the results qualitatively as "positive", "negative" or "borderline" and if applicable as milli-international Units/ml (miu/ml) for anti-hav-igg or anti-hav total. Test category 20: You were requested to report the results qualitatively as "positive", "negative" or "borderline" for anti-hav-igm. Please note that we asked 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. A result was not considered for evaluation in case you had specified that this result should only be taken as additional information and ignored as valid result. 343 Hepatitis A Virus ovember December 203 Letter doc 3

4 Sample o. Table : Testing for anti-hav-igg or anti-hav total (Qualitative reporting and reporting as miu/ml) Sample properties, target values, results and success rates Test category 0 Sample properties Sample source Dilution Target value # miu/ml Considered as "correct" results (target values / target value intervals) Pool serum; negative sera of two healthy blood donors negative 0-9 An anti-hav-igg positive serum of a healthy blood donor was diluted with negative sera : 500 (60)* positive 50* of two healthy blood donors Success rates for both samples in test category 0 & (qualitative results together with results as miu/ml) & Success rates for all methods per sample qualitative miu/ml qualitative miu/ml 86.0% (25/292) 99.3% (290/292) 85.% & (240/282) & 00% (39/39) 00%* (40/40)* & The success rate for both samples in test category 0 refers to the number of participating laboratories. Laboratories having reported results obtained by several methods in the corresponding test category are recorded only once. # Target value: determined for each sample from the results (in miu/ml) of all participants. Sample : Deviations were observed for the qualitative determination of anti-hav-igg with a CMIA of one manufacturer (Abbott, Architect HAVAb-G): 99 results in total were reported with this test of these 32 positive results 5 borderline results 62 negative results The unexpected positive / borderline results have been evaluated as "false", but are without any disadvantage for the certificate of successful participation for the affected participants. The deviating results unexpectedly occurred for sample during the EQA scheme. Such deviations were not observed by the ISTAD-Target Value Laboratories in the precharacterization before this sample was distributed to the participants of the official EQA scheme. The deviating results primarily concern single lots of the above mentioned test applied by the participants in the EQA scheme. The manufacturer and the ational Consiliary Laboratory for HAV and HEV have been notified in advance. Please note: For test samples with low positive measurement units near the cut-off of the respective test it is generally advised to control if this result is due to an unspecific reaction. Retesting of such samples should be performed for the respective analyte with another test format. * Sample : Some tests revealed values in miu/ml above the linear measuring range (62/75 analyses were 60 miu/ml). The value presented (60 miu/ml) is shown only for orientation and does not represent a target value. 343 Hepatitis A Virus ovember December 203 Letter doc 4

5 Sample o. Table 2: Qualitative testing for anti-hav-igm Sample properties, target values, results and success rates Test category 20 Sample properties Considered as correct Sample source Dilution results (target values) Pool serum; negative sera of two healthy blood donors An anti-hav-igm positive serum of a male patient with acute hepatitis A was diluted with negative serum of a healthy blood donor Success rate for both samples in test category 20 & ---- negative : 5 positive Success rates for all methods per sample 00% (279/279) 00% (279/279) 00% & (268/268) & & The success rate for both samples in test category 20 refers to the number of participating laboratories. Laboratories having reported results obtained by several methods in the corresponding test category are recorded only once. Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact ISTAD for details. Thank you very much for your kind cooperation. Prof. Dr. H. Zeichhardt 343 Hepatitis A Virus ovember December 203 Letter doc 5

6 ISTAD e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) - Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Analyses of anti-hav-igg or anti-hav total Qualitative results and results as miu/ml (test category 0) Differentiation according to method, manufacturer and test name 343 HAV qual u quant Deckblatt E.doc

7 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) 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 A (343) EQAS Virology ovember 203 Qualitative results for sample : negative Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-HAV total (0) % Siemens - Enzygnost Anti-HAV % DiaSorin - ETI-AB-HAVK Plus % MEIA-anti-HAV-total AxSYM (4) % Abbott - AxSYM HAVAB % ChLIA-anti-HAV total (2) % Siemens - ADVIA HAV-gesamt (ahavt) % Beckman Coulter - Access HAV Ab 00.0% DiaSorin - LIAISO Anti-HAV % Ortho - VITROS Anti-HAV-Gesamt % wrong test 00.0% ELFA-anti-HAV total (3) % biomerieux - VIDAS Anti-HAV Total % ECLIA-anti-HAV total (33) % Roche - Elecsys Anti-HAV II % CMIA-anti-HAV-IgG (34) % Abbott - ARCHITECT HAVAb-G % other anti-hav-igg t. (98) % Standard Diagn - SD Bioline HAV IgG/IgM 00.0% Deviations were observed for the qualitative determination of anti-hav-igg with a CMIA of one manufacturer (Abbott, Architect HAVAb-G): 99 results in total were reported with this test of these 32 positive results 5 borderline results 62 negative results The unexpected positive / borderline results have been evaluated as "false", but are without any disadvantage for the certificate of successful participation for the affected participants. The deviating results unexpectedly occurred for sample during the EQA scheme. Such deviations were not observed by the ISTAD-Target Value Laboratories in the pre-characterization before this sample was distributed to the participants of the official EQA scheme. The deviating results primarily concern single lots of the above mentioned test applied by the participants in the EQA scheme. The manufacturer and the ational Consiliary Laboratory for HAV and HEV have been notified in advance. Please note: For test samples with low positive measurement units near the cut-off of the respective test it is generally advised to control if this result is due to an unspecific reaction. Retesting of such samples should be performed for the respective analyte with another test format. CvirG / LgesQ Rv= :23h Bl. 32

8 Grp. 343 Qualitative results for sample : positive Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-HAV total (0) % Siemens - Enzygnost Anti-HAV % DiaSorin - ETI-AB-HAVK Plus % MEIA-anti-HAV-total AxSYM (4) % Abbott - AxSYM HAVAB % ChLIA-anti-HAV total (2) % Siemens - ADVIA HAV-gesamt (ahavt) % Beckman Coulter - Access HAV Ab 00.0% DiaSorin - LIAISO Anti-HAV % Ortho - VITROS Anti-HAV-Gesamt % wrong test 0.0% ELFA-anti-HAV total (3) % biomerieux - VIDAS Anti-HAV Total % ECLIA-anti-HAV total (33) % Roche - Elecsys Anti-HAV II % CMIA-anti-HAV-IgG (34) % Abbott - ARCHITECT HAVAb-G % other anti-hav-igg t. (98) % Standard Diagn - SD Bioline HAV IgG/IgM 0.0% CvirG / LgesQ Rv= :23h Bl. 33

9 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : negative miu/ml: 0-9 Frequency of methods sp percent = F ECLIA-Anti-HAV total 23.4 F ChLIA-Anti-HAV total 23.0 CMIA-Anti-HAV-IgG 3.0 MEIA-Anti-HAV-total AxSYM3 2.3 ELISA-Anti-HAV total 0.4 ELFA-Anti-HAV total other Anti-HAV-IgG t. cert.=90.5% F=4 37 F Virologie, Charité-CBF, RV-ovember Distr. of qual. results sp ( all methods ) percent = 292 negative (R) borderline (F).7 5 positive (F) 2.3 cert.=86.0% F= Virologie, Charité-CBF, RV-ovember 203 Bl. 9 Cvir2 / Lh Rv= :9h Srt=MR, Me=, Klebe=, Std=0, quantcb=, nhisto=

10 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : negative miu/ml: 0-9 Distribution of miu/ml results, all methods sp , miu/ml: 0-9 miu/ml percent = < < < < < < < < < cert.=00.0% F=0 target value=9 Virologie, Charité-CBF, RV-ovember 203 Bl. 30 Cvir2 / LH_Ges Rv= :57h Srt=MM, Me=, Klebe=0, Std=0, quantcb=, nhisto=

11 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : negative miu/ml: 0-9 ChLIA-Anti-HAV total sp , miu/ml: 0-9 miu/ml percent = 42 ChLIA-Anti-HAV total sp , miu/ml: 0-9 Beckman Coulter - Access HAV Ab miu/ml percent = < < < < < < < < < < < < < < < < cert.=00.0% F= Virologie, Charité-CBF, RV-ovember cert.=00.0% F= Virologie, Charité-CBF, RV-ovember 203 ChLIA-Anti-HAV total sp , miu/ml: 0-9 Siemens - ADVIA HAV-gesamt (ahavt) miu/ml percent = 33 ELFA-Anti-HAV total sp , miu/ml: 0-9 miu/ml percent = < < < < < < < < < cert.=00.0% F= Virologie, Charité-CBF, RV-ovember cert.=00.0% F= Virologie, Charité-CBF, RV-ovember 203 ELFA-Anti-HAV total sp , miu/ml: 0-9 biomerieux - VIDAS Anti-HAV Total miu/ml percent = 3 ECLIA-Anti-HAV total sp , miu/ml: 0-9 miu/ml percent = < < < < < cert.=00.0% F= Virologie, Charité-CBF, RV-ovember cert.=00.0% F=0 9 Virologie, Charité-CBF, RV-ovember 203 Bl. 28 Cvir2 / Lh Rv= :2h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

12 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : negative miu/ml: 0-9 ECLIA-Anti-HAV total sp , miu/ml: 0-9 Roche - Elecsys Anti-HAV II miu/ml percent = < < < < cert.=00.0% F=0 9 Virologie, Charité-CBF, RV-ovember 203 Bl. 29 Cvir2 / Lh Rv= :2h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

13 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : positive miu/ml: >= 50 Frequency of methods sp percent = ECLIA-Anti-HAV total F ChLIA-Anti-HAV total CMIA-Anti-HAV-IgG MEIA-Anti-HAV-total AxSYM3 2.3 ELISA-Anti-HAV total 0.4 ELFA-Anti-HAV total other Anti-HAV-IgG t. 40 cert.=99.5% F= Virologie, Charité-CBF, RV-ovember 203 Distr. of qual. results sp ( all methods ) percent = 292 negative (F) positive (R) 99.3 cert.=99.3% F= Virologie, Charité-CBF, RV-ovember 203 Bl. 2 Cvir2 / Lh Rv= :9h Srt=MR, Me=, Klebe=, Std=0, quantcb=, nhisto=

14 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : positive miu/ml: >= 50 Distribution of miu/ml results, all methods sp , miu/ml: >= 50.0* miu/ml percent = < < < < < < < cert.=00.0% F=0 60 Virologie, Charité-CBF, RV-ovember 203 * Some tests revealed values in miu/ml above the linear measuring range (62/75 analyses were 60 miu/ml). The value presented (60 miu/ml) is shown only for orientation and does not represent a target value. Bl. 32 Cvir2 / LH_Ges Rv= :57h Srt=MM, Me=, Klebe=0, Std=0, quantcb=, nhisto=

15 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : positive miu/ml: >= 50 ChLIA-Anti-HAV total sp , miu/ml: >= 50.0 miu/ml percent = 42 ChLIA-Anti-HAV total sp , miu/ml: >= 50.0 Beckman Coulter - Access HAV Ab miu/ml percent = < < < < < < cert.=00.0% F=0 84 Virologie, Charité-CBF, RV-ovember cert.=00.0% F= Virologie, Charité-CBF, RV-ovember 203 ChLIA-Anti-HAV total sp , miu/ml: >= 50.0 Siemens - ADVIA HAV-gesamt (ahavt) miu/ml percent = 33 ELFA-Anti-HAV total sp , miu/ml: >= 50.0 miu/ml percent = < < < < < cert.=00.0% F=0 85 Virologie, Charité-CBF, RV-ovember cert.=00.0% F= Virologie, Charité-CBF, RV-ovember 203 ELFA-Anti-HAV total sp , miu/ml: >= 50.0 biomerieux - VIDAS Anti-HAV Total miu/ml percent = 3 ECLIA-Anti-HAV total sp , miu/ml: >= 50.0 miu/ml percent = < < < < < < < < cert.=00.0% F= Virologie, Charité-CBF, RV-ovember < cert.=00.0% F=0 60 Virologie, Charité-CBF, RV-ovember 203 Bl. 3 Cvir2 / Lh Rv= :2h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

16 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Virusimmunology Hepatitis A (343) ovember 203 sample , anti-hav-igg or anti-hav total (qual. and results as miu/ml) : positive miu/ml: >= 50 ECLIA-Anti-HAV total sp , miu/ml: >= 50.0 Roche - Elecsys Anti-HAV II miu/ml percent = < < < < < < cert.=00.0% F=0 60 Virologie, Charité-CBF, RV-ovember 203 Bl. 32 Cvir2 / Lh Rv= :2h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

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18 ISTAD e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) - Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Qualitative analyses of anti-hav-igm (test category 20) Differentiation according to method, manufacturer and test name 343 HAV-IgM qual Deckblatt E.doc

19 Grp. 343 Qualitative results for sample Qualitative testing for anti-hav-igm : negative Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-HAV-IgM (0) % Siemens - Enzygnost Anti-HAV/IgM % DiaSorin - ETI-HA-IGMK PLUS 00.0% MEIA-anti-HAV-IgM AxSYM (2) % Abbott - AxSYM HAVAB-M % ChLIA-anti-HAV-IgM (20) % Siemens - ADVIA HAV IgM (ahavm) % Beckman Coulter - Access HAV IgM % DiaSorin - LIAISO HAV IgM % Ortho - VITROS Anti-HAV-IgM % ELFA-anti-HAV-IgM (30) % biomerieux - VIDAS HAV IgM % ECLIA-anti-HAV-IgM (33) % Roche - Elecsys Anti-HAV IgM 00.0% CMIA-anti-HAV-IgM (34) % Abbott - ARCHITECT HAVAb-M % otheranti-hav-igm (99) % Standard Diagn - SD Bioline HAV IgG/IgM 00.0% CvirG / LgesQ Rv= :23h Bl. 34

20 Grp. 343 Qualitative results for sample Qualitative testing for anti-hav-igm : positive Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-HAV-IgM (0) % Siemens - Enzygnost Anti-HAV/IgM % DiaSorin - ETI-HA-IGMK PLUS 00.0% MEIA-anti-HAV-IgM AxSYM (2) % Abbott - AxSYM HAVAB-M % ChLIA-anti-HAV-IgM (20) % Siemens - ADVIA HAV IgM (ahavm) % Beckman Coulter - Access HAV IgM % DiaSorin - LIAISO HAV IgM % Ortho - VITROS Anti-HAV-IgM % ELFA-anti-HAV-IgM (30) % biomerieux - VIDAS HAV IgM % ECLIA-anti-HAV-IgM (33) % Roche - Elecsys Anti-HAV IgM 00.0% CMIA-anti-HAV-IgM (34) % Abbott - ARCHITECT HAVAb-M % otheranti-hav-igm (99) % Standard Diagn - SD Bioline HAV IgG/IgM 00.0% CvirG / LgesQ Rv= :23h Bl. 35