Final Report External Quality Assessment Scheme (EQAS) - June 2012 Virus Immunology - HIV-1/HIV-2 (335) (Tests for anti-hiv-1 and anti-hiv-2)

Transkript

1 I N S T A N D e. V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstelle) WHO Collaborating Centre for Quality Assurance and Standardization in Laboratory Medicine in cooperation with Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) INSTAND-Geschäftsstelle Ubierstr Düsseldorf Telefon: +49 (0) Fax: +49 (0) instand@instand-ev.de EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt Dr. Hans-Peter Grunert Charité - Universitätsmedizin Berlin Institut für Biotechnologische Diagnostik in der GBD Institut für Virologie, Campus Benjamin Franklin Potsdamer Chaussee 80, Berlin Hindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) /23; Fax: +49-(0) HPGrunert@gmx.de Heinz.Zeichhardt@charite.de Internet: 14 August 2012 Final Report External Quality Assessment Scheme (EQAS) - June 2012 Virus Immunology - HIV-1/HIV-2 (335) (Tests for anti-hiv-1 and anti-hiv-2) INSTAND-Target Value Laboratories: Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen, Institut für Klinische und Molekulare Virologie, Nationales Referenzzentrum für Retroviren: Prof. Dr. B. Fleckenstein, Dr. K. Korn Charité - Universitätsmedizin Berlin, Campus Mitte, Institut für Medizinische Virologie, Nationales Konsiliarlaboratorium für Hantaviren: Prof. Dr. D. H. Krüger, PD Dr. J. Hofmann Charité - Universitätsmedizin Berlin, Infektionsserologisches interdisziplinäres Speziallabor (ISIS): Prof. Dr. R. Heilbronn, Prof. Dr. D. H. Krüger, Prof. Dr. R. Tauber DRK Blutspendedienst Ost ggmbh, Inst. f. Transfusionsmedizin Cottbus: Dr. R. Knels, Dr. R. Rothe, Dr. A. Vornwald Klinikum der Johann Wolfgang Goethe-Universität, Institut für Medizinische Virologie, Frankfurt/Main: Prof. Dr. O. T. Keppler, Prof. Dr. H. Rabenau, PD Dr. A. Berger, PD Dr. R. Allwinn 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 Robert Koch-Institut, Zentrum für HIV und Retrovirologie (FG 18), Berlin: Dr. C. Kücherer Uniklinik Köln, Institut für Virologie, Nationales Referenzzentrum für Papillom- und Polyomaviren: Prof. Dr. H. Pfister, Prof. Dr. U. Wieland, Dr. R. Kaiser 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 Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar; Prof. Dr. S. Smola, Prof. Dr. N. Müller-Lantzsch 335 HIV-1 and HIV-2 June 2012 Letter doc 1

2 Dear colleagues, Below please find the final report of the INSTAND External Quality Assessment (EQA) scheme "Virus Immunology - HIV-1/HIV-2" June Some days ago you received already the participation documents for this EQA scheme such as: - certificate of successful participation, - statement of participation, - statement of individual results. You have already been informed about changes as to the INSTAND EQA schemes in recent final reports and information letters. For details please see the INSTAND homepage under "Information on INSTAND External Quality Assessment (EQA) Schemes in Virus Diagnostics/as of 11 May 2012" (please use the download button) These changes concern: New RiliBÄK (Guideline of the German Medical Association) and validity period of certificates of INSTAND EQA schemes in virus diagnostics. Mailing of participation documents of a defined EQA scheme term in virus diagnostics. Electronic supply of pre-evaluations and final reports of the EQA schemes in virus diagnostics. Please note that INSTAND can only inform you about the electronic supply of pre-evaluations and final reports of the EQA schemes in virus diagnostics when you have already returned your address (see information letter as of 12 March 2012). Release of final reports of EQA schemes in virus diagnostics on the INSTAND homepage. Each final 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 ( ). 1 Evaluation criteria for the results of this EQA scheme As already recently practiced, 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: 10. Combined tests for the detection of anti-hiv-1/anti-hiv-2 (screening tests and other tests) - Kombiteste zum Nachweis von Anti-HIV-1/Anti-HIV-2 (Suchteste und andere Teste) 41. Combined tests for the detection of anti-hiv-1 (confirmation tests) - Kombiteste zum Nachweis von Anti-HIV-1 (Bestätigungsteste) 42. Combined tests for the detection of anti-hiv-2 (confirmation tests) - Kombiteste zum Nachweis von Anti-HIV-2 (Bestätigungsteste) 50. Tests for the exclusive detection of anti-hiv-1 (confirmation tests) - Teste zum alleinigen Nachweis von Anti-HIV-1 (Bestätigungsteste) 60. Tests for the exclusive detection of anti-hiv-2 (confirmation tests) - Teste zum alleinigen Nachweis von Anti-HIV-2 (Bestätigungsteste) 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 (100% correct results according to the target values). Please note: A corresponding proceeding is applied for tests for virus antigen and genome detection. Example - Program "Virus Immunology - HIV-1/HIV-2" (335): All 4 samples of the sample set have to be tested correctly with the same method in test category 10 "Combined tests for the detection of anti-hiv-1/anti-hiv-2 (screening tests and other tests) - Kombiteste Anti- HIV-1/Anti-HIV-2 (Suchteste und andere Teste)". The same applies for test categories 41, 42, 50 and 60 of this EQA scheme. 335 HIV-1 and HIV-2 June 2012 Letter doc 2

3 2 Details on samples Test category 10: You were requested to report the results qualitatively as "reactive", "negative" or "borderline". Test categories 41, 42, 50 und 60: You were requested to report the results qualitatively as "positive, "negative or "indeterminate. Please note that only the results of antibody detection tests were considered for the evaluation. The results of antigen detection tests were not considered. 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. Sample No * * Details on samples Sample source An anti-hiv-1 positive serum (heat inactivated) of a patient with HIV/AIDS was diluted with negative sera of healthy blood donors. An anti-hiv-2 positive serum (heat inactivated) of a patient with HIV/AIDS was diluted with negative sera of healthy blood donors. An anti-hiv-1 positive serum (heat inactivated) of a patient with HIV/AIDS was diluted with negative sera of healthy blood donors. Dilution 1 : 300* 1 : 75 1 : 150* Pool serum; negative sera of healthy blood donors ---- * The positive samples and were dilutions of the same serum of an anti-hiv-1 positive HIV/AIDS patient. The dilution sera were different. 3 Instructions for reporting of results in the protocol sheets Combined tests for the confirmation of anti-hiv-1 and anti-hiv-2 (test categories 41 and 42): Please state clearly only those proteins recognized by the respective antibodies which determine the interpretation for anti-hiv-1 positive (test category 41) and anti-hiv-2 positive (test category 42), resp.. Please note for future EQA schemes "Virus Immunology HIV-1/HIV-2" that it is required to report complete results for all of the 4 samples for screening tests and confirmation tests, respectively (see section 1). In case of samples determined "negative" in screening tests please fill in at least "nd = not done = nicht durchgeführt", when you do not perform confirmation testing with such samples. 4 Sample properties, target values, results and success rates Performed tests (Test category) Screening tests (10) Combined tests for the detection of anti-hiv-1/2 Confirmation tests (41) Combined tests for the detection of anti-hiv-1 1 (42) Combined tests for the detection of anti-hiv-2 1 (50) Tests for the exclusive detection of anti-hiv-1 1 (60) Tests for the exclusive detection of anti-hiv-2 1 Sample properties, target values, results and success rates Sample * 1 : 300 diluted anti-hiv-1 pos. reactive 99.8% (416/417) positive 98.9% (90/91) negative 97.8% (88/90) positive 100% (21/21) negative/ indeterminate 2 /nd 100% (20/20) Sample : 75 diluted anti-hiv-2 pos.. Sample * 1 : 150 diluted anti-hiv-1 pos. considered as "correct" results (target values) success rates for all methods per sample reactive 100% (417/417) not evaluated due to cross-react. with HIV-1 3 positive/ indeterminate 4 100% (91/91) not evaluated due to cross-react. with HIV-1 3 positive 100% (21/21) reactive 100% (417/417) positive 98.9% (90/91) negative 97.8% (88/90) positive 100% (21/21) negative/ indeterminate 2 /nd 100% (20/20) Sample anti-hiv-1/2 neg. negative 99.5% (415/417) negative/nd 100% (82/82) negative/nd 100% (81/81) negative/nd 100% (19/19) negative/nd 100% (18/18) Success rates for all 4 samples in test categories 10, 41, 42, 50 and 60, respectively & 99.2% & (359/362) & 98.9% & (90/91) & 96.7% & (88/91) & 100% & (21/21) & 100% & (21/21) & 335 HIV-1 and HIV-2 June 2012 Letter doc 3

4 * The positive samples and were dilutions of the same serum of an anti-hiv-1 positive HIV/AIDS patient. The dilution sera were different. & The success rates for all 4 samples in test categories 10, 41, 42, 50 and 60, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once in the corresponding test category. nd = not done indeterminate = fraglich / keine diagnostische Aussage möglich / nicht eindeutig Basis for the evaluation of the western blot analyses to be considered as correct results were the qualitative results reported by the participant. The interpretation of the results of commercial western blots and other immunoblots should be consistent with the manufacturer's instructions of the CE-marked test. In addition the recommendations of the Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV, German Association against Virus Diseases) were accepted for the interpretation of the blot analyses ( Interpretation der Immunoblots zum Nachweis von Antikörpern gegen HIV-1 und HIV-2"; Mitteilung der Deutschen Vereinigung zur Bekämpfung der Viruskrankheiten (DVV), Klinisches Labor 38, 71-72, 1992; Habermehl, K.-O. und Maass, G., Deutsches Ärzteblatt, 89. Jahrg., Heft 34/35, A1, , 1992). Discrepancies between the minimal requirements of DVV and commercial manufacturers for considering a western/immunoblot result as positive had no negative effect for your certificate. A revised recommendation for the interpretation of western/immunoblots for the confirmation of antibodies against HIV-1 and HIV-2 will soon be available. The anti-hiv-1 positive samples and showed immunological cross-reactivities in the region of HIV-2 antigen/s in some of the confirmation tests. The result "indeterminate" (= fraglich / keine diagnostische Aussage möglich / nicht eindeutig ) was therefore accepted as correct result additionally to negative for confirmation tests for the exclusive detection of anti-hiv-2 (test category 60 in the protocol). The anti-hiv-2 positive sample revealed partial immunological cross-reactivity with HIV-1 antigen/s. This cross-reactivity may be due to the fact that the patient was infected with an HIV-2 with untypical close antigenic relationship to HIV-1. Please note that sample does not represent a serum of a patient co-infected with HIV-1 and HIV-2. Due to the observed immunological cross-reactivity the results obtained by confirmation tests for anti-hiv-1 in test categories 41 and 50 were not evaluated (without disadvantage for the certificate). The anti-hiv-2 positive sample was correctly determined as "positive" with nearly all applied confirmation tests. The combined test which detects anti-hiv-2 with an extra band in addition to anti-hiv-1 (test category 42 in the protocol) from one manufacturer (MP Biomedicals) led to the final result "indeterminate". This manufacturer recommends that the detection of the isolated test specific "HIV-2 band" is not sufficient for final confirmation. The manufacturer recommends testing with another test, where required with a second independent sample collected after a certain time interval Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND for details. Thank you very much for your kind cooperation. Prof. Dr. H. Zeichhardt 335 HIV-1 and HIV-2 June 2012 Letter doc 4

5 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (INSTAND) in Zusammenarbeit mit Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e. V. (DVV) Gesellschaft für Virologie e. V. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM) Ringversuch Virologie Juni 2012 Virusimmunologie HIV-1 / HIV-2 (335) Qualitative Ergebnisse für Probe **** Suchteste und andere Teste **** Kombiteste Anti-HIV-1/Anti-HIV-2 : reaktiv gesamter Test Gesamt Reaktiv Grenzw. Negativ Quote % Methode / Hersteller gesamt reaktiv grenzw. negativ Quote ELISA HIV-1/2 (10) % Siemens - Enzygnost Anti-HIV 1/2 Plus % DiaSorin - Murex HIV-1.2.O % sonstiger Hersteller % biomerieux - Vironostika HIV Uni-Form II plus O % Bio-Rad - Genscreen HIV 1/2 Version % ELISA HIV-1/2 + p24 (21) % Siemens - Enzygnost HIV Integral II % DiaSorin - Murex HIV Ag/Ab Combo % Bio-Rad - Genscreen Ultra HIV Ag-Ab % biomerieux - Vironostika HIV Uni-Form II Ag/Ab % MEIA HIV-1/2 AxSYM (32) % Abbott - AxSYM HIV 1/2 go % MEIA HIV-1/2+p24 AxSYM (33) % Abbott - AxSYM HIV Ag/Ab Combo % ELFA HIV-1/2 + p24 (41) % biomerieux - VIDAS HIV DUO Quick % biomerieux - VIDAS HIV DUO Ultra % ChLIA HIV-1/2 (50) % Siemens - ADVIA HIV-1/O/2-Test (ehiv) % Ortho - VITROS Anti-HIV % Abbott - PRISM HIV O Plus % ChLIA HIV-1/2 + p24 (51) % Siemens - ADVIA HIV Ag/Ab-Kombotest (chiv) % Beckman Coulter - Access HIV combo % Abbott - PRISM HIV Ag/Ab Combo % DiaSorin - Liaison XL Murex HIV Ab/Ag % ECLIA HIV-1/2 + p24 (53) % Roche - Elecsys HIV combi % Roche - Elecsys HIV comb PT % CMIA HIV-1/2 + p24 (55) % Abbott - ARCHITECT HIV Ag/Ab Combo % Rapid-T.-Anti-HIV-1/2 (80) % Alere - Determine HIV-1/ % Qualpro Diagnostics - Retrochek HIV % sonstiger Hersteller % Standard Diagn - SD Bioline HIV 1/ % CvirG / LgesQ Rv= :59h Bl. 1

6 Qualitative Ergebnisse für Probe Suchteste und andere Teste Kombiteste Anti-HIV-1/Anti-HIV-2 Grp. 335 Methode / Hersteller gesamt reaktiv grenzw. negativ Quote Rapid-T.-Anti-HIV-1/2+p24AG (81) % Alere - Determine HIV-1/2 Ag/Ab Combo % CvirG / LgesQ Rv= :59h Bl. 2

7 Qualitative Ergebnisse für Probe **** Bestätigungsteste **** Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-1 : positiv % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Bio-Rad - Pepti-LAV % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % Qualitative Ergebnisse für Probe Bestätigungsteste Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-2 : negativ % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Bio-Rad - Pepti-LAV % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % CvirG / LgesQ Rv= :59h Bl. 3

8 50. Bestätigungsteste Anti-HIV-1 : positiv Qualitative Ergebnisse für Probe % Westernblot (100) % Bio-Rad - New LAV Blot I Assay % IFT (120) % eigene Herstellung % Qualitative Ergebnisse für Probe Bestätigungsteste Anti-HIV-2 : negativ, fraglich % Westernblot (100) % Bio-Rad - New LAV Blot II Assay % IFT (120) % eigene Herstellung % CvirG / LgesQ Rv= :59h Bl. 4

9 Qualitative Ergebnisse für Probe **** Suchteste und andere Teste **** Kombiteste Anti-HIV-1/Anti-HIV-2 : reaktiv gesamter Test Gesamt Reaktiv Grenzw. Negativ Quote % Methode / Hersteller gesamt reaktiv grenzw. negativ Quote ELISA HIV-1/2 (10) % Siemens - Enzygnost Anti-HIV 1/2 Plus % sonstiger Hersteller % DiaSorin - Murex HIV-1.2.O % Bio-Rad - Genscreen HIV 1/2 Version % biomerieux - Vironostika HIV Uni-Form II plus O % ELISA HIV-1/2 + p24 (21) % Siemens - Enzygnost HIV Integral II % Bio-Rad - Genscreen Ultra HIV Ag-Ab % DiaSorin - Murex HIV Ag/Ab Combo % biomerieux - Vironostika HIV Uni-Form II Ag/Ab % MEIA HIV-1/2 AxSYM (32) % Abbott - AxSYM HIV 1/2 go % MEIA HIV-1/2+p24 AxSYM (33) % Abbott - AxSYM HIV Ag/Ab Combo % ELFA HIV-1/2 + p24 (41) % biomerieux - VIDAS HIV DUO Quick % biomerieux - VIDAS HIV DUO Ultra % ChLIA HIV-1/2 (50) % Siemens - ADVIA HIV-1/O/2-Test (ehiv) % Ortho - VITROS Anti-HIV % Abbott - PRISM HIV O Plus % ChLIA HIV-1/2 + p24 (51) % Siemens - ADVIA HIV Ag/Ab-Kombotest (chiv) % Beckman Coulter - Access HIV combo % Abbott - PRISM HIV Ag/Ab Combo % DiaSorin - Liaison XL Murex HIV Ab/Ag % ECLIA HIV-1/2 + p24 (53) % Roche - Elecsys HIV combi % Roche - Elecsys HIV comb PT % CMIA HIV-1/2 + p24 (55) % Abbott - ARCHITECT HIV Ag/Ab Combo % Rapid-T.-Anti-HIV-1/2 (80) % Alere - Determine HIV-1/ % Standard Diagn - SD Bioline HIV 1/ % sonstiger Hersteller % Qualpro Diagnostics - Retrochek HIV % Rapid-T.-Anti-HIV-1/2+p24AG (81) % Alere - Determine HIV-1/2 Ag/Ab Combo % CvirG / LgesQ Rv= :59h Bl. 5

10 Qualitative Ergebnisse für Probe **** Bestätigungsteste **** Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-1 : ohne Bewertung West.Blot (100) MP Biomedicals - HIV-Blot Strip IA (140) Novartis - Chiron RIBA HIV-1/ HIV-2 SIA 1 1 Bio-Rad - Pepti-LAV Line IA (160) Innogenetics - INNO-LIA HIV I/II Score Mikrogen - recomline HIV-1 & HIV-2 IgG Qualitative Ergebnisse für Probe Bestätigungsteste Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-2 : positiv, fraglich % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Bio-Rad - Pepti-LAV % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % CvirG / LgesQ Rv= :59h Bl. 6

11 Qualitative Ergebnisse für Probe Bestätigungsteste Anti-HIV-1 : ohne Bewertung Westernblot (100) Bio-Rad - New LAV Blot I Assay IFT (120) eigene Herstellung Bestätigungsteste Anti-HIV-2 : positiv Qualitative Ergebnisse für Probe % Westernblot (100) % Bio-Rad - New LAV Blot II Assay % IFT (120) % eigene Herstellung % CvirG / LgesQ Rv= :59h Bl. 7

12 Qualitative Ergebnisse für Probe **** Suchteste und andere Teste **** Kombiteste Anti-HIV-1/Anti-HIV-2 : reaktiv gesamter Test Gesamt Reaktiv Grenzw. Negativ Quote % Methode / Hersteller gesamt reaktiv grenzw. negativ Quote ELISA HIV-1/2 (10) % Siemens - Enzygnost Anti-HIV 1/2 Plus % sonstiger Hersteller % DiaSorin - Murex HIV-1.2.O % Bio-Rad - Genscreen HIV 1/2 Version % biomerieux - Vironostika HIV Uni-Form II plus O % ELISA HIV-1/2 + p24 (21) % Siemens - Enzygnost HIV Integral II % DiaSorin - Murex HIV Ag/Ab Combo % Bio-Rad - Genscreen Ultra HIV Ag-Ab % biomerieux - Vironostika HIV Uni-Form II Ag/Ab % MEIA HIV-1/2 AxSYM (32) % Abbott - AxSYM HIV 1/2 go % MEIA HIV-1/2+p24 AxSYM (33) % Abbott - AxSYM HIV Ag/Ab Combo % ELFA HIV-1/2 + p24 (41) % biomerieux - VIDAS HIV DUO Quick % biomerieux - VIDAS HIV DUO Ultra % ChLIA HIV-1/2 (50) % Siemens - ADVIA HIV-1/O/2-Test (ehiv) % Ortho - VITROS Anti-HIV % Abbott - PRISM HIV O Plus % ChLIA HIV-1/2 + p24 (51) % Siemens - ADVIA HIV Ag/Ab-Kombotest (chiv) % Beckman Coulter - Access HIV combo % Abbott - PRISM HIV Ag/Ab Combo % DiaSorin - Liaison XL Murex HIV Ab/Ag % ECLIA HIV-1/2 + p24 (53) % Roche - Elecsys HIV combi % Roche - Elecsys HIV comb PT % CMIA HIV-1/2 + p24 (55) % Abbott - ARCHITECT HIV Ag/Ab Combo % Rapid-T.-Anti-HIV-1/2 (80) % Alere - Determine HIV-1/ % Qualpro Diagnostics - Retrochek HIV % sonstiger Hersteller % Standard Diagn - SD Bioline HIV 1/ % Rapid-T.-Anti-HIV-1/2+p24AG (81) % Alere - Determine HIV-1/2 Ag/Ab Combo % CvirG / LgesQ Rv= :59h Bl. 8

13 Qualitative Ergebnisse für Probe **** Bestätigungsteste **** Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-1 : positiv % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Bio-Rad - Pepti-LAV % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % Qualitative Ergebnisse für Probe Bestätigungsteste Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-2 : negativ % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Bio-Rad - Pepti-LAV % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % CvirG / LgesQ Rv= :59h Bl. 9

14 50. Bestätigungsteste Anti-HIV-1 : positiv Qualitative Ergebnisse für Probe % Westernblot (100) % Bio-Rad - New LAV Blot I Assay % IFT (120) % eigene Herstellung % Qualitative Ergebnisse für Probe Bestätigungsteste Anti-HIV-2 : negativ, fraglich % Westernblot (100) % Bio-Rad - New LAV Blot II Assay % IFT (120) % eigene Herstellung % CvirG / LgesQ Rv= :59h Bl. 10

15 Qualitative Ergebnisse für Probe **** Suchteste und andere Teste **** Kombiteste Anti-HIV-1/Anti-HIV-2 : negativ gesamter Test Gesamt Reaktiv Grenzw. Negativ Quote % Methode / Hersteller gesamt reaktiv grenzw. negativ Quote ELISA HIV-1/2 (10) % Siemens - Enzygnost Anti-HIV 1/2 Plus % sonstiger Hersteller % DiaSorin - Murex HIV-1.2.O % Bio-Rad - Genscreen HIV 1/2 Version % biomerieux - Vironostika HIV Uni-Form II plus O % ELISA HIV-1/2 + p24 (21) % Siemens - Enzygnost HIV Integral II % Bio-Rad - Genscreen Ultra HIV Ag-Ab % DiaSorin - Murex HIV Ag/Ab Combo % biomerieux - Vironostika HIV Uni-Form II Ag/Ab % MEIA HIV-1/2 AxSYM (32) % Abbott - AxSYM HIV 1/2 go % MEIA HIV-1/2+p24 AxSYM (33) % Abbott - AxSYM HIV Ag/Ab Combo % ELFA HIV-1/2 + p24 (41) % biomerieux - VIDAS HIV DUO Quick % biomerieux - VIDAS HIV DUO Ultra % ChLIA HIV-1/2 (50) % Siemens - ADVIA HIV-1/O/2-Test (ehiv) % Ortho - VITROS Anti-HIV % Abbott - PRISM HIV O Plus % ChLIA HIV-1/2 + p24 (51) % Siemens - ADVIA HIV Ag/Ab-Kombotest (chiv) % Beckman Coulter - Access HIV combo % Abbott - PRISM HIV Ag/Ab Combo % DiaSorin - Liaison XL Murex HIV Ab/Ag % ECLIA HIV-1/2 + p24 (53) % Roche - Elecsys HIV combi % Roche - Elecsys HIV comb PT % CMIA HIV-1/2 + p24 (55) % Abbott - ARCHITECT HIV Ag/Ab Combo % Rapid-T.-Anti-HIV-1/2 (80) % Alere - Determine HIV-1/ % Standard Diagn - SD Bioline HIV 1/ % sonstiger Hersteller % Qualpro Diagnostics - Retrochek HIV % Rapid-T.-Anti-HIV-1/2+p24AG (81) % Alere - Determine HIV-1/2 Ag/Ab Combo % CvirG / LgesQ Rv= :59h Bl. 11

16 Qualitative Ergebnisse für Probe **** Bestätigungsteste **** Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-1 : negativ % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Bio-Rad - Pepti-LAV % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % Qualitative Ergebnisse für Probe Bestätigungsteste Kombiteste Anti-HIV-1 / Anti-HIV-2 Nachweis von Anti-HIV-2 : negativ % West.Blot (100) % MP Biomedicals - HIV-Blot % Strip IA (140) % Bio-Rad - Pepti-LAV % Novartis - Chiron RIBA HIV-1/ HIV-2 SIA % Line IA (160) % Innogenetics - INNO-LIA HIV I/II Score % Mikrogen - recomline HIV-1 & HIV-2 IgG % CvirG / LgesQ Rv= :59h Bl. 12

17 50. Bestätigungsteste Anti-HIV-1 : negativ Qualitative Ergebnisse für Probe % Westernblot (100) % Bio-Rad - New LAV Blot I Assay % IFT (120) % eigene Herstellung % 60. Bestätigungsteste Anti-HIV-2 : negativ Qualitative Ergebnisse für Probe % Westernblot (100) % Bio-Rad - New LAV Blot II Assay % IFT (120) % eigene Herstellung % CvirG / LgesQ Rv= :59h Bl. 13