Final Report External Quality Assessment Scheme (EQAS) - March/April 2012 Virus Genome Detection - HIV-1 (RNA) (360) (PCR/NAT HIV-1)

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1 I S T A 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) ISTAD-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 CharitéCentrum für diagnostische und präventive Labormedizin Institut für Biotechnologische Diagnostik in der GBD Institut für Virologie, Campus Benjamin Franklin Potsdamer Chaussee 80, 49 Berlin Hindenburgdamm 7, 03 Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) /3; Fax: +49-(0) HPGrunert@gmx.de Heinz.Zeichhardt@charite.de Internet: 5 May 0 Final Report External Quality Assessment Scheme (EQAS) - March/April 0 Virus Genome Detection - HIV- (RA) (360) (PCR/AT HIV-) ISTAD-Target Value Laboratories: Friedrich-Alexander-Universität Erlangen-ürnberg, Universitätsklinikum Erlangen, Institut für Klinische und Molekulare Virologie, ationales Referenzzentrum für Retroviren: Prof. Dr. B. Fleckenstein, Dr. K. Korn Charité - Universitätsmedizin Berlin, Campus Mitte, Institut für Medizinische Virologie, ationales Konsiliarlaboratorium für Hantaviren: Prof. Dr. D. H. Krüger, PD Dr. J. Hofmann 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, Dr. R. Allwinn Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Abt. Virologie, FG Molekulare Virologie, Langen: PD Dr. M. übling, Dr. M. Chudy Robert Koch-Institut, Zentrum für HIV und Retrovirologie (FG 8), Berlin: Dr. C. Kücherer 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 Universitätsklinikum des Saarlandes, Institut für Virologie, Homburg/Saar; Prof. Dr. S. Smola, Prof. Dr.. Müller-Lantzsch 360 HIV- Genome March April 0 Letter 0055d.doc

2 Dear colleagues, Below please find the final report of the ISTAD External Quality Assessment (EQA) scheme "Virus Genome Detection - HIV- (RA)" March/April 0. 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 ISTAD EQA schemes in recent final reports and information letters. For details please see the ISTAD homepage under "Information on ISTAD External Quality Assessment (EQA) Schemes in Virus Diagnostics/as of May 0" (please use the download button) These changes concern: ew RiliBÄK (Guideline of the German Medical Association) and validity period of certificates of ISTAD 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 ISTAD 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 March 0). Release of final reports of EQA schemes in virus diagnostics on the ISTAD homepage. 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 genome detection) in English language ( and in German language ( 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: 0. Quantitative detection of HIV- (RA) - Quantitativer achweis von HIV- (RA) 0. Qualitative detection of HIV- (RA) - Qualitativer achweis von HIV- (RA) These test categories are individually evaluated in the certificate of successful participation and listed in all participation and evaluation documents. 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 (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). A corresponding proceeding is applied for tests for virus antigen and genome detection. Example - Program "Virus Genome Detection - HIV- (RA)" (360): All 4 samples of the sample set have to be tested correctly with the same method in test category 0 "Quantitative detection of HIV- (RA) - Quantitativer achweis von HIV- (RA)". The same applies for test category 0 of this EQA scheme. Please note for the quantitative evaluation that the assessment criterion for stating a result as "correct" is based on an interval of -.0 log 0 to +.0 log 0 of the median (based on all evaluated methods). Participants, whose quantitative results are outside of the indicated interval should control the performance and suitability of their test system. 360 HIV- Genome March April 0 Letter 0055d.doc

3 In order to assess the variance of all results (based on all evaluated methods) the confidence interval of -0.6 log 0 to +0.6 log 0 and the confidence interval of -0.5 log 0 to +0.5 log 0 of the median are depicted (Table 3). Please note: The interval of -0.6 log 0 to +0.6 log 0 has been introduced which will allow you to assign your quantitative result to "the acceptable variation range calculated as the logarithm to the base 0 of the target value = zulässige Abweichung vom dekadisch logarithmierten Sollwert beim Ringversuch". It is planned to introduce this requirement into the RiliBÄK section B 3 (direct detection and characterization of infectious diseases pathogens = Direkter achweis und Charakterisierung von Infektionserregern) which is in progress for the EQA scheme for virus genome detection of HIV- (RA). The quantitative and qualitative results are summarized in separate tables. The median values for copies/ml are based on the reported values of the participants. Details on samples You were requested to report your results as follows: Test category 0: You were requested to report the results quantitatively in "genome equivalents/ml = copies/ml", "International Units = IU/ml" or "below level of detection". Test category 0: You were requested to report the results qualitatively as "positive", "below level of detection/negative" or "indeterminate". The positive samples , and represent different dilution steps of a dilution series of a highly purified HIV- isolate (subtype B) of a patient with HIV/AIDS. The same negative plasma pool was used for dilution. A negative plasma pool was used for the negative sample early all quantitative results were reported as "copies/ml". For details on sample properties, target values, results and success rates please see Table. The simultaneous reporting of different results for one and the same sample cannot be accepted and will be evaluated as a missing value, e.g. the simultaneous reporting of a "positive" and "indeterminate" result will not be accepted. 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. 3 Instructions for reporting of results in the protocol sheets Reporting of quantitative results (test category 0): Please state your quantitative results as numerical value (copies/ml and IE/ml) in the corresponding column of the protocol. Attention: Quantitative values with > or >= will not be considered and assessed as missing result. Please dilute highly concentrated samples. Quantitative values with < or <= should be interpreted: Please indicate, if (i) you interpret a given sample as "negative" or (ii) the measured value is below level of detection of the corresponding test, however, represents a low virus concentration. In this case please report this low value if possible. 360 HIV- Genome March April 0 Letter 0055d.doc 3

4 4 Sample properties, target values, results and success rates Table : Summary of sample properties, target values, results and success rates Sample Sample * Sample 36003* Sample 36003* Sample properties HIV--negative HIV--positive HIV--positive HIV--positive Dilution : * : * : * Success rates for all 4 samples of the sample set & +/-.0 log 0 of the median Considered as correct qualitative results (target values - test category 0) below level of detection/ negative positive positive positive 98,6% (70/7) 00% (7/7) 00% (7/7) 00% (7/7) Considered as correct quantitative results (target values - test category 0) c/ml 00% (97/97) 00% (97/97) 00% (97/97) 00% (97/97) IU/ml w/o evaluation w/o evaluation w/o evaluation w/o evaluation 98.6% & (68/69) & 00% & (96/96) & +/-0.6 log 0 of the median +/-0.5 log 0 of the median Results within the confidence intervals c/ml % (95/97) 96.9% (94/97) 99.0% (96/97) IU/ml w/o evaluation w/o evaluation w/o evaluation w/o evaluation c/ml % (78/97) 78.4% (76/97) 76.3% (74/97) IU/ml w/o evaluation w/o evaluation w/o evaluation w/o evaluation & The success rates for all 4 samples of the corresponding sample set of test categories 0 and 0, 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. * The positive samples , and represent different dilution steps of a dilution series of a highly purified HIV- isolate diluted in the same negative plasma pool. Quantitative results reported in IU/ml are without evaluation due to the low number of analyses (please see the following Table ). 360 HIV- Genome March April 0 Letter 0055d.doc 4

5 Five participants reported results in International Units/ml (IU/ml) (Table ). These results are summarized in the following table and will be not evaluated (without any disadvantage for the certificate) due to the low number of analyses. Table : Quantitative detection in IU/ml: results without evaluation Method Manufacturer Participating laboratories Sample Sample * Sample 36003* Sample 36003* HIV--negative HIV--positive HIV--positive HIV--positive : * : * : * IU/ml IU/ml IU/ml IU/ml TaqMan Abbott Abbott RealTime HIV- T T T TaqMan in house T other PCR Qiagen artus HI Virus- RG RT-PCR Kit T * The positive samples , and represent different dilution steps of a dilution series of a highly purified HIV- isolate diluted in the same negative plasma pool. T = Teilnehmer = participant The quantitative and qualitative results are summarized in separate tables and figures. 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 360 HIV- Genome March April 0 Letter 0055d.doc 5

6 ISTAD e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstellen) - Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Quantitativer achweis von HIV- (RA) (Testkategorie 0) Quantitative detection of HIV- (RA) (Test category 0) 360 HIV- Genom 0 Quant Genomnachweis Deckblatt.doc

7 Methods Table 3: Quantitative Results of EQAS for Virus Genome Detection: PCR/AT HIV- (March/April 0) Correct results: 0 copies/ml or below level of detection Median copies/ml Correct results % o. of analyses Copies/ml Sample negative Interval of -0.6 log 0 to +0.6 log 0 of the median Limits of o. of interval analyses copies/ml Interval of -0.5 log 0 to +0.5 log 0 of the median Limits of interval copies/ml o. of analyses All methods / PCR 0 00 / TaqMan /90 bda 0 00 / ASBA 0 00 / other PCR /3 Methods Sample positive ( : ) Interval of Correct results in interval -0.6 log copies/ml 0 to +0.6 log 0 of the median Median copies/ml Correct results % o. of analyses All methods /97 PCR / TaqMan /90 bda / ASBA / other PCR /3 Limits of interval copies/ml o. of analyses 97.9% (95/97) Interval of -0.5 log 0 to +0.5 log 0 of the median Limits of interval copies/ml o. of analyses 80.4% (78/97) Please note for the quantitative evaluation that the assessment criterion for stating a result as "correct" is based on an interval of -.0 log 0 to +.0 log 0 of the median (based on all evaluated methods). In order to assess the variance of results for each sample the confidence interval of -0.6 log 0 to +0.6 log 0 and the confidence interval of -0.5 log 0 to +0.5 log 0 of the median (based on all evaluated methods) are depicted. Participants, whose quantitative results are outside of the indicated -.0 log 0 to +.0 log 0 interval around the median, should control the performance and suitability of their test system. 360 HIV- Genome March April 0 Table 0055d.doc

8 Continued Table 3: Quantitative Results of EQAS for Virus Genome Detection: PCR/AT HIV- (March/April 0) Copies/ml Methods Sample positive ( : ) Interval of Correct results in interval -0.6 log copies/ml 0 to +0.6 log 0 of the median Median copies/ml Correct results % o. of analyses All methods /97 PCR / TaqMan /90 bda / ASBA 0 00 / other PCR /3 Methods Limits of interval copies/ml o. of analyses 96.9% (94/97) Sample positive ( : ) Interval of Correct results in interval -0.6 log copies/ml 0 to +0.6 log 0 of the median Median copies/ml Correct results % o. of analyses All methods /97 PCR / TaqMan /90 bda / ASBA / other PCR /3 Limits of interval copies/ml o. of analyses 99.0% (96/97) Interval of -0.5 log 0 to +0.5 log 0 of the median Limits of interval copies/ml o. of analyses 78.4% (76/97) Interval of -0.5 log 0 to +0.5 log 0 of the median Limits of interval copies/ml o. of analyses 76.3% (74/97) Please note for the quantitative evaluation that the assessment criterion for stating a result as "correct" is based on an interval of -.0 log 0 to +.0 log 0 of the median (based on all evaluated methods). In order to assess the variance of results for each sample the confidence interval of -0.6 log 0 to +0.6 log 0 and the confidence interval of -0.5 log 0 to +0.5 log 0 of the median (based on all evaluated methods) are depicted. Participants, whose quantitative results are outside of the indicated -.0 log 0 to +.0 log 0 interval around the median, should control the performance and suitability of their test system. 360 HIV- Genome March April 0 Table 0055d.doc

9 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36009, Kopien/ml: 0 Methodenhäufigkeit Pr Prozent = 0 4 o. SW Taq Man 9. andere PCR 3.9 o. SW 4 94 bda.0 ASBA.0 PCR PCR Pr.36009, Kopien/ml: 0 = 0...<= PCR Pr.36009, Kopien/ml: 0 Roche - COBAS Amplicor HIV- Monitor v.5 = 0...<= Bl. 9 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

10 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36009, Kopien/ml: 0 Taq Man Pr.36009, Kopien/ml: 0 = <= Taq Man Pr = 4 0..<= TaqManPr eigene Herstellung = 0..<= Taq Man Pr.36009, Kopien/ml: 0 Roche - COBAS AmpliPrep/COBAS TaqMan HIV- = <= Taq Man Pr.36009, Kopien/ml: 0 Roche - COBAS TaqMan HIV- = <= Taq Man Pr.36009, Kopien/ml: 0 Roche - COBAS TaqMan HIV-, v.0 = <= Bl. 9 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

11 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36009, Kopien/ml: 0 Taq Man Pr.36009, Kopien/ml: 0 Abbott - Abbott RealTime HIV- = <= Taq Man Pr Abbott - Abbott RealTime HIV- = 3 0..<= bda Pr.36009, Kopien/ml: 0 = 0...<= bda Pr.36009, Kopien/ml: 0 Siemens - VERSAT HIV- RA 3.0 = 0...<= ASBA Pr.36009, Kopien/ml: 0 = 0...<= ASBA Pr.36009, Kopien/ml: 0 biomerieux - uclisens EasyQ HIV- v.0 = 0...<= Bl. 93 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

12 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36009, Kopien/ml: 0 andere PCR Pr.36009, Kopien/ml: 0 = <= andere PCR Pr = 0..<= andere PCR Pr.36009, Kopien/ml: 0 Siemens - VERSAT HIV- RA.0 (kpcr) = 0...<= andere PCR Pr.36009, Kopien/ml: 0 Qiagen - artus HI Virus- RG RT-PCR Kit = 0...<= andere PCR Pr Qiagen - artus HI Virus- RG RT-PCR Kit = 0..<= Bl. 94 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

13 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe , Kopien/ml: Methodenhäufigkeit Pr Prozent = 0 4 o. SW Taq Man 9. andere PCR 3.9 o. SW 4 94 bda.0 ASBA.0 PCR PCR Pr , Kopien/ml: = PCR Pr , Kopien/ml: Roche - COBAS Amplicor HIV- Monitor v.5 = Median= Median=400 Bl. 96 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

14 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe , Kopien/ml: Taq Man Pr , Kopien/ml: = 90 Taq Man Pr = < < < < < < Median= Median=6968 TaqManPr eigene Herstellung = Taq Man Pr , Kopien/ml: Roche - COBAS AmpliPrep/COBAS TaqMan HIV- = < < < <= Median= Median=6948 Taq Man Pr , Kopien/ml: Roche - COBAS TaqMan HIV- = 3 Taq Man Pr , Kopien/ml: Roche - COBAS TaqMan HIV-, v.0 = < < < Median= Median=5500 Bl. 97 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

15 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe , Kopien/ml: Taq Man Pr , Kopien/ml: Abbott - Abbott RealTime HIV- = 35 Taq Man Pr Abbott - Abbott RealTime HIV- = < < < <= Median= Median=953 bda Pr , Kopien/ml: = bda Pr , Kopien/ml: Siemens - VERSAT HIV- RA 3.0 = Median= Median=5469 ASBA Pr , Kopien/ml: = ASBA Pr , Kopien/ml: biomerieux - uclisens EasyQ HIV- v.0 = Median= Median=9900 Bl. 98 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

16 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe , Kopien/ml: andere PCR Pr , Kopien/ml: = 3 andere PCR Pr = Median= Median=8966 andere PCR Pr , Kopien/ml: Siemens - VERSAT HIV- RA.0 (kpcr) = andere PCR Pr , Kopien/ml: Qiagen - artus HI Virus- RG RT-PCR Kit = Median= Median=8535 andere PCR Pr Qiagen - artus HI Virus- RG RT-PCR Kit = Median=8966 Bl. 99 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

17 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Methodenhäufigkeit Pr Prozent = 0 4 o. SW Taq Man 9. andere PCR 3.9 o. SW 4 94 bda.0 ASBA.0 PCR PCR Pr.36003, Kopien/ml: = PCR Pr.36003, Kopien/ml: Roche - COBAS Amplicor HIV- Monitor v.5 = Bl. 0 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

18 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Taq Man Pr.36003, Kopien/ml: = 90 Taq Man Pr = < < < < < < < <= Median= Median=35 TaqManPr eigene Herstellung = Taq Man Pr.36003, Kopien/ml: Roche - COBAS AmpliPrep/COBAS TaqMan HIV- = < < < < < <= Median=45 Taq Man Pr.36003, Kopien/ml: Roche - COBAS TaqMan HIV- = 3 Taq Man Pr.36003, Kopien/ml: Roche - COBAS TaqMan HIV-, v.0 = < < < < Median= Median=40 Bl. 0 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

19 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Taq Man Pr.36003, Kopien/ml: Abbott - Abbott RealTime HIV- = 35 Taq Man Pr Abbott - Abbott RealTime HIV- = < < < < <= Median= Median=378 bda Pr.36003, Kopien/ml: = bda Pr.36003, Kopien/ml: Siemens - VERSAT HIV- RA 3.0 = 49...<= <= Median= Median=64 ASBA Pr.36003, Kopien/ml: = ASBA Pr.36003, Kopien/ml: biomerieux - uclisens EasyQ HIV- v.0 = Bl. 03 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

20 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: andere PCR Pr.36003, Kopien/ml: = 3 andere PCR Pr = 03...<= Median=46 andere PCR Pr.36003, Kopien/ml: Siemens - VERSAT HIV- RA.0 (kpcr) = andere PCR Pr.36003, Kopien/ml: Qiagen - artus HI Virus- RG RT-PCR Kit = 03...<= Median= andere PCR Pr Qiagen - artus HI Virus- RG RT-PCR Kit = Median=46 Bl. 04 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

21 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Methodenhäufigkeit Pr Prozent = 0 4 o. SW Taq Man 9. andere PCR 3.9 o. SW 4 94 bda.0 ASBA.0 PCR PCR Pr.36003, Kopien/ml: = PCR Pr.36003, Kopien/ml: Roche - COBAS Amplicor HIV- Monitor v.5 = Median= Median=6790 Bl. 06 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

22 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Taq Man Pr.36003, Kopien/ml: = 90 Taq Man Pr = < < < < < <= <= Median= Median=537 TaqManPr eigene Herstellung = Taq Man Pr.36003, Kopien/ml: Roche - COBAS AmpliPrep/COBAS TaqMan HIV- = < < < <= Median= Median=7930 Taq Man Pr.36003, Kopien/ml: Roche - COBAS TaqMan HIV- = 3 Taq Man Pr.36003, Kopien/ml: Roche - COBAS TaqMan HIV-, v.0 = < < < Median= Median=4090 Bl. 07 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

23 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: Taq Man Pr.36003, Kopien/ml: Abbott - Abbott RealTime HIV- = 35 Taq Man Pr Abbott - Abbott RealTime HIV- = < < <= <= Median= Median=6038 bda Pr.36003, Kopien/ml: = bda Pr.36003, Kopien/ml: Siemens - VERSAT HIV- RA 3.0 = 6...<= <= ASBA Pr.36003, Kopien/ml: = ASBA Pr.36003, Kopien/ml: biomerieux - uclisens EasyQ HIV- v.0 = Median= Median=4500 Bl. 08 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

24 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusgenom-achweis PCR- / AT- HIV- (360) März 0 Probe 36003, Kopien/ml: andere PCR Pr.36003, Kopien/ml: = 3 andere PCR Pr = <= Median= Median=440 andere PCR Pr.36003, Kopien/ml: Siemens - VERSAT HIV- RA.0 (kpcr) = andere PCR Pr.36003, Kopien/ml: Qiagen - artus HI Virus- RG RT-PCR Kit = <= Median= Median=98 andere PCR Pr Qiagen - artus HI Virus- RG RT-PCR Kit = Median=440 Bl. 09 Cvir / Lh Rv= :9h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

25

26 ISTAD e. V., Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (vormals Hämometerprüfstellen) - Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Qualitativer achweis von HIV- (RA) (Testkategorie 0) Qualitative detection of HIV- (RA) (Test category 0) 360 HIV- Genom 0 Qual Genomnachweis Deckblatt.doc

27 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Ringversuch Virologie März 0 Virusgenomnachweis PCR- / AT- HIV- (360) (Die quantitativen Ergebnisse entnehmen Sie bitte den beigefügten Grafiken.) Qualitative Ergebnisse für Probe Qualitative detection of HIV- (RA) : negativ gesamter Test Gesamt Positiv Fraglich egativ Quote % Methode / Hersteller gesamt positiv fraglich negativ Quote PCR () % Roche - COBAS AmpliScreen HIV- Test v % eigene Herstellung 00.0% nested PCR () % eigene Herstellung 00.0% Taq Man (3) % Roche - COBAS AmpliPrep/COBAS TaqMan HIV % Abbott - Abbott RealTime HIV % eigene Herstellung % DRK - HIV- PCR Kit 00.0% Roche - COBAS TaqMan HIV- 00.0% Light Cycler (40) % sonstiger Hersteller 00.0% TMA (60) % ovartis - Procleix Ultrio Assay 00.0% ovartis - Procleix Ultrio Plus Assay 00.0% Multiplex PCR (70) % GFE Blut - Virus Screening PCR Kit v % Multiplex Taq Man (75) % Roche - COBAS TaqScreen MPX Test 00.0% Roche - COBAS TaqScreen MPX Test, v % eigene Herstellung 00.0% GFE Blut - Virus Screening PCR Kit v. 00.0% andere PCR (98) % Qiagen - artus HI Virus- RG RT-PCR Kit % Sacace - HIV Real-TM Qual 50.0% Siemens - VERSAT HIV- RA.0 (kpcr) 00.0% CvirG / LgesQ Rv=.5.0 0:h Bl.

28 Grp. 360 Qualitative Ergebnisse für Probe Qualitative detection of HIV- (RA) : positiv gesamter Test Gesamt Positiv Fraglich egativ Quote % Methode / Hersteller gesamt positiv fraglich negativ Quote PCR () % Roche - COBAS AmpliScreen HIV- Test v % eigene Herstellung 00.0% nested PCR () % eigene Herstellung 00.0% Taq Man (3) % Abbott - Abbott RealTime HIV % Roche - COBAS AmpliPrep/COBAS TaqMan HIV % eigene Herstellung % DRK - HIV- PCR Kit 00.0% Roche - COBAS TaqMan HIV- 00.0% Light Cycler (40) % sonstiger Hersteller 00.0% TMA (60) % ovartis - Procleix Ultrio Assay 00.0% ovartis - Procleix Ultrio Plus Assay 00.0% Multiplex PCR (70) % GFE Blut - Virus Screening PCR Kit v % Multiplex Taq Man (75) % Roche - COBAS TaqScreen MPX Test 00.0% Roche - COBAS TaqScreen MPX Test, v % eigene Herstellung 00.0% GFE Blut - Virus Screening PCR Kit v. 00.0% andere PCR (98) % Qiagen - artus HI Virus- RG RT-PCR Kit % Sacace - HIV Real-TM Qual 00.0% Siemens - VERSAT HIV- RA.0 (kpcr) 00.0% CvirG / LgesQ Rv=.5.0 0:h Bl.

29 Grp. 360 Qualitative Ergebnisse für Probe Qualitative detection of HIV- (RA) : positiv gesamter Test Gesamt Positiv Fraglich egativ Quote % Methode / Hersteller gesamt positiv fraglich negativ Quote PCR () % Roche - COBAS AmpliScreen HIV- Test v % eigene Herstellung 00.0% nested PCR () % eigene Herstellung 00.0% Taq Man (3) % Abbott - Abbott RealTime HIV % Roche - COBAS AmpliPrep/COBAS TaqMan HIV % eigene Herstellung % DRK - HIV- PCR Kit 00.0% Roche - COBAS TaqMan HIV- 00.0% Light Cycler (40) % sonstiger Hersteller 00.0% TMA (60) % ovartis - Procleix Ultrio Assay 00.0% ovartis - Procleix Ultrio Plus Assay 00.0% Multiplex PCR (70) % GFE Blut - Virus Screening PCR Kit v % Multiplex Taq Man (75) % Roche - COBAS TaqScreen MPX Test 00.0% Roche - COBAS TaqScreen MPX Test, v % eigene Herstellung 00.0% GFE Blut - Virus Screening PCR Kit v. 00.0% andere PCR (98) % Qiagen - artus HI Virus- RG RT-PCR Kit % Sacace - HIV Real-TM Qual 00.0% Siemens - VERSAT HIV- RA.0 (kpcr) 00.0% CvirG / LgesQ Rv=.5.0 0:h Bl. 3

30 Grp. 360 Qualitative Ergebnisse für Probe Qualitative detection of HIV- (RA) : positiv gesamter Test Gesamt Positiv Fraglich egativ Quote % Methode / Hersteller gesamt positiv fraglich negativ Quote PCR () % Roche - COBAS AmpliScreen HIV- Test v % eigene Herstellung 00.0% nested PCR () % eigene Herstellung 00.0% Taq Man (3) % Abbott - Abbott RealTime HIV % Roche - COBAS AmpliPrep/COBAS TaqMan HIV % eigene Herstellung % DRK - HIV- PCR Kit 00.0% Roche - COBAS TaqMan HIV- 00.0% Light Cycler (40) % sonstiger Hersteller 00.0% TMA (60) % ovartis - Procleix Ultrio Assay 00.0% ovartis - Procleix Ultrio Plus Assay 00.0% Multiplex PCR (70) % GFE Blut - Virus Screening PCR Kit v % Multiplex Taq Man (75) % Roche - COBAS TaqScreen MPX Test 00.0% Roche - COBAS TaqScreen MPX Test, v % eigene Herstellung 00.0% GFE Blut - Virus Screening PCR Kit v. 00.0% andere PCR (98) % Qiagen - artus HI Virus- RG RT-PCR Kit % Sacace - HIV Real-TM Qual 00.0% Siemens - VERSAT HIV- RA.0 (kpcr) 00.0% CvirG / LgesQ Rv=.5.0 0:h Bl. 4