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

Transkript

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. 0, 403 Düsseldorf Hindenburgdamm 7, 03 Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) /3; Fax: +49-(0) donoso@instand-ev.de Heinz.Zeichhardt@charite.de 3 September 03 External Quality Assessment Scheme (EQAS) - June/July 03 Virus Immunology - Varicella Zoster Virus (353) (Tests for anti-vzv-igg/total and anti-vzv-igm) ISTAD-Target Value Laboratories: Universitätsklinikum Jena, Institut für Virologie und Antivirale Therapie, ationales Konsiliarlaboratorium für HSV und VZV: Prof. Dr. A. Sauerbrei, Prof. Dr. P. Wutzler Justus-Liebig-Universität Gießen, Institut für Medizinische Virologie, ationales Referenzzentrum für Hepatitis-B-Virus und Hepatitis-D-Virus: PD Dr. D. Glebe, Dr. Christian Schüttler, Prof. Dr. W. Gerlich Klinikum der Johann Wolfgang Goethe-Universität, 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. R. Allwinn Labor Enders, Institut für Virologie, Infektiologie und Epidemiologie, Stuttgart: Prof. Dr. Gisela Enders & Partner Uniklinik Köln, Institut für Virologie, ationales Referenzzentrum für Papillom- und Polyomaviren: Prof. Dr. H. Pfister, Prof. Dr. U. Wieland, Dr. R. Kaiser 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 353 Varicella Zoster Virus June July 03 Letter doc

2 Dear colleagues, We appreciate your understanding that ISTAD was forced to postpone the EQA scheme from June to July 03 due to the dramatic flood in some regions of Germany and neighboring countries. We ensured that due to this postponement you did not get any disadvantage: For those EQA schemes which will be performed by ISTAD again in September 03, we arranged with priority the evaluation of the EQA schemes and sending of certificates of successful participation. Start of the validity period of all certificates of successful participation of the EQA schemes June/July 03 follows the originally planned time schedule for June 03 and is therefore dated unchanged on 8 June 03 (see statement on the certificates of successful participation). aturally, the EQA samples were stored frozen at adequate conditions until shipment by the courier service. This procedure was in accordance with the technical specifications for virological ISTAD EQA schemes. Below please find the final report of the ISTAD External Quality Assessment (EQA) scheme "Virus Immunology - Varicella zoster virus" June/July 03. You receive the following participation documents for this EQA scheme by mail: - certificate of successful participation, - statement of participation, - statement of individual results. 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. In March 03, the new Guideline of the German Medical Association (Bundesärztekammer/ RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) has been completed by publicizing the specified Section B 3 "Direct detection and characterization of infectious pathogens = Direkter achweis und Charakterisierung von Infektionserregern". Please see for: specified Section B 3 - Deutsches Ärzteblatt, Jg. 0; Heft,. März 03, A ; updated compiled version of the RiliBÄK with Section A and the specified Sections B, B, B 3, B 4 and B 5 as well as frequently asked questions (FAQs) and a list of the appointed reference institutions (Referenzinstitutionen) - the link of the Bundesärztekammer (German Medical Association); For detailed information on the ISTAD EQA schemes in virus diagnostics and the new RiliBÄK (as of 9 May 03) please use the download button 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 ( 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. Testing for anti-vzv-igg or anti-vzv total. Testing for avidity of anti-vzv-igg These test categories are individually evaluated in the certificate of successful participation and listed in all participation documents and final reports. 353 Varicella Zoster Virus June July 03 Letter doc

3 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). Please note: A corresponding proceeding is applied for tests for virus antigen and genome detection. Specifications will follow. Example - Program "Virus immunology - Varicella zoster virus" (353): Both samples of the sample set have to be tested correctly with the same method in test category 0 "Testing for anti-vzv-igg or anti-vzv total". The same applies for test categories and 0 of this EQA scheme. Sample properties, target values, results and success rates Test categories 0 and 0: You were requested to report the results qualitatively as "positive", "negative" or "borderline" and additionally as titer values or milli-international Units/ml (miu/ml) for anti-vzv-igg and Units/ml (U/ml) for anti-vzv-igm, respectively. You were asked to link the titer values, miu/ml and U/ml, respectively, with a qualitative statement. The reporting of values as titer, miu/ml or U/ml with >= or <= was not considered. Only qualitative results were considered for receiving a certificate in this EQA scheme. Results as titer values, miu/ml or U/ml are depicted in the figures not evaluated (marked as "ohne Sollwert" = "o.sw"; without disadvantage for the certificate). 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. Test category : You were requested to report the avidity results for positive samples qualitatively as "high" and "low, respectively, and in percent. o avidity results are required for negative samples. 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. 353 Varicella Zoster Virus June July 03 Letter doc 3

4 Sample o * 35304* Sample properties Sample source Pool serum; sera of two healthy blood donors with a past VZV infection or vaccination Pool serum; sera of two healthy blood donors with a past VZV infection or vaccination Dilution IgG/ total Test category positive ---- positive Success rates for both samples in test categories 0, and 0, respectively & Considered as "correct" result Avidity Test category qualitative: high percent: 50-00% qualitative: high percent: 50-00% IgM Test category 0 negative negative Success rates for all methods per sample IgG/ Avidity IgM total Test Test Test category category category % (369/374) 98.7% (369/374) qualitative: 00% (3/3) percent: 00% (0/0) qualitative: 00% (3/3) percent: 00% (0/0) 99.4% (308/30) 00% (30/30) 98.8% & 00% & 99.3% & (33/37) & (/) & (98/300) & & The success rates for both samples in 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 samples and consist of sera of different blood donors. 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 353 Varicella Zoster Virus June July 03 Letter doc 4

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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) Qualitative determination Anti-VZV-IgG/total (test category 0) Avidity (test category ) Anti-VZV-IgM (test category 0) Differentiation according to method, manufacturer and test name 353 Varizella Zoster Virus Deckblatt qual E.doc

7 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) EQAS Virology June / July 03 Virus immunology Varicella zoster virus (353) Qualitative results for sample Testing for anti-vzv-igg or anti-vzv total : positive Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-VZV-IgG (0) % Siemens - Enzygnost Anti-VZV/IgG % EuroImmun - Anti-VZV-ELISA (IgG) % Virion/Serion - ELISA classic VZV IgG % Virotech - VZV ELISA IgG/IgM 00.0% ovatec - ovalisa VZV IgG-ELISA % Medac - VZV-IgG-ELISA PKS medac % R-Biopharm - Ridascreen VZV IgG % DIESSE - Varicella IgG 00.0% DRG - Varizella zoster IgG ELISA 00.0% IBL - Varicella-Zoster-Virus IgG ELISA 00.0% in house 00.0% Mast - Mastazyme VZV IgG 00.0% ViroImmun - VIR-ELISA ATI-VZV-IgG 00.0% IFT-anti-VZV-IgG (30) % EuroImmun - Anti-VZV-IIFT IgG % Viramed - VZV IgG IFT Testkit % ViroImmun - IFA VZV-IgG 00.0% in house 00.0% Mast - VZV-IgG Complete IF Test 00.0% Vidia - IF-VIDITEST anti-vzv 00.0% ELFA-anti-VZV-IgG (33) % biomerieux - VIDAS Varicella-Zoster IgG % ChLIA-anti-VZV-IgG (34) % DiaSorin - LIAISO VZV IgG % complement fixation test (40) % Virion/Serion - KBR VZV % Siemens - Varicella-Zoster-KBR 00.0% CvirG / LgesQ Rv= :37h Bl. 38

8 Grp Testing for avidity of anti-vzv-igg : high Qualitative results for sample Total test total high intermed. low Success rate % Method / Manufacturer total high intermed. low Success rate ELISA-anti-VZV-IgG (0) % EuroImmun - Anti-VZV-ELISA (IgG) Avidität % Siemens - Enzygnost Anti-VZV/IgG Avidität % Vidia - ELISA-VIDITEST VZV IgG avidity 00.0% Medac - VZV-IgG-ELISA PKS medac Avidität 00.0% IFT-anti-VZV-IgG (30) % in house 00.0% EuroImmun - Anti-VZV-IIFT IgG Avidität 00.0% : negative Qualitative results for sample Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-VZV-IgM (0) % Siemens - Enzygnost Anti-VZV/IgM % EuroImmun - Anti-VZV ELISA (IgM) % Virion/Serion - ELISA classic VZV IgM % Virotech - VZV ELISA IgM % ovatec - ovalisa VZV IgM-ELISA % Medac - VZV-IgM-ELA Test PKS medac % R-Biopharm - Ridascreen VZV IgM % DIESSE - Varicella IgM % DRG - Varizella Zoster IgM ELISA 00.0% Vidia - ELISA-VIDITEST anti-vzv IgM 00.0% Mast - Mastazyme VZV IgM 00.0% IBL - Varicella-Zoster-Virus IgM ELISA 00.0% ViroImmun - VIR-ELISA ATI-VZV-IgM 00.0% in house 00.0% other manufacturers 00.0% Bio-Rad - Platelia VZV IgM 00.0% IFT-anti-VZV-IgM (30) % EuroImmun - Anti-VZV-IIFT IgM % Viramed - VZV IgM IFT Testkit % Meridian - Merifluor VZV IgM IFA 00.0% ViroImmun - IFA VZV-IgM 00.0% Bios - Biognost VZV IgM 00.0% Vidia - IF-VIDITEST anti-vzv 00.0% Mast - VZV-IgM Complete IF Test 00.0% in house 00.0% ChLIA-anti-VZV-IgM (34) % DiaSorin - LIAISO VZV-IgM % CvirG / LgesQ Rv= :37h Bl. 39

9 Grp. 353 Qualitative results for sample Testing for anti-vzv-igg or anti-vzv total : positive Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-VZV-IgG (0) % Siemens - Enzygnost Anti-VZV/IgG % EuroImmun - Anti-VZV-ELISA (IgG) % Virion/Serion - ELISA classic VZV IgG % Virotech - VZV ELISA IgG/IgM 00.0% ovatec - ovalisa VZV IgG-ELISA % Medac - VZV-IgG-ELISA PKS medac % R-Biopharm - Ridascreen VZV IgG % IBL - Varicella-Zoster-Virus IgG ELISA 00.0% DIESSE - Varicella IgG 00.0% DRG - Varizella zoster IgG ELISA 00.0% in house 00.0% Mast - Mastazyme VZV IgG 00.0% ViroImmun - VIR-ELISA ATI-VZV-IgG 00.0% IFT-anti-VZV-IgG (30) % EuroImmun - Anti-VZV-IIFT IgG % Viramed - VZV IgG IFT Testkit % in house 00.0% Mast - VZV-IgG Complete IF Test 00.0% Vidia - IF-VIDITEST anti-vzv 00.0% ViroImmun - IFA VZV-IgG 00.0% ELFA-anti-VZV-IgG (33) % biomerieux - VIDAS Varicella-Zoster IgG % ChLIA-anti-VZV-IgG (34) % DiaSorin - LIAISO VZV IgG % complement fixation test (40) % Virion/Serion - KBR VZV % Siemens - Varicella-Zoster-KBR 00.0%. Testing for avidity of anti-vzv-igg : high Qualitative results for sample Total test total high intermed. low Success rate % Method / Manufacturer total high intermed. low Success rate ELISA-anti-VZV-IgG (0) % EuroImmun - Anti-VZV-ELISA (IgG) Avidität % Siemens - Enzygnost Anti-VZV/IgG Avidität % Medac - VZV-IgG-ELISA PKS medac Avidität 00.0% Vidia - ELISA-VIDITEST VZV IgG avidity 00.0% IFT-anti-VZV-IgG (30) % EuroImmun - Anti-VZV-IIFT IgG Avidität 00.0% in house 00.0% CvirG / LgesQ Rv= :37h Bl. 40

10 Grp. 353 : negative Qualitative results for sample Total test total positive borderline negative Success rate % Method / Manufacturer total positive borderline negative Success rate ELISA-anti-VZV-IgM (0) % Siemens - Enzygnost Anti-VZV/IgM % EuroImmun - Anti-VZV ELISA (IgM) % Virion/Serion - ELISA classic VZV IgM % Virotech - VZV ELISA IgM % Medac - VZV-IgM-ELA Test PKS medac % ovatec - ovalisa VZV IgM-ELISA % R-Biopharm - Ridascreen VZV IgM % DIESSE - Varicella IgM % DRG - Varizella Zoster IgM ELISA 00.0% Mast - Mastazyme VZV IgM 00.0% ViroImmun - VIR-ELISA ATI-VZV-IgM 00.0% Vidia - ELISA-VIDITEST anti-vzv IgM 00.0% IBL - Varicella-Zoster-Virus IgM ELISA 00.0% in house 00.0% other manufacturers 00.0% Bio-Rad - Platelia VZV IgM 00.0% IFT-anti-VZV-IgM (30) % EuroImmun - Anti-VZV-IIFT IgM % Viramed - VZV IgM IFT Testkit % Meridian - Merifluor VZV IgM IFA 00.0% ViroImmun - IFA VZV-IgM 00.0% Bios - Biognost VZV IgM 00.0% in house 00.0% Vidia - IF-VIDITEST anti-vzv 00.0% Mast - VZV-IgM Complete IF Test 00.0% ChLIA-anti-VZV-IgM (34) % DiaSorin - LIAISO VZV-IgM % CvirG / LgesQ Rv= :37h Bl. 4

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12 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) Determination of Anti-VZV-IgG/total (test category 0) Titer values and results as miu/ml Avidity (test category ) Percent values Anti-VZV-IgM (test category 0) Titer values and results as U/ml Differentiation according to method, manufacturer and test name 353 Varizella Zoster Virus Deckblatt quant E.doc

13 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total Frequency of methods (qual. and quant.) sp ELISA-anti-VZV-IgG percent = 65 F 0 w/o target value 3.6 ChLIA-anti-VZV-IgG 5.7 ELFA-anti-VZV-IgG 4.3 complement fixation test 3.5 IFT-anti-VZV-IgG cert.=99.% F=5 = correct (C) 37 4 F 4 w/o target value 8 w/o target value 3 5 w/o target value = false (F) = no target value (w/o. tv) 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp = 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp = < < < < < < <= median=878 Bl. 46 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

14 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Siemens - Enzygnost anti-vzv/igg = Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp in house = 509..< < < median= median= Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp R-Biopharm - Ridascreen VZV IgG = 3 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp EuroImmun - anti-vzv-elisa (IgG) = < < < < <= median= median= Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp IBL - Varicella-Zoster-Virus IgG ELISA = 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Mast - Mastazyme VZV IgG = 7...<= median= median=878 Bl. 47 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

15 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Medac - VZV-IgG-ELISA PKS medac = 4 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Virion/Serion - ELISA classic VZV IgG = <= < < <= median= median= Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp ViroImmun - VIR-ELISA ATI-VZV-IgG = 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp = Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Viramed - VZV IgG IFT testkit = 3 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgGsp in house = median= median=80 Bl. 48 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

16 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Mast - VZV-IgG Complete IF test = 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Vidia - IF-VIDITEST anti-vzv = median=40 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp EuroImmun - anti-vzv-iift IgG = 4 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp ViroImmun - IFA VZV-IgG = median=50 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp = 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp = < < < < median= = correct (C) = false (F) median=878 Bl. 49 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

17 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp DiaSorin - LIAISO VZV IgG = 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp DiaSorin - LIAISO VZV IgG = < < < < median= = correct (C) = false (F) median= Testing for anti-vzv-igg or anti-vzv total complement fixation test sp = 4 0. Testing for anti-vzv-igg or anti-vzv total complement fixation test sp Siemens - Varicella-Zoster-KBR = Testing for anti-vzv-igg or anti-vzv total complement fixation test sp Virion/Serion - KBR VZV = Bl. 50 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

18 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, avidity of anti-vzv-igg : high, % avidity: Testing for avidity of anti-vzv-igg Frequency of methods (qual. and quant.) sp percent = ELISA-anti-VZV-IgG IFT-anti-VZV-IgG = correct (C) = false (F). Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35303, % avidity: % avidity percent = 0. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35303, % avidity: Siemens - Enzygnost anti-vzv/igg avidity % avidity percent = < <= median= median=8 Bl. 5 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

19 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, avidity of anti-vzv-igg : high, % avidity: Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35303, % avidity: EuroImmun - anti-vzv-elisa (IgG) avidity % avidity percent = 6. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35303, % avidity: Medac - VZV-IgG-ELISA PKS medac avidity % avidity percent = 74..< <= median= median=8. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35303, % avidity: Vidia - ELISA-VIDITEST VZV IgG avidity % avidity percent = median=8 Bl. 5 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

20 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igm : negative Frequency of methods (qual. and quant.) sp ELISA-anti-VZV-IgM percent = 360 F 43 w/o target value ChLIA-anti-VZV-IgM IFT-anti-VZV-IgM cert.=99.4% F= = correct (C) 7 w/o target value = false (F) = no target value (w/o. tv) ELISA-Anti-VZV-IgM sp = ELISA-Anti-VZV-IgM sp U/ml percent = < < < <= median=3 Bl. 53 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

21 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igm : negative ELISA-Anti-VZV-IgM sp Siemens - Enzygnost anti-vzv/igm = 3 ELISA-Anti-VZV-IgM sp other manufacturer U/ml percent = median=3 ELISA-Anti-VZV-IgM sp R-Biopharm - Ridascreen VZV IgM U/ml percent = 4 ELISA-Anti-VZV-IgM sp in house U/ml percent = 3..< median= median=3 ELISA-Anti-VZV-IgM sp EuroImmun - anti-vzv ELISA (IgM) = ELISA-Anti-VZV-IgM sp IBL - Varicella-Zoster-Virus IgM ELISA U/ml percent = median=3 Bl. 54 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

22 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igm : negative ELISA-Anti-VZV-IgM sp Mast - Mastazyme VZV IgM U/ml percent = ELISA-Anti-VZV-IgM sp Medac - VZV-IgM-ELA test PKS medac U/ml percent = 0...<= median= median=3 ELISA-Anti-VZV-IgM sp Virion/Serion - ELISA classic VZV IgM U/ml percent = 9 0..< < ELISA-Anti-VZV-IgM sp ViroImmun - VIR-ELISA ATI-VZV-IgM = 5..<= median= IFT-Anti-VZV-IgM sp = IFT-Anti-VZV-IgM sp Viramed - VZV IgM IFT testkit = Bl. 55 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

23 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35303, anti-vzv-igm : negative IFT-Anti-VZV-IgM sp Mast - VZV-IgM Complete IF test = IFT-Anti-VZV-IgM sp EuroImmun - anti-vzv-iift IgM = IFT-Anti-VZV-IgM sp Bios - Biognost VZV IgM = IFT-Anti-VZV-IgM sp ViroImmun - IFA VZV-IgM = Bl. 56 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

24 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total Frequency of methods (qual. and quant.) sp ELISA-anti-VZV-IgG percent = 65 F 0 w/o target value 3.6 ChLIA-anti-VZV-IgG 5.7 ELFA-anti-VZV-IgG 4.3 complement fixation test 3.5 IFT-anti-VZV-IgG cert.=99.% F=5 = correct (C) 37 4 F 4 w/o target value 8 w/o target value 3 50 w/o target value = false (F) = no target value (w/o. tv) 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp = 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp = < < < < < < < < < median= = correct (C) = false (F) median=70 Bl. 57 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

25 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Siemens - Enzygnost anti-vzv/igg = Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp in house = 884..< < < < <= median= median=70 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp R-Biopharm - Ridascreen VZV IgG = 3 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp EuroImmun - anti-vzv-elisa (IgG) = < < < <= median= = correct (C) = false (F) median=70 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp IBL - Varicella-Zoster-Virus IgG ELISA = 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Mast - Mastazyme VZV IgG = 9...<= median= median=70 Bl. 58 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

26 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Medac - VZV-IgG-ELISA PKS medac = 4 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp Virion/Serion - ELISA classic VZV IgG = <= < < < <= median= = correct (C) = false (F) median=70 0. Testing for anti-vzv-igg or anti-vzv total ELISA-Anti-VZV-IgG sp ViroImmun - VIR-ELISA ATI-VZV-IgG = 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp = median= median=30 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Viramed - VZV IgG IFT testkit = 3 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgGsp in house = median= median=80 Bl. 59 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

27 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Mast - VZV-IgG Complete IF test = 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp Vidia - IF-VIDITEST anti-vzv = median=80 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp EuroImmun - anti-vzv-iift IgG = 4 0. Testing for anti-vzv-igg or anti-vzv total IFT-Anti-VZV-IgG sp ViroImmun - IFA VZV-IgG = median= median= Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp = 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp = < < < <= median= median=70 Bl. 60 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

28 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igg or anti-vzv total : positive 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp DiaSorin - LIAISO VZV IgG = 0. Testing for anti-vzv-igg or anti-vzv total ChLIA-Anti-VZV-IgG sp DiaSorin - LIAISO VZV IgG = < < < <= median= median=70 0. Testing for anti-vzv-igg or anti-vzv total complement fixation test sp = 4 0. Testing for anti-vzv-igg or anti-vzv total complement fixation test sp Siemens - Varicella-Zoster-KBR = Testing for anti-vzv-igg or anti-vzv total complement fixation test sp Virion/Serion - KBR VZV = Bl. 6 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

29 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, avidity of anti-vzv-igg : high, % avidity: Testing for avidity of anti-vzv-igg Frequency of methods (qual. and quant.) sp percent = ELISA-anti-VZV-IgG IFT-anti-VZV-IgG = correct (C) = false (F). Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35304, % avidity: % avidity percent = 0. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35304, % avidity: Siemens - Enzygnost anti-vzv/igg avidity % avidity percent = < <= <= median= median=84 Bl. 6 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

30 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, avidity of anti-vzv-igg : high, % avidity: Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35304, % avidity: EuroImmun - anti-vzv-elisa (IgG) avidity % avidity percent = 6. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35304, % avidity: Medac - VZV-IgG-ELISA PKS medac avidity % avidity percent = <= median= median=84. Testing for avidity of anti-vzv-igg ELISA-Anti-VZV-IgG sp.35304, % avidity: Vidia - ELISA-VIDITEST VZV IgG avidity % avidity percent = median=84 Bl. 63 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

31 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igm : negative Frequency of methods (qual. and quant.) sp percent = ELISA-anti-VZV-IgM 43 w/o target value ChLIA-anti-VZV-IgM IFT-anti-VZV-IgM = correct (C) 7 w/o target value = false (F) = no target value (w/o. tv) ELISA-Anti-VZV-IgM sp = ELISA-Anti-VZV-IgM sp U/ml percent = < < < <= = correct (C) = false (F) median= Bl. 64 Cvir / Lh Rv= :37h Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

32 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igm : negative ELISA-Anti-VZV-IgM sp Siemens - Enzygnost anti-vzv/igm = 3 ELISA-Anti-VZV-IgM sp other manufacturer U/ml percent = median= ELISA-Anti-VZV-IgM sp R-Biopharm - Ridascreen VZV IgM U/ml percent = 4 ELISA-Anti-VZV-IgM sp in house U/ml percent = 3..< median= median= ELISA-Anti-VZV-IgM sp EuroImmun - anti-vzv ELISA (IgM) = ELISA-Anti-VZV-IgM sp IBL - Varicella-Zoster-Virus IgM ELISA U/ml percent = median= Bl. 65 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

33 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igm : negative ELISA-Anti-VZV-IgM sp Mast - Mastazyme VZV IgM U/ml percent = 00.0 ELISA-Anti-VZV-IgM sp Medac - VZV-IgM-ELA test PKS medac U/ml percent = 0...<= median= median= ELISA-Anti-VZV-IgM sp Virion/Serion - ELISA classic VZV IgM U/ml percent = 9 0..< < ELISA-Anti-VZV-IgM sp ViroImmun - VIR-ELISA ATI-VZV-IgM = 5..<= median= IFT-Anti-VZV-IgM sp = IFT-Anti-VZV-IgM sp Viramed - VZV IgM IFT testkit = Bl. 66 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=

34 Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. (ISTAD) Virusimmunology Varicella zoster virus (353) June / July 03 sample 35304, anti-vzv-igm : negative IFT-Anti-VZV-IgM sp Mast - VZV-IgM Complete IF test = IFT-Anti-VZV-IgM sp EuroImmun - anti-vzv-iift IgM = IFT-Anti-VZV-IgM sp Bios - Biognost VZV IgM = IFT-Anti-VZV-IgM sp ViroImmun - IFA VZV-IgM = Bl. 67 Cvir / Lh Rv= :37h 074 Srt=MR, Me=, Klebe=0, Std=0, quantcb=, nhisto=