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1 Pre-evaluation of the EQA Schemes in Virus Diagnostics November/December 2015 INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Issued by: INSTAND e.v. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laborarien e.v. Düsseldorf/Berlin,

2 EQAS Adviser: Assistant EQAS Adviser: Univ.-Prof. i. R. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.v. Campus Benjamin Franklin, Institut für Virologie Ubierstr. 20, Düsseldorf Heinz.Zeichhardt@charite.de Tel.: +49-(0) ; Fax: +49-(0) donoso@instand-ev.de Correspondence address: Prof. Dr. Heinz Zeichhardt Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, Berlin Tel.: +49-(0) ; Fax: +49-(0) Heinz.Zeichhardt@iqvd.de Organisation and Logistics: INSTAND e.v. Ubierstr Düsseldorf Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: Pre-evaluation Virology November December a EN.doc 2 von 14

3 Dear colleagues, Pre-Evaluation and Mailing of Participation Documents INSTAND External Quality Assessment Schemes November/December 2015 Virus Immunology Virus Genome Detection by PCR/NAT You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in diagnostics of November/December Today you receive the pre-evaluation. By mail, you receive the following participation documents of those EQA schemes in which you have participated this time: certificate of successful participation statement of participation statement of individual results The EQA schemes having been performed in November/December 2015 are highlighted in bold in Tables 1 and 2. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail gether with this pre-evaluation. VIRUS IMMUNOLOGY: Cymegalo (351) Hepatitis A (343) Hepatitis B Prog. 1 (344) Hepatitis B Prog. 2 (345) Hepatitis C (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337) Table 1: EQA schemes performed with a frequency of four times per year VIRUS GENOME DETECTION: Cymegalo (365) Hepatitis A (377) Hepatitis B (361) Hepatitis C (362) HIV-1 (360) Parvo B19 (367) The EQA schemes having been performed in November/December 2015 are highlighted in bold (Table 1). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail gether with this pre-evaluation. Pre-evaluation Virology November December a EN.doc 3 von 14

4 VIRUS IMMUNOLOGY: Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in November/December 2015 are highlighted in bold) Dengue es (Ab/NS1-Ag) (350) Epstein Barr (352) TBE (FSME) (358) Hantaes (355) Hepatitis D (347) Hepatitis E (348) Herpes simplex es (354) HTLV-1/HTLV-2 (339) Measles (357) Mumps (356) Parvo B19 (342) Rubella (341) Rabies (Tollwut) (336) Varicella zoster (353) VIRUS GENOME DETECTION: Adenoes (371) BK (364) Chikungunya (392) Coronaes (340) Cymegalo training program (368) Cymegalo resistance determination (349) Dengue es (369) Enteroes (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr (376) Hepatitis B training program (378) Hepatitis B genotyping (396) Hepatitis B resistance determination (397) Hepatitis C training program (379) Hepatitis C geno-/subtyping (once a year) (375) Hepatitis C resistance determination (399) Hepatitis D (400) Hepatitis E (380) Herpes simplex type 1/2 (363) HIV-1 training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (395) Human Metapneumo (385) Human Papilloma es (373) Human Rhinoes (393) Influenza es (genome/ag) (370) JC (394) Measles (386) Mumps (387) Noro (381) Parainfluenza es (388) Respirary syncytial (Ag/genome) (359) Rotaes (401) Rubella (389) Rabies (Tollwut) (390) Varicella zoster (366) West Nile (391) The EQA schemes having been performed in November/December 2015 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail gether with this pre-evaluation. EQA schemes in Table 2 marked in italics were not performed in November/December Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme November/December You received information on sample properties already per on The reports of all EQA schemes will be released on the INSTAND homepage immediately after completion. For details please see the INSTAND homepage under "EQAS / Reports / Year and Category (Virus immunology / Virus genome detection)" in English language: and in German language: Pre-evaluation Virology November December a EN.doc 4 von 14

5 Please note: RiliBÄK A compilation of the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laborariumsmedizinischer Untersuchungen)" with all Sections including Section "Qualitative determinations in laborary medicine = Qualitative laborariumsmedizinische Untersuchungen" and Section "Direct detection and characterization of infectious diseases pathogens = Direkter Nachweis und Charakterisierung von Infektionserregern" has recently been published (in German language: Deutsches Ärzteblatt, Jg. 111, Heft 38, 19. September 2014, A A 1618) (please see link). An English version of the guideline translated by INSTAND e.v. with the consent of the Executive Board of the German Medical Association has been published in "German Medical Science" (in English language: Bundesärztekammer (German Medical Association), Instand e.v., Guidelines of the German Medical Association on quality assurance in medical laborary testing. GMS Z Forder Qualitatssich Med Lab. 2015;6:Doc03. DOI: /lab000018, URN: urn:nbn:de:0183- lab ) (please see link). Notice for German laboraries: The requirements laid down in Specified Section - effective since and with a transition period until should now be fulfilled. INSTAND EQA schemes in diagnostics and INSTAND ordering documents 2016 For details please see the INSTAND ordering documents 2016 incl. brochure and order form (please see link). Surplus samples of the current and previous EQA schemes in diagnostics are available for test assessment of your diagnostics. Please contact INSTAND for details. Thank you for your kind cooperation Prof. Dr. H. Zeichhardt Priv.-Doz. Dr. O. Donoso Mantke Pre-evaluation Virology November December a EN.doc 5 von 14

6 Table 3: EQA Schemes Virus Immunology - November/December 2015 pre-evaluation Program Group RiliBÄK Analyte Sample Sample properties qualitative dilution sample source Cy- anti-cmv-igg megalo anti-cmv-igm anti-cmv-igg past CMV infection (two healthy blood donors) anti-cmv-igm avidity: low 1 : 5 acute CMV infection anti-ebv-igg Epstein = past EBV infection Barr (four healthy blood donors) 352 anti-ebv-igm Tick-borne encephalitis (TBE = FSME) # Hepatitis A Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) anti-ebv-igg anti-ebv-igm anti-tbe-igg anti-tbe-igm anti-tbe-igg anti-tbe-igm = The accepted results will be shown in the report. The results for anti-tbe-igg (test category 10) obtained by a test of one manufacturer (Progen Immunozym FSME/TBE IgG) were inconsistent and are not evaluated (without disadvantage for the certificate). avidity: no avidity past EBV infection (four healthy blood donors) healthy blood donor healthy blood donor with indication of a past TBE infection/vaccination anti-hav healthy blood 0 15 miu/ml anti-hav anti-hav-igg 30 miu/ml 1 : 500 healthy blood donor (57 miu/ml)* anti-hav-igm : 10 acute hepatitis A infection anti-hav-igm healthy blood HBsAg IU/ml (a) 1 : 750 (4.88 IU/ml target value) HBsAg IU/ml (a) 1 : chronic hepatitis B (1.26 IU/ml target value) HBsAg IU/ml (a) 1 : (2.45 IU/ml target value) HBsAg healthy blood IU/ml (0.00 IU/ml target value) anti-hbs anti-hbs anti-hbs anti-hbs IU/l (0 IU/l target value) IU/l (61 IU/l target value) IU/l (224 IU/l target value) IU/l (112 IU/l target value) (b) 1 : 800 (b) 1 : 200 (b) 1 : 400 healthy blood anti-hbs healthy blood donor anti-hbc (c) 1 : chronic hepatitis B (HBeAg and anti-hbc (c) 1 : 600 anti-hbc-igm ) anti-hbc healthy blood anti-hbc (c) chronic hepatitis B 1 : (HBeAg and anti-hbc-igm ) a, b, c: Marked samples represent dilutions from the corresponding sck materials. Non-marked samples derive from independent preparations. # FSME = Frühsommer-Meningoenzephalitis * Some commercial tests for the detection of anti-hav-igg or anti-hav-tal reveal for highly concentrated samples values > 60 miu/ml, which are outside the linear measurement range of the respective test system. Therefore a final target value derived from a consensus value from all results stated in miu/ml could not be assigned highly concentrated samples. In this case a lower limit value in miu/ml is indicated in order assess a reported result of a laborary as a "correct" result. Pre-evaluation Virology November December a EN.doc 6 von 14

7 Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2015 pre-evaluation (anti-hbc-igm HBeAg anti-hbe) Hepatitis C (Ab and HCV-Ag) * plasma** Hepatitis D Hepatitis E Herpes simplex es HIV-1/ HIV-2 HIV-1 p24 Ag Program Group RiliBÄK Analyte Sample Sample properties qualitative dilution sample source healthy blood anti-hbc-igm Hepatitis B (prog. 2) anti-hbc-igm HBeAg : 110 acute hepatitis B infection anti-hcv HCV Ag healthy blood HBeAg : 670 chronic hepatitis B anti-hbe healthy blood anti-hbe chronic hepatitis B 1 : 135 ( for HBeAg) anti-hcv * Condition after chronic 1 : 8.2 hepatitis C HCV antigen (successful therapy) anti-hcv ** HCV antigen (d) 1 : 60 chronic hepatitis C anti-hcv * healthy blood HCV antigen anti-hcv HCV antigen anti-hdv-igg anti-hdv-igm anti-hdv-igg anti-hdv-igm anti-hev-igg anti-hev-igm anti-hev-igg anti-hev-igm anti-hsv-igg anti-hsv-igm anti-hsv-igg anti-hsv-igm ** not evaluated not evaluated The results for anti-hsv-1/2-igm obtained by a test of one manufacturer (DiaSorin, LIAISON HSV-1/2 IgM) were inconsistent and are not evaluated (without disadvantage for the certificate). (d) 1 : 30 chronic hepatitis C healthy blood donor 1 : 400 chronic hepatitis D past hepatitis E infection healthy blood donor past HSV-1 infection (one healthy blood donor) past HSV-1 infection (two healthy blood donors) anti-hiv (e) 1 : 75 HIV-1 infection anti-hiv-1/ healthy blood anti-hiv : 150 HIV-1 infection anti-hiv (e) 1 : 150 HIV-1 infection p24 Ag : p24 Ag d, e: Marked samples represent dilutions from the corresponding sck materials. Non-marked samples derive from independent preparations. HIV-1 infection (spiked pool of blood donors; HIV-1 heat inactivated) healthy blood Pre-evaluation Virology November December a EN.doc 7 von 14

8 Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2015 pre-evaluation Program Group RiliBÄK Analyte Sample HTLV-1/ HTLV-2 * plasma** Measles Mumps Parvo B19 * plasma** Rubella Sample properties qualitative dilution sample source anti-htlv ** 1 : 4 HTLV-2 infection** anti-htlv-1/ * healthy blood donor* anti-htlv * 1 : 150 HTLV-1 infection* anti-htlv ** 1 : 4 HTLV-2 infection** anti-measles-igg anti-measles-igm anti-measles-igg anti-measles-igm anti-mumps-igg anti-mumps-igm anti-mumps-igg anti-mumps-igm anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM titer HI test / HiG anti-rubella-igg anti-rubella-igm titer HI test / HiG anti-rubella-igg anti-rubella-igm * * * * = = anti-vzv-igg Varicella zoster anti-vzv-igm anti-vzv-igg anti-vzv-igm Non-marked samples derive from independent preparations. avidity: no avidity (256 target value) 95 IU/ml (300 IU/ml) # (256 target value) 95 IU/ml (301 IU/ml) # one healthy blood donor with indication of a past measles infection/vaccination two healthy blood donors with indication of a past measles infection/vaccination one healthy blood donor with indication of a past mumps infection/vaccination one healthy blood donor with indication of a past mumps infection/vaccination past parvo B19 infection (healthy blood donor)* healthy blood donor* past parvo B19 infection (healthy blood donor)* past parvo B19 infection (healthy blood donor)* sera of healthy blood donors with indication of a past rubella infection or vaccination (pool) past VZV infection (two healthy blood donors) past VZV infection (two healthy blood donors) Sample : Some participants having applied an avidity test of one manufacturer (Mikrogen recomline Parvo B19 IgG Avidität/avidity) reported as result "no statement possible". The intensities of those bands indicative of antibodies binding avidity relevant antigens were below the cuff of the IgG control. The avidity result "no statement possible" had no impact on the overall evaluation of sample , i.e. past parvo B19 infection (characteristic band pattern of anti-parvo-igg with anti-parvo- IgM). The avidity result "no statement possible" has been considered as "correct". # Some commercial tests for the detection of anti-rubella-igg reveal for highly concentrated samples values > 400 IU/ml and > 500 IU/ml, respectively, which are outside the linear measurement range of the respective test system. Therefore a final target value derived from a consensus value from all results stated in IU/ml could not be assigned highly concentrated samples. In this case a lower limit value in IU/ml is indicated in order assess a reported result of a laborary as a "correct" result. Pre-evaluation Virology November December a EN.doc 8 von 14

9 EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015 Pre-evaluation Notices Evaluation of results for quantitative genome detection of CMV 1 Notice for German and foreign participants of EQA scheme 365: For evaluation, "IU/ml" have primarily been considered as measurement units of the quantitative results for the analyte CMV. This is in accordance the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section, Table B. 3-2a, When applying CE-marked tests, which not (yet) allow reporting of results in IU/mL, it should be continued report the results as stated by the manufacturer. Evaluation of results for quantitative genome detection of HBV and HCV 2 3 Notice for German participants of EQA schemes 361 and 362: For evaluation, "IU/ml" have been considered as measurement units of the quantitative results for the analytes HBV and HCV. This is in accordance the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section, Table B. 3-2a. Statements in "copies/ml" will not be accepted anymore. Notice for foreign participants of EQA schemes 361 and 362: Please note that quantitative results in "copies/ml" for the genome detection of HBV and HCV, respectively, have not been evaluated due the low number of analyses or missing analyses. Evaluation of results for quantitative genome detection of HIV Notice for German participants of EQA scheme 360: For evaluation, "copies/ml" have been considered as measurement unit of the quantitative results for the analyte HIV-1. This is in accordance the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section, Table B. 3-2a. Statements in "IU/ml" will not be accepted anymore. Notice for foreign participants of EQA scheme 360: Please note that quantitative results in "IU/ml" for the genome detection of HIV-1 have not been evaluated due the low number of analyses or missing analyses. Pre-evaluation Virology November December a EN.doc 9 von 14

10 Table 4: EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015 Pre-evaluation Program Group RiliBÄK Sample CMV (DNA) plasma EBV (DNA) HAV spiked plasma HBV (DNA) plasma HCV plasma HEV * suspension of feces** HIV-1 spiked plasma HIV-2 spiked plasma HMPV Sample properties qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml For evaluation of results in copies/ml or IU/ml: see notice 1, page (a) 1 : approx approx (a) 1 : approx approx : approx approx (b) 1 : 800 approx approx (b) 1 : 100 approx approx (b) 1 : 400 approx approx (c) 1 : not evaluated # not evaluated # not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # (d) 1 : Results in approx copies/ml: 0 not accepted (d) 1 : approx or not evaluated (d) 1 : (see notices 2 and 3, page 9) approx (Subtyp 3a) (e) 1 : 100 Results in approx (Subtyp 1b) 1 : copies/ml: approx. 670 not accepted (Subtyp 3a) (e) 1 : 200 approx or not evaluated (see notices 2 approx. 0 and 3, page 9) ** 1 : not evaluated # not evaluated # * = not evaluated # not evaluated # * = not evaluated # not evaluated # * 1 : 28 not evaluated # not evaluated # : 7 approx Results in IU/ml: not accepted or : approx not evaluated (see notices : 100 approx. 896 and 5, page 9) (f) 1 : 9 not evaluated # not evaluated # not evaluated # not evaluated # : 9 not evaluated # not evaluated # (f) 1 : 90 not evaluated # not evaluated # (Subtyp A) 1 : not evaluated # (Subtyp A) (g) 1 : 64 not evaluated # (Subtyp A) (g) 1 : not evaluated # not evaluated # # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates) a, b, c, d, e, f, g: Marked samples derive from corresponding sck materials diluted in consecutive steps. Non-marked samples derive from independent preparations. Pre-evaluation Virology November December a EN.doc 10 von 14

11 Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015 Pre-evaluation Program Group RiliBÄK Sample Measles FTA cards Mumps FTA cards Parvo B19 (DNA) plasma Respirary syncytial (antigen/ genome) Rubella FTA cards VZV (DNA) qualitative (note on geno-/subtype) Sample properties Target value of all methods dilution (provisional data) copies/ml IU/ml (genotype D4) undiluted not evaluated # undiluted not evaluated # (genotype D8) undiluted not evaluated # (genotype B3) undiluted not evaluated # (genotype F) undiluted not evaluated # = undiluted not evaluated # (genotype G) undiluted not evaluated # = undiluted not evaluated # = not evaluated # (h) 1 : not evaluated # approx (h) 1 : not evaluated # approx = not evaluated # not evaluated # RSV A 1 : 40 not evaluated # RSV B (i) 1 : 30 not evaluated # RSV B (i) 1 : 15 not evaluated # = (genotype 2B) undiluted not evaluated # = (genotype 2B) undiluted not evaluated # undiluted not evaluated # (genotype 1G) undiluted not evaluated # : 400 approx (j) 1 : approx (j) 1 : 125 approx # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates) h, i, j: Marked samples derive from corresponding sck materials diluted in consecutive steps. Non-marked samples derive from independent preparations. Pre-evaluation Virology November December a EN.doc 11 von 14

12 Table 5: EQA Schemes Virus Genome Detection by PCR/NAT incl. typing November/December 2015 Pre-evaluation Program Group RiliBÄK Sample Adenoes (DNA) Coronaes Enteroes HSV-1/ HSV-2 (DNA) Human papilloma es qualitative Sample properties Target value of all methods copies/ml species type (note on dilution) Adeno D 1 : diluted (k) Adeno Quantitative results C 1 : diluted will be discussed in the final report D not evaluated # not evaluated # ---- Adeno 37 1 : diluted (k) MERS-CoV 1 : diluted (l) MERS-CoV 1 : 100 diluted (l) not evaluated # not evaluated # ---- CoV OC43 1 : diluted (m) not evaluated # ---- CoV OC43 1 : diluted (m) Entero 68 1 : 1000 diluted Echo Quantitative results : diluted will be discussed in the final report approx approx Echo 7 1 : 400 diluted HSV-2 1 : 900 diluted (n) HSV-1 1 : diluted (o) approx approx approx = High Risk High Risk High Risk = High Risk HSV-2 1 : diluted (n) HSV-1 1 : diluted (o) HSV-1 1 : diluted HPV 18 1 : 40 diluted (p) HPV 18 1 : 20 diluted (p) HPV 16 1 : 4 diluted HPV 18 1 : 40 diluted (p) # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates) k, l, m, n, o, p: Marked samples derive from corresponding sck materials diluted in consecutive steps. Non-marked samples derive from independent preparations. Pre-evaluation Virology November December a EN.doc 12 von 14

13 Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015 Pre-evaluation Program Group RiliBÄK Sample Humane Rhinoviren Noro suspension of feces Rotaviren suspension of feces qualitative Sample properties Target value of all methods copies/ml species not evaluated # not evaluated # ---- type (note on dilution) HRV A type 49 1 : 100 diluted HRV A type 30 1 : 100 diluted not evaluated # not evaluated # not evaluated # not evaluated # not evaluated # ---- HRV A type 56 1 : 10 diluted genogroup I 1 : 980 diluted genogroup II 1 : 200 diluted genogroup II 1 : 220 diluted not evaluated # : 200 diluted not evaluated # not evaluated # not evaluated # : 20 diluted not evaluated # ---- G2P[4] 1 : diluted (q) G2P[4] 1 : 100 diluted (q) G2P[4] 1 : diluted (q) # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates) q: Marked samples derive from corresponding sck materials diluted in consecutive steps. Non-marked samples derive from independent preparations. Pre-evaluation Virology November December a EN.doc 13 von 14

14 Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015 Pre-evaluation Program Group RiliBÄK Sample Influenza A-und B- es* inclusive influenza A(H1N1) pdm09 and avian influenza A (different subtypes) (genome/ antigen) 370* Sample properties and results considered as "correct" (target values) type/subtype strain origin for seasonal influenza B for seasonal influenza A(H3N2) (accepted target value for rapid tests for the detection of influenza A antigen: / borderline) for seasonal influenza B (accepted target value for rapid tests for the detection of influenza B antigen: / borderline) for Influenza A(H1N1) pdm09 (accepted target value for rapid tests for the detection of influenza A antigen: / borderline) B/Brisbane/60/2008 (vaccine strain) A/Switzerland/ / 2013 (vaccine strain) B/Phuket/3073/2013 (vaccine strain) A/California/7/2009 (vaccine strain) for avian influenza A(H5N8) (accepted target value for rapid tests for the detection of influenza A antigen: / borderline) A/Turkey/Germany/ R /2014 infected MDCKcells (lysate) (1 : 15 diluted) infected MDCKcells (lysate) (1 : 320 diluted) infected MDCKcells (lysate) (1 : 160 diluted) infected MDCKcells (lysate) (1 : 60 diluted) non-infected MDCK cells (lysate) allanic fluid (inactivated) (1 : 160 diluted) * The EQA program for influenza A and B es, incl. influenza A(H1N1) pdm09 and avian influenza A (different subtypes), is performed in cooperation with Nationales Referenzzentrum für Influenza, Robert Koch-Institut, Berlin, Dr. Brunhilde Schweiger and Nationales Referenzlabor für Aviäre Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, Prof. Dr. Timm C. Harder. For samples , , and , the reporting of "borderline" in test category 30 (Antigen detection of influenza A ) and test category 40 (Antigen detection of influenza B ) was accepted as additional correct result for tests for antigen detection of influenza A and B, respectively (in general rapid tests). Considering also the result "borderline" ensured that these samples would not have been misinterpreted as. Pre-evaluation Virology November December a EN.doc 14 von 14

INSTAND e.v. in cooperation with:

Pre-evaluation of the EQA Schemes in Virus Diagnostics June 2015 Corrected version: 10 August 2015 (See Table 3; program 346) INSTAND e.v. in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten