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1 Pre-evaluation of the EQA Schemes in Virus Diagnostics November/December 2014 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 doc. 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: Prof. Dr. Heinz Zeichhardt doc. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.v. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, Düsseldorf Hindenburgdamm 27, Berlin Tel.: +49-(0) ; Fax: +49-(0) Tel.: +49-(0) ; Fax: +49-(0) donoso@instand-ev.de Heinz.Zeichhardt@charite.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 11

3 Dear colleagues, Pre-Evaluation and Mailing of Participation Documents INSTAND External Quality Assessment Schemes - November/December 2014 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 2014 are highlighted in bold and italics in Tables 1 and 2. Table 1 EQA schemes performed with a frequency of four times per year VIRUS IMMUNOLOGY: VIRUS GENOME DETECTION: 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) Cymegalo (365) Hepatitis A (377) Hepatitis B (361) Hepatitis C (362) HIV-1 (360) Parvo B19 (367) Table 2 EQA schemes performed twice per year or with lower frequency VIRUS IMMUNOLOGY: VIRUS GENOME DETECTION: 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) Respirary syncytial (Ag/genome) (359) Rubella (341) Rabies (Tollwut) (336) Varicella zoster (353) Adenoes (371) BK (364) Cymegalo training program (368) Dengue es (369) Enteroes (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr (376) Hepatitis B training program (378) Hepatitis C training program (379) HCV genotyping (once a year) (375) 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) Influenza es (genome/ag) (370) Measles (386) Mumps (387) Noro (381) Parainfluenza es (388) Rubella (389) Rabies (Tollwut) (390) Varicella zoster (366) West Nile (391) Pre-evaluation Virology November December a EN.doc 3 von 11

4 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 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: 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). Note for German laboraries: The requirements laid down in Specified Section - effective since should be fulfilled by at the latest (end of transition period). In this context we refer especially the requirements defined in Table -2a "External quality assurance for the detection of concentration of nucleic acids of CMV, HBV, HCV and HIV-1 in blood//" = "Externe Qualitätssicherung bei der Bestimmung der Nukleinsäurekonzentration in Blut/Plasma/Serum". Please see our information on the INSTAND EQA schemes in diagnostics and the new RiliBÄK (as of 24 January 2014) (see link, paragraph 1.3). New INSTAND EQA schemes in diagnostics and INSTAND ordering documents 2015 We may inform you that 10 new EQA schemes for genome detection will be launched in 2015 after we have introduced 19 additional EQA schemes in diagnostics in For details please see the INSTAND ordering documents 2015 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 doc. Dr. O. Donoso Mantke Pre-evaluation Virology November December a EN.doc 4 von 11

5 Table 3: EQA Schemes Virus Immunology - November/December 2014 Program Group RiliBÄK Analyte Sample Cymegalo Epstein Barr Tick-borne encephalitis (TBE = FSME) # Hepatitis A Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) mandary: mandary: mandary: mandary: anti-cmv-igg anti-cmv-igm anti-cmv-igg anti-cmv-igm ---- anti-tbe-igg anti-tbe-igm anti-tbe-igg anti-tbe-igm qualitative dilution sample source avidity: no avidity The accepted results will be shown in the final report. anti-hav >= 60 miu/ml anti-hav >= 60 miu/ml healthy blood donor past CMV infection past EBV infection for anti-ebna-1 for anti-vca-igm past EBV infection for anti-ebna-1 for anti-vca-igm indication of a past TBE infection/vaccination indication of a past TBE infection/vaccination (a) 1 : 100 anti-hav-igg (a) healthy blood donor 1 : 200 anti-hav-igm : 4 acute hepatitis A infection anti-hav-igm HBsAg HBsAg HBsAg HBsAg anti-hbs anti-hbs anti-hbs anti-hbs IU/ml (0.00 IU/ml target value) IU/ml (2.40 IU/ml target value) IU/ml (0.00 IU/ml target value) IU/ml (4.69 IU/ml target value) IU/l (105 IU/l target value) 0-9 IU/l (0 IU/l target value) IU/l (205 IU/l target value) 0-9 IU/l (0 IU/l target value) (b) (b) (c) (c) healthy blood healthy blood 1 : chronic hepatitis B healthy blood 1 : 800 chronic hepatitis B 1 : : 250 anti-hbc (d) 1 : anti-hbc anti-hbs healthy blood donor healthy blood anti-hbs healthy blood donor healthy blood chronic hepatitis B ( for anti-hbc-igm and HBeAg, resp.) healthy blood anti-hbc (d) 1 : chronic hepatitis B anti-hbc (d) 1 : 500 a, b, c, d: Marked samples represent dilutions from the corresponding sck materials. # FSME = Frühsommer-Meningoenzephalitis ( for anti-hbc-igm and HBeAg, resp.) Pre-evaluation Virology November December a EN.doc 5 von 11

6 Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2014 Program Group RiliBÄK Analyte Sample qualitative dilution sample source mandary: anti-hbc-igm : 110 acute hepatitis B infection Hepatitis B anti-hbc-igm healthy blood donor (prog. 2) mandary: HBeAg : 540 chronic hepatitis B (anti-hbc-igm 345 HBeAg HBeAg healthy blood donor anti-hbe) mandary: anti-hbe healthy blood donor chronic hepatitis B anti-hbe : 65 ( for HBeAg) Hepatitis C (Ab and HCV-Ag) Hepatitis D Hepatitis E Herpes simplex es HIV-1/ HIV anti-hcv mandary: anti-hcv HCV antigen anti-hcv HCV antigen anti-hcv 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 anti-hiv-1/ not evaluated not evaluated Pre-evaluation Virology November December a EN.doc 6 von 11 (e) (e) (f) 1 : (f) 1 : anti-hiv (g) 1 : 100 anti-hiv (g) 1 : 50 anti-hiv (g) 1 : : 100 past hepatitis C infection 1 : 15 chronic hepatitis C 1 : 50 past hepatitis C infection healthy blood chronic hepatitis D acute hepatitis E infection healthy blood donor past HSV-1 infection healthy blood donor healthy blood HIV-1 infection HCV Ag mandary: mandary: HIV-1 mandary: p24 Ag (h) 1 : p24 Ag 337 p24 Ag (h) 1 : HTLV-1/ anti-htlv * (i) 1 : 240 HTLV-1 infection HTLV-2 anti-htlv ** (j) 1 : HTLV-2 infection anti-htlv ** (j) 1 : 2.5 * ** anti-htlv * (i) 1 : 120 HTLV-1 infection anti-measles-igg Measles anti-measles-igm anti-measles-igg anti-measles-igm anti-mumps-igg Mumps anti-mumps-igm anti-mumps-igg anti-mumps-igm e, f, g, h, i, j: Marked samples represent dilutions from the corresponding sck materials. HIV-1 infection (spiked pool of blood donors; HIV-1 heat inactivated) indication of a past measles infection/vaccination indication of a past measles infection/vaccination indication of a past mumps infection/vaccination indication of a past mumps infection/vaccination

7 Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2014 Program Group RiliBÄK Analyte Sample Parvo B19 Respirary syncytial (antigen/ genome) Rubella Varicella zoster mandary: mandary: anti-parvo B19-IgG = avidity: no avidity anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM qualitative dilution sample source anti-parvo B19-IgG = avidity: no avidity anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM RSV : 2.4 RSV A : 20 titer Hi test / HiG anti-rubella-igg anti-rubella-igm titer Hi test / HiG anti-rubella-igg anti-rubella-igm anti-vzv-igg anti-vzv-igm anti-vzv-igg anti-vzv-igm The samples and are identical IU/ml (120 IU/ml target value) IU/ml (233 IU/ml target value) sera of healthy blood past parvo B19 infection ( of one healthy blood donor) sera of healthy blood past parvo B19 infection (sera of two healthy blood donors) RSV B infected HEp-2 cells (lysate) RSV A infected HEp-2 cells (lysate) sera of two healthy blood donors with indication of a past rubella infection or vaccination sera of three healthy blood donors with indication of a past rubella infection or vaccination past VZV infection past VZV infection Pre-evaluation Virology November December a EN.doc 7 von 11

8 Table 4: EQA Schemes Virus Genome Detection by PCR/NAT - November/December 2014 EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked HMPV Program Group RiliBÄK Sample qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml $ = (a) 1 : approx approx CMV mandary: (a) 1 : 313 approx approx $ = (a) 1 : approx approx CMV Global approx approx Collaboration approx approx approx approx approx approx (b) 1 : 100 approx approx mandary: mandary: mandary: mandary: mandary: & = & = (b) 1 : 400 approx approx = (c) 1 : not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # = (c) 1 : not evaluated # not evaluated # not evaluated # not evaluated # (d) 1 : not evaluated # approx not evaluated # (d) 1 : not evaluated # approx not evaluated # not evaluated # (subtype 3a) 1 : 50 not evaluated # approx (subtype 2a/2c) (e) 1 : not evaluated # approx (subtype 2a/2c) (e) 1 : 300 not evaluated # approx * not evaluated # not evaluated # * (f) 1 : 12.5 not evaluated # not evaluated # * (f) 1 : 25 not evaluated # not evaluated # ** 1 : 17 not evaluated # not evaluated # (subtype B) 1 : approx. 726 not evaluated # (subtype B) (g) 1 : approx not evaluated # not evaluated # (subtype B) (g) 1 : approx not evaluated # (h) 1 : not evaluated # not evaluated # (h) 1 : 10 not evaluated # not evaluated # not evaluated # not evaluated # (h) 1 : 100 not evaluated # not evaluated # % = (subtype A) (i) 1 : not evaluated # (subtype A) (i) 1 : not evaluated # (subtype A) (i) 1 : 100 not evaluated # % = (subtype A) (i) 1 : not evaluated # # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). a, b, c, d, e, f, g, h, i: Marked samples derive from corresponding sck materials diluted in consecutive steps. $ The samples and are identical. The samples and are identical. & The samples and are identical. % The samples and are identical. Pre-evaluation Virology November December a EN.doc 8 von 11

9 Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - November/December 2014 Program Group RiliBÄK Sample qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml (genotype D4) 1 : 10 not evaluated # Measles (genotype A) 1 : 10 not evaluated # low (genotype D8) (j) 1 : 100 not evaluated # FTA cards not evaluated* (genotype D8) (j) 1 : 10 not evaluated # Mumps FTA cards Parvo B19 Rubella FTA cards VZV mandary: mandary: (genotype G) (k) 1 : 10 not evaluated # (genotype G) (k) undiluted not evaluated # not evaluated # (genotype F) undiluted not evaluated # (l) 1 : approx approx (l) 1 : approx approx (l) 1 : approx approx (genotype 2B) (m) undiluted not evaluated # (genotype 1G) undiluted not evaluated # (genotype 2B) (m) 1 : 10 not evaluated # not evaluated # (n) 1 : approx (n) 1 : 250 approx (n) 1 : 500 approx * The qualitative results for sample low for measles - are not evaluated due inconsistent results (without disadvantage for the certificate). # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). j, k, l, m, n: Marked samples derive from corresponding sck materials diluted in consecutive steps. Pre-evaluation Virology November December a EN.doc 9 von 11

10 Table 5: EQA Schemes Virus Genome Detection by PCR/NAT - November/December 2014 incl. Typing Program Group RiliBÄK Sample qualitative dilution species type (note on dilution) Adenoes mandary: Enteroes HSV-1/ HSV mandary: mandary: Quantitative results D will be discussed in the final report. C C Quantitative results will be discussed in the final report = A ---- approx approx = approx approx approx approx Adeno 31 1 : 600 diluted Adeno 37 1 : diluted Adeno 2 1 : diluted (o) Adeno 2 1 : diluted (o) Coxsackie B3 1 : diluted Echo 30 1 : diluted Echo 7 1 : 200 diluted (p) Echo 7 1 : 400 diluted (p) Entero 68 1 : 100 diluted HSV-1 1 : diluted (q) HSV-2 1 : 450 diluted (r) HSV-1 1 : diluted (q) HSV-1 1 : diluted (q) HSV-2 1 : diluted (r) HSV-2 1 : 900 diluted (r) Human papilloma es * **biopsy material Noro suspension of feces mandary: * * High Risk ** Low Risk * High Risk * High Risk & = HPV 16 1 : 40 diluted HPV 6 1 : 88 diluted HPV 16 1 : 5 diluted HPV 18 1 : 40 diluted genogroup I Quantitative results : 125 diluted will be discussed in & = the final report genogroup II 1 : 200 diluted o, p, q, r: Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples and are identical. & : The samples and are identical. Pre-evaluation Virology November December a EN.doc 10 von 11

11 Table 5 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - November/December 2014 incl. Typing Program Group RiliBÄK Sample Influenza A and B es* inclusive influenza A(H1N1) pdm09, avian influenza A(H5N1) and avian influenza A(H7N9) (genome/ antigen) 370* mandary: and results considered as "correct" (target values) type/subtype strain origin for Influenza A(H1N1) pdm09-virus (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) A/California/7/2009 (vaccine strain) B/Massachusetts/2/2012 (vaccine strain) # for avian influenza A(H7N9) # (accepted target value for rapid tests for the detection of influenza A antigen: / borderline) for avian influenza A(H5N1) (accepted target value for rapid tests for the detection of influenza A antigen: / borderline) for seasonal influenza A(H3N2) A/Anhui/1/2013 A/Whooper swan/ Germany/R65-2/2006 A/Vicria/361/2011 (vaccine strain) infected MDCK cells (lysate) (1 : 60 diluted) infected MDCK cells (lysate) (1 : 66 diluted) non-infected MDCK cells (lysate) allanic fluid (inactivated) (1 : 330 diluted) allanic fluid (inactivated) (1 : 40 diluted) infected MDCK cells (lysate) (1 : 30 diluted) * The EQA program for influenza A and B es, incl. influenza A(H1N1) pdm09, avian influenza A(H5N1) and avian influenza A(H7N9), 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, PD 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. # Sample for avian influenza A(H7N9) : The results in test category 10 (genome detection of influenza A) obtained by a test of one manufacturer (Cepheid; GeneXpert Flu Assay) have not been evaluated due results. The affected laboraries are advised contact the manufacturer for a modified test capable detect also avian influenza A(H7N9). Pre-evaluation Virology November December a EN.doc 11 von 11

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