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in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) Gesellschaft für Virologie (GfV) Deutsche

1 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 (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: Prof. Dr. Heinz Zeichhardt Priv.-Doz. 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 June corr EN.doc 2 von 11

3 Dear colleagues, Pre-Evaluation and Mailing of Participation Documents INSTAND External Quality Assessment Schemes June 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 June 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 and which are performed with a frequency of four times a year, i.e. also in September 2015 (see Table 1): certificate of successful participation statement of participation statement of individual results 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) Please note: The participation documents of those INSTAND EQA schemes in diagnostics performed twice a year or with lower frequency are mailed in due time before the next run of the corresponding EQA schemes (see Table 2). VIRUS IMMUNOLOGY: Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in June 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) Pre-evaluation Virology June corr 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 June You received information on sample properties already per on 16 July 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). 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). Note for German laboraries: The requirements laid down in Specified Section - effective since and with a transition period until should be fulfilled now. 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 20 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 Priv.-Doz. Dr. O. Donoso Mantke Pre-evaluation Virology June corr EN.doc 4 von 11

5 Table 3: EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Cymegalo Epstein Barr Tick-borne encephalitis (TBE = FSME) # Hepatitis A Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) anti-cmv-igg anti-cmv-igm anti-cmv-igg anti-cmv-igm anti-ebv-igg anti-ebv-igm anti-ebv-igg anti-ebv-igm anti-tbe-igg anti-tbe-igm anti-tbe-igg anti-tbe-igm qualitative dilution sample source The accepted results will be shown in the report. anti-hav miu/ml anti-hav miu/ml (4 miu/ml target anti-hav-igm : 18.5 past CMV infection (one healthy blood donor) past CMV infection (one healthy blood donor) past EBV infection (three healthy blood donors) past EBV infection (two healthy blood donors) healthy blood donor with indication of a past TBE infection/vaccination healthy blood donor with indication of a past TBE infection/vaccination anti-hav-igg healthy blood donor healthy blood donor healthy blood anti-hav-igm : 25 acute hepatitis A infection HBsAg HBsAg HBsAg HBsAg anti-hbs anti-hbs anti-hbs anti-hbs IU/ml (7.54 IU/ml target IU/ml (0.00 IU/ml target IU/ml (0.84 IU/ml target IU/ml (2.52 IU/ml target IU/l (53 IU/l target IU/l (200 IU/l target 0-9 IU/l (0 IU/l target IU/l (103 IU/l target (a) 1 : acute hepatitis B infection (a) 1 : (a) 1 : (b) 1 : 700 (b) 1 : 175 (b) 1 : 350 healthy blood acute hepatitis B infection anti-hbs healthy blood donor healthy blood anti-hbs healthy blood donor anti-hbc (c) 1 : 300 chronic hepatitis B ( for HBeAg, antianti-hbc (c) 1 : 150 HBc-IgM ) anti-hbc healthy blood anti-hbc (c) chronic hepatitis B 1 : 600 ( for HBeAg, anti- HBc-IgM ) a, b, c: Marked samples represent dilutions from the corresponding sck materials. # FSME = Frühsommer-Meningoenzephalitis Pre-evaluation Virology June corr EN.doc 5 von 11

6 Table 3 (contd.): EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Hepatitis B (prog. 2) (anti-hbc-igm HBeAg anti-hbe) Hepatitis C (Ab and HCV-Ag) Hepatitis D Hepatitis E Herpes simplex es HIV-1/ HIV anti-hcv qualitative dilution sample source anti-hbc-igm (d) 1 : 70 anti-hbc-igm (d) 1 : 140 acute hepatitis B infection HBeAg = HBeAg = : 600 chronic hepatitis B anti-hbe healthy blood anti-hbe chronic hepatitis B 1 : 70 ( for HBeAg) 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 $ = $ = not evaluated not evaluated 1 : 1.7 chronic hepatitis C 1 : 6 1 : 6 Condition after chronic hepatitis C (successful therapy) healthy blood Condition after chronic hepatitis C (successful therapy) 1 : chronic hepatitis D healthy blood donor healthy blood donor 1 : 2 acute hepatitis E infection healthy blood past HSV-1 infection (two healthy blood donors) anti-hiv-1/ healthy blood anti-hiv : 80 HIV-1 infection anti-hiv-1/ healthy blood anti-hiv : 60 HIV-2 infection HCV Ag healthy blood p24 Ag HIV-1 HIV-1 infection p24 Ag 337 (spiked pool of p24 Ag : blood donors; HIV-1 heat inactivated) HTLV-1/ anti-htlv-1/ * blood donor HTLV-2 anti-htlv * 1 : 300 HTLV-1 infection 339 anti-htlv-1/ ** blood donor * ** anti-htlv ** 1 : 4 HTLV-2 infection d: Marked samples represent dilutions from the corresponding sck materials. The samples and are identical. $ The samples and are identical. corrected on 10 August Pre-evaluation Virology June corr EN.doc 6 von 11

7 Table 3 (contd.): EQA Schemes Virus Immunology - June pre-evaluation Program Group RiliBÄK Analyte Sample Measles Mumps Parvo B19 Rubella Varicella zoster anti-measles-igg avidity: low 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 * =342044* anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM ** ** qualitative dilution sample source acute measles infection healthy blood donor with indication of a past measles infection/vaccination healthy blood donor with indication of a past mumps infection/vaccination healthy blood donor with indication of a past mumps infection/vaccination past parvo B19 infection (sera of two healthy blood donors) past parvo B19 infection (sera of one healthy blood donor) avidity: low 1 : 2 acute parvo-b19 infection anti-parvo B19-IgG * =342041* 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 anti-vzv-igm anti-vzv-igg anti-vzv-igm The samples and are identical IU/ml (350 IU/ml target IU/ml (141 IU/ml target past parvo B19 infection (sera of two healthy blood donors) sera of two healthy blood donors with indication of a past rubella infection or vaccination sera of two healthy blood donors with indication of a past rubella infection or vaccination past VZV infection (two healthy blood donors) past VZV infection (two healthy blood donors) Pre-evaluation Virology June corr EN.doc 7 von 11

8 Table 4: EQA Schemes Virus Genome Detection by PCR/NAT - June pre-evaluation Program Group RiliBÄK Sample CMV EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked HMPV qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml : approx approx (e) 1 : approx approx : approx approx (e) 1 : approx approx (f) 1 : 800 approx approx (f) 1 : 200 approx approx (f) 1 : 50 approx approx (g) 1 : not evaluated # not evaluated # (g) 1 : not evaluated # not evaluated # not evaluated # not evaluated # (g) 1 : not evaluated # not evaluated # not evaluated # (h) 1 : not evaluated # approx (h) 1 : not evaluated # approx (h) 1 : not evaluated # approx (subtype 2a/2c) (i) 1 : 600 not evaluated # approx not evaluated # (subtype 2a/2c) (i) 1 : 300 not evaluated # approx (subtype 2a/2c) (i) 1 : not evaluated # approx * (j) 1 : 28 not evaluated # not evaluated # ** 1 : not evaluated # not evaluated # * not evaluated # not evaluated # * (j) 1 : 14 not evaluated # not evaluated # (k) 1 : 7 approx not evaluated # (k) 1 : 700 approx. 602 not evaluated # : 100 approx not evaluated # (k) 1 : 70 approx not evaluated # (l) 1 : 900 not evaluated # not evaluated # : 9 not evaluated # not evaluated # e (l) 1 : 90 not evaluated # not evaluated # (l) 1 : 9 not evaluated # not evaluated # (subtype A) (m) 1 : not evaluated # not evaluated # (subtype A) (m) 1 : 64 not evaluated # (subtype A) (m) 1 : 320 not evaluated # # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). e, f, g, h, i, j, k, l, m: Marked samples derive from corresponding sck materials diluted in consecutive steps. Pre-evaluation Virology June corr EN.doc 8 von 11

9 Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - June pre-evaluation Program Group RiliBÄK Sample Measles FTA cards Mumps FTA cards Parvo B19 Respirary syncytial (antigen/ genome) Rubella FTA cards VZV qualitative (note on geno-/subtype) Target value of all methods dilution (provisional data) copies/ml IU/ml (genotype B3) undiluted not evaluated # (genotype D8) undiluted not evaluated # (genotype A) undiluted not evaluated # (genotype D4) undiluted not evaluated # (genotype F) (n) undiluted not evaluated # (genotype F) (n) 1 : 10 not evaluated # (genotype G) (o) undiluted not evaluated # (genotype G) (o) 1 : 10 not evaluated # : not evaluated # approx not evaluated # (p) 1 : not evaluated # approx (p) 1 : not evaluated # approx RSV A (q) 1 : 60 not evaluated # RSV B 1 : 20 not evaluated # RSV A 1 : 80 not evaluated # RSV A (q) 1 : 180 not evaluated # (genotype 1G) (r) undiluted not evaluated # (genotype1g) (r) 1 : 2 not evaluated # (genotype 2B) (s) undiluted not evaluated # (genotype 2B) (s) 1 : 2 not evaluated # (t) 1 : 200 approx (t) 1 : 100 approx (t) 1 : 800 approx # The quantitative results are not evaluated due the low number of analyses (without disadvantage for the certificate). n, o, p, q, r, s, t: Marked samples derive from corresponding sck materials diluted in consecutive steps. Pre-evaluation Virology June corr EN.doc 9 von 11

10 Table 5: EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 incl. Typing - pre-evaluation Program Group RiliBÄK Sample Adenoes Coronaes Enteroes HSV-1/ HSV-2 Human papilloma es * qualitative Target value of all methods copies/ml species type (note on dilution) Quantitative results will be discussed in Adeno 31 the final report. A 1 : diluted B Adeno 11 1 : diluted (u) CoV OC43 1 : diluted (v) B Adeno 11 1 : diluted (u) Quantitative results MERS-CoV will be discussed in : 100 diluted (w) the final report. CoV OC : 100 diluted (v) MERS-CoV : diluted (w) Quantitative results ---- will be discussed in the final report approx = Entero 68 1 : 1000 diluted Coxsackie B3 1 : diluted Coxsackie A21 1 : diluted HSV-1 1 : diluted (x) approx approx = HSV-2 1 : 5 00 diluted (y) HSV-1 1 : diluted (x) approx High Risk High Risk HSV-2 1 : 4000 diluted (y) HPV 18 1 : 15 diluted (z) HPV 16 1 : 5 diluted High Risk High Risk u, v, w, x, y, z: Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples and are identical. HPV 18 1 : 30 diluted (z) HPV 16 1 : 20 diluted Pre-evaluation Virology June corr EN.doc 10 von 11

11 Table 5 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 incl. Typing - pre-evaluation Program Group RiliBÄK Sample Human rhinoes * Rotaes suspension of feces aa, bb: = qualitative Target value of all methods copies/ml species type (note on dilution) Quantitative results will be discussed in HRV A Typ the final report : 100 diluted (aa) = HRV A Typ : 10 diluted (aa) G2P[4] : diluted (bb) ---- HRV A Typ 30 1 : 10 diluted (aa) Quantitative results will be discussed in G2P[4] the final report : 100 diluted (bb) G2P[4] : diluted (bb) Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples and are identical. Pre-evaluation Virology June corr EN.doc 11 von 11

June Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics. Prof. Dr. Heinz Zeichhardt. Dr.

June Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics. Prof. Dr. Heinz Zeichhardt. Dr. June 2018 Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung