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

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1 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 in medizinischen Laborarien e.v. Düsseldorf/Berlin, Germany, Pre-evaluation Virology June of 13

2 INSTAND EQA schemes in virology in cooperation with: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.v. (DVV) Gesellschaft für Virologie e.v. (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie e.v. (DGHM) EQAS Adviser: Prof. i.r. Dr. Heinz Zeichhardt Professor of Virology Charité - University Medicine Berlin Correspondence address: Prof. Dr. Heinz Zeichhardt Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, D Berlin, Germany Tel.: +49-(0) ; Fax: +49-(0) Heinz.Zeichhardt@iqvd.de Assistant EQAS Adviser: Dr. Martin Kammel c/o INSTAND e.v. Ubierstr. 20, D Düsseldorf, Germany Tel.: +49-(0) ; Fax: +49-(0) M.Kammel@iqvd.de Carried out by: INSTAND e.v. Ubierstr. 20 D Düsseldorf, Germany Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: Pre-evaluation Virology June of 13

3 Pre-Evaluation and Mailing of Participation Documents INSTAND External Quality Assessment Schemes June 2018 Virus Immunology Virus Genome Detection by PCR/NAT Dear colleagues, 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: certificate of successful participation confirmation of participation statement of individual results The EQA schemes having been performed in June 2018 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 June 2018 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 June of 13

4 VIRUS IMMUNOLOGY: Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in June 2018 are highlighted in bold) Chikungunya (402) 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) Zika (338) 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 (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) Zika (403) The EQA schemes having been performed in June 2018 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 June 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 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 Online / Service for EQA tests / EQA area (Virus immunology / Virus genome detection)" in English language: and in German language: Pre-evaluation Virology June of 13

5 Please note: RiliBAEK A compilation of the "Guidelines of the German Medical Association on quality assurance in medical laborary testing (Bundesaerztekammer / RiliBAEK = Richtlinie der Bundesaerztekammer zur Qualitaetssicherung laborariumsmedizinischer Untersuchungen)" with all Sections including Section "Qualitative medical laborary testing = Qualitative laborariumsmedizinische Untersuchungen" and Section "Direct detection and characterisation of infectious agents = Direkter Nachweis und Charakterisierung von Infektionserregern" has been published (in German language: Deutsches Aerzteblatt, 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: Bundesaerztekammer (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] (please see link). INSTAND EQA schemes in diagnostics and INSTAND ordering documents 2018 For details please see the INSTAND ordering documents 2018 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 e.v. for details. Thank you for your kind cooperation. Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Pre-evaluation Virology June of 13

6 Table 3: EQA Schemes Virus Immunology June 2018 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 anti-hav anti-hav qualitative dilution sample source avidity: high/intermediate/ no statement possible The accepted results will be shown in the report. avidity: no avidity 40 miu/ml (61 miu/ml)* 0-19 miu/ml (2 miu/ml) 1 : 360 past CMV infection (two healthy blood donors) past CMV infection (two healthy blood donors) past EBV infection (two healthy blood donors) healthy blood healthy blood donor healthy blood donor with indication of a past TBE infection/vaccination anti-hav-igg healthy blood donor healthy blood anti-hav-igm : 20 acute hepatitis A anti-hav-igm HBsAg HBsAg HBsAg HBsAg anti-hbs anti-hbs anti-hbs anti-hbs IU/l (0.00 IU/l target value) IU/l (1.46 IU/l target value) IU/l (2.92 IU/l target value) IU/l (0.00 IU/l target value) 0-9 IU/l (0 IU/l target value) IU/l (59 IU/l target value) IU/l (30 IU/l target value) IU/l (117 IU/l target value) a, b: Marked samples derive from corresponding sck materials diluted in consecutive steps. (a) 1 :400 (a) 1 : 200 (b) 1 : 50 (b) 1 : 100 (b) 1 : 25 healthy blood healthy blood chronic hepatitis B (HBsAg carrier) healthy blood healthy blood patient after acute hepatitis B (healed up with complete seroconversion) # FSME = Frühsommer-Meningoenzephalitis * For highly concentrated samples some commercial tests for the detection of anti-hav-igg or anti-hav-tal reveal 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 June of 13

7 Table 3 (contd.): EQA Schemes Virus Immunology June 2018 Pre-evaluation Program Group RiliBÄK Analyte Sample Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) (continued) 344 qualitative dilution sample source anti-hbc (c) 1 : 400 chronic hepatitis B ( for HBeAg, anti-hbc (c) 1 : 200 anti-hbc-igm ) anti-hbc healthy blood anti-hbc (c) chronic hepatitis B 1 : 800 ( for HBeAg, anti-hbc-igm ) anti-hbc-igm healthy blood / borderline 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 HCV Ag anti-hbc-igm HBeAg The results for this low /reactive sample obtained by a test of one manufacturer (Roche - Elecsys Anti-HBc-IgM) were inconsistent. Please note for this test the evaluation for the grey zone ( COI). 1 : 60 acute hepatitis B healthy blood HBeAg :750 chronic hepatitis B anti-hbe : 100 anti-hbe 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 (d) (d) 1 : 80 1 : 18 1 : 40 chronic hepatitis B ( for HBeAg) healthy blood healthy blood chronic hepatitis C (subtype 1b) condition after chronic hepatitis C (subtype 1b) (successful therapy) chronic hepatitis C (subtype 1b) healthy blood 1 : chronic hepatitis D past hepatitis E (two healthy blood donors) healthy blood donor healthy blood donor past HSV-1 infection (one healthy blood donor) Anti-HIV (e) 1 : 50 HIV-1 infection Anti-HIV-1/ healthy blood Anti-HIV (e) 1 : 100 HIV-1 infection Anti-HIV : 3 HIV-2 infection c, d, e: The marked dilutions were performed with the same sck materials. Pre-evaluation Virology June of 13

8 Table 3 (contd.): EQA Schemes Virus Immunology June 2018 Pre-evaluation Program Group RiliBÄK Analyte Sample HIV-1 p24 Ag HTLV-1/ HTLV-2 * ** Measles Mumps Parvo B19 * ** Rubella Varicella zoster qualitative dilution sample source p24 Ag (f) 1 : p24 Ag (f) 1 : HIV-1 infection (spiked pool of blood donors; HIV-1 heat inactivated) anti-htlv * 1 : 300 HTLV-1 infection anti-htlv-1/ ** healthy blood donor anti-htlv * 1 : 400 HTLV-1 infection anti-htlv ** 1 : 5 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 anti-vzv-igm anti-vzv-igg anti-vzv-igm * * * * f: The marked dilutions were performed with the same sck materials. avidity: no avidity (192 target value) 45 IU/ml (189 target value) # (48 target value) 40 IU/ml (82 target value) # one healthy blood donor with indication of a past measles infection/vaccination one healthy blood donor 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) past parvo B19 infection (healthy blood donor) healthy blood donor past parvo B19 infection (healthy blood donor) two healthy blood donors with indication of a past rubella infection or vaccination 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) # 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 June of 13

9 EQA Schemes Virus Genome Detection by PCR/NAT June 2018 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 (Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK Section, Table B. 3-2a, When applying CE-marked tests, which not (yet) allow reporting of results in IU/ml, you should continue 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 (Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK 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 (Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK 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 June of 13

10 Table 4: EQA Schemes Virus Genome Detection June 2018 Pre-evaluation Program Group RiliBÄK Sample CMV spiked EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked 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 : (a) 1 : (a) 1 : : (b) 1 : (b) 1 : not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # (c) 1 : not evaluated # not evaluated # (d) 1 : 700 Results in copies/ml: not accepted or (d) 1 : not evaluated (d) 1 : (see notices 2 and 3, page 9) Results in copies/ml: (subtype 1b) (e) 1 : 225 not accepted or (subtype 1b) (e) 1 : 75 not evaluated (subtype 1b) (e) 1 : (see notices 2 and 3, page 9) ** (subtype 3c) (f) 1 : 90 not evaluated # not evaluated # ** 1 : 200 not evaluated # not evaluated # ** (subtype 3c) (f) 1 : not evaluated # not evaluated # ** (subtype 3c) (f) 1 : 900 not evaluated # not evaluated # (group M / subtype B) (g) 1 : (group M / subtype B) (group M / subtype F) strain: ROD10 strain: ROD10 (g) 1 : : Results in IU/ml: not accepted or not evaluated (see notices 4 and 5, page 9) (h) 1 : not evaluated # not evaluated # (h) 1 : 100 not evaluated # not evaluated # not evaluated # not evaluated # strain: ROD10 (h) 1 : not evaluated # not evaluated # a, b, c, d, e, f, g, h: Marked samples derive from corresponding sck materials diluted in consecutive steps. # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates). Pre-evaluation Virology June of 13

11 Table 4 (contd.): EQA Schemes Virus Genome Detection June 2018 Pre-evaluation Program HMPV Group RiliBÄK Sample 385 qualitative (note on geno-/subtype) Target value of all methods dilution (provisional data) copies/ml IU/ml (subtype A) (i) 1 : 375 not evaluated # not evaluated # (subtype A) (i) 1 : not evaluated # (subtype A) (i) 1 : 750 not evaluated # (genotype H1) not evaluated # Measles FTA cards not evaluated # (genotype D8) not evaluated # (genotype B3) not evaluated # Mumps FTA cards (genotype C) not evaluated # (genotype G) not evaluated # not evaluated # (genotype H) not evaluated # Parvo B (j) 1 : (j) 1 : Respirary syncytial (antigen/ genome) RSV A (k) 1 : 40 not evaluated # RSV B indeterminate* 1 : 40 not evaluated # RSV A (k) 1 : 20 not evaluated # not evaluated # not evaluated # Rubella FTA cards (genotype 1F) not evaluated # (genotype 1J) not evaluated # (genotype 2B) not evaluated # VZV : : : i, j, k: Marked samples derive from corresponding sck materials diluted in consecutive steps. * For sample (1 : 40 diluted), the reporting of "indeterminate" in test category 10 (Qualitative detection of RSV antigen) was accepted as additional correct result for rapid tests for antigen detection of RSV. Considering also the result "indeterminate" ensured that this sample would not have been misinterpreted as. # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates). Pre-evaluation Virology June of 13

12 Table 5: EQA Schemes Virus Genome Detection incl. Typing June 2018 Pre-evaluation Program Group RiliBÄK Sample Adenoes qualitative Target value of all methods copies/ml species Quantitative results A will be discussed in the final report. B C D type (note on dilution) Adeno 37 1 : diluted Adeno 31 1 : diluted Adeno 11 1 : diluted Adeno 2 1 : diluted not evaluated # Coronaes not evaluated # not evaluated # not evaluated # not evaluated # ---- MERS-CoV 1 : diluted (l) CoV OC43 1 : diluted (m) MERS-CoV 1 : diluted (l) CoV OC43 1 : diluted (m) not evaluated # Enteroes HSV-1/ HSV Entero : diluted Echo Quantitative results : 125 diluted (n) will be discussed in the final report Echo 7 1 : 250 diluted (n) HSV-1 1 : diluted (o) HSV-2 1 : 300 diluted (p) HSV-1 1 : diluted HSV-2 1 : 900 diluted (p) HSV-1 1 : diluted (o) l, m, n, o, p: Marked samples derive from corresponding sck materials diluted in consecutive steps. # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates). Pre-evaluation Virology June of 13

13 Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing June 2018 Pre-evaluation Program Group RiliBÄK Sample Human papilloma es biopsy* ** 373 qualitative Target value of all methods copies/ml species ** High Risk ** High Risk ** High Risk ** High Risk type (note on dilution) HPV 16 (also low for HPV 18) 1 : 32 diluted (q) HPV 18 1 : 20 diluted (r) HPV 18 1 : 40 diluted (r) HPV 16 (also low for HPV 18) 1 : 16 diluted (q) ** not evaluated # Human Rhinoes not evaluated # not evaluated # ---- HRV A type 49 1 : 200 diluted (s) HRV A type 30 1 : 200 diluted not evaluated # ---- HRV A type 49 1 : diluted (s) not evaluated # : 200 diluted Rotaes suspension of feces not evaluated # not evaluated # ---- G1P[8] 1 : 550 diluted (t) G1P[8] 1 : 55 diluted (t) not evaluated # ---- G2P[4] 1 : diluted q, r, s, t: Marked samples derive from corresponding sck materials diluted in consecutive steps. # The quantitative results are not evaluated due the low number of analysis (without disadvantage for the certificates). Pre-evaluation Virology June of 13

June EQA schemes closed. Information on sample properties. Prof. Dr. Heinz Zeichhardt. Dr. Martin Kammel

June EQA schemes closed. Information on sample properties. Prof. Dr. Heinz Zeichhardt. Dr. Martin Kammel June 2018 EQA schemes closed Information on sample properties Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Issued by: INSTAND Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laborarien