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

Transcription

1 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 e.v. Düsseldorf/Berlin, Germany, Virology June doc 1 of 10

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: Virology June doc 2 of 10

3 INSTAND External Quality Assessment Schemes June 2018 Virus Immunology Virus Genome Detection Information on Sample Properties Dear colleagues, You have registered for one or several of the INSTAND external quality assessment (EQA) schemes in diagnostics in June The INSTAND EQA schemes June 2018 for immunology and genome detection are now closed. For orientation, you receive information on the properties of the samples which were tested in the respective EQA scheme of June The pre-evaluation of these EQA schemes which you usually receive, will be supplied in due time gether with participation documents (certificate of successful participation, statement of participation, statement of individual results). will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the For questions, please do not hesitate contact us. Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel Virology June doc 3 of 10

4 Table 1: EQA Schemes Virus Immunology June 2018 Information on sample properties 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 1 : 360 past CMV infection past CMV infection past EBV infection 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 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 will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 4 of 10

5 Table 1 (contd.): EQA Schemes Virus Immunology June 2018 Information on sample properties Program Group RiliBÄK Analyte Sample Hepatitis B (prog. 1) (HBsAg anti-hbs anti-hbc) (continued) 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-2 HIV-1 p24 Ag anti-hcv HCV Ag 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 anti-hbc-igm / borderline 1 : 60 acute hepatitis B HBeAg 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 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 p24 Ag (f) 1 : p24 Ag (f) 1 : c, d, e, f: The marked dilutions were performed with the same sck materials. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the HIV-1 infection (spiked pool of blood donors; HIV-1 heat inactivated) Virology June doc 5 of 10

6 Table 1 (contd.): EQA Schemes Virus Immunology June 2018 Information on sample properties Program Group RiliBÄK Analyte Sample qualitative dilution sample source HTLV-1/ HTLV-2 * ** Measles Mumps Parvo B19 * ** Rubella Varicella zoster 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 * * * * avidity: no avidity one healthy blood donor measles infection/vaccination one healthy blood donor measles infection/vaccination one healthy blood donor mumps infection/vaccination one healthy blood donor 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 rubella infection or vaccination two healthy blood donors rubella infection or vaccination past VZV infection past VZV infection will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 6 of 10

7 Table 2: EQA Schemes Virus Genome Detection June 2018 Information on sample properties Program Group RiliBÄK Sample CMV spiked EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked qualitative (note on geno-/subtype) (a) 1 : (a) 1 : (a) 1 : : (b) 1 : (b) 1 : (c) 1 : (c) 1 : (c) 1 : (d) 1 : (d) 1 : (d) 1 : (subtype 1b) (e) 1 : (subtype 1b) (e) 1 : (subtype 1b) (e) 1 : ** (subtype 3c) (f) 1 : ** 1 : ** (subtype 3c) (f) 1 : ** (subtype 3c) (f) 1 : (group M / subtype B) Target value of all methods dilution (provisional data) copies/ml IU/ml (g) 1 : (group M / subtype B) (group M / subtype F) strain: ROD10 strain: ROD10 (g) 1 : : (h) 1 : (h) 1 : strain: ROD10 (h) 1 : be be be be be be be be a, b, c, d, e, f, g, h: Marked samples derive from corresponding sck materials diluted in consecutive steps.. be be be be be be be be will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 7 of 10

8 Table 2 (contd.): EQA Schemes Virus Genome Detection June 2018 Information on sample properties Program HMPV Group RiliBÄK Sample 385 qualitative (note on geno-/subtype) (subtype A) (i) 1 : (subtype A) (i) 1 : (subtype A) (i) 1 : 750 Target value of all methods dilution (provisional data) copies/ml IU/ml (genotype H1) --- Measles FTA cards (genotype D8) (genotype B3) --- Mumps FTA cards (genotype C) (genotype G) (genotype H) --- Parvo B (j) 1 : (j) 1 : Respirary syncytial (antigen/ genome) RSV A (k) 1 : RSV B (indeterminate*) 1 : RSV A (k) 1 : Rubella FTA cards (genotype 1F) (genotype 1J) (genotype 2B) --- 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. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 8 of 10

9 Table 3: EQA Schemes Virus Genome Detection incl. Typing June 2018 Information on sample properties Program Group RiliBÄK Sample Adenoes qualitative Target value of all methods copies/ml species A B C D type (note on dilution) Adeno 37 1 : diluted Adeno 31 1 : diluted Adeno 11 1 : diluted Adeno 2 1 : diluted Coronaes MERS-CoV 1 : diluted (l) CoV OC43 1 : diluted (m) MERS-CoV 1 : diluted (l) CoV OC43 1 : diluted (m) Enteroes HSV-1/ HSV Entero : diluted Echo : 125 diluted (n) Echo 7 1 : 250 diluted (n) HSV : diluted HSV-1 1 : diluted (o) HSV-2 1 : 300 diluted (p) 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. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 9 of 10

10 Table 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing June 2018 Information on sample properties 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 1 : 32 diluted (q) HPV 18 1 : 20 diluted (r) HPV 18 1 : 40 diluted (r) HPV 16 1 : 16 diluted (q) ** Human Rhinoes HRV A type 49 1 : 200 diluted (s) HRV A type 30 1 : 200 diluted HRV A type 49 1 : diluted (s) : 200 diluted Rotaes suspension of feces G1P[8] 1 : 550 diluted (t) G1P[8] 1 : 55 diluted (t) G2P[4] 1 : diluted q, r, s, t: Marked samples derive from corresponding sck materials diluted in consecutive steps. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the Virology June doc 10 of 10