November/ December 2016

Transcription

1 November/ December 2016 Corrected version: 02 February 2017 (See Table 3; page 11; program 401) 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 November December b corr doc 1 of 13

2 INSTAND EQA Schemes in Virus Diagnostics 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: Assistant EQAS Adviser: Prof. i. R. Dr. Heinz Zeichhardt Dr. Martin Kammel Charité - University Medicine Berlin c/o INSTAND e.v. Ubierstr. 20, Düsseldorf Correspondence address: Tel.: +49-(0) ; Fax: +49-(0) Prof. Dr. Heinz Zeichhardt M.Kammel@iqvd.de Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, D Berlin, Germany Tel.: +49-(0) ; Fax: +49-(0) Heinz.Zeichhardt@iqvd.de Organisation and Logistics: INSTAND e.v. Ubierstr. 20 D Düsseldorf, Germany Tel.: +49 (0) Fax: +49 (0) instand@instand-ev.de Internet: Virology November December b corr doc 2 of 13

3 INSTAND External Quality Assessment Schemes November/December 2016 Virus Immunology Virus Genome Detection Information on Sample Properties Dear colleagues, You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in diagnostics of November/December The INSTAND EQA schemes November/December 2016 for immunology and genome detection are now closed. An exception are the programs for drug resistance determination with the extended deadline of : cymegalo (349) hepatitis B (397) hepatitis C (399) HIV-1 standard program (383) HIV-1 additional program (384). For orientation, you receive information on the properties of the samples which were tested in the respective EQA scheme of November/December 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 corresponding For questions, please do not hesitate contact us. Thank you very much for your kind cooperation. Merry Christmas and a Happy New Year Prof. Dr. H. Zeichhardt Virology November December b corr doc 3 of 13

4 Table 1: EQA Schemes Virus Immunology - November/December 2016 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) mandary: mandary: mandary: 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 avidity: no avidity / no statement possible avidity: low = = anti-hav anti-hav The accepted results will be shown in the report. healthy blood donor (Pool) 1 : 4 acute CMV infection 1 : 15 past EBV infection (two healthy blood donors) healthy blood three healthy blood donor with indication of a past TBE infection/vaccination healthy blood anti-hav-igg healthy blood donor anti-hav-igm : 10 acute hepatitis A anti-hav-igm healthy blood HBsAg (a) 1 : acute hepatitis B HBsAg (a) 1 : 500 HBsAg healthy blood HBsAg (a) 1 : acute hepatitis B anti-hbs (b) 1 : anti-hbs anti-hbs anti-hbs a, b: Marked samples derive from corresponding sck materials diluted in consecutive steps. The samples and are identical. (b) 1 : (b) 1 : anti-hbs healthy blood donor healthy blood # FSME = Frühsommer-Meningoenzephalitis will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 4 of 13

5 Table 1 (contd.): EQA Schemes Virus Immunology - November/December 2016 Information on sample properties Program Group RiliBÄK Analyte Sample qualitative dilution sample source Hepatitis B anti-hbc (c) 1 : 350 chronic hepatitis B ( for HBeAg, anti- (prog. 1) anti-hbc (c) 1 : 175 HBc-IgM ) mandary: 344 healthy blood anti-hbc (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 chronic hepatitis B anti-hbc (c) 1 : 700 ( for HBeAg, anti- HBc-IgM ) mandary: anti-hbc-igm : 150 acute hepatitis B healthy blood anti-hbc-igm mandary: healthy blood HBeAg HBeAg : 750 chronic hepatitis B mandary: ( for HBeAg) chronic hepatitis B anti-hbe : 170 healthy blood anti-hbe anti-hcv anti-hcv healthy blood * mandary: HCV antigen HCV Ag mandary: mandary: mandary: 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 Virology November December b corr doc 5 of 13 1 : 10 1 : 10 1 : 50 chronic hepatitis C (subtype 3a) condition after chronic hepatitis C (successful therapy) chronic hepatitis C (subtype 1b) 1 : 350 chronic hepatitis D healthy blood donor past hepatitis E healthy blood donor past HSV-1/HSV-2 infection (one healthy blood donor) anti-hiv-1/ healthy blood anti-hiv : 100 HIV-1 infection anti-hiv : 3.6 HIV-2 infection anti-hiv : 75 HIV-1 infection HIV-1 infection p24 Ag : (spiked pool of blood donors; HIV-1 heat inactivated) p24 Ag healthy blood c: Marked samples derive from corresponding sck materials diluted in consecutive steps. & The samples and are identical. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding

6 Table 1 (contd.): EQA Schemes Virus Immunology - November/December 2016 Information on sample properties Program Group RiliBÄK Analyte Sample qualitative dilution sample source HTLV-1/ healthy blood anti-htlv-1/ * HTLV-2 donor 339 anti-htlv ** 1 : 4 HTLV-2 infection * anti-htlv * 1 : 500 HTLV-1 infection ** Measles Mumps Parvo B19 * ** Rubella mandary: anti-htlv ** 1 : 500 HTLV-1 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 ** * * * avidity: no avidity / no statement possible / no statement possible avidity: no avidity one healthy blood donor with indication of a past measles infection/vaccination one healthy blood donor with indication of a past measles infection/vaccination healthy blood donor 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) past parvo B19 infection (two healthy blood donors) 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 will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 6 of 13

7 Table 1 (contd.): EQA Schemes Virus Immunology - November/December 2016 Information on sample properties Program Group RiliBÄK Analyte Sample Varicella zoster Zika * * anti-vzv-igg anti-vzv-igm anti-vzv-igg anti-vzv-igm anti-zika-igg anti-zika-igm anti-zika-igg anti-zika-igm anti-zika-igg anti-zika-igm qualitative dilution sample source The results for anti-zika- IgM obtained by a test of one manufacturer (EuroImmun, Arbo- Fever-Mosaic 2) were inconsistent and have not been evaluated (without disadvantage for the certificate)., borderline past VZV infection (two healthy blood donors) past VZV infection (two healthy blood donors) sample and sample derive from the same patient Z3 sample is a follow-up of patient Z3 past Zika infection for anamnestic information see sample blood collected: approx. 4 months after onset of disease sample and sample derive from the same patient Z3 sample is the primarily derived from patient Z3 post-acute Zika infection, Zika RNA not detectable anymore stay in South America (Columbia, Peru, Chile, Bolivia and Argentina) Clinical signs: fever, headache, muscle pain, joint pain and rash blood collected: approx. 3 weeks after onset of disease healthy blood donor * The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbo and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich and Prof. Dr. Dr. Jonas Schmidt-Chanasit). will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 7 of 13

8 Table 2: EQA Schemes Virus Genome Detection - November/December 2016 Information on sample properties 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 CMV (d) 1 : 100 mandary: 365 mandary: mandary: mandary: mandary: mandary: (d) 1 : (d) 1 : (d) 1 : (e) 1 : (e) 1 : (e) 1 : : (f) 1 : (f) 1 : (g) 1 : (g) 1 : (g) 1 : (subtype 4a) (h) 1 : (subtype 4a) (subtype 4a) (subtype 4a) (h) 1 : 40 (h) 1 : 400 (h) 1 : ** (subtype 3c) 1 : ** (subtype 3e) (i) 1 : ** 1 : ** (subtype 3e) (i) 1 : 310 (group M/ (j) 1 : subtype F) (group M/ (j) 1 : subtype F) (group M/ (j) 1 : subtype F) (group M/ (j) 1 : subtype F) strain: EHO (k) 1 : strain: EHO (k) 1 : strain: EHO (k) 1 : (subtype A) (l) 1 : (subtype A) (l) 1 : (subtype A) (l) 1 : 320 d, e, f, g, h, i, j, k, l: 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 corresponding Virology November December b corr doc 8 of 13

9 Table 2 (contd.): EQA Schemes Virus Genome Detection November/December Information on sample properties Program Group RiliBÄK Sample qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml Measles (genotype B3) undiluted (genotype H1) undiluted undiluted be be FTA cards (genotype D8) undiluted Mumps FTA cards Parvo B19 Respirary syncytial (antigen/ genome) Rubella FTA cards VZV mandary: mandary: mandary: (genotype H) undiluted (genotype G) undiluted (genotype F) undiluted undiluted (m) 1 : (m) 1 : (m) 1 : (m) 1 : RSV A (n) 1 : RSV B (o) 1 : RSV A (n) 1 : / RSV B borderline (o) 1 : (genotype 2B) undiluted undiluted (genotype 1E) undiluted (genotype 1A) undiluted (p) 1 : (p) 1 : : (p) 1 : 250 be be be be be be be be be be m, n, o, p: Marked samples derive from corresponding sck materials diluted in consecutive steps. For sample , the reporting of "borderline" 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 "borderline" ensured that these sample would not have been misinterpreted as. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 9 of 13

10 Table 3: EQA Schemes Virus Genome Detection incl. Typing November/December Information on sample properties Program Group RiliBÄK Sample Adenoes mandary: Coronaes Enteroes HBV- Genotyping* HSV-1/ HSV * 363 mandary: mandary: qualitative Target value of all methods copies/ml species D A C type (note on dilution) Adeno 2 1 : diluted Adeno 37 1 : diluted Adeno 31 1 : 300 diluted CoV OC43 1 : diluted (q) MERS-CoV 1 : diluted (r) MERS-CoV 1 : diluted (r) CoV OC43 1 : diluted (q) MERS-CoV 1 : diluted (r) Echo 30 1 : diluted (s) Coxsackie B : diluted Echo 30 1 : diluted (s) genotype B2 1 : diluted genotype D1 1 : 586 diluted genotype A1 1 : diluted genotype D3 1 : diluted $ = HSV : diluted (t) HSV : diluted (u) $ = HSV : diluted (t) HSV-1 1 : diluted (u) HSV-2 1 : diluted (t) q, r, s, t, u: Marked samples derive from corresponding sck materials diluted in consecutive steps. $ The samples and are identical. * The EQA program Virus Genome Detection - HBV-Genotyping (396) is performed in cooperation with Paul-Ehrlich-Institut (WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Bundesinstitut für Impfsffe und biomedizinische Arzneimittel, Abteilung Virologie, PD Dr. Micha Nübling, Dr. Michael Chudy, Dr. Sally A. Baylis und Dr. Julia Kreß). will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 10 of 13

11 Table 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December Information on sample properties Program Group RiliBÄK Sample Human papilloma es biopsy* ** Human Rhinoes Noro suspension of feces Rotaes suspension of feces Zika & & mandary: qualitative Target value of all methods copies/ml species type (note on dilution) * Low Risk - HPV 6 1 : 80 diluted ** ** High Risk - HPV 18 1 : 20 diluted ** High Risk - HPV 16 1 : 4 diluted ** High Risk - HPV 18 1 : 40 diluted HRV A type 30 1 : 500 diluted HRV A type be 1 : 50 diluted (v) HRV A type 49 1 : 500 diluted (v) : 200 diluted be genogroup II 1 : 731 diluted genogroup II 1 : 794 diluted G2P[4] 1 : diluted G4P[8] 1 : diluted (w) be G4P[8] 1 : 82 diluted (w) G4P[8] 1 : diluted (w) v, w, x: Marked samples derive from corresponding sck materials diluted in consecutive steps.. Non-marked samples derive from independent preparations genogroup II 1 : 440 diluted African lineage (inactivated) 1 : 400 diluted (x) African lineage (inactivated) 1 : diluted (x) African lineage (inactivated) 1 : 40 diluted (x) * The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbo and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit and Dr. Petra Emmerich). corrected on 02 February will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 11 of 13

12 Table 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December Information on sample properties Program Group RiliBÄK Sample Influenza A-und B- es* inclusive influenza A(H1N1) pdm09 and avian influenza A (different subtypes) (genome/ antigen) 370* mandary: and results considered as "correct" (target values) type/subtype strain origin for avian influenza A(H7N9) for seasonal influenza B for Influenza A(H1N1) pdm09 A/Anhui/1/2013 B/Brisbane/60/2008 (vaccine strain) A/California/7/2009 (vaccine strain) for seasonal influenza B for seasonal influenza A(H3N2) B/Phuket/3073/2013 (vaccine strain) A/Switzerland/ / 2013 (vaccine strain) allanic fluid (inactivated) (1 : 400 diluted) infected MDCKcells (lysate) (1 : 8 diluted) infected MDCKcells (lysate) (1 : 100 diluted) non-infected MDCK cells (lysate) infected MDCKcells (lysate) (1 : 150 diluted) infected MDCKcells (lysate) (1 : 250 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, PD Dr. Timm C. Harder. will be in the forthcoming pre-evaluation, the participation documents as well as the reports of the corresponding Virology November December b corr doc 12 of 13

13 Table 4: EQA Schemes Virus Genome Detection for Drug Resistance Determination November/December Information on sample properties Program Group RiliBÄK Sample CMV drug resistance 349 a) and results considered as "correct" (target values) The EQA scheme (349) is still running (extended deadline: ) Target values will be in the forthcoming pre-evaluation. HBV drug resistance plasmid 397 b) The EQA scheme (397) is still running (extended deadline: ) Target values will be in the forthcoming pre-evaluation HCV drug resistance 399 c) The EQA scheme (399) is still running (extended deadline: ) Target values will be in the forthcoming pre-evaluation HIV-1 drug resistance standard program * plasmid** HIV-1 drug resistance additional program 383 d) 384 d) * * * ** Non-marked samples derive from independent preparations The EQA scheme (383) is still running (extended deadline: ) Target values will be in the forthcoming pre-evaluation. The EQA scheme (384) is still running (extended deadline: ) Target values will be in the forthcoming pre-evaluation. The above mentioned EQA schemes were performed in cooperation with: a) CMV drug resistance (349) Nationales Konsiliarlaborarium für Cymegalie (CMV) - (Schwerpunkt) CMV-Infektionen bei immunsupprimierten Personen Universitätsklinikum Ulm, Institut für Virologie; Prof. Dr. Thomas Mertens, Prof. Dr. Detlef Michel Nationales Konsiliarlaborarium für Cymegalie (CMV) - (Schwerpunkt) kongenitale/postnatale CMV-Infektionen Universitätsklinikum Tübingen, Institut für Medizinische Virologie; Prof. Dr. Gerhard Jahn, Prof. Dr. Klaus Hamprecht b) HBV drug resistance (397) Nationales Referenzzentrum für Hepatitis-B-Virus u. Hepatitis-D-Virus Justus-Liebig-Universität Gießen, Institut für Medizinische Virologie; Prof. Dr. Dieter Glebe, Dr. Christian Schüttler, Prof. Dr. Wolfram Gerlich, Prof. Dr. John Ziebuhr c) HCV drug resistance (399) Nationales Referenzzentrum für Hepatitis-C-Viren, Universitätsklinikum Essen, Institut für Virologie; Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross, Prof. Dr. Michael Roggendorf d) HIV-1 drug resistance - standard program (383) and additional program (384) Universitätsklinikum Erlangen, Institut für Klinische und Molekulare Virologie; Prof. Dr. Klaus Überla, Dr. Klaus Korn Ludwig-Maximilians-Universität München, Max-von-Pettenkofer Institut, Klinische Virologie; Prof. Dr. Oliver T. Keppler, Prof. Dr. Josef Eberle, Prof. Dr. Lutz Gürtler Nationales Referenzzentrum für Retroviren, Universitätsklinikum Frankfurt, Institut für Medizinische Virologie; Prof. Dr. Volkhard A.J. Kempf, Prof. Dr. Holger F. Rabenau, Prof. Dr. Annemarie Berger, PD Dr. Martin Stürmer Uniklinik Köln, Institut für Virologie; Prof. Dr. Herbert Pfister, Dr. Rolf Kaiser Virology November December b corr doc 13 of 13