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, 24.07.2015
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, 40223 Düsseldorf Hindenburgdamm 27, 12203 Berlin Tel.: +49-(0)30-81054305; Fax: +49-(0)30-81054303 Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: donoso@instand-ev.de Email: Heinz.Zeichhardt@charite.de Organisation and Logistics: INSTAND e.v. Ubierstr. 20 40223 Düsseldorf Tel.: +49 (0)211-1592 13 0 Fax: +49 (0)211-1592 1330 Email: instand@instand-ev.de Internet: www.instand-ev.de Pre-evaluation Virology June 2015 20150724 corr 20150810 EN.doc 2 von 11
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 2015. 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 2015 20150724 corr 20150810 EN.doc 3 von 11
Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme June 2015. You received information on sample properties already per email on 16 July 2015. 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: http://www.instandev.de/en/eqas/reports/ and in German language: http://www.instandev.de/ringversuche/kommentare/. 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 1583 - 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: 10.3205/lab000018, URN: urn:nbn:de:0183- lab0000182) (please see link). Note for German laboraries: The requirements laid down in Specified Section - effective since 01.04.2013 and with a transition period until 31.05.2015 - 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 2014. 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 2015 20150724 corr 20150810 EN.doc 4 von 11
Table 3: EQA Schemes Virus Immunology - June 2015 - 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) 351 352 358 343 344 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 351041 351042 352021 352022 358021 358022 qualitative dilution sample source The accepted results will be shown in the report. anti-hav 343081 30 miu/ml anti-hav 343082 0-19 miu/ml (4 miu/ml target anti-hav-igm 343083 1 : 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 343084 1 : 25 acute hepatitis A infection HBsAg 344241 HBsAg 344242 HBsAg 344243 HBsAg 344244 anti-hbs 344245 anti-hbs 344246 anti-hbs 344247 anti-hbs 344248 5.40-11.70 IU/ml (7.54 IU/ml target 0.00-0.06 IU/ml (0.00 IU/ml target 0.60-1.30 IU/ml (0.84 IU/ml target 1.80-3.90 IU/ml (2.52 IU/ml target 13-80 IU/l (53 IU/l target 50-320 IU/l (200 IU/l target 0-9 IU/l (0 IU/l target 25-160 IU/l (103 IU/l target (a) 1 : 1 000 acute hepatitis B infection (a) 1 : 9 000 (a) 1 : 3 000 (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 344249 (c) 1 : 300 chronic hepatitis B ( for HBeAg, antianti-hbc 344250 (c) 1 : 150 HBc-IgM ) anti-hbc 344251 healthy blood anti-hbc 344252 (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 2015 20150724 corr 20150810 EN.doc 5 von 11
Table 3 (contd.): EQA Schemes Virus Immunology - June 2015 - 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-2 345 346 347 348 354 335 anti-hcv qualitative dilution sample source anti-hbc-igm 345121 (d) 1 : 70 anti-hbc-igm 345122 (d) 1 : 140 acute hepatitis B infection HBeAg 345123 = 345124 HBeAg 345124 = 345123 1 : 600 chronic hepatitis B anti-hbe 345125 healthy blood anti-hbe 345126 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 346081 346082 $ = 346084 346083 346084 $ = 346082 347021 347022 348021 348022 354021 354022 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 : 5 000 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-1/2 335081 healthy blood anti-hiv-1 335082 1 : 80 HIV-1 infection anti-hiv-1/2 335083 healthy blood anti-hiv-2 335084 1 : 60 HIV-2 infection HCV Ag healthy blood p24 Ag 337041 HIV-1 HIV-1 infection p24 Ag 337 (spiked pool of p24 Ag 337042 1 : 54 000 blood donors; HIV-1 heat inactivated) HTLV-1/ anti-htlv-1/2 339017* blood donor HTLV-2 anti-htlv-1 339018* 1 : 300 HTLV-1 infection 339 anti-htlv-1/2 339019** blood donor * ** anti-htlv-2 339020** 1 : 4 HTLV-2 infection d: Marked samples represent dilutions from the corresponding sck materials. The samples 345123 and 345124 are identical. $ The samples 346082 and 346084 are identical. corrected on 10 August 2015. Pre-evaluation Virology June 2015 20150724 corr 20150810 EN.doc 6 von 11
Table 3 (contd.): EQA Schemes Virus Immunology - June 2015 - pre-evaluation Program Group RiliBÄK Analyte Sample Measles Mumps Parvo B19 Rubella Varicella zoster 357 356 342 341 353 anti-measles-igg 357021 avidity: low anti-measles-igm anti-measles-igg 357022 anti-measles-igm anti-mumps-igg 356021 anti-mumps-igm anti-mumps-igg 356022 anti-mumps-igm anti-parvo B19-IgG 342041* =342044* anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM anti-parvo B19-IgG anti-parvo B19-IgM 342042** 342043** 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 342044* =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 342041 and 342044 are identical. 341021 341022 353021 353022 128-2 048 90 IU/ml (350 IU/ml target 32-512 60 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 2015 20150724 corr 20150810 EN.doc 7 von 11
Table 4: EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 - pre-evaluation Program Group RiliBÄK Sample CMV EBV HAV spiked HBV HCV HEV * suspension of feces** HIV-1 spiked HIV-2 spiked HMPV 365 376 377 361 362 380 360 395 385 qualitative Target value of all methods (note on dilution (provisional data) geno-/subtype) copies/ml IU/ml 365081 1 : 5 000 approx. 6 738 approx. 20 565 365082 (e) 1 : 10 000 approx. 35 300 approx. 42 089 365083 1 : 10 000 approx. 27 037 approx. 40 150 365084 (e) 1 : 100 000 approx. 2 880 approx. 3 711 376041 (f) 1 : 800 approx. 1 225 approx. 2 025 376042 (f) 1 : 200 approx. 5 595 approx. 7 990 376043 (f) 1 : 50 approx. 27 900 approx. 29 750 376044 ------- 0 0 377081 (g) 1 : 5 000 not evaluated # not evaluated # 377082 (g) 1 : 1 250 not evaluated # not evaluated # 377083 ------- not evaluated # not evaluated # 377084 (g) 1 : 20 000 not evaluated # not evaluated # 361081 ------- not evaluated # 0 361082 (h) 1 : 25 000 not evaluated # approx. 21 850 361083 (h) 1 : 5 000 not evaluated # approx. 103 500 361084 (h) 1 : 125 000 not evaluated # approx. 4 093 362081 (subtype 2a/2c) (i) 1 : 600 not evaluated # approx. 7 881 362082 ------- not evaluated # 0 362083 (subtype 2a/2c) (i) 1 : 300 not evaluated # approx. 14 835 362084 (subtype 2a/2c) (i) 1 : 1 200 not evaluated # approx. 3 711 380017* (j) 1 : 28 not evaluated # not evaluated # 380018** 1 : 1 000 not evaluated # not evaluated # 380019* ------- not evaluated # not evaluated # 380020* (j) 1 : 14 not evaluated # not evaluated # 360081 (k) 1 : 7 approx. 56 050 not evaluated # 360082 (k) 1 : 700 approx. 602 not evaluated # 360083 1 : 100 approx. 1 002 not evaluated # 360084 (k) 1 : 70 approx. 7 635 not evaluated # 395005 (l) 1 : 900 not evaluated # not evaluated # 395006 1 : 9 not evaluated # not evaluated # 395007 e (l) 1 : 90 not evaluated # not evaluated # 395008 (l) 1 : 9 not evaluated # not evaluated # 385009 (subtype A) (m) 1 : 1 600 not evaluated # ------- 385010 ------- not evaluated # ------- 385011 (subtype A) (m) 1 : 64 not evaluated # ------- 385012 (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 2015 20150724 corr 20150810 EN.doc 8 von 11
Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - June 2015 - pre-evaluation Program Group RiliBÄK Sample Measles FTA cards Mumps FTA cards Parvo B19 Respirary syncytial (antigen/ genome) Rubella FTA cards VZV 386 387 367 359 389 366 qualitative (note on geno-/subtype) Target value of all methods dilution (provisional data) copies/ml IU/ml 386009 (genotype B3) undiluted not evaluated # ------- 386010 (genotype D8) undiluted not evaluated # ------- 386011 (genotype A) undiluted not evaluated # ------- 386012 (genotype D4) undiluted not evaluated # ------- 387005 (genotype F) (n) undiluted not evaluated # ------- 387006 (genotype F) (n) 1 : 10 not evaluated # ------- 387007 (genotype G) (o) undiluted not evaluated # ------- 387008 (genotype G) (o) 1 : 10 not evaluated # ------- 367081 1 : 300 000 not evaluated # approx. 75 100 367082 ------- not evaluated # 0 367083 (p) 1 : 800 000 not evaluated # approx. 7 190 367084 (p) 1 : 12 500 not evaluated # approx. 268 000 359021 RSV A (q) 1 : 60 not evaluated # ------- 359022 RSV B 1 : 20 not evaluated # ------- 359023 RSV A 1 : 80 not evaluated # ------- 359024 RSV A (q) 1 : 180 not evaluated # ------- 389005 (genotype 1G) (r) undiluted not evaluated # ------- 389006 (genotype1g) (r) 1 : 2 not evaluated # ------- 389007 (genotype 2B) (s) undiluted not evaluated # ------- 389008 (genotype 2B) (s) 1 : 2 not evaluated # ------- 366041 (t) 1 : 200 approx. 19 900 ------- 366042 (t) 1 : 100 approx. 40 000 ------- 366043 ------- 0 ------- 366044 (t) 1 : 800 approx. 4 840 ------- # 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 2015 20150724 corr 20150810 EN.doc 9 von 11
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 * 371 340 372 363 373 371041 qualitative Target value of all methods copies/ml species type (note on dilution) 371042 Quantitative results --- --- 371043 will be discussed in Adeno 31 the final report. A 1 : 1 200 diluted 371044 B Adeno 11 1 : 50 000 diluted (u) 340001 ---- CoV OC43 1 : 1 000 diluted (v) B Adeno 11 1 : 5 000 diluted (u) 340002 ---- --- Quantitative results MERS-CoV 340003 will be discussed in ---- 1 : 100 diluted (w) the final report. CoV OC43 340004 ---- 1 : 100 diluted (v) MERS-CoV 340005 ---- 1 : 1 000 diluted (w) 372042 372043 Quantitative results ---- will be discussed in 372044 the final report. ---- 372045 ---- 363061 approx. 6 680 ---- 363062 = 363065 ---- --- Entero 68 1 : 1000 diluted Coxsackie B3 1 : 25 000 diluted Coxsackie A21 1 : 7 500 diluted HSV-1 1 : 152 000 diluted (x) 0 ---- ---- 363063 approx. 77 254 ---- 363064 approx. 56 800 ---- 363065 = 363062 HSV-2 1 : 5 00 diluted (y) HSV-1 1 : 19 000 diluted (x) 0 ---- ---- 363066 approx. 10 980 ---- 373051 High Risk ----- ---- 373052 High Risk ----- ---- HSV-2 1 : 4000 diluted (y) HPV 18 1 : 15 diluted (z) HPV 16 1 : 5 diluted 373053 ----- ---- ---- 373054 High Risk ----- ---- 373055 High Risk ----- ---- u, v, w, x, y, z: Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples 363062 and 363065 are identical. HPV 18 1 : 30 diluted (z) HPV 16 1 : 20 diluted Pre-evaluation Virology June 2015 20150724 corr 20150810 EN.doc 10 von 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: 393 401 393001 = 393004 qualitative Target value of all methods copies/ml species type (note on dilution) 393002 Quantitative results ---- ---- will be discussed in HRV A Typ 30 393003 the final report. ---- 1 : 100 diluted (aa) 393004 = HRV A Typ 30 ---- 393001 1 : 10 diluted (aa) G2P[4] 401001 ---- 1 : 10 000 diluted (bb) ---- HRV A Typ 30 1 : 10 diluted (aa) 401002 Quantitative results ---- ---- will be discussed in G2P[4] 401003 the final report. ---- 1 : 100 diluted (bb) G2P[4] 401004 ---- 1 : 1 000 diluted (bb) Marked samples derive from corresponding sck materials diluted in consecutive steps. : The samples 393001 and 393004 are identical. Pre-evaluation Virology June 2015 20150724 corr 20150810 EN.doc 11 von 11