instand e.v. · hepatitis c virus training program (379) hepatitis c virus geno-/subtyping (once a...
TRANSCRIPT
Pre-evaluation
of the EQA Schemes
in Virus Diagnostics
November/December 2015
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 Laboratorien e.V. Düsseldorf/Berlin, 22.01.2016
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EQAS Adviser: Assistant EQAS Adviser: Univ.-Prof. i. R. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.V. Campus Benjamin Franklin, Institut für Virologie Ubierstr. 20, 40223 Düsseldorf Email: [email protected] Tel.: +49-(0)30-81054-305; Fax: +49-(0)30-81054-303 Email: [email protected] Correspondence address: Prof. Dr. Heinz Zeichhardt Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, 14129 Berlin Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: [email protected]
Organisation and Logistics:
INSTAND e.V. Ubierstr. 20 40223 Düsseldorf Tel.: +49 (0)211 - 1592 13 0 Fax: +49 (0)211 - 1592 1330 Email: [email protected] Internet: www.instand-ev.de
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Pre-Evaluation and
Mailing of Participation Documents
INSTAND External Quality Assessment Schemes – November/December 2015
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 virus diagnostics of November/December 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:
certificate of successful participation statement of participation statement of individual results
The EQA schemes having been performed in November/December 2015 are highlighted in bold in Tables 1 and 2. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.
Table 1: EQA schemes performed with a frequency of four times per year
VIRUS IMMUNOLOGY:
Cytomegalovirus (351) Hepatitis A virus (343) Hepatitis B virus Prog. 1 (344) Hepatitis B virus Prog. 2 (345) Hepatitis C virus (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337)
VIRUS GENOME DETECTION:
Cytomegalovirus (365) Hepatitis A virus (377) Hepatitis B virus (361) Hepatitis C virus (362) HIV-1 (RNA) (360) Parvovirus B19 (367)
The EQA schemes having been performed in November/December 2015 are highlighted in bold (Table 1). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.
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Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in November/December 2015 are highlighted in bold)
VIRUS IMMUNOLOGY:
Dengue viruses (Ab/NS1-Ag) (350) Epstein Barr virus (352) TBE (FSME) virus (358) Hantaviruses (355) Hepatitis D virus (347) Hepatitis E virus (348) Herpes simplex viruses (354) HTLV-1/HTLV-2 (339) Measles virus (357) Mumps virus (356) Parvovirus B19 (342) Rubella virus (341) Rabies (Tollwut) virus (336) Varicella zoster virus (353)
VIRUS GENOME DETECTION:
Adenoviruses (371) BK virus (364) Chikungunya virus (392) Coronaviruses (340) Cytomegalovirus training program (368) Cytomegalovirus resistance determination (349) Dengue viruses (369) Enteroviruses (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr virus (376) Hepatitis B virus training program (378) Hepatitis B virus genotyping (396) Hepatitis B virus resistance determination (397) Hepatitis C virus training program (379) Hepatitis C virus geno-/subtyping (once a year) (375) Hepatitis C virus resistance determination (399) Hepatitis D virus (400) Hepatitis E virus (380) Herpes simplex virus type 1/2 (363) HIV-1 (RNA) training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (RNA) (395) Human Metapneumovirus (385) Human Papilloma viruses (373) Human Rhinoviruses (393) Influenza viruses (genome/Ag) (370) JC virus (394) Measles virus (386) Mumps virus (387) Norovirus (381) Parainfluenza viruses (388) Respiratory syncytial virus (Ag/genome) (359) Rotaviruses (401) Rubella virus (389) Rabies (Tollwut) virus (390) Varicella zoster virus (366) West Nile virus (391)
The EQA schemes having been performed in November/December 2015 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation. EQA schemes in Table 2 marked in italics were not performed in November/December 2015. Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme November/December 2015. You received information on sample properties already per email on 22.12.2015. 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/.
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Please note:
RiliBÄK A compilation of the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen)" with all Sections including Section B 2 "Qualitative determinations in laboratory medicine = Qualitative laboratoriumsmedizinische Untersuchungen" and Section B 3 "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 laboratory testing. GMS Z Forder Qualitatssich Med Lab. 2015;6:Doc03. DOI: 10.3205/lab000018, URN: urn:nbn:de:0183-lab0000182) (please see link).
Notice for German laboratories: The requirements laid down in Specified Section B 3 - effective since 01.04.2013 and with a transition period until 31.05.2015 - should now be fulfilled.
INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2016 For details please see the INSTAND ordering documents 2016 incl. brochure and order form (please see link).
Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND for details.
Thank you for your kind cooperation
Prof. Dr. H. Zeichhardt Priv.-Doz. Dr. O. Donoso Mantke
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Table 3: EQA Schemes Virus Immunology - November/December 2015 pre-evaluation
Program Group RiliBÄK Analyte Sample Sample properties
qualitative dilution sample source
Cyto-megalo-
virus (Ab)
serum
351
conform to
B 2
anti-CMV-IgG anti-CMV-IgM
351045 positive avidity: low positive
1 : 5 acute CMV infection
anti-CMV-IgG anti-CMV-IgM
351046 positive avidity: high negative
past CMV infection (two healthy blood donors)
Epstein Barr virus
(Ab)
serum
352
conform to
B 2
anti-EBV-IgG anti-EBV-IgM
352023= 352024
The accepted results will be shown in the report.
past EBV infection (four healthy blood donors)
anti-EBV-IgG anti-EBV-IgM
352024= 352023
past EBV infection (four healthy blood donors)
Tick-borne encephalitis
virus (TBE = FSME)#
(Ab)
serum
358
conform to
B 2
anti-TBE-IgG anti-TBE-IgM
358023
negative The results for anti-TBE-IgG (test category 10) obtained by a test of one manufacturer (Progen Immunozym FSME/TBE IgG) were inconsistent and are not evaluated (without disadvantage for the certificate).
avidity: no avidity negative
negative healthy blood donor
anti-TBE-IgG anti-TBE-IgM
358024 positive avidity: high negative
healthy blood donor with indication of a past TBE virus infection/vaccination
Hepatitis A virus (Ab)
serum
343
manda-tory:
B 2
anti-HAV 343089 negative 0 – 15 mIU/ml
negative healthy blood donors (pool)
anti-HAV 343090 positive ≥ 30 mIU/ml (57 mIU/ml)*
1 : 500 anti-HAV-IgG positive healthy blood donor
anti-HAV-IgM 343091 positive 1 : 10 acute hepatitis A infection
anti-HAV-IgM 343092 negative negative healthy blood donors (pool)
Hepatitis B virus
(prog. 1)
(HBsAg anti-HBs anti-HBc)
serum
344
manda-tory:
B 3
HBsAg 344265 positive 3.60 – 7.60 IU/ml (4.88 IU/ml target value)
(a) 1 : 750
chronic hepatitis B HBsAg 344266 positive 0.90 – 1.90 IU/ml (1.26 IU/ml target value)
(a) 1 : 3 000
HBsAg 344267 positive 1.80 – 3.80 IU/ml (2.45 IU/ml target value)
(a) 1 : 1 500
HBsAg 344268 negative 0.00 – 0.051 IU/ml (0.00 IU/ml target value)
negative healthy blood donors (pool)
manda-tory:
B 2
anti-HBs 344269 negative 0 – 9.3 IU/l (0 IU/l target value)
negative healthy blood donors (pool)
anti-HBs 344270 positive 20 – 90 IU/l (61 IU/l target value)
(b) 1 : 800
anti-HBs positive healthy blood donor
anti-HBs 344271 positive 80 – 360 IU/l (224 IU/l target value)
(b) 1 : 200
anti-HBs 344272 positive 40 – 180 IU/l (112 IU/l target value)
(b) 1 : 400
manda-tory:
B 2
anti-HBc 344273 positive (c) 1 : 2 400 chronic hepatitis B (HBeAg negative and anti-HBc-IgM negative) anti-HBc 344274 positive (c) 1 : 600
anti-HBc 344275 negative negative healthy blood donors (pool)
anti-HBc 344276 positive (c) 1 : 1 200 chronic hepatitis B (HBeAg negative and anti-HBc-IgM negative)
a, b, c: Marked samples represent dilutions from the corresponding stock materials.
Non-marked samples derive from independent preparations. # FSME = Frühsommer-Meningoenzephalitis
* Some commercial tests for the detection of anti-HAV-IgG or anti-HAV-total reveal for highly concentrated samples 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 to highly concentrated samples. In this case a lower limit value in mIU/ml is indicated in order to assess a reported result of a laboratory as a "correct" result.
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Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2015 pre-evaluation
Program Group RiliBÄK Analyte Sample Sample properties
qualitative dilution sample source
Hepatitis B virus
(prog. 2)
(anti-HBc-IgM HBeAg
anti-HBe)
serum
345
manda-tory:
B 2
anti-HBc-IgM 345133 negative negative healthy blood donors (pool)
anti-HBc-IgM 345134 positive 1 : 110 acute hepatitis B infection
manda-tory:
B 3
HBeAg 345135 negative negative healthy blood donors (pool)
HBeAg 345136 positive 1 : 670 chronic hepatitis B
manda-tory:
B 2
anti-HBe 345137 negative negative healthy blood donors (pool)
anti-HBe 345138 positive 1 : 135 chronic hepatitis B (negative for HBeAg)
Hepatitis C virus
(Ab and
HCV-Ag)
serum*
plasma**
346
anti-HCV
manda-tory:
B 2 HCV Ag
manda-tory:
B 3
anti-HCV HCV antigen
346089* positive negative
1 : 8.2 Condition after chronic hepatitis C (successful therapy)
anti-HCV HCV antigen
346090** positive positive
(d) 1 : 60 chronic hepatitis C
anti-HCV HCV antigen
346091* negative negative
negative healthy blood donors (pool)
anti-HCV HCV antigen
346092** positive positive
(d) 1 : 30 chronic hepatitis C
Hepatitis D virus (Ab)
serum
347
conform to
B 2
anti-HDV-IgG anti-HDV-IgM
347023 negative not evaluated
negative healthy blood donor
anti-HDV-IgG anti-HDV-IgM
347024 positive not evaluated
1 : 400 chronic hepatitis D
Hepatitis E virus (Ab)
serum
348
conform to
B 2
anti-HEV-IgG anti-HEV-IgM
348023 positive negative
past hepatitis E infection
anti-HEV-IgG anti-HEV-IgM
348024 negative negative
negative healthy blood donor
Herpes simplex viruses
(Ab)
serum
354
conform to
B 2
anti-HSV-IgG anti-HSV-IgM
354023 positive negative
past HSV-1 infection (one healthy blood donor)
anti-HSV-IgG anti-HSV-IgM
354024
positive negative The results for anti-HSV-1/2-IgM obtained by a test of one manufacturer (DiaSorin, LIAISON HSV-1/2 IgM) were inconsistent and are not evaluated (without disadvantage for the certificate).
past HSV-1 infection (two healthy blood donors)
HIV-1/ HIV-2 (Ab)
serum
335
manda-tory:
B 2
anti-HIV-1 335089 positive (e) 1 : 75 HIV-1 infection
anti-HIV-1/2 335090 negative negative healthy blood donors (pool)
anti-HIV-1 335091 positive 1 : 150 HIV-1 infection
anti-HIV-1 335092 positive (e) 1 : 150 HIV-1 infection
HIV-1 p24 Ag
serum
337
manda-tory:
B 3
p24 Ag 337045 positive 1 : 38 000
HIV-1 infection (spiked serum pool of negative blood donors; HIV-1 heat inactivated)
p24 Ag 337046 negative negative healthy blood donors (pool)
d, e: Marked samples represent dilutions from the corresponding stock materials.
Non-marked samples derive from independent preparations.
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Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2015 pre-evaluation
Program Group RiliBÄK Analyte Sample Sample properties
qualitative dilution sample source
HTLV-1/ HTLV-2
(Ab)
serum*
plasma**
339
conform to
B 2
anti-HTLV-2 339021** positive 1 : 4 HTLV-2 infection**
anti-HTLV-1/2 339022* negative negative healthy blood donor*
anti-HTLV-1 339023* positive 1 : 150 HTLV-1 infection*
anti-HTLV-2 339024** positive 1 : 4 HTLV-2 infection**
Measles virus (Ab)
serum
357
conform to
B 2
anti-measles-IgG anti-measles-IgM
357023 positive avidity: high negative
one healthy blood donor with indication of a past measles virus infection/vaccination
anti-measles-IgG anti-measles-IgM
357024 positive avidity: high negative
two healthy blood donors with indication of a past measles virus infection/vaccination
Mumps virus (Ab)
serum
356
conform to
B 2
anti-mumps-IgG anti-mumps-IgM
356023 positive avidity: high negative
one healthy blood donor with indication of a past mumps virus infection/vaccination
anti-mumps-IgG anti-mumps-IgM
356024 positive avidity: high negative
one healthy blood donor with indication of a past mumps virus infection/vaccination
Parvovirus B19 (Ab)
serum*
plasma**
342
conform to
B 2
anti-parvo B19-IgG anti-parvo B19-IgM
342045* positive avidity: high negative
past parvo B19 infection (healthy blood donor)*
anti-parvo B19-IgG anti-parvo B19-IgM
342046* negative avidity: no avidity negative
negative healthy blood donor*
anti-parvo B19-IgG anti-parvo B19-IgM
342047* positive avidity: high§ negative
past parvo B19 infection (healthy blood donor)*
anti-parvo B19-IgG anti-parvo B19-IgM
342048* positive avidity: high negative
past parvo B19 infection (healthy blood donor)*
Rubella virus (Ab)
serum
341
manda-tory:
B 2
titer HI test / HiG
341023 = 341024
64 - 1024 (256 target value)
sera of healthy blood donors with indication of a past rubella virus infection or vaccination (pool)
anti-rubella-IgG
positive ≥ 95 IU/ml (300 IU/ml)#
avidity: high
anti-rubella-IgM negative
titer HI test / HiG
341024 = 341023
64 - 1024 (256 target value)
anti-rubella-IgG
positive ≥ 95 IU/ml (301 IU/ml)#
avidity: high
anti-rubella-IgM negative
Varicella zoster virus
(Ab)
serum
353
conform to
B 2
anti-VZV-IgG anti-VZV-IgM
353023 positive avidity: high negative
past VZV infection (two healthy blood donors)
anti-VZV-IgG anti-VZV-IgM
353024 positive avidity: high negative
past VZV infection (two healthy blood donors)
Non-marked samples derive from independent preparations.
§ Sample 342047: Some participants having applied an avidity test of one manufacturer (Mikrogen recomLine Parvo B19 IgG Avidität/avidity) reported as result "no statement possible". The intensities of those bands indicative of antibodies binding to avidity relevant antigens were below the cutoff of the IgG control. The avidity result "no statement possible" had no impact on the overall evaluation of sample 342047, i.e. past parvo B19 infection (characteristic band pattern of anti-parvo-IgG with negative anti-parvo-IgM). The avidity result "no statement possible" has been considered as "correct".
# 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 to highly concentrated samples. In this case a lower limit value in IU/ml is indicated in order to assess a reported result of a laboratory as a "correct" result.
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EQA Schemes Virus Genome Detection by PCR/NAT
November/December 2015
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 to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a,
When applying CE-marked tests, which not (yet) allow reporting of results in IU/mL, it should be continued to report the results as stated by the manufacturer.
Evaluation of results for quantitative genome detection of HBV and HCV
2 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 to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a. Statements in "copies/ml" will not be accepted anymore.
3 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 to the low number of analyses or missing analyses.
Evaluation of results for quantitative genome detection of HIV-1 (RNA)
4 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 (RNA). This is in accordance to the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a. Statements in "IU/ml" will not be accepted anymore.
5 Notice for foreign participants of EQA scheme 360: Please note that quantitative results in "IU/ml" for the genome detection of HIV-1 (RNA) have not been evaluated due to the low number of analyses or missing analyses.
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Table 4: EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015
Pre-evaluation
Program Group RiliBÄK Sample
Sample properties
qualitative (note on
geno-/subtype) dilution
Target value of all methods (provisional data)
copies/ml IU/ml
CMV (DNA)
plasma
365
manda-tory:
B 3
For evaluation of results in copies/ml or IU/ml:
see notice 1, page 9
365089 positive (a) 1 : 10 000 approx. 3 183 approx. 7.365
365090 negative ------- 0 0
365091 positive (a) 1 : 5 000 approx. 6 723 approx. 17.488
365092 positive 1 : 10 000 approx. 32 000 approx. 40.875
EBV (DNA)
cell lysates
376
manda-tory:
B 3
376045 negative ------- 0 0
376046 positive (b) 1 : 800 approx. 1 120 approx. 1 687
376047 positive (b) 1 : 100 approx. 9 321 approx. 13 470
376048 positive (b) 1 : 400 approx. 2 475 approx. 3 006
HAV (RNA)
spiked plasma
377
manda-tory:
B 3
377089 positive (c) 1 : 1 250 not evaluated# not evaluated#
377090 negative ------- not evaluated# not evaluated#
377091 positive (c) 1 : 10 000 not evaluated# not evaluated#
377092 positive (c) 1 : 5 000 not evaluated# not evaluated#
HBV (DNA)
plasma
361
manda-tory:
B 3
361089 positive (d) 1 : 5 000 Results in copies/ml:
not accepted or
not evaluated (see notices 2 and
3, page 9)
approx. 84 250
361090 negative ------- 0
361091 positive (d) 1 : 125 000 approx. 3 995
361092 positive (d) 1 : 25 000 approx. 19 708
HCV (RNA)
plasma
362
manda-tory:
B 3
362089 positive (Subtyp 3a) (e) 1 : 100 Results in copies/ml:
not accepted or
not evaluated (see notices 2 and 3, page 9)
approx. 7 304
362090 positive (Subtyp 1b) 1 : 3 200 approx. 670
362091 positive (Subtyp 3a) (e) 1 : 200 approx. 3 910
362092 negative ------- approx. 0
HEV (RNA)
serum*
suspension of feces**
380
conform to
B 3
380021** positive 1 : 1 000 not evaluated# not evaluated#
380022* = 380023
negative ------- not evaluated# not evaluated#
380023* = 380022
negative ------- not evaluated# not evaluated#
380024* positive 1 : 28 not evaluated# not evaluated#
HIV-1 (RNA)
spiked plasma
360
manda-tory:
B 3
360089 positive 1 : 7 approx. 49 100 Results in IU/ml: not accepted
or not evaluated (see notices 4 and 5, page 9)
360090 negative ------- 0
360091 positive 1 : 120 000 000 approx. 3 010
360092 positive 1 : 100 approx. 896
HIV-2 (RNA)
spiked plasma
395
conform to
B 3
395009 positive (f) 1 : 9 not evaluated# not evaluated# 395010 negative ------- not evaluated# not evaluated# 395011 positive 1 : 9 not evaluated# not evaluated#
395012 positive (f) 1 : 90 not evaluated# not evaluated#
HMPV (RNA)
cell lysates
385
conform to
B 3
385013 positive (Subtyp A) 1 : 10 000 not evaluated# -----
385014 positive (Subtyp A) (g) 1 : 64 not evaluated# -----
385015 positive (Subtyp A) (g) 1 : 1 600 not evaluated# -----
385016 negative ------- not evaluated# -----
# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates)
a, b, c, d, e, f, g: Marked samples derive from corresponding stock materials diluted in consecutive steps.
Non-marked samples derive from independent preparations.
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Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015
Pre-evaluation
Program Group RiliBÄK Sample
Sample properties
qualitative (note on
geno-/subtype) dilution
Target value of all methods (provisional data)
copies/ml IU/ml
Measles virus
(RNA)
FTA cards
386
conform to
B 3
386013 positive (genotype D4) undiluted not evaluated# -----
386014 negative undiluted not evaluated# -----
386015 positive (genotype D8) undiluted not evaluated# -----
386016 positive (genotype B3) undiluted not evaluated# -----
Mumps virus (RNA)
FTA cards
387
conform to
B 3
387009 positive (genotype F) undiluted not evaluated# -----
387010 = 387012
negative undiluted not evaluated# -----
387011 positive (genotype G) undiluted not evaluated# -----
387012 = 387010
negative undiluted not evaluated# -----
Parvovirus B19
(DNA)
plasma
367
manda-tory:
B 3
367089 = 367092
negative ------- not evaluated# 0
367090 positive (h) 1 : 900 000 not evaluated# approx. 25 800
367091 positive (h) 1 : 100 000 not evaluated# approx. 213 000
367092 = 367089
negative ------- not evaluated# 0
Respiratory syncytial
virus (antigen/ genome)
cell lysates
359
manda-tory:
B 3
359025 negative ------- not evaluated# -----
359026 positive RSV A 1 : 40 not evaluated# -----
359027 positive RSV B (i) 1 : 30 not evaluated# -----
359028 positive RSV B (i) 1 : 15 not evaluated# -----
Rubella virus (RNA)
FTA cards
389
conform to
B 3
389009 = 389010
positive (genotype 2B) undiluted not evaluated# -----
389010 = 389009
positive (genotype 2B) undiluted not evaluated# -----
389011 negative undiluted not evaluated# -----
389012 positive (genotype 1G) undiluted not evaluated# -----
VZV (DNA)
cell lysates
366
manda-tory:
B 3
366045 positive 1 : 400 approx. 13 410 -----
366046 negative ------- 0 -----
366047 positive (j) 1 : 1 000 approx. 7 230 -----
366048 positive (j) 1 : 125 approx. 59 000 -----
# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates)
h, i, j: Marked samples derive from corresponding stock materials diluted in consecutive steps.
Non-marked samples derive from independent preparations.
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Table 5: EQA Schemes Virus Genome Detection by PCR/NAT incl. typing November/December 2015
Pre-evaluation
Program Group RiliBÄK Sample
Sample properties
qualitative Target value of all
methods copies/ml
species type (note on dilution)
Adeno-viruses (DNA)
cell lysates
371
manda-tory:
B 3
371045 positive
Quantitative results will be discussed in
the final report.
D Adenovirus 37 1 : 5 000 diluted (k)
371046 positive C Adenovirus 2 1 : 100 000 diluted
371047 negative ---- ---
371048 positive D Adenovirus 37 1 : 500 000 diluted (k)
Corona-viruses (RNA)
cell lysates
340
conform to
B 3
340006 positive not evaluated# ---- MERS-CoV 1 : 1 000 diluted (l)
340007 positive not evaluated# ---- MERS-CoV 1 : 100 diluted (l)
340008 negative not evaluated# ---- ---
340009 positive not evaluated# ---- CoV OC43 1 : 1 000 diluted (m)
340010 positive not evaluated# ---- CoV OC43 1 : 10 000 diluted (m)
Entero-viruses (RNA)
cell lysates
372
manda-tory:
B 3
372046 positive
Quantitative results will be discussed in
the final report.
---- Enterovirus 68 1 : 1000 diluted
372047 positive ---- Echovirus 30 1 : 100 000 diluted
372048 negative ---- ---
372049 positive ---- Echovirus 7 1 : 400 diluted
HSV-1/ HSV-2 (DNA)
cell lysates
363
manda-tory:
B 3
363067 positive approx.28 121 ---- HSV-2 1 : 900 diluted (n)
363068 positive approx.7 325 ---- HSV-1 1 : 152 000 diluted (o)
363069 negative 0 ---- ---
363070 positive approx.13 500 ---- HSV-2 1 : 1 800 diluted (n)
363071 positive approx.60 000 ---- HSV-1 1 : 19 000 diluted (o)
363072 positive approx.50 250 ---- HSV-1 1 : 15 000 diluted
Human papilloma
viruses (RNA)
cell lysates
373
manda-tory:
B 3
373056 = 373059
High Risk positive ----- ---- HPV 18 1 : 40 diluted (p)
373057 High Risk positive ----- ---- HPV 18 1 : 20 diluted (p)
373058 High Risk positive ----- ---- HPV 16 1 : 4 diluted
373059 = 373056
High Risk positive ----- ---- HPV 18 1 : 40 diluted (p)
373060 negative ----- ---- ---
# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates)
k, l, m, n, o, p: Marked samples derive from corresponding stock materials diluted in consecutive steps.
Non-marked samples derive from independent preparations.
Pre-evaluation Virology November December 2015 20160122a EN.doc 13 von 14
Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015
Pre-evaluation
Program Group RiliBÄK Sample
Sample properties
qualitative Target value of all
methods copies/ml
species type (note on dilution)
Humane Rhinoviren
(RNA)
cell lysates
393
conform to
B 3
393005 positive not evaluated# ---- HRV A type 49 1 : 100 diluted
393006 positive not evaluated# ---- HRV A type 30 1 : 100 diluted
393007 negative not evaluated# ---- ----
393008 positive not evaluated# ---- HRV A type 56 1 : 10 diluted
Norovirus (RNA)
suspension of feces
381
conform to
B 3
381021 positive not evaluated# ---- genogroup I 1 : 980 diluted
381022 positive not evaluated# ---- genogroup II 1 : 200 diluted
381023 positive not evaluated# ---- genogroup II 1 : 220 diluted
381024 negative not evaluated# ---- 1 : 200 diluted
Rotaviren (RNA)
suspension of feces
401
conform to
B 3
401005 positive not evaluated# ---- G2P[4] 1 : 100 000 diluted (q)
401006 positive not evaluated# ---- G2P[4] 1 : 100 diluted (q)
401007 negative not evaluated# ---- 1 : 20 diluted
401008 positive not evaluated# ---- G2P[4] 1 : 10 000 diluted (q)
# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates)
q: Marked samples derive from corresponding stock materials diluted in consecutive steps.
Non-marked samples derive from independent preparations.
Pre-evaluation Virology November December 2015 20160122a EN.doc 14 von 14
Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015
Pre-evaluation
Program Group RiliBÄK Sample Sample properties and results considered as "correct" (target values)
type/subtype strain origin
Influenza A-und B-viruses*
inclusive
influenza A(H1N1)
pdm09 virus
and
avian influenza A
virus (different subtypes)
(genome/ antigen)
370*
manda-tory:
B 3
370065
positive
for seasonal influenza B virus
B/Brisbane/60/2008 (vaccine strain)
infected MDCK-cells (lysate)
(1 : 15 diluted)
370066
positive
for seasonal influenza A(H3N2) virus
(accepted target value for rapid tests for the detection of
influenza A virus antigen: positive / borderline)§
A/Switzerland/9715293/ 2013
(vaccine strain)
infected MDCK-cells (lysate)
(1 : 320 diluted)
370067
positive
for seasonal influenza B virus
(accepted target value for rapid tests for the detection of
influenza B virus antigen: positive / borderline)§
B/Phuket/3073/2013 (vaccine strain)
infected MDCK-cells (lysate)
(1 : 160 diluted)
370068
positive
for Influenza A(H1N1) pdm09 virus
(accepted target value for rapid tests for the detection of
influenza A virus antigen: positive / borderline)§
A/California/7/2009 (vaccine strain)
infected MDCK-cells (lysate)
(1 : 60 diluted)
370069 negative ----- non-infected MDCK cells
(lysate)
370070
positive
for avian influenza A(H5N8) virus
(accepted target value for rapid tests for the detection of
influenza A virus antigen: positive / borderline)§
A/Turkey/Germany/ R2485-86/2014
allantoic fluid (inactivated)
(1 : 160 diluted)
* The EQA program for influenza A and B viruses, incl. influenza A(H1N1) pdm09 virus and avian influenza A virus (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, Prof. Dr. Timm C. Harder.
§ For samples 370066, 370067, 370068 and 370070, the reporting of "borderline" in test category 30 (Antigen detection of influenza A virus) and test category 40 (Antigen detection of influenza B virus) was accepted as additional correct result for tests for antigen detection of influenza A virus and B virus, respectively (in general rapid tests). Considering also the result "borderline" ensured that these positive samples would not have been misinterpreted as negative.