September 2020 - INSTAND eV
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September
2020
Summary of sample properties and
target values 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 Laboratorien e.V.
Düsseldorf/Berlin, Germany, 19.10.2020
Summary of sample properties and target values Virology September 2020 20201019.doc 1 of 17INSTAND 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: Assistant EQAS Adviser:
Prof. i.R. Dr. Heinz Zeichhardt Dr. Martin Kammel
Professor of Virology c/o INSTAND e.V.
Charité - University Medicine Berlin Ubierstr. 20, D-40223 Düsseldorf, Germany
Tel.: +49-(0)30-81054-304; Fax: +49-(0)30-81054-303
Correspondence address: Email: M.Kammel@iqvd.de
Prof. Dr. Heinz Zeichhardt
IQVD GmbH
Institut für Qualitätssicherung in der Virusdiagnostik
Potsdamer Chaussee 80, D-14129 Berlin, Germany
Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303
Email: Heinz.Zeichhardt@iqvd.de
Carried out by:
INSTAND e.V.
Ubierstr. 20
D-40223 Düsseldorf, Germany
Tel.: +49 (0)211 - 1592 13 0
Fax: +49 (0)211 - 1592 1330
Email: instand@instand-ev.de
Internet: www.instand-ev.de
Summary of sample properties and target values Virology September 2020 20201019.doc 2 of 17INSTAND External Quality Assessment Schemes – September 2020
Virus Immunology
Virus Genome Detection by PCR/NAT
Dear colleagues,
You have registered for one or several of the INSTAND external quality assessment (EQA) schemes in virus
diagnostics of September 2020. Today you receive information on the provision of your participation
documents and the provision of the summary of sample properties and target values.
Since the EQAS term September 2019, your participation documents are available only online.
Paper based documents are not sent by mail anymore.
1. Participation documents
With the "EQAS (RV) Online system", you have direct access to your individual participation documents for the
corresponding EQA scheme via the button "Evaluation" after login on the INSTAND website
https://rv-online.instandev.de/ .
For download are available:
• certificate (button "Certificate Download")
• certificate, certificate of participation, listing and evaluation of results (button "Evaluation Download")
• individual summary of results (button "General overview Download")
2. Summary of sample properties and target values
The summary of sample properties and target values is available:
• by email with a link to the document "Summary of sample properties and target values"
and
• on the INSTAND homepage under
"EQAS Online / Service for EQA tests / EQA area (Virus immunology / Virus genome detection)"
in English language: http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html and
in German language: http://www.instand-ev.de/ringversuche-online/ringversuche-service.html.
Please see the following Tables 1 - 4 for details on sample properties and the expected target values for this
EQA scheme September 2020.
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: http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html and
in German language: http://www.instand-ev.de/ringversuche-online/ringversuche-service.html.
Summary of sample properties and target values Virology September 2020 20201019.doc 3 of 172.1 Notes on the Guidelines of the German Medical Association on quality assurance in medical
laboratory testing (RiliBAEK)
Please note:
• According to the decision of the Board of the German Medical Association from 18
October 2019, new Guidelines of the German Medical Association on quality
assurance in medical laboratory testing (RiliBAEK 2019) have been released on 23
December 2019 in the "Deutsches Aerzteblatt" (DOI:
10.3238/arztebl.2019.rili_baek_QS_Labor20192312, English version will follow).
The following additional EQA schemes are now subject to the RiliBAEK:
Immunological EQA schemes (see Table B2-2)
Measles virus, antibodies against
Mumps virus, antibodies against
Varicella zoster virus, antibodies against
EQA schemes for direct detection and characterization of infectious agents (see Table
B3-2)
Hepatitis E virus, genome detection
Measles virus, genome detection
Mumps virus, genome detection
Norovirus, genome detection
Rubella virus, genome detection
West Nile virus, genome detection
• The following "Summary of sample properties and target values" for the EQA term
September 2020 will still refer to the previous RiliBAEK version in accordance with the
decision of the Executive Board from 11 April 2014 and 20 June 2014 (published in
German language: Deutsches Ärzteblatt, Jg. 111, Heft 38, 19. November/December
2014, A 1583 - A 1618). The RiliBAEK version of 2014 will expire on 22 December
2021 after the end of the transition period for the recently released RiliBAEK 2019.
• INSTAND EQA schemes in virus diagnostics and INSTAND brochure 2021
Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test
assessment of your virus diagnostics. Please contact INSTAND e.V. for details.
Thank you for your kind cooperation.
Prof. Dr. Heinz Zeichhardt Dr. Martin Kammel
Summary of sample properties and target values Virology September 2020 20201019.doc 4 of 17Table 1: EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Grou RiliBÄ Sample properties
Program Analyte Sample
p K qualitative dilution sample source
serum from patient G-C7
with a past chikungunya
virus infection.
traveler returned from
anti-CHIKV-IgG positive Ecuador;
402018
anti-CHIKV-IgM negative clinical signs at onset of
disease: fever, limb pain;
blood collected:
approx. 3 years after
onset of disease
anti-CHIKV-IgG negative
402019$= serum of a healthy blood
402020 donor without signs of
anti-CHIKV-IgM negative
an acute, recent or past
anti-CHIKV-IgG negative
Chikun- 402020$= chikungunya virus
gunya 402019 infection
conform anti-CHIKV-IgM negative
virus# 402# serum from patient G-C8
to
(Ab) with a recent/acute
B2
chikungunya virus
serum infection.
chikungunya virus RNA
negative;
traveler returned from
anti-CHIKV-IgG positive Maldives (Meeru Island);
402021
clinical signs at onset of
anti-CHIKV-IgM positive
disease: exanthema (first
the face and décolleté,
then all over the body),
loss of appetite, diarrhea,
fever, swelling of the feet;
blood collected:
47 days after onset of
disease
Cyto- anti-CMV IgG negative
negative healthy blood
megalo- 351083 avidity: no avidity / not done
conform anti-CMV IgM donors (pool)
virus negative
351 to
(Ab)
B 2 anti-CMV IgG positive
past CMV infection
351084 avidity: high
serum (two healthy blood donors)
anti-CMV IgM negative
Non-marked samples derive from independent preparations.
$ The samples 402019 and 402020 are identical.
# The EQA program Virus Immunology - Chikungunya Virus (402) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg
(Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie, WHO Collaborating Centre for Arbovirus and
Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich und Prof. Dr. Dr. Jonas Schmidt-
Chanasit).
Summary of sample properties and target values Virology September 2020 20201019.doc 5 of 17Table 1 (contd.): EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Analyte Sample
qualitative dilution sample source
serum from patient G-D34
with a recent dengue
virus infection (DENV-1);
anti-Dengue IgG positive traveler returned from
Thailand,
anti-Dengue IgM 350082 positive clinical signs at onset of
disease: fever;
Dengue NS1-Ag negative exanthema, limb pains
blood collected:
34 days after onset of
disease
serum of a healthy blood
donor without signs of
anti-Dengue IgG negative
an acute, recent or past
dengue virus infection;
anti-Dengue IgM 350083 negative negative for anti-CHIKV,
anti- anti-DENV, anti-TBEV,
negative
Dengue Dengue NS1-Ag anti-WNV, anti-YF and
conform anti-ZIKV
Dengue
viruses* to serum (pool serum) from
patient G-D26 with a past
(Ab and B2 primary dengue virus
350*
NS1-Ag) anti-Dengue IgG positive infection (DENV-3);
NS 1 Ag (inconsistent results
serum conform especially traveler returned from
to with rapid tests Malaysia and Indonesia;
350084
B3 clinical signs at onset of
anti-Dengue IgM negative disease: diarrhea, fever;
Dengue NS1-Ag negative blood collected:
12.5 months and 21.5
months after onset of
disease
dengue virus serum
G-D40 represents an
anti-Dengue IgG negative
acute primary dengue
virus infection positive
anti-Dengue IgM negative
for NS1-Ag only
Dengue NS1-Ag 350085 positive 1 : 625 serum of a healthy blood
(inconsistent results donor without signs of an
especially acute or past dengue
with rapid tests virus infection spiked with
a cell culture propagated
virus (DENV-4; heat
inactivated)
Non-marked samples derive from independent preparations.
* The EQA program Virus Immunology - Dengue Viruses (350) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg
(Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie, WHO Collaborating Centre for Arbovirus and
Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich und Prof. Dr. Dr. Jonas Schmidt-
Chanasit).
Summary of sample properties and target values Virology September 2020 20201019.doc 6 of 17Table 1 (contd.): EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Analyte Sample
qualitative dilution sample source
serum from patient G-H25,
with an acute Puumala virus
infection,
probably acquired in Vienna,
Austria
anamnesis for a stay abroad
outside Europe excluded
anti-Puumala IgG positive at onset of disease
355081 hospitalization necessary;
anti-Puumala IgM positive characteristic flu-like
symptoms with fever,
elevated creatinine, limb
pains and acute renal failure
blood collected 33 days after
onset of disease
serum is negative for
Hantavirus RNA
serum from patient G-H13,
with a past Dobrava-
Belgrade virus infection,
probably acquired in
Brandenburg, Germany,
anamnesis for a stay abroad
outside Europe excluded
anti-Dobrava IgG positive
Hanta- at onset of disease
conform 355082
viruses* hospitalization necessary,
to anti-Dobrava IgM negative
(Ab) 355* characteristic symptoms such
B2 as elevated creatinine, flu-like
serum symptoms and abnormal
fatigue
blood collected approx.
3 years and 7.5 months
after onset of disease
serum of healthy blood
anti-Hanta IgG negative
donors (pool) without signs
355083
of an acute or past hanta
anti-Hanta IgM negative
virus infection
serum from patient G-H16
with an acute Dobrava-
Belgrade virus infection§,
probably acquired in
Mecklenburg Western
Pomerania, Germany,
anamnesis concerning a stay
anti-Dobrava IgG positive anamnesis for a stay abroad
355084§ outside Europe excluded,
anti-Dobrava IgM positive
at onset of disease
hospitalization necessary
Blood collected approx. 3
weeks after onset of
disease
serum is negative for
Hantavirus RNA
Non-marked samples derive from independent preparations.
§ Sample 355084: Several participants reported equally strong band intensities for their IgM immunoblots in regard to the
nucleocapsid proteins PuN and DobN. This indicates a strong cross-reaction with the nucleocapsid proteins of the two viruses for
the IgM in sample 355084. Due to this strong cross-reaction, several participants were not able to make a clear serotype
differentiation (parameter 99). For sample 355084, the results for serotype differentiation (parameter 99) are therefore not evaluated
(without disadvantage for the certificate).
* The EQA program Virus Immunology - Hantaviruses (355) is performed in cooperation with Nationales Konsiliarlaboratorium für
Hantaviren (Charité - Universitätsmedizin Berlin, Campus Mitte, Institut für Virologie: Prof. Dr. Jörg Hofmann, Prof. Dr. Christian
Drosten).
Summary of sample properties and target values Virology September 2020 20201019.doc 7 of 17Table 1 (contd.): EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Analyte Sample
qualitative dilution sample source
anti-HAV IgG /
343165 positive (a) 1 : 200
anti- HAV total anti-HAV IgG positive
Hepatitis A anti-HAV IgG / healthy blood donor
virus manda- anti- HAV total 343166 positive (a) 1 : 400
(Ab) 343 tory:
B2 negative healthy blood
anti-HAV IgM 343167 negative
serum donors (pool)
anti-HAV IgM 343168 positive 1 : 20 acute hepatitis A
negative
< 0.075 IU/ml negative healthy blood
HBsAg 344493
(0.027 IU/ml target donors (pool)
value)
positive
manda- HBsAg 344494 1.90 – 3.40 IU/ml (aa) 1 : 200
tory: (2.48 IU/ml target value)
B3 positive
HBsAg 344495 0.95 – 1.70 IU/ml (aa) 1 : 400 chronic hepatitis B
(1.25 IU/ml target value)
positive
HBsAg 344496 3.80 – 6.80 IU/ml (aa) 1 : 100
(4.99 IU/ml target value)
Hepatitis B
positive
virus
anti-HBs 344497 20.0 - 250 IU/l (b) 1 : 400
(prog. 1)
(111 IU/l target value) anti-HBs positive healthy
(HBsAg 344 positive blood donor
anti-HBs manda- anti-HBs 344498 40.0 - 500 IU/l (b) 1 : 200
anti-HBc) tory: (212 IU/l target value)
serum B2 negative negative healthy blood
anti-HBs 344499Table 1 (contd.): EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Analyte Sample
qualitative dilution sample source
serum of patient A
condition after chronic
anti-HCV reactive/positive hepatitis C (subtype 4a)
(screening tests) (successful therapy)
3rd blood collection
HCV antigen 346165* negative (d) 1 : 20 (Oct. 2016)
serum diluted 1 : 20;
anti-HCV positive, the same serum of
(complementary tests) indeterminate patient A of Oct. 2016 was
used for sample 346167
(1 : 40 diluted)
anti-HCV non-reactive/
(screening tests) negative
negative healthy blood
HCV antigen 346166* negative
donors (pool)
anti-HCV anti-HCV negative,
Hepatitis C (complementary tests) not done
manda-
virus tory: serum of patient A
(Ab and condition after chronic
B2 hepatitis C (subtype 4a)
HCV-Ag) 346 anti-HCV reactive/positive
(successful therapy)
HCV Ag (screening tests)
serum* 3rd blood collection
manda-
HCV antigen 346167* negative (d) 1 : 40 (Oct. 2016)
tory:
plasma**
serum diluted 1 : 40;
B3 anti-HCV positive, the same serum of
(complementary tests) indeterminate patient A of Oct. 2016 was
used for sample 346165
(1 : 20 diluted)
follow-up serum of
patient A
condition after chronic
anti-HCV reactive/positive hepatitis C (subtype 4a)
(screening tests) (successful therapy)
4th blood collection
HCV antigen 346168* negative 1 : 30 (Oct. 2017)
Follow-up serum of
anti-HCV positive, patient A whose serum of
(complementary tests) indeterminate the 3rd blood collection
(Oct. 2016) was used for
samples 346165 and
346167
Anti-HIV-2$ 335165$ positive$ 1 : 40 HIV-2 infection$
HIV-1/
HIV-2 manda- Anti-HIV-1 335166 positive (dd) 1 : 160
(Ab) 335 tory:
B2 Anti-HIV-1 335167 positive (dd) 1 : 320 HIV-1 infection
serum
Anti-HIV-1 335168 positive (dd) 1 : 80
HIV-1 infection
HIV-1 manda- p24 Ag 337083 positive 1 : 20 000 (serum pool of negative
p24 Ag tory:
337 blood donors spiked with
B3 p24 Ag 337084 positive 1 : 80 000 HIV-1;
serum
HIV-1 heat inactivated)
Non-marked samples derive from independent preparations.
$ The anti-HIV-2 positive sample 335165 revealed partial immunological cross-reactivity with HIV-1 antigen/s. This crossreactivity
may be due to the fact that the patient was infected with an HIV-2 with untypical close antigenic relationship to HIV-1.
Please note that sample 335165 does not represent a serum of a patient co-infected with HIV-1 and HIV-2.
Due to the observed immunological cross-reactivity the results obtained by confirmation tests for anti-HIV-1/anti-HIV-2 in
parameter 20 were not evaluated (without disadvantage for the certificate).
Summary of sample properties and target values Virology September 2020 20201019.doc 9 of 17Table 1 (contd.): EQA Schemes Virus Immunology – September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Analyte Sample
qualitative dilution sample source
SARS-CoV-2 The INSTAND EQA scheme (416) virus immunology SARS-CoV-2 (ab) was shipped on
416 conform 16 September 2020 (deadline 2 October 2020) and is currently under evaluation.
(Ab) (4161) to
(4162) B2 The target values will be specified in a separate evaluation.
serum You will be notified by email.
Tollwut- recent active rabies
anti-RABV 336013 positive
virus§ conform vaccination
(Rabies to
336*
Virus) negative healthy blood
B2 anti-RABV 336014 negative
donor
serum
serum of patient G-Z7
with a recent Zika virus
infection;
stay at ABC Islands, South
America
anti-Zika IgG positive clinical signs at onset of
338022 disease:
anti-Zika IgM not evaluated due to fever, head and body aches,
inconsistent results exanthema
(without disadvantage for blood collected:
the certificate) 59 days after onset of
disease
Zika
virus* conform serum is negative for
(Ab) 338* to Zika virus RNA
anti-Zika IgG negative
B2
serum 338023 negative healthy blood donor
anti-Zika IgM negative
serum of patient G-Z8
with a past Zika virus
infection
stay in Peru, South America
anti-Zika IgG positive
clinical signs:
338024
fever, body aches, chills and
anti-Zika IgM negative$
exanthema
blood collected:
approx. 1 year and 6
months after onset of
disease
Non-marked samples derive from independent preparations.
§ The EQA program Virus Immunology - Rabies Virus (338) is performed in cooperation with Nationales Konsiliarlabor für
Tollwut (Universitätsklinikum Essen, Institut für Virologie, Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross).
$ Sample 338024. anti-Zika IgM: Participants having used the tests of 3 different manufacturers (tests of Euroimmun – Anti-Zika-IFT
(IgM) or Arboviren-Fieber-Mosaik 2, test of Inbios International – ZIKV Detect 2.0 IgM Capture Elisa Kit and tests of Vircell – ZIKV-
DENV-CHIKV IFA IgM or Zika VirClia IgM Monotest or Anti-Zika Elisa IgM), reported unexpected "borderline" or "negative" results.
The results obtained by the above-mentioned tests are depicted as "false", however not evaluated (without disadvantage for the
certificate). The Nationale Referenzzentrum für tropische Infektionserreger, Bernhard-Nocht-Institut, Hamburg, and the
manufacturers will be informed in advance. The Joint Diagnostic Council of DVV and GfV will consider this problem.
* The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg
(Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie, WHO Collaborating Centre for Arbovirus and
Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, Dr. Petra Emmerich und Prof. Dr. Dr. Jonas Schmidt-
Chanasit).
Summary of sample properties and target values Virology September 2020 20201019.doc 10 of 17EQA Schemes Virus Genome Detection by PCR/NAT
September 2020
Summary of Sample Properties and Target Values
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
(Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK Section B 3, Table B. 3-2a,
When applying CE-marked tests, which not (yet) allow reporting of results in IU/ml, you should continue 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
(Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK 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
(Bundesaerztekammer / RiliBAEK)", Specified RiliBAEK 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.
Summary of sample properties and target values Virology September 2020 20201019.doc 11 of 17Table 2: EQA Schemes Virus Genome Detection - September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Sample qualitative Target value of all methods
(note on dilution (provisional data)
geno-/subtype) copies/ml IU/ml
BK virus 364053 positive (a) 1 : 10 000 75 190 57 893
(DNA) conform to 364054 negative 1 : 100 0 0
364
suspension B3 364055 positive 1 : 40 000 22 312 14 093
of urine 364056 positive (a) 1 : 100 6 485 955 5 695 901
positive 1 : 3 000
392045
Chikunguny (Martinique) (inactivated)
a virus& positive (b) 1 : 16 000
conform to 392046
(RNA) 392& (S27) (inactivated) Quantitative results were not reported
B3 positive (b) 1 : 1 000
392047
cell lysates (S27) (inactivated)
392048 negative ----
For evaluation of results
in copies/ml or IU/ml:
CMV see notice 1, page 11
(DNA) manda- 365165 positive (c) 1 : 31 250 14 324 11 788
365 tory:
spiked 365166 negative ---- 0 0
B3
plasma 365167 positive 1 : 1 250 259 808 201 994
365168 positive (c) 1 : 1 250 308 497 292 108
377165 negative ---- ----# ----#
HAV
manda-
(RNA) 377166 positive (d) 1 : 10 000 ----# ----#
377 tory:
spiked 377167 positive (d) 1 : 2 500 ----# ----#
B3
plasma
377168 positive (d) 1 : 5 000 ----# ----#
361165 negative ---- 0
Results in
HBV 361166$ = positive copies/ml:
manda- (e) 1 : 50 000 not accepted 5 152
(DNA) 361168 (genosubtype D1)
361 tory: or
positive not evaluated
B3 361167 (e) 1 : 5 000 47 993
plasma (genosubtype D1) (see notices
361168$ = positive 2 and 3, page 11)
(e) 1 : 50 000 5 173
361166 (genosubtype D1)
362165 positive (subtype 4a) 1 : 35 Results in 18 210
copies/ml:
HCV manda- not accepted
362166 positive (genotype 2) (f) 1 : 125 22 532
(RNA) 362 tory: or
B3 362167 negative ---- not evaluated 0
plasma (see notices
362168 positive (genotype 2) (f) 1 : 3952.8 2 and 3, page 11) 747
400045 positive (g) 1 : 2 500 ----# 2 944
HDV
(RNA) conform to 400046 positive (g) 1 : 625 ----# 9 647
400
B3 400047 negative ---- ----# 0
plasma
400048 positive (g) 1 : 1 250 ----# 4 630
Non-marked samples derive from independent preparations.
a, b, c, d, e, f, g: Marked samples derive from corresponding stock materials diluted in consecutive steps.
$ The samples 361166 and 361168 are identical.
# A target value has not been assigned due to the limited number of quantitative analyses. An evaluation interval has instead been
set for each of the corresponding positive samples by the EQA scheme adviser (ET), considering the results of the INSTAND
Expert Laboratories. The evaluation interval is shown in "listing and evaluation of the results" and in the report.
& The EQA programs Virus Genome Detection – Chikungunya virus (392), Dengue Viruses (369), West Nile Virus (391) and Zika
Virus (403) are performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische
Infektionserreger, Abteilung für Virologie und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and
Research: Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit und Dr. Petra Emmerich).
Summary of sample properties and target values Virology September 2020 20201019.doc 12 of 17Table 2 (contd.): EQA Schemes Virus Genome Detection - September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Sample qualitative Target value of all methods
(note on dilution (provisional data)
geno-/subtype) copies/ml IU/ml
HEV
(RNA) 380073** positive 1 : 50 ----# 4 180
plasma* for
spiked RiliBÄK-
with positive (plasmid)
B3 380074*2 1 : 2 600 000 ----# not evaluated§
1HEV (genotype 4)
obligation
positive 380
please
suspension refer
of feces 380075* negative ---- ----# 0
Section
or 2.1
2plasmid
suspension 380076*1 positive 1 : 50 ----# 3 203
of feces**
positive
360165 (group M / subtype B) (h) 1 : 158 114 1 583
(heat inactivated)
Results in IU/ml:
HIV-1 positive
manda- not accepted
(RNA) 360166 (group M / subtype B) (h) 1 : 15 811 16 151 or
360 tory: (heat inactivated) not evaluated
spiked B3 positive (see notices 4
plasma 360167 (group M / subtype B) (h) 1 : 50 000 5 042 and 5, page 11)
(heat inactivated)
360168 negative ---- 0
405005 positive (i) 1 : 100 99 233 104 132
HHV-6 conform
(DNA) 405006 negative ---- 0 0
405 to
B3 405007 positive (i) 1 : 300 35 070 34 629
cell lysates
405008 positive (i) 1 : 900 12 083 12 966
394045 positive (j) 1 : 150 1 270 305 69 485
JC virus
(DNA) conform 394046 positive$ 1 : 75 not evaluated$ 307 861
394 to
suspension B3 394047 positive (j) 1 : 600 309 445 18 897
of urine
394048 negative 1 : 1 000 0 0
407005 positive (type 3) (k) 1 : 500
Parechovirus conform
(RNA) 407006 positive (type 3) (k) 1 : 125
407 to Quantitative results were not reported
B3 407007 negative ----
cell lysates
407008 positive (type 3) (k) 1 : 250
Non-marked samples derive from independent preparations.
h, i, j, k: Marked samples derive from corresponding stock materials diluted in consecutive steps.
# A target value has not been assigned due to the limited number of quantitative analyses. An evaluation interval has instead been
set for each of the corresponding positive samples by the EQA scheme adviser (ET), considering the results of the INSTAND
Expert Laboratories. The evaluation interval is shown in "listing and evaluation of the results" and in the report.
§ Sample 380074: Due to inconsistent results, the quantitative statements in IU/ml for this sample are not evaluated (without
disadvantage for the certificate).
$ Sample 394046 (positive for JC virus and BK virus):
- Parameter 20 "JC virus (DNA) – qualitative": Some participants reported unexpected negative results for this sample for the
parameter "JC virus (DNA) – qualitative" by using the test of one manufacturer (TIB MOLBIOL LightMix Polyoma BK/JC Virus Kit).
These unexpected positive results have not been evaluated for this EQA scheme (without disadvantage for the certificate). The
"Nationales Referenzzentrum für Papillom- und Polyomaviren" (Uniklinik Köln) and the manufacturer will be informed. The Joint
Diagnostic Council of DVV and GfV will consider this problem.
- Parameter 10 "JC virus (DNA) - quantitative": In addition, inconsistent results in copies/ml were reported in the parameter
"JC virus (DNA) - quantitative" for this sample 394046 (positive for JCV and BKV). This applies to tests from different
manufacturers. These results are not evaluated (without disadvantage for the certificate).
Summary of sample properties and target values Virology September 2020 20201019.doc 13 of 17Table 2 (contd.): EQA Schemes Virus Genome Detection - September 2020
Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Sample qualitative Target value of all methods
(note on dilution (provisional data)
geno-/subtype) copies/ml IU/ml
367165 negative ---- 0 0
Parvovirus 367166$=
B19 manda- positive (genotype 1) (l) 1 : 400 000 100 484 45 209
tory: 367167
(DNA) 367
367167$=
B3 positive (genotype 1) (l) 1 : 400 000 95 888 49 892
plasma 367166
367168 positive (genotype 1) (l) 1 : 80 000 438 160 238 909
390025 positive (m) 1 : 35 000
Rabies virus* conform 390026 negative ----
to Quantitative results were not
390*
390027 positive (m) 1 : 3 500 reported
vaccine B3
390028 positive (m) 1 : 350
Torque Teno 408001 positive (n) 1 : 500 ----# ----
virus
(DNA) conform 408002 negative ---- ----# ----
408 to
plasma 408003 positive (n) 1 : 5 000 ----# ----
spiked with B3
TTV positive 408004 positive (n) 1 : 50 ----# ----
urine
Non-marked samples derive from independent preparations.
l, m, n: Marked samples derive from corresponding stock materials diluted in consecutive steps.
$ The samples 367166 and 367167 are identical.
# A target value has not been assigned due to the limited number of quantitative analyses. An evaluation interval has instead been
set for each of the corresponding positive samples by the EQA scheme adviser (ET), considering the results of the INSTAND
Expert Laboratories. The evaluation interval is shown in "listing and evaluation of the results" and in the report.
* The EQA program Virus Genome Detection - Rabies Virus (390) is performed in cooperation with Nationales Konsiliarlabor für
Tollwut (Rabies Virus) (Universitätsklinikum Essen, Institut für Virologie, Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross).
Summary of sample properties and target values Virology September 2020 20201019.doc 14 of 17Table 3: EQA Schemes Virus Genome Detection incl. Typing
September 2020 - Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Sample Target value of all
type
qualitative dilution methods
(species, if applicable)
copies/ml
369053 positive DENV-2 (inactivated) 1 : 100
Dengue
viruses& conform 369054 negative ---- ---- Quantitative results
(RNA) 369& to in copies/ml were not
B3 369055 positive DENV-3 (inactivated) 1 : 300 reported
cell lysates
369056 positive DENV-1 (inactivated) 1 : 100
375051 positive subtype 1a 1 : 32 ----
HCV- 375052 positive subtype 3a 1 : 14 ----
Geno-/Sub manda-
typing* 375* tory: 375053 positive subtype 2c 1 : 95 ----
B3
serum 375054 positive subtype 1b 1 : 22 ----
375055 positive genotype 5 1 : 14 ----
388053 positive PIV-3 (o) 1 : 2 000 ----#
Para-
influenza- conform 388054 positive PIV-2 1 : 2 400 ----#
viruses to
388
(RNA)
B3 388055 positive PIV-3 (o) 1 : 8 000 ----#
cell lysates
388056 positive PIV-3 1 : 2 500 ----#
Non-marked samples derive from independent preparations.
o: Marked samples derive from corresponding stock materials diluted in consecutive steps.
# A target value has not been assigned due to the limited number of quantitative analyses. An evaluation interval has instead been
set for each of the corresponding positive samples by the EQA scheme adviser (ET), considering the results of the INSTAND
Expert Laboratories. The evaluation interval is shown in "listing and evaluation of the results" and in the report.
* The EQA program Virus Genome Detection - HCV-Genotyping (375) is performed in cooperation with "Nationales Referenzzentrum
für Hepatitis C-Viren", Universitätsklinikum Düsseldorf, Institut für Virologie, Prof. Dr. Jörg Timm, Dr. Nadine Lübke, and
Universitätsklinikum Essen, Institut für Virologie, Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross.
& The EQA program Virus Genome Detection – Dengue Viruses (369) is performed in cooperation with Bernhard-Nocht-Institut,
Hamburg (Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie und WHO Collaborating Centre for
Arbovirus and Haemorrhagic Fever Reference and Research: Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit und
Dr. Petra Emmerich).
Summary of sample properties and target values Virology September 2020 20201019.doc 15 of 17Table 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing
September 2020 - Summary of sample properties and target values
Sample properties
Program Group RiliBÄK Sample Target value of all
type
qualitative dilution methods
(species, if applicable)
copies/ml
WNV-2
391095 positive (p) 1 : 7 500 ----#
(inactivated)
for WNV-2
391096 positive (p) 1 : 2 500 ----#
RiliBÄK- (inactivated)
West Nile B3 WNV-1
virus& 391097 positive 1 : 750 ----#
obligation (inactivated)
(RNA) 391&
please
refer 391098 negative ---- ---- ----#
plasma
Section WNV-1
2.1 391099 positive (q) 1 : 10 000 ----#
(inactivated)
WNV-1
391100 positive (q) 1 : 2 500 ----#
(inactivated)
403037 negative ---- ---- ----#
Zika virus& conform Asian lineage
403038 positive (r) 1 : 1 000 ----#
(RNA) to (inactivated)
403&
Asian lineage
plasma B3 403039 positive (r) 1 : 62.5 ----#
(inactivated)
Asian lineage
403040 positive (r) 1 : 250 ----#
(inactivated)
Non-marked samples derive from independent preparations.
p, q, r: Marked samples derive from corresponding stock materials diluted in consecutive steps.
# A target value has not been assigned due to the limited number of quantitative analyses. An evaluation interval has instead been
set for each of the corresponding positive samples by the EQA scheme adviser (ET), considering the results of the INSTAND
Expert Laboratories. The evaluation interval is shown in "listing and evaluation of the results" and in the report.
& The EQA programs Virus Genome Detection – West Nile Virus (391) and Zika Virus (403) are performed in cooperation with
Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie und WHO
Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research: Prof. Dr. Stephan Günther,
Prof. Dr. Dr. Jonas Schmidt-Chanasit and Dr. Petra Emmerich).
Summary of sample properties and target values Virology September 2020 20201019.doc 16 of 17Table 4: EQA Schemes Virus Genome Detection for Drug Resistance Determination
September / October 2020 - Evaluation
Sample properties and
Program Group RiliBÄK Sample
results considered as "correct" (target values)
CMV 349021**
drug The EQA scheme (349) was shipped on 16 September 2020
resistance conform
349022* (deadline 23 October 2020).
to
plasma* 349a)
349023* The target values will be specified in a separate evaluation.
B3
extracted You will be notified by email.
virus DNA** 349024*
397021
HBV The EQA scheme (397) was shipped on 16 September 2020
conform
drug 397022 (deadline 23 October 2020).
to
resistance 397b)
397023 The target values will be specified in a separate evaluation.
plasmid B3
You will be notified by email.
397024
HCV 399022**
drug The EQA scheme (399) was shipped on 16 September 2020
conform
resistance 399023** (deadline 23 October 2020).
to
399c)
plasma* 399024* The target values will be specified in a separate evaluation.
B3
You will be notified by email.
serum** 399025**
HIV-1 383027
drug The EQA scheme (383) was shipped on 16 September 2020
resistance conform
383028 (deadline 23 October 2020).
to
383d)
standard
383029 The target values will be specified in a separate evaluation.
program B3
You will be notified by email.
plasma 383030
HIV-1
drug 384015 The EQA scheme (384) was shipped on 16 September 2020
resistance conform
(deadline 23 October 2020).
to
384d)
additional
The target values will be specified in a separate evaluation.
program B3 384016 You will be notified by email.
plasma
The above mentioned EQA schemes are performed in cooperation with:
a) CMV drug resistance (349)
Nationales Konsiliarlaboratorium für Cytomegalievirus (CMV) - (Schwerpunkt) CMV-Infektionen bei immunsupprimierten Personen
Universitätsklinikum Ulm, Institut für Virologie: Prof. Dr. Thomas Stamminger, Prof. Dr. Detlef Michel
Nationales Konsiliarlaboratorium für Cytomegalievirus (CMV) - (Schwerpunkt) kongenitale/postnatale CMV-Infektionen
Universitätsklinikum Tübingen, Institut für Medizinische Virologie: Prof. Dr. Thomas Iftner, Prof. Dr. Klaus Hamprecht
b) HBV drug resistance (397)
Nationales Referenzzentrum für Hepatitis-B-Virus und Hepatitis-D-Virus
Justus-Liebig-Universität Gießen, Institut für Medizinische Virologie:
Prof. Dr. Dieter Glebe, Dr. Christian Schüttler, Dr. Heiko Slanina, M. Sc. Felix Lehmann, Prof. Dr. Wolfram Gerlich,
Prof. Dr. John Ziebuhr
c) HCV drug resistance (399)
Nationales Referenzzentrum für Hepatitis-C-Viren, Universitätsklinikum Düsseldorf, Institut für Virologie:
Prof. Dr. Jörg Timm, Dr. Nadine Lübke
Universitätsklinikum Essen, Institut für Virologie:
Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross
d) HIV-1 drug resistance - standard program (383) and additional program (384)
Nationales Referenzzentrum für Retroviren, Ludwig-Maximilians-Universität München, Max-von-Pettenkofer Institut,
Klinische Virologie: Prof. Dr. Oliver T. Keppler, Prof. Dr. Josef Eberle, Prof. Dr. Lutz Gürtler, Dr. Hans Nitschko
Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen, Institut für Klinische und Molekulare Virologie:
Prof. Dr. Klaus Überla, Dr. Klaus Korn
IMD Medizinisches Versorgungszentrum, Frankfurt: PD Dr. Dr. Martin Stürmer
Medizinisches Infektiologiezentrum Berlin: Dr. Martin Obermeier, M. Schütze
Uniklinik Köln, Institut für Virologie: Prof. Dr. Florian Klein, Prof. Dr. Ulrike Wieland, Dr. Steffi Silling, Dr. Rolf Kaiser,
Dr. Eva Heger, Dr. Elena Knops
Universitätsklinikum Frankfurt, Institut für Medizinische Virologie: Prof. Dr. Sandra Ciesek, Prof. Dr. Holger F. Rabenau,
Prof. Dr. Annemarie Berger
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