summary of virology eqass september 2020 of...traveler returned from maldives (meeru island);...

Summary of sample properties and target values Virology September 2020 20201019.doc 1 of 17

Summary of sample properties and target values of the External Quality Assessment Schemes in Virus Diagnostics

September 2020

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


INSTAND EQA schemes in virology in cooperation with:

Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V. (DVV)

Gesellschaft für Virologie e.V. (GfV)

Deutsche Gesellschaft für Hygiene und Mikrobiologie e.V. (DGHM)

EQAS Adviser: 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: [email protected] 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: [email protected]

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: [email protected] Internet: www.instand-ev.de

mailto:[email protected]

mailto:[email protected]

http://www.instand-ev.de/


INSTAND 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.

https://rv-online.instandev.de/

http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html

http://www.instand-ev.de/ringversuche-online/ringversuche-service.html

http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html

http://www.instand-ev.de/ringversuche-online/ringversuche-service.html


2.1 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

https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/QS/Rili_BAEK_Qualitaetssicherg_laboratoriumsmedUntersuchungen_2019.pdf

http://www.egms.de/static/pdf/journals/lab/2015-6/lab000018.pdf

https://www.instand-ev.de/en/eqas/eqa-program.html


Table 1: EQA Schemes Virus Immunology – September 2020 Summary of sample properties and target values

Program Grou

p RiliBÄ

K Analyte Sample

Sample properties

qualitative dilution sample source

Chikun-gunya virus# (Ab)

serum

402#

conform to

B 2

anti-CHIKV-IgG anti-CHIKV-IgM

402018 positive negative

serum from patient G-C7 with a past chikungunya virus infection.

traveler returned from Ecuador;

clinical signs at onset of disease: fever, limb pain;

blood collected: approx. 3 years after onset of disease


402019$=402020

negative negative

serum of a healthy blood donor without signs of an acute, recent or past chikungunya virus infection


402020$=402019

negative negative


402021 positive positive

serum from patient G-C8 with a recent/acute

chikungunya virus infection.

chikungunya virus RNA negative;

traveler returned from Maldives (Meeru Island);

clinical signs at onset of 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-megalo-

virus (Ab)

serum

351 conform

to B 2

anti-CMV IgG anti-CMV IgM

351083 negative avidity: no avidity / not done negative

negative healthy blood donors (pool)

anti-CMV IgG anti-CMV IgM

351084 positive avidity: high negative

past CMV infection (two healthy blood donors)

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).


Table 1 (contd.): EQA Schemes Virus Immunology – September 2020

Summary of sample properties and target values

Program Group RiliBÄK Analyte Sample Sample properties


Dengue viruses*

(Ab and NS1-Ag)

serum

350*

anti-Dengue

conform to

B 2

NS 1 Ag

conform to

B 3

anti-Dengue IgG anti-Dengue IgM Dengue NS1-Ag

350082

positive positive negative

serum from patient G-D34 with a recent dengue virus infection (DENV-1);

traveler returned from Thailand,

clinical signs at onset of disease: fever; exanthema, limb pains



350083

negative negative negative

serum of a healthy blood donor without signs of an acute, recent or past dengue virus infection; negative for anti-CHIKV, anti-DENV, anti-TBEV, anti-WNV, anti-YF and anti-ZIKV


350084

positive (inconsistent results especially with rapid tests negative negative

serum (pool serum) from patient G-D26 with a past primary dengue virus infection (DENV-3);

traveler returned from Malaysia and Indonesia;

clinical signs at onset of disease: diarrhea, fever;

blood collected: 12.5 months and 21.5 months after onset of disease


350085

negative negative positive (inconsistent results especially with rapid tests

1 : 625

dengue virus serum G-D40 represents an acute primary dengue virus infection positive for NS1-Ag only

serum of a healthy blood donor without signs of an acute or past dengue virus infection spiked with a cell culture propagated virus (DENV-4; heat inactivated)


* 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).


Table 1 (contd.): EQA Schemes Virus Immunology – September 2020 Summary of sample properties and target values



Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Puumala IgG anti-Puumala IgM

355081 positive positive

serum from patient G-H25,

with an acute Puumala virus infection,

probably acquired in Vienna, Austria

anamnesis for a stay abroad outside Europe excluded

at onset of disease hospitalization necessary; 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

anti-Dobrava IgG anti-Dobrava IgM

355082 positive negative

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

at onset of disease hospitalization necessary, characteristic symptoms such as elevated creatinine, flu-like symptoms and abnormal fatigue

blood collected approx. 3 years and 7.5 months after onset of disease

anti-Hanta IgG anti-Hanta IgM

355083 negative negative

serum of healthy blood donors (pool) without signs of an acute or past hanta virus infection

anti-Dobrava IgG anti-Dobrava IgM

355084§ positive positive

serum from patient G-H16

with an acute Dobrava-Belgrade virus infection§,

probably acquired in Mecklenburg Western Pomerania, Germany, anamnesis concerning a stay anamnesis for a stay abroad outside Europe excluded,

at onset of disease hospitalization necessary

Blood collected approx. 3 weeks after onset of disease

serum is negative for Hantavirus RNA


§ 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).


Table 1 (contd.): EQA Schemes Virus Immunology – September 2020

Summary of sample properties and target values



Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV IgG / anti- HAV total

343165 positive (a) 1 : 200 anti-HAV IgG positive healthy blood donor anti-HAV IgG /

anti- HAV total 343166 positive (a) 1 : 400

anti-HAV IgM 343167 negative negative healthy blood donors (pool)

anti-HAV IgM 343168 positive 1 : 20 acute hepatitis A

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344493

negative < 0.075 IU/ml (0.027 IU/ml target value)


HBsAg 344494 positive 1.90 – 3.40 IU/ml (2.48 IU/ml target value)

(aa) 1 : 200

chronic hepatitis B HBsAg 344495 positive 0.95 – 1.70 IU/ml (1.25 IU/ml target value)

(aa) 1 : 400

HBsAg 344496 positive 3.80 – 6.80 IU/ml (4.99 IU/ml target value)

(aa) 1 : 100

manda-tory:

B 2

anti-HBs 344497 positive 20.0 - 250 IU/l (111 IU/l target value)

(b) 1 : 400

anti-HBs positive healthy blood donor

anti-HBs 344498 positive 40.0 - 500 IU/l (212 IU/l target value)

(b) 1 : 200

anti-HBs 344499 negative <10 IU/l


anti-HBs 344500 positive 10.0 - 125 IU/l (57.8 IU/l target value)

(b) 1 : 800 anti-HBs positive healthy blood donor

manda-tory:

B 2

anti-HBc 344501 negative negative healthy blood donors (pool)

anti-HBc 344502 positive (c) 1 : 300

chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)



Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc IgM 345247 negative negative healthy blood donors (pool)

anti-HBc IgM 345248 positive 1 : 170 acute hepatitis B

manda-tory:

B 3

HBeAg 345249 positive 1 :600 chronic hepatitis B

HBeAg 345250 negative negative healthy blood donors (pool)

manda-tory:

B 2

anti-HBe 345251 negative negative healthy blood donors (pool)

anti-HBe 345252 positive 1 : 100 chronic hepatitis B (negative for HBeAg)


a, aa, b, c: The marked dilutions were performed with the same stock materials.





Hepatitis C virus

(Ab and HCV-Ag)

serum*

plasma**

346

anti-HCV

manda-tory:

B 2 HCV Ag

manda-tory:

B 3

anti-HCV (screening tests) HCV antigen anti-HCV (complementary tests)

346165*

reactive/positive negative positive, indeterminate

(d) 1 : 20

serum of patient A condition after chronic hepatitis C (subtype 4a) (successful therapy)

3rd blood collection (Oct. 2016)

serum diluted 1 : 20; the same serum of patient A of Oct. 2016 was used for sample 346167 (1 : 40 diluted)


346166*

non-reactive/ negative negative negative, not done



346167*


(d) 1 : 40

serum of patient A condition after chronic hepatitis C (subtype 4a) (successful therapy)

3rd blood collection (Oct. 2016)

serum diluted 1 : 40; the same serum of patient A of Oct. 2016 was used for sample 346165 (1 : 20 diluted)


346168*


1 : 30

follow-up serum of patient A condition after chronic hepatitis C (subtype 4a) (successful therapy)

4th blood collection (Oct. 2017)

Follow-up serum of patient A whose serum of the 3rd blood collection (Oct. 2016) was used for samples 346165 and 346167

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

Anti-HIV-2$ 335165$ positive$ 1 : 40 HIV-2 infection$

Anti-HIV-1 335166 positive (dd) 1 : 160

HIV-1 infection Anti-HIV-1 335167 positive (dd) 1 : 320

Anti-HIV-1 335168 positive (dd) 1 : 80

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337083 positive 1 : 20 000 HIV-1 infection (serum pool of negative blood donors spiked with HIV-1; HIV-1 heat inactivated)

p24 Ag 337084 positive 1 : 80 000


$ 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).





SARS-CoV-2

(Ab)

serum

416 (4161) (4162)

conform to

B 2

The INSTAND EQA scheme (416) virus immunology SARS-CoV-2 (ab) was shipped on 16 September 2020 (deadline 2 October 2020) and is currently under evaluation.

The target values will be specified in a separate evaluation.

You will be notified by email.

Tollwut-virus§

(Rabies Virus)

serum

336*

conform to

B 2

anti-RABV 336013 positive recent active rabies vaccination

anti-RABV 336014 negative negative healthy blood donor

Zika virus* (Ab)

serum

338*

conform to

B 2

anti-Zika IgG anti-Zika IgM

338022

positive not evaluated due to inconsistent results (without disadvantage for the certificate)

serum of patient G-Z7

with a recent Zika virus infection;

stay at ABC Islands, South America

clinical signs at onset of disease: fever, head and body aches, exanthema


serum is negative for Zika virus RNA


338023

negative

negative

negative healthy blood donor


338024 positive negative$

serum of patient G-Z8

with a past Zika virus infection

stay in Peru, South America

clinical signs: fever, body aches, chills and exanthema

blood collected: approx. 1 year and 6 months after onset of disease


§ 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).


EQA 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.


Table 2: EQA Schemes Virus Genome Detection - September 2020 Summary of sample properties and target values

Program Group RiliBÄK Sample

Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

BK virus (DNA)

suspension of urine

364 conform to

B 3

364053 positive (a) 1 : 10 000 75 190 57 893

364054 negative 1 : 100 0 0

364055 positive 1 : 40 000 22 312 14 093

364056 positive (a) 1 : 100 6 485 955 5 695 901

Chikungunya virus&

(RNA)

cell lysates

392& conform to

B 3

392045 positive (Martinique)

1 : 3 000 (inactivated)

Quantitative results were not reported 392046

positive (S27)

(b) 1 : 16 000 (inactivated)

392047 positive (S27)

(b) 1 : 1 000 (inactivated)

392048 negative ----

CMV (DNA)

spiked plasma

365

manda-tory:

B 3

For evaluation of results

in copies/ml or IU/ml: see notice 1, page 11

365165 positive (c) 1 : 31 250 14 324 11 788

365166 negative ---- 0 0

365167 positive 1 : 1 250 259 808 201 994

365168 positive (c) 1 : 1 250 308 497 292 108

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377165 negative ---- ----# ----#

377166 positive (d) 1 : 10 000 ----# ----#

377167 positive (d) 1 : 2 500 ----# ----#

377168 positive (d) 1 : 5 000 ----# ----#

HBV (DNA)

plasma

361

manda-tory:

B 3

361165 negative ---- Results in copies/ml:

not accepted or

not evaluated (see notices

2 and 3, page 11)

0

361166$ = 361168

positive (genosubtype D1)

(e) 1 : 50 000 5 152

361167 positive (genosubtype D1)

(e) 1 : 5 000 47 993

361168$ = 361166

positive (genosubtype D1)

(e) 1 : 50 000 5 173

HCV (RNA)

plasma

362

manda-tory:

B 3

362165 positive (subtype 4a) 1 : 35 Results in copies/ml:

not accepted or

not evaluated (see notices

2 and 3, page 11)

18 210

362166 positive (genotype 2) (f) 1 : 125 22 532

362167 negative ---- 0

362168 positive (genotype 2) (f) 1 : 3952.8 747

HDV (RNA)

plasma

400 conform to

B 3

400045 positive (g) 1 : 2 500 ----# 2 944

400046 positive (g) 1 : 625 ----# 9 647

400047 negative ---- ----# 0

400048 positive (g) 1 : 1 250 ----# 4 630


a, b, c, d, e, f, g: 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 – 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).


Table 2 (contd.): EQA Schemes Virus Genome Detection - September 2020 Summary of sample properties and target values


Sample properties




copies/ml IU/ml

HEV (RNA)

plasma* spiked

with 1HEV

positive suspension

of feces or

2plasmid

suspension of feces**

380

for RiliBÄK-

B3 obligation

please refer

Section 2.1

380073** positive 1 : 50 ----# 4 180

380074*2 positive (plasmid) (genotype 4)

1 : 2 600 000 ----# not evaluated§

380075* negative ---- ----# 0

380076*1 positive 1 : 50 ----# 3 203

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360165 positive (group M / subtype B) (heat inactivated)

(h) 1 : 158 114 1 583

Results in IU/ml: not accepted

or not evaluated (see notices 4

and 5, page 11)


(h) 1 : 15 811 16 151


(h) 1 : 50 000 5 042

360168 negative ---- 0

HHV-6 (DNA)

cell lysates

405

conform to

B 3

405005 positive (i) 1 : 100 99 233 104 132

405006 negative ---- 0 0

405007 positive (i) 1 : 300 35 070 34 629

405008 positive (i) 1 : 900 12 083 12 966

JC virus (DNA)

suspension of urine

394

conform to

B 3

394045 positive (j) 1 : 150 1 270 305 69 485

394046 positive$ 1 : 75 not evaluated$ 307 861

394047 positive (j) 1 : 600 309 445 18 897

394048 negative 1 : 1 000 0 0

Parechovirus (RNA)

cell lysates

407

conform to

B 3

407005 positive (type 3) (k) 1 : 500

Quantitative results were not reported 407006 positive (type 3) (k) 1 : 125


407008 positive (type 3) (k) 1 : 250


h, i, j, k: Marked samples derive from corresponding stock materials diluted in consecutive steps.


§ 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).


Table 2 (contd.): EQA Schemes Virus Genome Detection - September 2020 Summary of sample properties and target values


Sample properties




copies/ml IU/ml

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367165 negative ---- 0 0

367166$= 367167

positive (genotype 1) (l) 1 : 400 000 100 484 45 209

367167$= 367166

positive (genotype 1) (l) 1 : 400 000 95 888 49 892

367168 positive (genotype 1) (l) 1 : 80 000 438 160 238 909

Rabies virus*

vaccine 390*

conform to

B 3

390025 positive (m) 1 : 35 000

Quantitative results were not reported


390027 positive (m) 1 : 3 500

390028 positive (m) 1 : 350

Torque Teno virus

(DNA)

plasma spiked with

TTV positive urine

408

conform to

B 3

408001 positive (n) 1 : 500 ----# ----

408002 negative ---- ----# ----

408003 positive (n) 1 : 5 000 ----# ----

408004 positive (n) 1 : 50 ----# ----


l, m, n: Marked samples derive from corresponding stock materials diluted in consecutive steps.



* 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).


Table 3: EQA Schemes Virus Genome Detection incl. Typing

September 2020 - Summary of sample properties and target values


Sample properties

qualitative type

(species, if applicable) dilution

Target value of all methods copies/ml

Dengue viruses& (RNA)

cell lysates

369&

conform to

B 3

369053 positive DENV-2 (inactivated) 1 : 100

Quantitative results in copies/ml were not

reported

369054 negative ---- ----



HCV- Geno-/Sub

typing*

serum

375*

manda-tory:

B 3

375051 positive subtype 1a 1 : 32 ----

375052 positive subtype 3a 1 : 14 ----

375053 positive subtype 2c 1 : 95 ----

375054 positive subtype 1b 1 : 22 ----

375055 positive genotype 5 1 : 14 ----

Para- influenza-

viruses (RNA)

cell lysates

388

conform to

B 3

388053 positive PIV-3 (o) 1 : 2 000 ----#

388054 positive PIV-2 1 : 2 400 ----#

388055 positive PIV-3 (o) 1 : 8 000 ----#

388056 positive PIV-3 1 : 2 500 ----#


o: Marked samples derive from corresponding stock materials diluted in consecutive steps.


* 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).


Table 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing

September 2020 - Summary of sample properties and target values


Sample properties

qualitative type

(species, if applicable) dilution

Target value of all methods copies/ml

West Nile virus& (RNA)

plasma

391&

for RiliBÄK-

B3 obligation

please refer

Section 2.1

391095 positive WNV-2 (inactivated)

(p) 1 : 7 500 ----#


(p) 1 : 2 500 ----#


1 : 750 ----#

391098 negative ---- ---- ----#


(q) 1 : 10 000 ----#


(q) 1 : 2 500 ----#

Zika virus& (RNA)

plasma

403&

conform to

B 3

403037 negative ---- ---- ----#

403038 positive Asian lineage (inactivated)

(r) 1 : 1 000 ----#


(r) 1 : 62.5 ----#


(r) 1 : 250 ----#


p, q, r: Marked samples derive from corresponding stock materials diluted in consecutive steps.


& 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).


Table 4: EQA Schemes Virus Genome Detection for Drug Resistance Determination September / October 2020 - Evaluation

Program Group RiliBÄK Sample Sample properties and

results considered as "correct" (target values)

CMV drug

resistance

plasma*

extracted virus DNA**

349a)

conform to

B 3

349021**

The EQA scheme (349) was shipped on 16 September 2020 (deadline 23 October 2020).



349022*

349023*

349024*

HBV drug

resistance

plasmid

397b)

conform to

B 3

397021




397022

397023

397024

HCV drug

resistance

plasma*

serum**

399c)

conform to

B 3

399022**




399023**

399024*

399025**

HIV-1 drug

resistance

standard program

plasma

383d)

conform to

B 3

383027




383028

383029

383030

HIV-1 drug

resistance

additional program

plasma

384d)

conform to

B 3

384015 The EQA scheme (384) was shipped on 16 September 2020 (deadline 23 October 2020).


You will be notified by email. 384016

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

summary of virology eqass september 2020 of...traveler returned from maldives (meeru island);...

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