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Summary of sample properties and target values Virology March April 2020 20200529f.doc 1 of 15

Summary of Sample Properties and Target Values of the External Quality Assessment Schemes in Virus Diagnostics

March/April 2020

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 29.05.2020


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 – March/April 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 March/April 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")

1.1 Extended deadline

Due to the exceptional situation in the context of SARS-CoV-2, INSTAND e.V. had extended the deadline for the EQA schemes in virus diagnostics (sample shipment 11 March 2020) by 4 weeks from 27 March to 24 April 2020. Therefore, the participation documents refer to 24 April 2020. 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 - 3 for details on sample properties and the expected target values for this EQA scheme March/April 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 Ärzteblatt" (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 characterisation 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 March/April 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 2020

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 – March/April 2020 Summary of Sample Properties and Target Values

Program Group RiliBAEK Analyte Sample Sample properties

qualitative dilution sample source

Cyto-megalo-

virus (Ab)

serum

351 conform

to B 2

anti-CMV IgG anti-CMV IgM

351079 positive avidity: high negative

past CMV infection (two healthy blood donors)

anti-CMV IgG anti-CMV IgM

351080 positive avidity: high negative

past CMV infection (two healthy blood donors)

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

350078

negative negative positive

1 : 8.3

dengue virus serum G-D31 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-1; heat inactivated)


350079

positive positive negative

mix of 2 sera from patient G-D32 with an recent primary dengue virus infection (DENV-2, heat inactivated)

traveler returned from Philippines

clinical signs at onset of disease: severe headache, fever, diarrhea, faintness, sore throat

blood collected: 8 and 90 days after onset of disease


350080

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 and anti-ZIKV


350081

positive positive negative

serum from patient G-D33 with a recent primary dengue virus infection (DENV-2, heat inactivated)

traveler returned from Thailand (Koh Samui)

clinical signs at onset of disease: headache and back pain, fever, exanthema, faintness

blood collected: 25 days after onset of disease

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).


Table 1 (contd.): EQA Schemes Virus Immunology – March/April 2020 Summary of Sample Properties and Target Values



Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Puumala IgG anti-Puumala IgM

355077 positive negative

serum from patient G-H37

with a past Puumala virus infection,

probably acquired in North Rhine-Westphalia, Germany

anamnesis concerning a stay abroad outside Europe excluded,

at onset of disease hospitalization necessary; characteristic flu-like symptoms, limb pains and in addition acute renal failure

blood collected approx. 7.5 weeks after onset of disease

anti-Hanta IgG anti-Hanta IgM

355078 negative negative

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

anti-Puumala IgG anti-Puumala IgM

355079 positive positive

serum from patient G-H36

with an acute Puumala virus infection,

probably acquired in North Rhine-Westphalia, Germany, anamnesis concerning a stay abroad outside Europe excluded,

at onset of disease hospitalization necessary; flu-like symptoms, fever, flank pain and acute renal failure

Blood collected approx. 4 weeks after onset of disease

serum is negative for Hantavirus RNA

anti-Dobrava IgG anti-Dobrava IgM

355080 positive negative

serum from patient G-H13,

with a past Dobrava-Belgrade virus infection,

probably acquired in Brandenburg, Germany, anamnesis concerning 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. 5 years and 2 months after onset of disease


* 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 – March/April 2020 Summary of Sample Properties and Target Values



Hepatitis A virus

(Ab)

serum

343

manda-tory:

B 2

anti-HAV IgG / anti- HAV total

343157 negative negative healthy blood donors (pool)

anti-HAV IgG / anti- HAV total

343158 positive 1 : 200 anti-HAV IgG positive healthy blood donor

anti-HAV IgM 343159 positive 1 : 25 acute hepatitis A

anti-HAV IgM 343160 negative negative healthy blood donors (pool)

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344469 positive 3.40 - 6.60 IU/ml (5.03 IU/ml target value)

(a) 1 : 2 000

acute hepatitis B


(a) 1 :4 000


(a) 1 :1 000


(a) 1 :8 000

manda-tory:

B 2

anti-HBs 344473* =

344476 negative$ <10 IU/l$

negative healthy blood donors (pool)

anti-HBs 344474 positive 13 - 80 IU/l (47.0 IU/l target value)

(b) 1 : 900

anti-HBs positive healthy blood donor

anti-HBs 344475 positive 39 - 240 IU/l (129 IU/l target value)

(b) 1 : 300

anti-HBs 344476* =

344473 negative$ <10 IU/l$


manda-tory:

B 2

anti-HBc 344477 positive (c) 1 : 1 200

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

anti-HBc 344478 positive (c) 1 : 2 400

anti-HBc 344479 positive (c) 1 : 600

anti-HBc 344480 negative negative healthy blood donors (pool)


a, b, c: Marked samples derive from corresponding stock materials diluted in consecutive steps.

* The samples 344473 and 344476 are identical.

$ Samples 344473 and 344476 (identical samples; negative for anti-HBs): Some participants (14 of 159) reported unexpected positive results with >10 IU/l for both samples when using the test of one manufacturer (Roche, Elecsys Anti-HBs II). These results have not been evaluated for this EQA scheme (without disadvantage for the certificate).

Furthermore, 14 of 159 participants having applied the same test (Roche, Elecsys Anti-HBs II) reported for both samples quantitative results between 4.5 and 9.5 IU/l and interpreted these quantitative results as "reactive/positive". This qualitative statement contradicts the manufacturer's specifications for results <10 IU/l and was evaluated as false (see test instructions for the test concerned).

The "Nationales Referenzzentrum für Hepatitis-B-Virus und Hepatitis-D-Virus" (University Giessen) and the manufacturer have been informed. The Joint Diagnostic Council of DVV and GfV will consider these problems.


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



Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc IgM 345235 positive 1 : 170 acute hepatitis B

anti-HBc IgM 345236 negative negative healthy blood donors (pool)

manda-tory:

B 3

HBeAg 345237 positive 1 :750 chronic hepatitis B

HBeAg 345238 negative negative healthy blood donors (pool)

manda-tory:

B 2

anti-HBe 345239 positive 1 : 170 chronic hepatitis B (negative for HBeAg)

anti-HBe 345240 negative negative healthy blood donors (pool)

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

346157** positive positive

1 : 20

chronic hepatitis C (subtype 4a)

primarily derived plasma (before therapy; blood collected July 2015) from the same patient whose follow-up sera were used for samples 346158 and 346160


346158* positive negative

1 : 20

condition after chronic hepatitis C (subtype 4a) (successful therapy)

follow-up serum (blood collected Oct. 2016) of the same patient whose primarily derived plasma (before therapy) was used for sample 346157


346159* negative negative



346160* positive$

negative 1 : 20

condition after chronic hepatitis C (subtype 4a) (successful therapy)

follow-up serum (blood collected Oct. 2017) of the same patient whose primarily derived plasma (before therapy) was used for sample 346157

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

Anti-HIV-1/2 335157 negative negative healthy blood donors (pool)

Anti-HIV-1 335158 positive 1 : 75 HIV-1 infection

Anti-HIV-1/2 335159 negative negative healthy blood donors (pool)

Anti-HIV-2 335160 positive 1 : 3 HIV-2 infection

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337079 negative negative healthy blood donors (pool)

p24 Ag 337080 positive 1 : 50 000

HIV-1 infection (spiked serum pool of negative blood donors; HIV-1 heat inactivated)


$ Sample 346160: Accepted target values for complementary tests (parameter 20) are positive and indeterminate.


EQA Schemes Virus Genome Detection by PCR/NAT March/April 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 – March/April 2020 Summary of Sample Properties and Target Values

Program Group RiliBAEK 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

364049 negative 1 : 100 0 0

364050 positive 1 : 30 000 36 185 17 765

364051 positive (a) 1 : 1 000 719 012 600 931

364052 positive (a) 1 : 100 6 766 176 5 853 943

Chikungunya virus&

(RNA)

cell lysates

392&

conform to

B 3

392041 positive (S27)

(b) 1 : 4 500 (inactivated)

Quantitative results in copies/ml were

not reported

----

392042 negative ---- ----



----



----

CMV (DNA)

spiked plasma

365

manda-tory:

B 3

For evaluation of results

in copies/ml or IU/ml: see notice 1, page 9

365157 positive (c) 1 : 1 529.2 160 188 238 381

365158 positive (c, d) 1 : 48 356.5 4 187 6 543

365159 positive (c) 1 : 15 291.7 13 828 21 947

365160 positive (c) 1 : 4 835.6 44 286 63 697

CMV (DNA)

training program

spiked plasma

368 conform

to

B 3

368033 positive (c, d) 1 : 48 356.5 5 343 8 082

368034 not evaluated (positive)

(c) 1 : 1 529 166.7

not evaluated (calculated

consensus value: 138)


consensus value: 296)

368035 positive (c) 1 : 152 916.7 1 476 2 643

368036 positive (c) 1 : 483 565 377 752

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377157 positive (e) 1 : 9 450 ----# ----#

377158 negative ---- ----# ----#

377159 positive (e) 1 : 350 ----# ----#

377160 positive (e) 1 : 3 150 ----# ----#

HBV (DNA)

plasma

361

manda-tory:

B 3

361157 positive (f) 1 : 14 687.5 Results in copies/ml:

not accepted or

not evaluated (see notices

2 and 3, page 9)

3 073

361158 positive (f) 1 : 1 468.8 29 947

361159 positive (f, g) 1 : 46 446 987

361160 positive (f) 1 : 4 644.6 9 513

HBV (DNA)

training program

plasma

378

conform to

B 3

378033 positive (f, g) 1 : 46 446 Results in copies/ml:

not accepted or


2 and 3, page 9)

1 026

378034 positive (f) 1 : 1 468 750 36.4

378035 positive (f) 1 : 146 875 347

378036 positive (f) 1 : 464 459.5 109


a, b, c, d, e, f: Marked samples derive from corresponding stock materials diluted in consecutive steps.

d, g: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBAEK Section B 3) and the corresponding training program

& 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).

# 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.


Table 2 (contd.): EQA Schemes Virus Genome Detection – March/April 2020

Summary of Sample Properties and Target Values

Program Group

RiliBAEK Sample

Sample properties

qualitative

(note on geno-/subtype)

dilution Target value of all methods

(provisional data)

copies/ml IU/ml

HCV (RNA)

plasma

362

manda-tory:

B 3

362157 positive (genotype 3) 1 : 405 Results in copies/ml:

not accepted or


2 and 3, page 9)

1 294

362158 positive (genotype 2) (h) 1 : 395.3 6 971

362159 positive (genotype 2) (h, i) 1 : 3 952.8 733

362160 positive (genotype 2) (h) 1 : 1 250 2 336

HCV (RNA)

training program

plasma

379

conform to

B 3

379033 positive (genotype 2) (h, i) 1 : 3 952.8 Results in copies/ml:

not accepted or


2 and 3, page 9)

717

379034 positive (genotype 2) (h) 1 : 39 528.5 75.4

379035 not evaluated (positive (genotype 2))

(h) 1 : 125 000


consensus value: 25.0)

379036 positive (genotype 2) (h) 1 : 12 500 251

HDV (RNA)

plasma

400

conform to

B 3

400041 positive (j) 1 : 1 250 ----# 5 376

400042 positive (j) 1 : 625 ----# 8 080

400043 positive (j) 1 :2 500 ----# 2 447

400044 positive (j) 1 : 312.5 ----# 17 543

HEV (RNA)

spiked plasma*

suspension of feces**

380

conform to

B 3

for RiliBAEK

see section

2.1

380065** positive 1 : 90 ----# 50 324

380066** negative 1 : 20 ----# 0

380067* positive 1 : 6 ----# 197 186

380068* negative ---- ----# 0

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360157 positive (group M / subtype B) (heat inactivated)

(k) 1 : 8 000 37 785

Results in IU/ml: not accepted

or not evaluated (see notices 4

and 5, page 9)


(k, l) 1 : 252 982.2 1 280


(k) 1 : 25 298.2 12 173


(k) 1 : 80 000 3 910

HIV-1 (RNA)

training program

spiked plasma

382

conform to

B 3

382033 positive (group M/ subtype B) (heat inactivated)

(k) 1 : 2 529 822 108

Results in IU/ml: not accepted

or not evaluated (see notices

4 and 5, page 9)


(k) 1 : 8 000 000 41.8


(k, l) 1 : 252 982.2 1 084


(k) 1 : 800 000 350


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

i, l: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBAEK

Section B 3) and the corresponding training program



Table 2 (contd.): EQA Schemes Virus Genome Detection – March/April 2020 Summary of Sample Properties and Target Values


Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

HHV-6 (DNA)

cell lysate

405

conform to

B 3

405001 positive (m) 1 : 50 252 950 187 794

405002 positive (m) 1 : 800 18 501 16 099

405003 negative ---- 0 0

405004 positive (m) 1 : 200 67 503 50 200

HHV-8 (DNA)

cell lysate

406

conform to

B 3

406001 positive (n) 1 : 800 496 932 ----

406001 negative ---- 0 ----

406003 positive (n) 1 : 200 2 336 456 ----

406004 positive (n) 1 : 50 9 851 658 ----

JC virus (DNA)

suspension of urine

394

conform to

B 3

394041 positive 1 : 35 975 814 49 550

394042 negative 1 : 1 000 0 0

394043 positive 1 : 35 503 968 25 106

394044 negative 1 : 100 0 0

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367157 positive (genotype 1) (o) 1 : 2 000 000 25 414 10 596

367158 positive (genotype 1) (o) 1 : 16 000 1 618 626 1 447 312

367159 negative ---- 0 0

367160 positive (genotype 1) 1 : 250 000 76 441 89 023

Parechovirus (RNA)

cell lysate

407

conform to

B 3

407001 positive (type 3) (p) 1 : 50 ----## ----

407002 negative ---- ----## ----

407003 positive (type 3) (p) 1 : 50 ----## ----

407004 positive (type 3) (p) 1 : 500 ----## ----


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

## The quantitative results are not evaluated due to the low number of analyses.


Table 3: EQA Schemes Virus Genome Detection incl. Typing

March/April 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

369049 positive DENV-3 (inactivated) 1 : 500

Quantitative results in copies/ml were not

reported


369051 negative ---- ----


Enterovirus

PCR/

Cultivation

and Typing*

suspension

of feces

374*

according

to

RKI-

Entero-

Sur-

veillance

Progr.

374023

The EQA scheme (374) has been closed and is currently under evaluation.

The target values will be specified in a separate evaluation. You will be notified by email.

374024

374025

374026

374027

Norovirus (RNA)

suspension of feces

381

conform to

B 3

for RiliBAEK

see section

2.1

381058 positive genogroup II 1 : 41 ----#

381059 negative ---- 1 : 20 ----#



Para- influenza-

viruses (RNA)

cell lysate

388

conform to

B 3

388049 negative ---- ---- ----#

388050 positive PIV-3 (q) 1 : 8 000 ----#

388051 positive PIV-3 (q) 1 : 500 ----#

388052 positive PIV-2 1 : 600 ----#


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


* The Special EQA program in accordance with the RKI-entero surveillance programm - virus detection - Enterovirus - PCR / Cultivation and Typing (374) is performed in cooperation with Nationales Referenzzentrum für Poliomyelitis und Enteroviren, Regionales Referenzlabor der WHO/EURO für Poliomyelitis, Robert Koch-Institut, Berlin, Dr. Sabine Diedrich and Dr. Sindy Boettcher

& The EQA programs Virus Genome Detection – Dengue Viruses (369), West Nile Virus (391) 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 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing



Sample properties

qualitative type

(species, if applicable)

dilution Target value of all

methods copies/ml

West Nile virus& (RNA)

plasma

391&

conform to

B 3

for RiliBAEK

see section

2.1

391083 positive WNV-2 (inactivated)

(r) 1 : 27 000 ----#


(r) 1 : 3 000 ----#

391085 negative ---- ---- ----#


(s) 1 : 750 ----#


(s) 1 : 3 000 ----#


(r) 1 : 9 000 ----#

Zika virus& (RNA)

plasma

403&

conform to

B 3

403033 positive Asian lineage (inactivated)

(t) 1 : 600 ----#*


(t) 1 : 120 ----#*

403035 negative ---- ---- ----#*


(t) 1 : 3 000 ----#*


r, s, t: 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 3 (contd.): EQA Schemes Virus Genome Detection incl. Typing


Program Group RiliBAEK Sample Sample properties and results considered as "correct" (target values)

type/subtype type/subtype 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

370119 positive

for seasonal influenza B virus

B/Colorado/06/2017-like (B/Victoria-line) (vaccine strain)

infected MDCK-cells (lysate)

(1 : 60 diluted)

370120

positive for

seasonal influenza A(H1N1)pdm09 virus

A/Brisbane/02/2018 (H1N1)pdm09-like

(vaccine strain)


(1 : 200 diluted)

370121 positive

for seasonal influenza B virus

B/Phuket/3073/2013-like (B/Yamagata-line)

(vaccine strain)


(1 : 100 diluted)

370122 negative ---- not-infected MDCK cells

(lysate)

370123 positive

for seasonal influenza A(H3N2) virus

A/Kansas/14/2017 (H3N2)-like

(vaccine strain)


(1 : 100 diluted)

370124 positive

for avian influenza A(H5N1) virus

A/Whooper Swan/R65/2006

(H5N1)

allantoic fluid (inactivated)

(1 : 300 diluted)

370125 positive

for avian influenza A(H5N8) virus

A/DE-SH/Reiherente/AR 8444/2016

(H5N8)

allantoic fluid (inactivated)

(1 : 1 000 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. Ralf Dürrwald and Dr. Barbara Biere and Nationales Referenzlabor für Aviäre Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, PD Dr. Timm C. Harder.

summary of virology eqass march/april 2020 of...traveler returned from philippines clinical signs at...

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