Pre-evaluation of virology EQASs - March 2018 Virology... · Please see the following Tables 3, 4...

Pre-evaluation Virology March 2018 20180516 corr 20180731.doc 1 of 16

Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics deadline postponed to: 23 March 2018

only for program 374: 06 April 2018

March 2018

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 31.07.2018

Corrected version: 31 July 2018 (See Table 3; page 10, program 338)


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

Institut für Qualitätssicherung in der Virusdiagnostik - IQVD 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/


Pre-Evaluation and

Mailing of Participation Documents

INSTAND External Quality Assessment Schemes – March 2018

Virus Immunology Virus Genome Detection by PCR/NAT

Dear colleagues,

You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in virus diagnostics of March 2018. Today you receive the pre-evaluation.

By mail, you receive the following participation documents of those EQA schemes in which you have participated this time:

certificate of successful participation confirmation of participation statement of individual results

The EQA schemes having been performed in March 2018 are highlighted in bold in Tables 1 and 2. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.

Table 1: EQA schemes performed with a frequency of four times per year

VIRUS IMMUNOLOGY:

Cytomegalovirus (351) Hepatitis A virus (343) Hepatitis B virus Prog. 1 (344) Hepatitis B virus Prog. 2 (345) Hepatitis C virus (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337)

VIRUS GENOME DETECTION:

Cytomegalovirus (365) Hepatitis A virus (377) Hepatitis B virus (361) Hepatitis C virus (362) HIV-1 (RNA) (360) Parvovirus B19 (367)

The EQA schemes having been performed in March 2018 are highlighted in bold (Table 1). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.


Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in March 2018 are highlighted in bold)

VIRUS IMMUNOLOGY:

Chikungunya virus (402) Dengue viruses (Ab/NS1-Ag) (350) Epstein Barr virus (352) TBE (FSME) virus (358) Hantaviruses (355) Hepatitis D virus (347) Hepatitis E virus (348) Herpes simplex viruses (354) HTLV-1/HTLV-2 (339) Measles virus (357) Mumps virus (356) Parvovirus B19 (342) Rubella virus (341) Rabies (Tollwut) virus (336) Varicella zoster virus (353) Zika virus (338)

VIRUS GENOME DETECTION:

Adenoviruses (371) BK virus (364) Chikungunya virus (392) Coronaviruses (340) Cytomegalovirus training program (368) Cytomegalovirus resistance determination (349) Dengue viruses (369) Enteroviruses (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr virus (376) Hepatitis B virus training program (378) Hepatitis B virus genotyping (396) Hepatitis B virus resistance determination (397) Hepatitis C virus training program (379) Hepatitis C virus geno-/subtyping (375) Hepatitis C virus resistance determination (399) Hepatitis D virus (400) Hepatitis E virus (380) Herpes simplex virus type 1/2 (363) HIV-1 (RNA) training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (RNA) (395) Human Metapneumovirus (385) Human Papilloma viruses (373) Human Rhinoviruses (393) Influenza viruses (genome/Ag) (370) JC virus (394) Measles virus (386) Mumps virus (387) Norovirus (381) Parainfluenza viruses (388) Respiratory syncytial virus (Ag/genome) (359) Rotaviruses (401) Rubella virus (389) Rabies (Tollwut) virus (390) Varicella zoster virus (366) West Nile virus (391) Zika virus (403)

The EQA schemes having been performed in March 2018 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.

EQA schemes in Table 2 marked in italics were not performed in March 2018.

Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme March 2018. You received information on sample properties already per email on 25.04.2018.

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.

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

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


Please note:

RiliBAEK A compilation of the "Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesaerztekammer / RiliBAEK = Richtlinie der Bundesaerztekammer zur Qualitaetssicherung laboratoriumsmedizinischer Untersuchungen)" with all Sections including Section B 2 "Qualitative medical laboratory testing = Qualitative laboratoriumsmedizinische Untersuchungen" and Section B 3 "Direct detection and characterisation of infectious agents = Direkter Nachweis und Charakterisierung von Infektionserregern" has been published (in German language: Deutsches Aerzteblatt, Jg. 111, Heft 38, 19. September 2014, A 1583 - A 1618) (please see link).

An English version of the guideline translated by INSTAND e.V. with the consent of the Executive Board of the German Medical Association has been published in "German Medical Science" [in English language: Bundesaerztekammer (German Medical Association), Instand e.V., Guidelines of the German Medical Association on quality assurance in medical laboratory testing. GMS Z Forder Qualitatssich Med Lab. 2015; 6] (please see link).

INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2018 For details please see the INSTAND ordering documents 2018 incl. brochure and order form (please see link).

Additional training programs in virus genome detection

Additional training programs were provided for the seventh time with the EQAS term March 2018.

Cytomegalovirus (368) Hepatitis B virus (378) Hepatitis C virus (379) HIV-1 (RNA) (382)

Please note: Additional training programs for virus genome detection of CMV, HBV, HCV and HIV-1 (RNA), respectively, containing low virus concentrations, are offered once only in March.

A training program contains low-concentration samples for each of the viruses to verify test sensitivities. The low-concentration samples are used as a complement to the respective main EQA scheme and contain samples with virus concentrations within the requirements of the new Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesaerztekammer/RiliBAEK = Richtlinie der Bundesaerztekammer zur Qualitaetssicherung laboratoriumsmedizinischer Untersuchungen) as specified in Table B 3-2a of the RiliBAEK.

Please note: A training program can only be ordered together with the corresponding main EQA scheme (next time in March 2019).

Separate certificates will be issued for each main EQA scheme (subject to RiliBAEK-B 3) and each training program.

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

http://www.bundesaerztekammer.de/downloads/Rili-BAEK-Laboratoriumsmedizin.pdf

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

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


Table 3: EQA Schemes Virus Immunology – March 2018 Pre-evaluation

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

351063

positive

avidity: high/intermediate/ no statement possible

negative

past CMV infection (two healthy blood donors)

anti-CMV-IgG

anti-CMV-IgM

351064

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

350062

negative negative positive/borderline

dengue virus serum D27 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)

anti-dengue-IgG

anti-dengue-IgM

dengue NS1-Ag

350063

negative negative negative

serum of a healthy blood donor without signs of an acute,

recent or past dengue virus infection


350064

positive positive negative

sample 350064 and sample 350065 derive from the same patient D25

sample 350064 is a primarily derived serum from patient

D25

pool of sera from one and the same patient D25 with a recent primary dengue virus

infection (DENV-1)

traveller returned from Sri Lanka,

blood collected 2 1/2, 6 and 7 weeks after onset of disease


350065§

positive not evaluated§

negative

sample 350065 and sample 350064 derive from the same patient D25

sample 350065 is a follow-up serum of patient D25 and represents a past / acute

primary dengue virus infection (DENV-1)

traveller returned from Sri Lanka,

blood collected 18 months after onset of disease

Non-marked samples derive from independent preparations.

* The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger, Abteilung Virologie und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research: Prof. Dr. Stephan Günther, Dr. Petra Emmerich and

Prof. Dr. Dr. Jonas Schmidt-Chanasit).

§ Sample 350065: The question concerning persisting anti-Dengue-IgM will be commented in the forthcoming report.


Table 3 (contd.): EQA Schemes Virus Immunology – March 2018 Pre-evaluation



Hanta-viruses*

(Ab)

serum

355* conform to

B 2

anti-Hanta-IgG anti-Hanta-IgM

355061 negative negative

serum of healthy blood donors (pool) without signs of an acute

or past hanta virus infection

anti-Puumala-IgG anti-Puumala-IgM

355062 positive positive

serum of patient H29

with an acute Puumala virus infection,

probably acquired in Saxony,

Germany, anamnesis concerning a stay abroad outside Europe excluded,

at onset of disease hospitalization necessary, characteristic flu-like symptoms with fever, body aches and in addition acute renal failure,

blood collected 2,5 weeks after onset of disease, serum is

negative for Hantavirus RNA

anti-Dobrava-IgG anti-Dobrava-IgM

355063 positive positive

1 : 2

serum of patient H19

(diluted with sera from healthy blood donors (pool))

with an acute Dobrava-Belgrade virus infection,

acquired in Mecklenburg-Western Pomerania, Germany; anamnesis concerning 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

anti-Dobrava-IgG anti-Dobrava-IgM

355064 positive negative

serum from patient 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 after onset of disease


* The EQA program Virus Immunology - Hantaviruses (355) is performed in cooperation with Nationales Konsiliarlaboratorium für Hantaviren (Charité - Universitaetsmedizin Berlin, Campus Mitte, Institut für Virologie: Prof. Dr. Joerg Hofmann; Prof. Dr. Christian Drosten).





Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343125 positive ≥ 20 mIU/ml (60 mIU/ml)*

1 : 360 anti-HAV-IgG positive healthy blood donor

anti-HAV 343126 negative 0 - 19 mIU/ml (4 mIU/ml target value)

negative healthy blood donors (pool)

anti-HAV-IgM 343127 negative negative healthy blood donors (pool)

anti-HAV-IgM 343128 positive 1 : 20 acute hepatitis A

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344373 positive 1.50 - 4.00 IU/l (2.71 IU/l target value)

(a) 1 : 200 chronic hepatitis B

HBsAg 344374 negative 0.00 - 0.05 IU/l (0.00 IU/l target value)


HBsAg 344375 negative 0.00 - 0.05 IU/l (0.00 IU/l target value)


HBsAg 344376 positive 0.75 - 2.00 IU/l (1.37 IU/l target value)

(a) 1 : 400 chronic hepatitis B

manda-tory:

B 2

anti-HBs 344377 positive 36 - 200 IU/l (115 IU/l target value)

(b) 1 : 25 patient after acute hepatitis B (healed up with seroconversion)

anti-HBs 344378 negative 0 - 9 IU/l (0 IU/l target value)



(b) 1 : 100 patient after acute hepatitis B (healed up with seroconversion)


(b) 1 : 50

manda-tory:

B 2

anti-HBc 344381 positive (c) 1 : 200 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)

anti-HBc 344382 negative negative healthy blood donors (pool)

anti-HBc 344383 positive (c) 1 : 800 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative) anti-HBc 344384 positive (c) 1 : 400


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

* For highly concentrated samples some commercial tests for the detection of anti-HAV-IgG or anti-HAV-total reveal values > 60 mIU/ml, which are outside the linear measurement range of the respective test system. Therefore, a final target value derived from a consensus value from all results stated in mIU/ml could not be assigned to highly concentrated samples. In this case a lower limit value in mIU/ml is indicated in order to assess a reported result of a laboratory as a "correct" result.





Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345187 negative negative healthy blood donors (pool)

anti-HBc-IgM 345188

positive

The results obtained by a test of one manufacturer (Roche - Elecsys Anti-HBc-IgM) were inconsistent and will not be evaluated (without disadvantage for the certificate). The manufacturer and National Reference Center for HBV/HDV are informed.

1 : 60 acute hepatitis B

manda-tory:

B 3

HBeAg 345189 positive 1 : 750 chronic hepatitis B

HBeAg 345190 negative negative healthy blood donors (pool)

manda-tory:

B 2

anti-HBe 345191 negative negative healthy blood donors (pool)

anti-HBe 345192 positive 1 : 100 chronic hepatitis B (negative for HBeAg)

Hepatitis C virus

(Ab and HCV-Ag)

serum*

plasma**

346

anti-HCV

manda-tory:

B 2

HCV Ag

manda-tory:

B 3

anti-HCV HCV antigen

346125** positive positive

(d) 1 : 40 chronic hepatitis C (subtype 1b)


346126* positive negative

1 : 18 condition after chronic hepatitis C (subtype 1b) (successful therapy)


346127* negative negative



346128** positive positive

(d) 1 : 80 chronic hepatitis C (subtype 1b)

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335125 positive (e) 1 : 100 HIV-1 infection

anti-HIV-2 335126 positive 1 : 3 HIV-2 infection

anti-HIV-1/2 335127 negative negative healthy blood donors (pool)

anti-HIV-1 335128 positive (e) 1 : 50 HIV-1 infection

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337063 negative negative healthy blood donors (pool)

p24 Ag 337064

positive

The results obtained by a test of one manufacturer (Alere - HIV Combo 4.0) were inconsistent and will not be evaluated (without disadvantage for the certificate). The manufacturer and National Reference Center for Retroviruses are informed

1 : 130 000

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


d, e: The marked dilutions were performed with the same stock materials.





Zika virus* (Ab)

serum

338* conform to

B 2

anti-Zika-IgG anti-Zika-IgM

338013 negative negative

negative healthy blood donor


338014

positive / borderline negative

serum of patient Z6 with a past Zika virus infection

stay in Sao Paulo and Ponta Negara, Brazil

clinical signs at onset of disease: strong headaches, nausea, intestinal disorders, skin rash (not itchy), fever to 38,5°C

blood collected: 26 months and 12 days after onset of disease


338015

positive / borderline negative

serum of patient Z1 with a past Zika virus infection

stay in Sao Paulo and Ponta Negara, Brazil

clinical signs at onset of disease: strong headaches, nausea, intestinal disorders, skin rash (not itchy), fever to 38,5°C

blood collected: 25 months and 23 days after onset of disease


* The EQA program Virus Immunology - Zika Virus (338) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger, Abteilung Virologie und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research: Prof. Dr. Stephan Günther, Dr. Petra Emmerich and

Prof. Dr. Dr. Jonas Schmidt-Chanasit). Pre-evaluation corrected on 31 July 2018.


EQA Schemes Virus Genome Detection by PCR/NAT March 2018

Pre-evaluation

Notices

Evaluation of results for quantitative genome detection of CMV

1 Notice for German and foreign participants of EQA scheme 365: For evaluation, "IU/ml" have primarily been considered as measurement units of the quantitative results for the analyte CMV. This is in accordance to the "Guideline of the German Medical Association (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 4: EQA Schemes Virus Genome Detection – March 2018 Pre-evaluation

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

364033 positive (a) 1 : 4 000 161 990.8 not evaluated# 364034 negative 1 : 100 0.0 not evaluated#

364035 positive (a) 1 : 400 1 677 040.7 not evaluated#

364036 positive (a) 1 : 40 000 16 413.4 not evaluated#

Chikungunya virus&

(RNA)

cell lysates

392&

conform to

B 3

392025 positive (Martinique)

(b) 1 : 1 500 (inactivated)

Quantitative results were not reported

-----

392026 negative ------- -----

392027 positive (Martinique)

(b) 1 : 4 500 (inactivated)

-----

392028 positive (S27)

1 : 4 500 (inactivated)

-----

CMV (DNA)

spiked plasma

365

manda-tory:

B 3

For evaluation of results in

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

365125 positive (c) 1 : 714 47 877.6 98 039.1

365126 positive (d) 1 : 1 143 211 632.7 297 714.3

365127 positive (d, e) 1 : 114 286 2 037.3 3 503.3

365128 positive (d) 1 : 11 429 22 099.0 34 259.3

CMV (DNA)

training program

spiked plasma

368 conform

to

B 3

368025 positive (d, e) 1 : 114 286 2 475.2 3 958.3

368026 positive (c) 1 : 7 143 6 270.8 9 659.7

368027 positive (c) 1 : 71 429 556.8 1 280.6

368028 positive (d) 1 : 1 142 857

not evaluated (calculated

consensus value: 233.8)



HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377125 positive (f) 1 : 1 000 not evaluated# not evaluated# 377126 negative ------- not evaluated# not evaluated#

377127 positive (f) 1 : 2 000 not evaluated# not evaluated#

377128 negative ------- not evaluated# not evaluated#

HBV (DNA)

plasma

361

manda-tory:

B 3

361125 positive (genosubtype D1)

(g) 1 : 166 667 Results in copies/ml:

not accepted or

not evaluated (see notices

2 and 3, page 11)

1 801.7


(g) 1 : 52 705 5 665.4


(g, h) 1 : 527 046 565.1


(g) 1 : 16 667 17 461.2

HBV (DNA)

training program

plasma

378

conform to

B 3


(g, h) 1 : 527 046

Results in copies/ml:

not accepted or


2 and 3, page 11)

529.8

378026 not evaluated (positive) (genosubtype D1)

(g) 1 : 16 666 667




(g) 1 : 1 666 667 175.6


(g) 1 : 5 270 463 45.5


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

e, h: 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).

# The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates).


Table 4 (contd.): EQA Schemes Virus Genome Detection – March 2018 Pre-evaluation


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

362125 positive (subtype 1b) (i, j) 1 : 2 025 Results in copies/ml:

not accepted or


2 and 3, page 11)

513.8

362126 positive (subtype 1b) (i) 1 : 75 11 872.6



HCV (RNA)

training program

plasma

379

conform to

B 3

379025 positive (subtype 1b) (i) 1 : 6 075 Results in copies/ml:

not accepted or


2 and 3, page 11)

166.5

379026 not evaluated (positive) (subtype 1b)

(i) 1 : 54 675




379028 positive (subtype 1b) (i, j) 1 : 2 025 492.7

HDV (RNA)

plasma

400

conform to

B 3

400025 positive (k) 1 : 200 not evaluated# not evaluated#

400026 positive 1 : 100 not evaluated# not evaluated#

400027 positive (k) 1 : 5 000 not evaluated# not evaluated#

400028 negative ------- not evaluated# not evaluated#

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360125 positive (group M/

subtype F) (l) 1 : 13 390 4 799.9

Results in IU/ml: not accepted

or not evaluated (see notices

4 and 5, page 11)


subtype F) (l) 1 : 1 339 41 104.9


subtype F) (l, m) 1 : 42 351 1 479.6


subtype F) (l) 1 : 4 235 13 948.9

HIV-1 (RNA)

training program

spiked plasma

382

conform to

B 3


subtype F) (l) 1 : 1 339 000 45.9

Results in IU/ml: not accepted

or not evaluated (see notices

4 and 5, page 11)


subtype F) (l) 1 : 133 900 428.6


subtype F) (l) 1 : 423 513 124.7


subtype F) (l, m) 1 : 42 351 1 412.7

JC virus (DNA)

suspension of urine

394

conform to

B 3

394025 positive (n) 1 : 73 601 248.0 not evaluated#

394026 positive (n) 1 : 733 70 750.9 not evaluated#

394027 negative 1 : 1 000 0.0 not evaluated#

394028 positive 1 : 35 43 661.5 not evaluated#

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367125 negative ------- 0.0 0.0

367126 positive (genotype 1) (o) 1 : 2 250 000 15 441.0 11 347.3

367127 positive (genotype 1) (o) 1 : 250 000 107 887.1 90 085.5

367128 positive (genotype 1) (o) 1 : 750 000 48 791.7 31 438.6


i, k, l, n, o: The marked dilutions were performed with the same stock materials.

j, m: 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 5: EQA Schemes Virus Genome Detection incl. Typing

March 2018 – Pre-evaluation


Sample properties

qualitative Target value of

all methods copies/ml

species type

(note on dilution)

Dengue viruses& (RNA)

cell lysates

369&

conform to

B 3

369033 positive not evaluated# ---- DENV-2 (inactivated) 1 : 100 diluted


369035 negative not evaluated# ---- ----


Enterovirus

PCR/

Cultivation

and Typing*

suspension

of feces

374*

according

to

RKI-

Entero-

Sur-

veillance

Progr.

374018 positive ---- Enterovirus C Coxsackievirus A21

374019 positive ---- Enterovirus A Coxsackievirus A6

374020 negative ---- ---- ----

374021 positive ---- Enterovirus C Poliovirus type 1 (Sabin)

vaccine strain

374022 positive ---- Enterovirus B Coxsackievirus B5

Norovirus (RNA)

suspension of feces

381

conform to

B 3

381042 positive not evaluated# ---- GII.P16_GII.2 1 : 60 diluted

381043 positive not evaluated# ---- GII.P16_GII.2 1 : 1 155 diluted

381044 positive not evaluated# ---- GII.P16_GII.4 2016 1 : 55 diluted

381045 negative not evaluated# ---- 1 : 200 diluted

Para- influenza-

viruses (RNA)

cell lysates

388

conform to

B 3

388033 positive not evaluated# ---- PIV-2 1 : 10 000 diluted (p)


388035 positive not evaluated# ---- PIV-3 1 : 100 diluted

388036 positive not evaluated# ---- PIV-2 1 : 1 000 diluted (p)


p: The marked dilutions were performed with the same stock materials. & 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 and Dr. Petra Emmerich).

* 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



Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing



Sample properties

qualitative Target value of all

methods copies/ml

species type (note on dilution)

West Nile virus& (RNA)

cell lysates

391&

conform to

B 3


391048 positive not evaluated# ---- WNV-2 (inactivated) 1 : 10 000 diluted (q)

391049 positive not evaluated# ---- WNV-1 (inactivated) 1 : 10 000 diluted (r)

391050 positive not evaluated# ---- WNV-2 (inactivated) 1 : 1 000 diluted (q)


391052 positive not evaluated# ---- WNV-1 (inactivated) 1 : 1 000 diluted (r)

Zika virus& (RNA)

plasma

403&

conform to

B 3

403017 positive not evaluated# ---- Asian lineage (inactivated) 1 : 30 diluted (s)


403019 positive not evaluated# ---- African lineage (inactivated) 1 : 200 diluted

403020 positive not evaluated# ---- Asian lineage (inactivated) 1 : 300 diluted (s)


q, r, s: The marked dilutions were performed with the same stock materials.

& 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 and Dr. Petra Emmerich).



Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing


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

type/subtype strain origin

Influenza A-und B-viruses*

inclusive

influenza A(H1N1)

pdm09 virus

and

avian influenza A

virus (different subtypes)

(genome/ antigen)

370*

manda-tory:

B 3

370095

positive

for seasonal influenza A(H1N1) pdm09

virus

A/Michigan/45/2015 (vaccine strain)

infected MDCK cells (lysate)

(1 : 500 diluted)

370096

positive

for avian influenza A(H7N9) virus

A/Anhui/1/2013 allantoic fluid (inactivated)

(1 : 400 diluted)

370097

positive

for avian influenza A(H5N8) virus

A/DE-SH/ Reiherente/AR8444/

2016

allantoic fluid (inactivated)

(1 : 500 diluted)

370098

positive

for seasonal influenza B virus

B/Phuket/3073/2013 (vaccine strain)

infected MDCK-cells (lysate)

(1 : 150 diluted)

370099 negative ---- not-infected MDCK

cells (lysat)

370100

positive

for seasonal influenza A(H3N2) virus

patient isolate A/Thüringen/5/2017

(Clade 3C2a.1)

infected MDCK-cells (lysate)

(1 : 500 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 Aviaere Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, PD Dr. Timm C. Harder.

Pre-evaluation of virology EQASs - March 2018 Virology... · Please see the following Tables 3, 4...

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