Pre-evaluation of virology EQASs September 2018 · 2018-11-20 · Pre-evaluation Virology September...

Pre-evaluation Virology September 2018 20181109 corr 20181120.doc 1 of 16

Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics

September 2018

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 09.11.2018

Corrected version: 20 November 2018 (See Table 3; page 9, program 344)


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 – September 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 September 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

Please note: Starting in September 2018, INSTAND e.V. has introduced the “EQAS (RV) Online system” for result entry for the following 5 EQA schemes:

Virus Immunology – Cytomegalovirus (Ab) (351)

Virus Immunology – Hepatitis B Virus Program 1 (HBsAg, Anti-HBs, Anti-HBc) (344)

Virus Immunology – HIV-1/HIV-2 (Ab) (335)

Virus Genome Detection – Cytomegalovirus Program 1 (365)

Virus Genome Detection – Parainfluenza Viruses (388)

For these 5 EQA programs, data processing and generation of participation documents are now performed by the new "RV Online system". This enables you to get direct access to your participation documents via the button "Evaluation" and the buttons corresponding to "Certificate" and "Evaluation". Please see: Annex 1 "Overview of the function and operation of RV Online", page 17.

Starting with the EQA term November 2018, all EQA programs in virus diagnostics will be performed online (details will follow).

For the forthcoming EQA schemes, participants having yet not used the RV Online system are kindly

advised to follow the information in Annex 1.

The EQA schemes having been performed in September 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)

Legend to Table 1: The EQA schemes having been performed in September 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.

The results of the 5 EQA schemes highlighted underlined in bold with colour in Tables 1 and 2 have been processed and evaluated by the new "RV Online system" for the first time in September 2018.


Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in September 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)

Legend to Table 2: $ The EQA scheme virus immunology – Zika virus (338) will be performed only once per year (term September) due to the changed

epidemiologic situation of infections with Zika virus.

* INSTAND will increase the frequency for the EQA schemes for genome detection of hepatitis E virus (380) and West Nile Virus

(391) from 2 to 4 times per year, as – for Germany – the Paul-Ehrlich-Institut (German Federal Institute for Vaccines and Biomedicines) plans to change/changed the requirements for institutions involved in virus safety testing of certain blood products by testing with appropriate nucleic acid amplification techniques (NAT).

The EQA schemes having been performed in September 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.

The results of the 5 EQA schemes highlighted underlined in bold with colour in Tables 1 and 2 have been processed and evaluated by the new "RV Online system" for the first time in September 2018.

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

Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme September 2018. You received information on sample properties already per email on 19.10.2018.

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 in 2019 For details please see the INSTAND brochure 2019 (please see link).

Surplus samples of the current and previous EQA schemes in virus diagnostics are available for test assessment of your virus diagnostics. Please contact INSTAND 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/RL/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 – September 2018 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Chikun- gunya virus# (Ak)

serum*

plasma**

402#

conform to

B 2

anti-CHIKV-IgG anti-CHIKV-IgM

402010* negative negative

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

recent or past chikungunya virus infection


402011*,§= 402012

positive negative

The samples 402011 and 402012 are identical. The sera derive from patient G-C5.

N.B.: The same patient G-C5 also donated the primarily derived serum, which was used for sample 402013.

Samples 402011 and 402012 represent the follow-up serum

(pool serum) of patient G-C5 with a past chikungunya virus

infection.

anamnestic details: see sample 402013;

blood collected: 9 months and 16 months after onset of disease


402012*,§= 402011

positive negative


402013* positive positive

The sera for sample 402013 derive from patient G-C5.

N.B.: The same patient G-C5 also donated the follow-up serum, which was used for the identical samples 402011 and 402012.

Sample 402013 (pool serum) represents the primarily derived serum from patient G-C5 with an acute chikungunya

virus infection.

chikungunya virus RNA negative;

traveler returned from French Guiana;

clinical signs at onset of disease: exanthema on the legs, heavy joint paint, limb pain, fever;

blood collected 7 days, 22 days and 30 days after onset of disease

§ The samples 402011 and 402012 are identical.

Non-marked samples derive from independent preparations.

# 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 3 (contd.): EQA Schemes Virus Immunology – September 2018 Pre-evaluation



Cyto-megalo-

virus (Ab)

serum

351

conform to

B 2

anti-CMV-IgG anti-CMV-IgM

351067

negative avidity: no avidity/ not done negative

negative healthy blood donors (pool)

anti-CMV-IgG anti-CMV-IgM

351068 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

350066

negative negative negative

serum of a healthy blood donor without signs of an

acute, recent or past dengue virus infection

anti-Dengue-IgG

anti-Dengue-IgM

Dengue NS1-Ag

350067

positive positive negative

serum from patient G-D26 with a recent primary

dengue virus infection (DENV-3);

traveller returned from Malaysia and Indonesia;

clinical signs at onset of disease: diarrhea, fever;

blood collected 4 weeks after onset of disease


350068

negative negative negative

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


350069

negative negative positive

dengue virus serum G-D28 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-2; 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).





Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Dobrava-IgG anti-Dobrava-IgM

355065 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 after onset of disease

anti-Hanta-IgG anti-Hanta-IgM

355066§= 355067

negative negative

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

or past hanta virus infection anti-Hanta-IgG anti-Hanta-IgM

355067§= 355066

negative negative

anti-Puumala-IgG anti-Puumala-IgM

355068

positive detection of persisting anti-PUUV-IgM possible accepted results: negative/ borderline/ positive

serum from patient G-H9

with a past / post-acute Puumala virus infection,

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

at onset of disease outpatient treatment, characteristic symptoms such as elevated creatinine, increased liver test values and flu-like symptoms;

Blood collected approx. 4 months after onset of disease

§ The samples 355066 and 355067 are identical.


* 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).





Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343133 positive ≥ 50 mIU/ml (75 mIU/ml)*

(a) 1 : 150

anti-HAV-IgG positive healthy blood donor

anti-HAV 343134 positive ≥ 50 mIU/ml (71 mIU/ml)*

(a) 1 : 300

anti-HAV-IgM 343135 negative negative healthy blood donors (pool)

anti-HAV-IgM 343136 positive 1 : 30 acute hepatitis A

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344397 positive 2.40 - 8.00 IU/ml (4.10 IU/ml target value)

(b) 1 : 2 000

acute hepatitis B

HBsAg 344398 positive 1.20 – 4.00 IU/ml (2.10 IU/ml target value)

(b) 1 :4 000


(b) 1 : 1 000


(b) 1 : 8 000

manda-tory:

B 2

anti-HBs 344401 negative <10 IU/l (1.66 IU/l target value)


anti-HBs 344402 low positive (≤10 IU/l) not evaluated

anti-HBs positive healthy blood donor

anti-HBs 344403 positive 70 - 200 IU/l (135 IU/l target value)

1 : 1 375 anti-HBs positive healthy blood donor

anti-HBs 344404 positive 40 - 150 IU/l (117 IU/l target value)

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

manda-tory:

B 2

anti-HBc 344405 negative negative healthy blood donors (pool)

anti-HBc 344406 positive (c) 1 : 2 000 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)

anti-HBc 344407 positive (c) 1 : 500

anti-HBc 344408 positive (c) 1 : 1 000

Hepatitis B virus

(prog. 2)

(anti-HBc-IgM

HBeAg anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345199 negative negative healthy blood donors (pool)

anti-HBc-IgM 345200 positive 1 : 160 acute hepatitis B

manda-tory:

B 3

HBeAg 345201 negative negative healthy blood donors (pool)

HBeAg 345202 positive 1 :800 chronic hepatitis B

manda-tory:

B 2

anti-HBe 345203 positive (d) 1 : 90 chronic hepatitis B (negative for HBeAg)

anti-HBe 345204 positive (d) 1 : 180


a, b, c, d: 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.

Pre-evaluation corrected on 20 November 2018.





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

346133** negative negative



346134** positive positive

1 : 20

chronic hepatitis C (subtype 4a)

primarily derived plasma (before therapy) from the same patient whose follow-up plasma was used for sample 346136


346135* negative negative



346136** positive$ negative

1 : 20

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

follow-up plasma whose primarily derived plasma (before therapy) was used for sample 346134

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335133 positive (e) 1 : 50

HIV-1 infection anti-HIV-1 335134 positive (e) 1 : 100

anti-HIV-1 335135 positive (e) 1 : 50

anti-HIV-1/2 335136 negative negative healthy blood donors (pool)

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337067 positive 1 : 25 000

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

p24 Ag 337068 negative negative healthy blood donors (pool)

Rabies virus*

serum

336*

conform to

B 2

anti-RABV 336009 negative negative healthy blood donor

anti-RABV 336010 positive recent active rabies vaccination


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

$ Sample 346136: Accepted target values for complementary tests (test category 20): positive and indeterminate.

* The EQA program Virus Immunology - Rabies Virus (336) is performed in cooperation with Nationales Konsiliarlabor für Tollwut (Rabies Virus) (Universitätsklinikum Essen, Institut für Virologie, Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross).





Zika virus* (Ab)

serum

338*

conform to

B 2

anti-Zika-IgG anti-Zika-IgM

338016 positive negative

serum of patient G-Z1 (pool serum)

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: 14 and 26 months after onset of disease


338017 negative negative

negative healthy blood donor


338018 positive positive

serum of patient G-Z4

with a post-acute Zika virus

infection (Zika virus RNA not detectable anymore);

stay in the Caribbean / Martinique

clinical signs: diarrhea, night sweats, exanthema, swelling of the joints, conjunctivitis

blood collected: 53 days 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 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 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 - September 2018

Pre-evaluation

Program Group RiliBÄK Sample

Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

BK virus (DNA)

suspension of urine

364

conform to

B 3

364037 positive 1 : 50 000 8 861.5 6 370.5

364038 positive (a) 1 : 400 1 837 802.9 1 591 528.8

364039 negative 1 : 100 0.0 0.0

364040 positive (a) 1 : 4 000 172 807.1 162 563.5

Chikungunya virus&

(RNA)

cell lysates

392&

conform to

B 3

392029 negative ------- not evaluated# -----

392030 positive (S27)

(b) 1 : 1 500 (inactivated)

not evaluated# -----

392031 positive (S27)

(b) 1 : 13 500 (inactivated)


392032 positive (Martinique)

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 12

365133 negative ------- 0.0 0.0

365134 positive 1 : 7 142.9 6 763.0 11 918.0

365135 positive 1 : 2 000 136 726.0 191 466.0

365136 positive 1 : 1 142.9 237 250.0 276 438.0

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377133 positive (c) 1 : 9 000 not evaluated# not evaluated#

377134 positive 1 : 500 not evaluated# not evaluated#

377135 negative ------- not evaluated# not evaluated#

377136 positive (c) 1 : 3 000 not evaluated# not evaluated#

HBV (DNA)

plasma

361

manda-tory:

B 3

361133 positive (d) 1 : 2 213.6 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and

3, page 12)

24 337.4

361134 positive (d) 1 : 70 000 757.3

361135 positive (d) 1 : 700 73 104.0

361136 negative ------- 0.0

HCV (RNA)

plasma

362

manda-tory:

B 3

362133 positive (subtype 1b) 1 : 675 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and

3, page 12)

1 424.1

362134 positive (genotype 3) (e) 1 : 100 55 268.4

362135 negative ------- 0.0

362136 positive (genotype 3) (e) 1 : 1 000 4 969.6

HDV (RNA)

plasma

400

conform to

B 3

400029 positive 1 : 5 000 not evaluated# not evaluated#

400030 positive (f) 1 : 100 not evaluated# not evaluated#

400031 negative ------- not evaluated# not evaluated#

400032 positive (f) 1 : 900 not evaluated# not evaluated#

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360133 positive (group M / subtype B)

(g) 1 : 50 000 4 708.1

not accepted or

not evaluated (see notices 4

and 5, page 12)


(g) 1 : 158 115.4 1 541.7


(g) 1 : 15 811.5 14 737.9

360136 negative ------- 0.0


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

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

& 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 4 (contd.): EQA Schemes Virus Genome Detection - September 2018

Pre-evaluation


Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

JC virus (DNA)

suspension of urine

394

conform to

B 3

394029 negative 1 : 1 000 0.0 0.0

394030 positive 1 : 33 388 185.7 29 326.1

394031 positive 1 : 66 47 852.4 3 585.7

394032 positive 1 : 50 60 233.8 5 242.0

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367133 positive (genotype 1) 1 : 750 000 34 944.0 31 033.4

367134 positive (genotype 1) (h) 1 : 30 000 512 268.7 734 787.7

367135 negative ------- 0.0 0.0

367136 positive (genotype 1) (h) 1 : 3 000 000 7 945.2 7 585.7

Rabies virus*

vaccine 390*

conform to

B 3

390017 positive (i) 1 : 1 250

Quantitative results were not reported

390018 positive (i) 1 : 6 250

390019 positive (i) 1 : 250

390020 negative -------


h, i: 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 5: EQA Schemes Virus Genome Detection incl. Typing

September 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

369037 positive not evaluated# ---- DENV-3 (inactivated) 1 : 100 diluted (j)

369038 negative not evaluated# ---- ----

369039 positive not evaluated# ---- DENV-3 (inactivated) 1 : 900 diluted (j)

369040 positive not evaluated# ---- DENV-2 (inactivated) 1 : 300 diluted

HCV- Geno-/Sub

typing*

serum

375*

manda-tory:

B 3

375041** positive ---- ---- genotype 3**/(subtype 3a)**

1 : 118.8 diluted

375042§ positive ---- ---- genotype 1 / subtype 1a§ 1 : 190 diluted

375043$ positive ---- ---- genotype 1$ / subtype 1b$ 1 : 52.8 diluted

375044** positive ---- ---- genotype 2**/(subtype 2b)**

1 : 82.6 diluted

375045% positive ---- ---- genotype 2% / (subtype 2a)%

1 : 95 diluted

Para- influenza-

viruses (RNA)

cell lysate

388

conform to

B 3

388037 negative ----## ---- ----

388038 positive ----## ---- PIV-3 1 : 100 000 diluted (k)

388039 positive ----## ---- PIV-2 1 : 1 000 diluted

388040 positive ----## ---- PIV-3 1 : 10 000 diluted (k)


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

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

## Samples 388038, 388039 and 388040: The target ranges for the quantitative results are set by the EQAS expert (ET).

& 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 EQA program Virus Genome Detection - HCV-Genotyping (375) is performed in cooperation with Nationales Referenzzentrum für Hepatitis C-Viren (Universitätsklinikum Essen, Institut für Virologie, Prof. Dr. Ulf Dittmer, Prof. Dr. Stefan Ross).

** Samples 375041 (subtype 3a) and 375044 (subtype 2b): The statement of the correct genotype will be considered for obtaining a

certificate of successful participation.

§ Sample 375042 (subtype 1a): The statement of the correct subtype is necessary for obtaining a certificate of successful participation.

$ Sample 375043 (subtype 1b): In test category 30, some participants could not determine the subtype by using the test of one manufacturer (Abbott - RealTime HCV Genotype II). These inconsistent results have not been evaluated for this EQA scheme (without disadvantage for the certificate of successful participation). The Nationales Referenzzentrum für HCV (Essen) and the manufacturer have been informed.

% Sample 375045 (subtype 2a): The statement on the correct genotype will be considered for obtaining a certificate of successful participation. Tests from different manufacturers were unable to differentiate between subtype 2a and subtype 2c for this sample.


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

September 2018 – Pre-evaluation


Sample properties

qualitative Target value of all

methods copies/ml

species type

(note on dilution)

West Nile virus& (RNA)

cell lysate

391&

conform to

B 3

391053 positive not evaluated# ---- WNV-1 (inactivated) 1 : 3 diluted (l)

391054 positive not evaluated# ---- WNV-2 (inactivated) 1 : 100 000 diluted

391055 positive not evaluated# ---- WNV-2 (inactivated) 1 : 30 000 diluted




Zika virus& (RNA)

plasma

403&

conform to

B 3

403021 positive not evaluated# ---- African lineage (inactivated) 1 : 200 diluted

403022 positive not evaluated# ---- Asian lineage (inactivated) 1 : 5 000 diluted

403023 positive not evaluated# ---- Asian lineage (inactivated) 1 : 30 diluted



l: The marked dilutions were performed with the same stock materials. # The quantitative results are not evaluated due to the low number of analysis (without disadvantage for the certificates).

& 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).

Pre-evaluation of virology EQASs September 2018 · 2018-11-20 · Pre-evaluation Virology September...

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