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Pre-evaluation Virology June 2017 20170809.doc 1 of 13

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

June

2017

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 09.08.2017


INSTAND EQA Schemes in Virus Diagnostics 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 Charité - University Medicine Berlin c/o INSTAND e.V. Ubierstr. 20, 40223 Düsseldorf Correspondence address: Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Prof. Dr. Heinz Zeichhardt Email: [email protected]

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]

Organisation and Logistics:

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]



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


Pre-Evaluation

and Mailing of Participation Documents

INSTAND External Quality Assessment Schemes – June 2017

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 June 2017. 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 June 2017 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 June 2017 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 June 2017 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 June 2017 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with

EQA schemes in Table 2 marked in italics were not performed in June 2017.

Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme June 2017. You received information on sample properties already per email on 28.07.2017.

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:

RiliBÄK A compilation of the "Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung 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 recently been published (in German language: Deutsches Ärzteblatt, 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: Bundesärztekammer (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).

Notice for German laboratories: The requirements laid down in Specified Section B 3 - effective since 01.04.2013 and with a transition period until 31.05.2015 - should now be fulfilled.

INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2017 For details please see the INSTAND ordering documents 2017 incl. brochure and order form (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

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 - June 2017 Pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Cyto-megalovirus

(Ab)

serum

351

conform to

B 2

anti-CMV-IgG anti-CMV-IgM

351057 positive avidity: high negative

past CMV infection (two healthy blood donors)

anti-CMV-IgG anti-CMV-IgM

351058

positive avidity: high/ no statement possible negative

past CMV infection (two healthy blood donors)

Epstein Barr virus (Ab)

serum

352

conform to

B 2

anti-EBV-IgG anti-EBV-IgM

352029 The accepted results will be shown in the report.

past EBV infection (two healthy blood donors)

anti-EBV-IgG anti-EBV-IgM

352030 past EBV infection (two healthy blood donors)

Tick-borne encephalitis

virus (TBE = FSME)#

(Ab)

serum

358

conform to

B 2

anti-TBE-IgG anti-TBE-IgM

358029 positive / borderline avidity: w/o evaluation negative

one healthy blood donor with indication of a past TBE virus infection/ vaccination

anti-TBE-IgG anti-TBE-IgM

358030 negative avidity: no avidity negative

negative healthy blood donor

Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343113 positive ≥ 20 mIU/ml (60 mIU/ml)*

1 : 380 anti-HAV-IgG positive healthy blood donor

anti-HAV 343114 negative 0 -19 mlU/ml (4 mIU/ml target value)

negative healthy blood donors (pool)

anti-HAV-IgM 343115 positive 1 : 10 acute hepatitis A

anti-HAV-IgM 343116 negative negative healthy blood donors (pool)

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344337 positive 4.80 – 9.30 IU/ml (7.05 IU/ml target value)

(a) 1 : 600

chronic hepatitis B HBsAg 344338 positive 1.60 – 3.10 IU/ml (2.35 IU/ml target value)

(a) 1 : 1 800

HBsAg 344339 positive 14.40 – 27.90 IU/ml (20.00 IU/ml target value)

(a) 1 : 200

HBsAg 344340 negative 0.00 - 0.05 IU/ml (0.00 IU/ml target value)


manda-tory:

B 2

anti-HBs 344341 positive 20 - 80 IU/l (52 IU/l target value)

(b) 1 : 600

anti-HBs positive healthy blood donor


(b) 1 : 150

anti-HBs 344343 negative 0 - 9 IU/l (0 IU/l target value)



(b) 1 : 300 anti-HBs positive healthy blood donor

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

Non-marked samples derive from independent preparations. # FSME = Frühsommer-Meningoenzephalitis

* 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.


Table 3 (contd.): EQA Schemes Virus Immunology - June 2017 Pre-evaluation



Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

(continued)

serum

344

manda-tory:

B 2

anti-HBc 344345 positive (c) 1 : 800

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

anti-HBc 344346 positive (c) 1 : 1 600

anti-HBc 344347 positive (c) 1 : 400

anti-HBc 344348 negative negative healthy blood donors (pool)

Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345169 negative negative healthy blood donors (pool)

anti-HBc-IgM 345170 positive 1 : 60 acute hepatitis B

manda-tory:

B 3

HBeAg 345171 negative negative healthy blood donors (pool)

HBeAg 345172 positive 1 : 750 chronic hepatitis B

manda-tory:

B 2

anti-HBe 345173 negative negative healthy blood donors (pool)

anti-HBe 345174 positive 1 : 90 chronic hepatitis B

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

346113** positive positive

(d) 1 : 60 chronic hepatitis C (subtype 1b) anti-HCV

HCV antigen 346114**

positive positive

(d) 1 : 30


346115* negative negative



346116* positive negative

1 : 15 condition after chronic hepatitis C (subtype 1b) (successful therapy)

Hepatitis D virus (Ab)

serum

347

conform to

B 2

anti-HDV-IgG anti-HDV-IgM

347029 negative not evaluated


anti-HDV-IgG anti-HDV-IgM

347030 positive not evaluated

1 : 3 500 chronic hepatitis D

Hepatitis E virus (Ab)

serum

348

conform to

B 2

anti-HEV-IgG anti-HEV-IgM

348029 positive positive

1 : 2 acute hepatitis E

anti-HEV-IgG anti-HEV-IgM

348030 positive negative

past hepatitis E

Herpes simplex viruses

(Ab)

serum

354

conform to

B 2

anti-HSV-IgG anti-HSV-IgM

354029 positive/borderline negative

past HSV-1 infection (one healthy blood donor)

anti-HSV-IgG anti-HSV-IgM

354030

negative negative tests for anti- HSV 1/2-IgM not evaluated


HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335113 positive (e) 1 : 60 HIV-1 infection

anti-HIV-1/2 335114 negative negative healthy blood donors (pool)

anti-HIV-1 335115 positive (e) 1 : 240 HIV-1 infection

anti-HIV-1 335116 positive (e) 1 : 120

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337057 positive (f) 1 : 32 500 HIV-1 infection (spiked serum pool of negative blood donors; HIV-1 heat inactivated)

p24 Ag 337058 positive (f) 1 : 65 000

HTLV-1/ HTLV-2

(Ab)

serum*

plasma**

339

conform to

B 2

anti-HTLV-1 339033** positive 1 : 500 HTLV-1 infection

anti-HTLV-1 339034* positive 1 : 300 HTLV-1 infection

anti-HTLV-2 339035** positive 1 : 4 HTLV-2 infection

anti-HTLV-1/2 339036** negative negative healthy blood donor

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

Non-marked samples derive from independent preparations.


Table 3 (contd.): EQA Schemes Virus Immunology - June 2017 Pre-evaluation



Measles virus (Ab)

serum

357

conform to

B 2

anti-measles-IgG anti-measles-IgM


two healthy blood donors with indication of a past measles virus infection/vaccination

anti-measles-IgG anti-measles-IgM


one healthy blood donor with indication of a past measles virus infection/vaccination

Mumps virus (Ab)

serum

356

conform to

B 2

anti-mumps-IgG anti-mumps-IgM


one healthy blood donor with indication of a past mumps virus infection/vaccination

anti-mumps-IgG anti-mumps-IgM


one healthy blood donor with indication of a past mumps virus infection/vaccination

Parvovirus B19 (Ab)

serum*

plasma**

342

conform to

B 2

anti-parvo B19-IgG anti-parvo B19-IgM

342057* positive avidity: high negative

past parvo B19 infection (one healthy blood donor)


342058* negative avidity: no avidity negative

one negative healthy blood donor


342059*

positive avidity: high/ intermediate/ no statement possible negative

past parvo B19 infection (one healthy blood donor)


342060* negative avidity: no avidity negative

two negative healthy blood donors

Rubella virus (Ab)

serum

341

manda-tory:

B 2

titer HI test / HiG

341029

16 – 256 (64 target value)

two healthy blood donors with indication of a past rubella virus infection or vaccination

anti-rubella-IgG

positive 40 - 500 IU/ml (106 IU/ml target value)

avidity: high

anti-rubella-IgM negative

titer HI test / HiG

341030

8 – 128 (32 target value)

two healthy blood donors with indication of a past rubella virus infection or vaccination

anti-rubella-IgG

positive 20 - 250 IU/ml (58 IU/ml target value)

avidity: high

anti-rubella-IgM negative

Varicella zoster virus

(Ab)

serum

353

conform to

B 2

anti-VZV-IgG anti-VZV-IgM


past VZV infection (two healthy blood donors)

anti-VZV-IgG anti-VZV-IgM


past VZV infection (two healthy blood donors)



EQA Schemes Virus Genome Detection by PCR/NAT

June 2017

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 (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK Section B 3, Table B. 3-2a,

When applying CE-marked tests, which not (yet) allow reporting of results in IU/ml, it should be continued 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 (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK 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 (Bundesärztekammer / RiliBÄK)", Specified RiliBÄK 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 - June 2017 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

CMV (DNA)

plasma

365

manda-tory:

B 3

For evaluation of results

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

365113 positive (a) 1 : 100 12 194 815.7 13 778 491.3

365114 negative ------- 0.0 0.0

365115 positive 1 : 10 000 3 789.2 8 764.1

365116 positive (a) 1 : 100 000 6 084.5 7 199.0

EBV (DNA)

cell lysate

376

manda-tory:

B 3

376057 positive (b) 1 : 540 2 839.3 2 535.7

376058 positive 1 : 50 32 314.0 28 851.7

376059 negative ------- 0.0 0.0

376060 positive (b) 1 : 20 76 423.1 69 595.4

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377113 negative ------- not evaluated# not evaluated#

377114 positive (c) 1 : 8 000 not evaluated# not evaluated#



HBV (DNA)

plasma

361

manda-tory:

B 3

361113 negative (d) ------- Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 9)

0.0

361114 negative (d) ------- 0.0

361115 positive (e) 1 : 2 000 22 899.8

361116 positive (e) 1 : 400 97 992.5

HCV (RNA)

plasma

362

manda-tory:

B 3

362113 positive (subtype 4a) (f) 1 : 400 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3,

page 9)

2 335.5

362114 positive (subtype 1b) 1 : 300 3 870.1

362115 positive (subtype 4a) (f) 1 : 40 19 880.1

362116 positive (subtype 4a) (f) 1 : 1 265 782.7

HEV (RNA)

serum*

suspension of feces**

380

conform to

B 3

380033** negative 1 : 20 not evaluated# not evaluated#

380034** positive (subtype 3e) 1 : 310 not evaluated# not evaluated#

380035** positive (subtype 3c) (g) 1 : 1 000 not evaluated# not evaluated#

380036** positive (subtype 3c) (g) 1 : 100 not evaluated# not evaluated#

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360113 positive (group M/

subtype F) (h) 1 : 16 000 5 433.6

Results in IU/ml: not accepted

or not evaluated (see notices 4

and 5, page 9)


subtype B) 1 : 1 600 000 13 751.5


subtype F) (h) 1 : 64 000 1 403.1


subtype F) (h) 1 : 1 000 69 675.9

HIV-2 (RNA)

spiked plasma

395

conform to

B 3

395021 positive strain:

ROD10 (i) 1 : 7.5 not evaluated# not evaluated#

395022 negative ------- not evaluated# not evaluated#


EHO 1 : 90 not evaluated# not evaluated#


ROD10 (i) 1 : 75 not evaluated# not evaluated#

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

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

d: Marked samples represent the same negative plasma pool.



Table 4 (contd.): EQA Schemes Virus Genome Detection - June 2017 Pre-evaluation


Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

HMPV (RNA)

cell lysate

385

conform to

B 3

385025 positive (subtype A) 1 : 320 not evaluated# -----

385026 positive (subtype A) (j) 1 : 1 280 not evaluated# -----

385027 positive (subtype A) (j) 1 : 80 not evaluated# -----

385028 negative ------- not evaluated# -----

Measles virus (RNA)

FTA cards

386

conform to

B 3

386025 positive (genotype D8) 1 : 2 not evaluated# -----


386027 positive (genotype H1) 1 : 2 not evaluated# -----

386028 positive (genotype B3) 1 : 2 not evaluated# -----

Mumps virus (RNA)

FTA cards

387

conform to

B 3

387021§= 387024

positive (genotype G) 1 : 2 not evaluated# -----


387023 positive (genotype H) 1 : 2 not evaluated# -----

387024§= 387021

positive (genotype G) 1 : 2 not evaluated# -----

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367113 positive (k) 1 : 160 000 not evaluated# 19 232.9



367116 negative ------- not evaluated# 0.0

Respiratory syncytial

virus (antigen/ genome)

cell lysate

359

manda-tory:

B 3

359037 positive RSV B 1 : 50 not evaluated# -----

359038 positive RSV A 1 : 100 not evaluated# -----

359039 positive RSV A (l) 1 : 75 not evaluated# -----

359040* positive/ RSV A (indeterminate*)

(l) 1 : 375 not evaluated# -----

Rubella virus (RNA)

FTA cards

389

conform to

B 3

389021 positive (genotype 1E) 1 : 2 not evaluated# -----

389022 positive (genotype 1A) 1 : 2 not evaluated# -----


389024 positive (genotype 2B) 1 : 2 not evaluated# -----

VZV (DNA)

cell lysate

366

manda-tory:

B 3

366057 positive (m) 1 : 500 1 031 951.0 -----

366058 positive (m) 1 : 50 000 11 685.4 -----

366059 negative ------- 0.0 -----

366060 positive 1 : 500 21 578.3 -----


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


§ The samples 387021 and 387024 are identical.

* For sample 359040 (1 : 375 diluted), the reporting of "indeterminate" in test category 10 (Qualitative detection of RSV antigen) was

accepted as additional correct result for rapid tests for antigen detection of RSV. Considering also the result "indeterminate" ensured

that this positive sample would not have been misinterpreted as negative.


Table 5: EQA Schemes Virus Genome Detection incl. Typing

June 2017 - Pre-evaluation


Sample properties

qualitative Target value of all

methods copies/ml

species type

(note on dilution)

Adeno-viruses (DNA)

cell lysate

371

manda-tory:

B 3

371057 positive

Quantitative results will be discussed in

the final report.

A Adenovirus 31 1 : 10 000 diluted (n)

371058 positive C Adenovirus 2 1 : 50 000 diluted (o)

371059 positive C Adenovirus 2 1 : 150 000 diluted (o)

371060 positive A Adenovirus 31 1 : 100 000 diluted (n)

Corona-viruses (RNA)

cell lysate

340

conform to

B 3

340023 positive not evaluated# ---- MERS-CoV 1 : 4 500 diluted

340024 positive not evaluated# ---- CoV OC43 1 : 4 500 diluted (p)

340025 negative not evaluated# ---- ---

340026 positive not evaluated# ---- CoV OC43 1 : 20 000 diluted

340027 positive not evaluated# ---- CoV OC43 1 : 13 500 diluted (p)

340028 positive not evaluated# ---- MERS-CoV 1 : 80 000 diluted

Entero-viruses (RNA)

cell lysate

372

manda-tory:

B 3

372058 positive

Quantitative results will be discussed in

the final report.

---- Coxsackievirus B4 1 : 1 000 diluted

372059 negative ---- ---

372060 positive ---- Echovirus 30 1 : 50 000 diluted

372061 positive ---- Coxsackievirus A21 1 : 10 000 diluted

HSV-1/ HSV-2 (DNA)

cell lysate

363

manda-tory:

B 3

363085 positive 51 276.0 ---- HSV-1 1 : 25 000 diluted (q)


363087 positive 32 170.7 ---- HSV-2 1 : 1 000 diluted (r)





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



Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing June 2017 - Pre-evaluation


Sample properties

qualitative Target value of all

methods copies/ml

species type

(note on dilution)

Human papilloma

viruses (DNA)

biopsy*

cell lysate**

373

manda-tory:

B 3

373071** negative ----- ---- ---

373072** High Risk positive ----- ---- HPV 18 1 : 50 diluted (s)

373073* Low Risk positive ----- ---- HPV 6 1 : 80 diluted

373074** High Risk positive ----- ---- HPV 18 1 : 25 diluted (s)

373075** High Risk positive ----- ---- HPV 16 1 : 25 diluted

Human Rhinoviruses

(RNA)

cell lysate

393

conform to

B 3

393017 positive not evaluated# ---- HRV A type 49 1 : 500 diluted


393019 negative not evaluated# ---- ----


Rotaviruses (RNA)

suspension of feces

401

conform to

B 3

401017 positive not evaluated# ---- G2P[4] 1 : 750 diluted (t)

401018 positive not evaluated# ---- G4P[8] 1 : 820 diluted

401019 positive not evaluated# ---- G2P[4] 1 : 75 000 diluted (t)

401020 negative not evaluated# ---- 1 : 200 diluted


s, t: Marked samples derive from corresponding stock materials diluted in consecutive steps.


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