instand e.v. · hepatitis c virus training program (379) hepatitis c virus geno-/subtyping (once a...

Pre-evaluation

of the EQA Schemes

in Virus Diagnostics

November/December 2015

INSTAND e.V. in cooperation with:

Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten (DVV)

Gesellschaft für Virologie (GfV) Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM)

Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Issued by:

INSTAND e.V. Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V. Düsseldorf/Berlin, 22.01.2016

Pre-evaluation Virology November December 2015 20160122a EN.doc 2 von 14

EQAS Adviser: Assistant EQAS Adviser: Univ.-Prof. i. R. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.V. Campus Benjamin Franklin, Institut für Virologie Ubierstr. 20, 40223 Düsseldorf Email: [email protected] Tel.: +49-(0)30-81054-305; Fax: +49-(0)30-81054-303 Email: [email protected] Correspondence address: Prof. Dr. Heinz Zeichhardt Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, 14129 Berlin Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: [email protected]

Organisation and Logistics:

INSTAND e.V. Ubierstr. 20 40223 Düsseldorf 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 – November/December 2015

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 November/December 2015. 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 statement of participation statement of individual results

The EQA schemes having been performed in November/December 2015 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 November/December 2015 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 November/December 2015 are highlighted in bold)

VIRUS IMMUNOLOGY:

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)

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 (once a year) (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)

The EQA schemes having been performed in November/December 2015 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 November/December 2015. Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme November/December 2015. You received information on sample properties already per email on 22.12.2015. 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 / Reports / Year and Category (Virus immunology / Virus genome detection)" in English language: http://www.instandev.de/en/eqas/reports/ and in German language: http://www.instandev.de/ringversuche/kommentare/.

http://www.instandev.de/en/eqas/reports/

http://www.instandev.de/ringversuche/kommentare/


Please note:

RiliBÄK A compilation of the "Guideline of the German Medical Association (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen)" with all Sections including Section B 2 "Qualitative determinations in laboratory medicine = Qualitative laboratoriumsmedizinische Untersuchungen" and Section B 3 "Direct detection and characterization of infectious diseases pathogens = 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:Doc03. DOI: 10.3205/lab000018, URN: urn:nbn:de:0183-lab0000182) (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 2016 For details please see the INSTAND ordering documents 2016 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 for details.

Thank you for your kind cooperation

Prof. Dr. H. Zeichhardt Priv.-Doz. Dr. O. Donoso Mantke

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

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

http://www.instandev.de/en/eqas.html


Table 3: EQA Schemes Virus Immunology - November/December 2015 pre-evaluation

Program Group RiliBÄK Analyte Sample Sample properties

qualitative dilution sample source

Cyto-megalo-

virus (Ab)

serum

351

conform to

B 2

anti-CMV-IgG anti-CMV-IgM

351045 positive avidity: low positive

1 : 5 acute CMV infection

anti-CMV-IgG anti-CMV-IgM

351046 positive avidity: high negative

past CMV infection (two healthy blood donors)

Epstein Barr virus

(Ab)

serum

352

conform to

B 2

anti-EBV-IgG anti-EBV-IgM

352023= 352024

The accepted results will be shown in the report.

past EBV infection (four healthy blood donors)

anti-EBV-IgG anti-EBV-IgM

352024= 352023

past EBV infection (four healthy blood donors)

Tick-borne encephalitis

virus (TBE = FSME)#

(Ab)

serum

358

conform to

B 2

anti-TBE-IgG anti-TBE-IgM

358023

negative The results for anti-TBE-IgG (test category 10) obtained by a test of one manufacturer (Progen Immunozym FSME/TBE IgG) were inconsistent and are not evaluated (without disadvantage for the certificate).

avidity: no avidity negative

negative healthy blood donor

anti-TBE-IgG anti-TBE-IgM


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

Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343089 negative 0 – 15 mIU/ml

negative healthy blood donors (pool)

anti-HAV 343090 positive ≥ 30 mIU/ml (57 mIU/ml)*

1 : 500 anti-HAV-IgG positive healthy blood donor

anti-HAV-IgM 343091 positive 1 : 10 acute hepatitis A infection

anti-HAV-IgM 343092 negative negative healthy blood donors (pool)

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344265 positive 3.60 – 7.60 IU/ml (4.88 IU/ml target value)

(a) 1 : 750

chronic hepatitis B HBsAg 344266 positive 0.90 – 1.90 IU/ml (1.26 IU/ml target value)

(a) 1 : 3 000

HBsAg 344267 positive 1.80 – 3.80 IU/ml (2.45 IU/ml target value)

(a) 1 : 1 500

HBsAg 344268 negative 0.00 – 0.051 IU/ml (0.00 IU/ml target value)


manda-tory:

B 2

anti-HBs 344269 negative 0 – 9.3 IU/l (0 IU/l target value)


anti-HBs 344270 positive 20 – 90 IU/l (61 IU/l target value)

(b) 1 : 800

anti-HBs positive healthy blood donor


(b) 1 : 200


(b) 1 : 400

manda-tory:

B 2

anti-HBc 344273 positive (c) 1 : 2 400 chronic hepatitis B (HBeAg negative and anti-HBc-IgM negative) anti-HBc 344274 positive (c) 1 : 600

anti-HBc 344275 negative negative healthy blood donors (pool)

anti-HBc 344276 positive (c) 1 : 1 200 chronic hepatitis B (HBeAg negative and anti-HBc-IgM negative)

a, b, c: Marked samples represent dilutions from the corresponding stock materials.

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

* Some commercial tests for the detection of anti-HAV-IgG or anti-HAV-total reveal for highly concentrated samples 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 - November/December 2015 pre-evaluation



Hepatitis B virus

(prog. 2)

(anti-HBc-IgM HBeAg

anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345133 negative negative healthy blood donors (pool)

anti-HBc-IgM 345134 positive 1 : 110 acute hepatitis B infection

manda-tory:

B 3

HBeAg 345135 negative negative healthy blood donors (pool)

HBeAg 345136 positive 1 : 670 chronic hepatitis B

manda-tory:

B 2

anti-HBe 345137 negative negative healthy blood donors (pool)

anti-HBe 345138 positive 1 : 135 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

346089* positive negative

1 : 8.2 Condition after chronic hepatitis C (successful therapy)


346090** positive positive

(d) 1 : 60 chronic hepatitis C


346091* negative negative



346092** positive positive

(d) 1 : 30 chronic hepatitis C

Hepatitis D virus (Ab)

serum

347

conform to

B 2

anti-HDV-IgG anti-HDV-IgM

347023 negative not evaluated


anti-HDV-IgG anti-HDV-IgM

347024 positive not evaluated

1 : 400 chronic hepatitis D

Hepatitis E virus (Ab)

serum

348

conform to

B 2

anti-HEV-IgG anti-HEV-IgM

348023 positive negative

past hepatitis E infection

anti-HEV-IgG anti-HEV-IgM

348024 negative negative


Herpes simplex viruses

(Ab)

serum

354

conform to

B 2

anti-HSV-IgG anti-HSV-IgM

354023 positive negative

past HSV-1 infection (one healthy blood donor)

anti-HSV-IgG anti-HSV-IgM

354024

positive negative The results for anti-HSV-1/2-IgM obtained by a test of one manufacturer (DiaSorin, LIAISON HSV-1/2 IgM) were inconsistent and are not evaluated (without disadvantage for the certificate).

past HSV-1 infection (two healthy blood donors)

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335089 positive (e) 1 : 75 HIV-1 infection

anti-HIV-1/2 335090 negative negative healthy blood donors (pool)

anti-HIV-1 335091 positive 1 : 150 HIV-1 infection

anti-HIV-1 335092 positive (e) 1 : 150 HIV-1 infection

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337045 positive 1 : 38 000

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

p24 Ag 337046 negative negative healthy blood donors (pool)

d, e: Marked samples represent dilutions from the corresponding stock materials.

Non-marked samples derive from independent preparations.


Table 3 (contd.): EQA Schemes Virus Immunology - November/December 2015 pre-evaluation



HTLV-1/ HTLV-2

(Ab)

serum*

plasma**

339

conform to

B 2

anti-HTLV-2 339021** positive 1 : 4 HTLV-2 infection**

anti-HTLV-1/2 339022* negative negative healthy blood donor*

anti-HTLV-1 339023* positive 1 : 150 HTLV-1 infection*

anti-HTLV-2 339024** positive 1 : 4 HTLV-2 infection**

Measles virus (Ab)

serum

357

conform to

B 2

anti-measles-IgG anti-measles-IgM


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

anti-measles-IgG anti-measles-IgM


two healthy blood donors 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

342045* positive avidity: high negative

past parvo B19 infection (healthy blood donor)*


342046* negative avidity: no avidity negative

negative healthy blood donor*


342047* positive avidity: high§ negative



342048* positive avidity: high negative


Rubella virus (Ab)

serum

341

manda-tory:

B 2

titer HI test / HiG

341023 = 341024

64 - 1024 (256 target value)

sera of healthy blood donors with indication of a past rubella virus infection or vaccination (pool)

anti-rubella-IgG

positive ≥ 95 IU/ml (300 IU/ml)#

avidity: high

anti-rubella-IgM negative

titer HI test / HiG

341024 = 341023

64 - 1024 (256 target value)

anti-rubella-IgG

positive ≥ 95 IU/ml (301 IU/ml)#

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)


§ Sample 342047: Some participants having applied an avidity test of one manufacturer (Mikrogen recomLine Parvo B19 IgG Avidität/avidity) reported as result "no statement possible". The intensities of those bands indicative of antibodies binding to avidity relevant antigens were below the cutoff of the IgG control. The avidity result "no statement possible" had no impact on the overall evaluation of sample 342047, i.e. past parvo B19 infection (characteristic band pattern of anti-parvo-IgG with negative anti-parvo-IgM). The avidity result "no statement possible" has been considered as "correct".

# Some commercial tests for the detection of anti-rubella-IgG reveal for highly concentrated samples values > 400 IU/ml and > 500 IU/ml, respectively, 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 IU/ml could not be assigned to highly concentrated samples. In this case a lower limit value in IU/ml is indicated in order to assess a reported result of a laboratory as a "correct" result.


EQA Schemes Virus Genome Detection by PCR/NAT

November/December 2015

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 by PCR/NAT November/December 2015

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

365089 positive (a) 1 : 10 000 approx. 3 183 approx. 7.365

365090 negative ------- 0 0

365091 positive (a) 1 : 5 000 approx. 6 723 approx. 17.488

365092 positive 1 : 10 000 approx. 32 000 approx. 40.875

EBV (DNA)

cell lysates

376

manda-tory:

B 3

376045 negative ------- 0 0

376046 positive (b) 1 : 800 approx. 1 120 approx. 1 687



HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377089 positive (c) 1 : 1 250 not evaluated# not evaluated#

377090 negative ------- not evaluated# not evaluated#



HBV (DNA)

plasma

361

manda-tory:

B 3

361089 positive (d) 1 : 5 000 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and

3, page 9)

approx. 84 250

361090 negative ------- 0

361091 positive (d) 1 : 125 000 approx. 3 995

361092 positive (d) 1 : 25 000 approx. 19 708

HCV (RNA)

plasma

362

manda-tory:

B 3

362089 positive (Subtyp 3a) (e) 1 : 100 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and 3, page 9)

approx. 7 304

362090 positive (Subtyp 1b) 1 : 3 200 approx. 670

362091 positive (Subtyp 3a) (e) 1 : 200 approx. 3 910

362092 negative ------- approx. 0

HEV (RNA)

serum*

suspension of feces**

380

conform to

B 3

380021** positive 1 : 1 000 not evaluated# not evaluated#

380022* = 380023

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

380023* = 380022

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

380024* positive 1 : 28 not evaluated# not evaluated#

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360089 positive 1 : 7 approx. 49 100 Results in IU/ml: not accepted

or not evaluated (see notices 4 and 5, page 9)

360090 negative ------- 0

360091 positive 1 : 120 000 000 approx. 3 010

360092 positive 1 : 100 approx. 896

HIV-2 (RNA)

spiked plasma

395

conform to

B 3

395009 positive (f) 1 : 9 not evaluated# not evaluated# 395010 negative ------- not evaluated# not evaluated# 395011 positive 1 : 9 not evaluated# not evaluated#

395012 positive (f) 1 : 90 not evaluated# not evaluated#

HMPV (RNA)

cell lysates

385

conform to

B 3

385013 positive (Subtyp A) 1 : 10 000 not evaluated# -----

385014 positive (Subtyp A) (g) 1 : 64 not evaluated# -----

385015 positive (Subtyp A) (g) 1 : 1 600 not evaluated# -----

385016 negative ------- not evaluated# -----

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

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



Table 4 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT November/December 2015

Pre-evaluation


Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

Measles virus

(RNA)

FTA cards

386

conform to

B 3

386013 positive (genotype D4) undiluted not evaluated# -----

386014 negative undiluted not evaluated# -----

386015 positive (genotype D8) undiluted not evaluated# -----

386016 positive (genotype B3) undiluted not evaluated# -----

Mumps virus (RNA)

FTA cards

387

conform to

B 3

387009 positive (genotype F) undiluted not evaluated# -----

387010 = 387012

negative undiluted not evaluated# -----

387011 positive (genotype G) undiluted not evaluated# -----

387012 = 387010

negative undiluted not evaluated# -----

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367089 = 367092

negative ------- not evaluated# 0

367090 positive (h) 1 : 900 000 not evaluated# approx. 25 800

367091 positive (h) 1 : 100 000 not evaluated# approx. 213 000

367092 = 367089

negative ------- not evaluated# 0

Respiratory syncytial

virus (antigen/ genome)

cell lysates

359

manda-tory:

B 3

359025 negative ------- not evaluated# -----

359026 positive RSV A 1 : 40 not evaluated# -----

359027 positive RSV B (i) 1 : 30 not evaluated# -----

359028 positive RSV B (i) 1 : 15 not evaluated# -----

Rubella virus (RNA)

FTA cards

389

conform to

B 3

389009 = 389010

positive (genotype 2B) undiluted not evaluated# -----

389010 = 389009

positive (genotype 2B) undiluted not evaluated# -----

389011 negative undiluted not evaluated# -----

389012 positive (genotype 1G) undiluted not evaluated# -----

VZV (DNA)

cell lysates

366

manda-tory:

B 3

366045 positive 1 : 400 approx. 13 410 -----

366046 negative ------- 0 -----

366047 positive (j) 1 : 1 000 approx. 7 230 -----

366048 positive (j) 1 : 125 approx. 59 000 -----


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



Table 5: EQA Schemes Virus Genome Detection by PCR/NAT incl. typing November/December 2015

Pre-evaluation


Sample properties

qualitative Target value of all

methods copies/ml

species type (note on dilution)

Adeno-viruses (DNA)

cell lysates

371

manda-tory:

B 3

371045 positive

Quantitative results will be discussed in

the final report.

D Adenovirus 37 1 : 5 000 diluted (k)

371046 positive C Adenovirus 2 1 : 100 000 diluted

371047 negative ---- ---

371048 positive D Adenovirus 37 1 : 500 000 diluted (k)

Corona-viruses (RNA)

cell lysates

340

conform to

B 3

340006 positive not evaluated# ---- MERS-CoV 1 : 1 000 diluted (l)

340007 positive not evaluated# ---- MERS-CoV 1 : 100 diluted (l)

340008 negative not evaluated# ---- ---

340009 positive not evaluated# ---- CoV OC43 1 : 1 000 diluted (m)

340010 positive not evaluated# ---- CoV OC43 1 : 10 000 diluted (m)

Entero-viruses (RNA)

cell lysates

372

manda-tory:

B 3

372046 positive

Quantitative results will be discussed in

the final report.

---- Enterovirus 68 1 : 1000 diluted

372047 positive ---- Echovirus 30 1 : 100 000 diluted

372048 negative ---- ---

372049 positive ---- Echovirus 7 1 : 400 diluted

HSV-1/ HSV-2 (DNA)

cell lysates

363

manda-tory:

B 3

363067 positive approx.28 121 ---- HSV-2 1 : 900 diluted (n)

363068 positive approx.7 325 ---- HSV-1 1 : 152 000 diluted (o)

363069 negative 0 ---- ---

363070 positive approx.13 500 ---- HSV-2 1 : 1 800 diluted (n)

363071 positive approx.60 000 ---- HSV-1 1 : 19 000 diluted (o)

363072 positive approx.50 250 ---- HSV-1 1 : 15 000 diluted

Human papilloma

viruses (RNA)

cell lysates

373

manda-tory:

B 3

373056 = 373059

High Risk positive ----- ---- HPV 18 1 : 40 diluted (p)

373057 High Risk positive ----- ---- HPV 18 1 : 20 diluted (p)

373058 High Risk positive ----- ---- HPV 16 1 : 4 diluted

373059 = 373056

High Risk positive ----- ---- HPV 18 1 : 40 diluted (p)

373060 negative ----- ---- ---


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



Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015

Pre-evaluation


Sample properties

qualitative Target value of all

methods copies/ml

species type (note on dilution)

Humane Rhinoviren

(RNA)

cell lysates

393

conform to

B 3

393005 positive not evaluated# ---- HRV A type 49 1 : 100 diluted


393007 negative not evaluated# ---- ----


Norovirus (RNA)

suspension of feces

381

conform to

B 3

381021 positive not evaluated# ---- genogroup I 1 : 980 diluted

381022 positive not evaluated# ---- genogroup II 1 : 200 diluted

381023 positive not evaluated# ---- genogroup II 1 : 220 diluted

381024 negative not evaluated# ---- 1 : 200 diluted

Rotaviren (RNA)

suspension of feces

401

conform to

B 3

401005 positive not evaluated# ---- G2P[4] 1 : 100 000 diluted (q)

401006 positive not evaluated# ---- G2P[4] 1 : 100 diluted (q)

401007 negative not evaluated# ---- 1 : 20 diluted

401008 positive not evaluated# ---- G2P[4] 1 : 10 000 diluted (q)


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



Table 5 (contd.): EQA Schemes Virus Genome Detection incl. Typing November/December 2015

Pre-evaluation

Program Group RiliBÄK 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

370065

positive

for seasonal influenza B virus

B/Brisbane/60/2008 (vaccine strain)

infected MDCK-cells (lysate)

(1 : 15 diluted)

370066

positive

for seasonal influenza A(H3N2) virus

(accepted target value for rapid tests for the detection of

influenza A virus antigen: positive / borderline)§

A/Switzerland/9715293/ 2013

(vaccine strain)


(1 : 320 diluted)

370067

positive

for seasonal influenza B virus


influenza B virus antigen: positive / borderline)§

B/Phuket/3073/2013 (vaccine strain)


(1 : 160 diluted)

370068

positive

for Influenza A(H1N1) pdm09 virus



A/California/7/2009 (vaccine strain)


(1 : 60 diluted)

370069 negative ----- non-infected MDCK cells

(lysate)

370070

positive

for avian influenza A(H5N8) virus



A/Turkey/Germany/ R2485-86/2014

allantoic fluid (inactivated)

(1 : 160 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. Brunhilde Schweiger and Nationales Referenzlabor für Aviäre Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, Prof. Dr. Timm C. Harder.

§ For samples 370066, 370067, 370068 and 370070, the reporting of "borderline" in test category 30 (Antigen detection of influenza A virus) and test category 40 (Antigen detection of influenza B virus) was accepted as additional correct result for tests for antigen detection of influenza A virus and B virus, respectively (in general rapid tests). Considering also the result "borderline" ensured that these positive samples would not have been misinterpreted as negative.