INSTAND e.V. · anamnesis concerning a stay abroad outside Europe at onset of disease...

Pre-evaluation

of the EQA Schemes

in Virus Diagnostics

March 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, 11.05.2015

Pre-evaluation Virology March 2015 20150511c EN.doc 2 von 12

EQAS Adviser: Assistant EQAS Adviser: Prof. Dr. Heinz Zeichhardt Priv.-Doz. Dr. Oliver Donoso Mantke Charité - Universitätsmedizin Berlin c/o INSTAND e.V. Institut für Virologie, Campus Benjamin Franklin Ubierstr. 20, 40223 Düsseldorf Hindenburgdamm 27, 12203 Berlin Tel.: +49-(0)30-688197730; Fax: +49-(0)30-688197741 Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: [email protected] 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]

mailto:[email protected]

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


Pre-Evaluation and

Mailing of Participation Documents

INSTAND External Quality Assessment Schemes - March 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 March 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 March 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.

Please note: The participation documents of the following EQA schemes will be sent out later by mail:

Influenza viruses (genome/antigen) (370) This EQA scheme was postponed from March to April 2015 in order to consider other circulating drift variants of influenza A(H3N2) viruses. The evaluation of this EQA scheme has not been completed at the time of release of this pre-evaluation. The properties of the 10 samples are given in Table 5 for orientation.

Cytomegalovirus training program (368)

Hepatitis B virus training program (378)

Hepatitis C virus training program (379)

HIV-1 (RNA) training program (382)

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 2015 are highlighted in bold. 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

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 March 2015 are highlighted in bold. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation. Please note: The participation documents of the following EQA schemes will be sent out later by mail:

• Influenza viruses (genome/antigen) (370) • Cytomegalovirus training program (368) • Hepatitis B virus training program (378) • Hepatitis C virus training program (379) • HIV-1 (RNA) training program (382)

EQA schemes marked in italics were not performed in March 2015.

Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme March 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).

Note for German laboratories: The requirements laid down in Specified Section B 3 - effective since 01.04.2013 - should be fulfilled by 31.05.2015 at the latest (end of transition period).

New INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2015 We may inform you that 10 new EQA schemes for virus genome detection will be launched in 2015 after we have introduced 20 additional EQA schemes in virus diagnostics in 2014. For details please see the INSTAND ordering documents 2015 incl. brochure and order form (please see link).

Additional training programs in virus genome detection

Additional training programs were provided for the third time with the EQAS term March 2015.

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

A training program can only be ordered together with the corresponding main EQA scheme of always the same EQA scheme term (e.g. the training program "Cytomegalovirus" (368) in March 2015 together with the main EQA scheme "Cytomegalovirus" (365) in March 2015).

Reason for this is that a training program is directly linked with its respective main EQA scheme: A training program contains low-concentration samples for each of the viruses to verify test sensitivities. The low-concentration samples are used as complement to the respective main EQA scheme which samples contain virus concentrations within the requirements of the new Guideline of the German Medical Association (Bundesärztekammer/ RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) as specified in Table B 3-2a of the RiliBÄK.

Separate certificates will be issued for each main EQA scheme (subject to RiliBÄK-B 3) and 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 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 - March 2015

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

351039 positive avidity: high negative

past CMV infection (one healthy blood donor)

anti-CMV-IgG anti-CMV-IgM

351040

positive avidity: high negative The results for anti-CMV-IgM obtained by a test of one manufacturer (DiaSorin, LIAISON CMV II IgM) were inconsistent and are not evaluated (without disadvantage for the certificate).

past CMV infection (one healthy blood donor)

Dengue-viruses**

(Ab and

NS1-Ag)

serum

350**

conform to

B 2

anti-Dengue-IgG anti-Dengue-IgM Dengue NS1-Ag

350037

negative negative negative

Serum of a healthy blood donor without signs of an

acute, recent or past dengue virus infection.


350038

positive negative negative

Patient D16 with a past

primary dengue virus infection (DENV-4); traveler returned from Thailand; blood collected 7 months after onset of disease.


350039

positive positive negative

Patient D17 with a recent

primary dengue virus infection (DENV-2); traveler returned from Tanzania (Zanzibar); blood collected 3 months after onset of disease.


350040 positive positive positive Several participants falsely reported as clinical interpretation: "recent infection".

Please note that a clinical statement on an acute dengue virus infection must be based on the presence of NS1 antigen detected by a reliable test. Applying only tests for the detection of anti-dengue-IgG and anti-dengue-IgM without testing on NS1 antigen does not allow a statement on an acute dengue virus infection!

Patient D12 with an acute

primary dengue virus infection (DENV-1); traveler returned with dengue fever from South Thailand; blood collected 12 days after onset of disease

undiluted serum (heat inactivated)

Non-marked samples derive from independent preparations.

** The EQA program Dengue viruses (350) is performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research; Prof. Dr. Stephan Günther, PD Dr. Jonas Schmidt-Chanasit and Dr. Petra Emmerich).


Table 3 (contd.): EQA Schemes Virus Immunology - March 2015



Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Hanta-IgG anti-Hanta-IgM

355037 negative negative

Serum of healthy blood donors (pool) without signs

of an acute or past hanta virus infection.

anti-Dobrava-IgG anti-Dobrava-IgM

355038 positive negative

1 : 3

Patient H6 with a past Dobrava-Belgrade virus infection acquired in

Mecklenburg-Western Pomerania, Germany at onset of disease characteristic symptoms

blood collected approx. 22.5 months after onset of disease.

anti-Dobrava-IgG anti-Dobrava-IgM

355039 positive positive

1 : 2

Patient H19 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.

anti-Puumala-IgG anti-Puumala-IgM


1 : 2

Patient H4 wth a past Puumala virus infection

acquired in the Bavarian Forest, Germany, anamnesis concerning a stay abroad outside Europe excluded

hospitalization necessary; characteristic flu-like symptoms with fever

blood collected approx. 21 months after onset of disease

Hepatitis A virus (Ab)

serum

343

manda-tory:

B 2

anti-HAV 343077 positive ≥ 30 mIU/ml

1 : 400 anti-HAV-IgG positive healthy blood donor

anti-HAV 343078

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

negative healthy blood donors (pool)

anti-HAV-IgM 343079 positive 1 : 20 acute hepatitis A infection

anti-HAV-IgM 343080 negative negative healthy blood donors (pool)


* The EQA program Hantaviruses (355) is performed in cooperation with Nationalen Konsiliarlaboratorium für Hantaviren (Charité - Universitätsmedizin Berlin, Campus Mitte, Institut für Medizinische Virologie, Labor Berlin-Charité Vivantes GmbH Prof. Dr. D. H. Krüger, Prof. Dr. J. Hofmann).


Table 3 (contd.): EQA Schemes Virus Immunology - March 2015



Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344229 positive 1.00 - 2.25 IU/ml (1.57 IU/ml target value)

(a) 1 : 12 000

chronic hepatitis B

HBsAg 344230

positive 8.00 - 18.00 IU/ml (11.11 IU/ml target value)

(a) 1 : 1 500


(a) 1 : 6 000


(a) 1 : 3 000

manda-tory:

B 2

anti-HBs 344233 positive 50 - 300 IU/l (176 IU/l target value)

(b) 1 : 1 000

anti-HBs positive healthy blood donor

anti-HBs 344234 positive 12.5 - 75 IU/l (43 IU/l target value)

(b) 1 : 4 000


(b) 1 : 500


(b) 1 : 2 000

manda-tory:

B 2

anti-HBc 344237 negative negative healthy blood donors (pool)

anti-HBc 344238 positive (c) 1 : 400 chronic hepatitis B (negative for anti-HBc-IgM and HBeAg, resp.) anti-HBc 344239 positive (c) 1 : 200

anti-HBc 344240 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 345115 positive 1 : 50 acute hepatitis B infection

anti-HBc-IgM 345116 negative negative healthy blood donor

manda-tory:

B 3

HBeAg 345117 negative negative healthy blood donor

HBeAg 345118 positive 1 : 700 chronic hepatitis B

manda-tory:

B 2

anti-HBe 345119 positive 1 : 160 chronic hepatitis B (negative for HBeAg)

anti-HBe 345120 negative negative healthy blood donor

Hepatitis C virus

(Ab and

HCV-Ag)

serum

346

anti-HCV

manda-tory:

B 2

HCV Ag

manda-tory:

B 3

anti-HCV HCV antigen




346078 positive positive

1 : 20 chronic hepatitis C



1 : 160 past hepatitis C infection




HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-2 335077 positive 1 : 50 HIV-2 infection

anti-HIV-1 335078 positive (d) 1 : 180 HIV-1 infection

anti-HIV-1/2 335079 negative negative healthy blood donors (pool)

anti-HIV-1 335080 positive (d) 1 : 90 HIV-1 infection

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337039 negative negative healthy blood donors (pool)

p24 Ag 337040 positive 1 : 19 000

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

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



Table 4: EQA Schemes Virus Genome Detection by PCR/NAT - March 2015

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

364009§ = 364011

positive (a) 1 : 1 000 approx. 670 000 -------

364010 negative 1 : 100 0 -------

364011§ = 364009

positive (a) 1 : 1 000 approx. 870 000 -------

364012 positive (a) 1 : 10 000 approx. 68 760 -------

Chikungunya virus

(RNA)

cell lysates

392

conform to

B 3

392001 positive (b) 1 : 100

Quantitative results were not reported.

-------

392002 negative ------- -------

392003 positive (b) 1 : 10 000 -------

392004 positive 1 : 100 -------

CMV (DNA)

plasma

365

manda-tory:

B 3

365077 negative ------- 0 0

365078 positive (c, d) 1 : 20 000 approx. 2 419 approx. 3 927

365079 positive (c) 1 : 1 250 approx. 41 300 approx. 60 000

365080 positive (c) 1 : 5 000 approx. 10 180 approx. 18 761

CMV (DNA)

training progr.

plasma

368

conform to

B 3

368009$ = 368012

positive (c) 1 : 320 000 approx. 144 approx. 218

368010 positive (c) 1 : 80 000 approx. 665 approx. 1 000

368011 positive (c, d) 1 : 20 000 approx. 2 800 approx. 3 671

368012$ = 368009

positive (c) 1 : 320 000 approx. 123 approx. 293

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377077 positive (e) 1 : 10 000 not evaluated# not evaluated#




HBV (DNA)

plasma

361

manda-tory:

B 3

361077 positive (f) 1 : 10 000 not evaluated# approx. 4 390

361078 positive (f) 1 : 400 not evaluated# approx. 102 000

361079 negative ------- not evaluated# 0

361080 positive (f, g) 1 : 50 000 not evaluated# approx. 881

HBV (DNA)

training progr.

plasma

378

conform to

B 3

378009 positive (f, g) 1 : 50 000 not evaluated# approx. 858

378010 positive (f) 1 : 6 250 000 not evaluated# approx. 3

378011 positive (f) 1 : 250 000 not evaluated# approx. 176

378012 positive (f) 1 : 1 250 000 not evaluated# approx. 42

HCV (RNA)

plasma

362

manda-tory:

B 3

362077& = 362079

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

362078 positive (subtype 1b) (h, i) 1 : 675 not evaluated# approx. 2 336

362079& = 362077

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

362080 positive (subtype 1b) (h) 1 : 2 025 not evaluated# approx. 887

HCV (RNA)

training progr.

plasma

379

conform to

B 3



379011 positive (subtype 1b) (h, i) 1 : 675 not evaluated# approx. 2 400


HDV (DNA)

plasma

400

conform to

B 3

400001 positive (j) 1 : 1 000 not evaluated# not evaluated#

400002 positive (j) 1 : 10 not evaluated# not evaluated#

400003 negative ------- not evaluated# not evaluated#

400004 positive (j) 1 : 100 not evaluated# not evaluated#

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

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

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

§ The samples 364009 and 364011 are identical. $ The samples 368009 and 368012 are identical.

& The samples 362077 and 362079 are identical.



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


Sample properties

qualitative (note on

geno-/subtype) dilution

Target value of all methods (provisional data)

copies/ml IU/ml

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360077 positive (subtype B) (k) 1 : 64 000 000 approx. 7 614 not evaluated#

360078 positive (subtype B) (k) 1 : 125 000 approx. 3 265 000 not evaluated#

360079 negative ------- 0 not evaluated#

360080 positive (subtype B) (k, l) 1 : 512 000 000 approx. 1 003 not evaluated#

HIV-1 (RNA)

training progr.

spiked plasma

382

conform to

B 3

382009 positive (subtype B) (k) 1 : 32 768 000 000 not evaluated# not evaluated#

382010 positive (subtype B) (k) 1 : 2 048 000 000 approx. 289 not evaluated#

382011 positive (subtype B) (k, l) 1 : 512 000 000 approx. 920 not evaluated#

382012 positive (subtype B) (k) 1 : 8 192 000 000 approx. 66 not evaluated#

JC virus (DNA)

suspension of urine

394

conform to

B 3

394001 positive 1 : 92 approx. 67 700 -------

394002 negative 1 : 107 0 -------

394003 positive 1 : 92 approx. 31 114 -------

394004 positive 1 : 165 approx. 3 330 -------

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367077 positive (m) 1 : 900 000 approx. 11 927 approx. 25 750



367080 positive (m) 1 : 2 700 000 approx. 3 745 approx. 9 795

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

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

l: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBÄK Section B 3 and the corresponding training program.



Table 5: EQA Schemes Virus Genome Detection by PCR/NAT - March 2015 incl. Typing


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

369009 positive

Quantitative results were not reported.

---- DENV-1 (inactivated) 1 : 2.5 diluted (n)

369010 positive ---- DENV-2 (inactivated) 1 : 500 diluted (o)

369011 positive ---- DENV-2 (inactivated) 1 : 5 diluted (o)

369012 positive ---- DENV-1 (inactivated) 1 : 250 diluted (n)

Norovirus (RNA)

suspension of feces

381

conform to

B 3

381017 positive not evaluated# ---- genogroup II 1 : 200 diluted

381018 negative not evaluated# ---- 1 : 200 diluted

381019 positive not evaluated# ---- genogroup II 1 : 1 320 diluted

381020 positive not evaluated# ---- genogroup I 1 : 100 diluted

Para-influenza viruses (RNA)

cell lysates

388

conform to

B 3

388009 negative not evaluated# ---- -------

388010 positive not evaluated# ---- PIV-3 1 : 10 diluted

388011 positive not evaluated# ---- PIV-2 1 : 10 diluted (p)

388012 positive not evaluated# ---- PIV-2 1 : 100 diluted (p)

West Nile virus

(RNA)

cell lysates

391

conform to

B 3

391011 positive not evaluated# ---- WNV-1 (inactivated) 1 : 300 diluted (q)

391012 positive not evaluated# ---- WNV-2 (inactivated) 1 : 300 diluted (r)

391013 negative not evaluated# ---- -------

391014 positive not evaluated# ---- WNV-1 (inactivated) 1 : 3 000 diluted (q)

391015 extra

sample positive not evaluated# ----

WNV-2 (inactivated) 1 : 30 000 diluted (r) highly diluted sample to monitor test sensitivity

391016 extra

sample positive not evaluated# ----

WNV-1 (inactivated) 1 : 30 000 diluted (q) highly diluted sample to monitor test sensitivity

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



Table 5 (contd.): EQA Schemes Virus Genome Detection by PCR/NAT - March 2015 incl. Typing

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

type/subtype strain origin

The EQA scheme influenza viruses A and B (370) was postponed from March to April 2015 in order to consider other circulating drift variants of influenza A(H3N2) viruses.

The evaluation of this EQA scheme has not been completed at the time of release of this pre-evaluation. The properties of the 10 samples below are given for orientation.

The samples 370061, 370062, 370063 and 370064 were included as training samples and will not be used as basis for receiving a certificate of successful participation.

Influenza A and B viruses*

inclusive

influenza A(H1N1)

pdm09 virus,

avian influenza A(H5N1)

virus

and

avian influenza A(H7N9)

virus

(genome/ antigen)

370*

manda-tory:

B 3

370055

positive

for seasonal influenza B virus

B/Massachusetts/2/2012 (vaccine strain)

infected MDCK cells (lysate)

(1 : 66 diluted)

370056

positive

for Influenza A(H1N1) pdm09-Virus

A/California/7/2009 (vaccine strain)


(1 : 50 diluted)

370057

positive

for seasonal influenza A(H3N2) virus

A/Victoria/361/2011 (vaccine strain)


(1 : 30 diluted)

370058 negative ----- non-infected MDCK cells

(lysate)

370059

positive

for seasonal influenza B virus

B/Brisbane/60/2008 (vaccine strain)


(1 : 20 diluted)

370060

positive

for avian influenza A(H7N9) virus

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

(1 : 330 diluted)

training samples

370061

positive


A/Sachsen/2/2015 (drift variant)


(1 : 300 dil.) (s)

370062

positive


A/NRW/1/2015 (drift variant)


(1 : 300 000 dil.) (t)

370063

positive


A/Sachsen/2/2015 (drift variant)


(1 : 30 000 dil.) (s)

370064

positive


A/NRW/1/2015 (drift variant)


(1 : 300 dil.) (t)

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


NRW = Nordrhein-Westfalen = North Rhine-Westphalia

* The EQA program for influenza A and B viruses, incl. influenza A(H1N1) pdm09 virus, avian influenza A(H5N1) virus and avian influenza A(H7N9) virus, 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, PD Dr. Timm C. Harder

The following laboratories are gratefully acknowledged for their cooperation to include the four training samples on short notice.

Prof. Dr. Dr. A. Gessner, Prof. Dr. B. Schmidt and Dr. J. Wenzel, Universität Regensburg, Institut für Medizinische Mikrobiologie und Hygiene, Bereich Klinische Virologie und Infektionsimmunologie, Nationales Konsiliarlaboratorium für HAV und HEV,

Prof. Dr. K. Überla und Dr. K. Korn, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsklinikum Erlangen, Institut für Klinische und Molekulare Virologie,

Dr. A. Baillot, Niedersächsisches Landesgesundheitsamt, Fachbereich Virologie, Hannover, and

Dr. Brunhilde Schweiger, Nationalen Referenzzentrum für Influenza, Robert Koch-Institut, Berlin.

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