Summary of virology EQASs March 2019 of sample properties... · Summary of sample properties and target values Virology March 2019 20190418 corr 20190729 ASz.doc 5 of 32 Please see

Summary of sample properties and target values Virology March 2019 20190418 corr 20190729 ASz.doc 1 of 32

Summary of sample properties and target values of the External Quality Assessment Schemes in Virus Diagnostics

March 2019

Prof. Dr. Heinz Zeichhardt

Dr. Martin Kammel

Issued by:

INSTAND

Gesellschaft zur Förderung

der Qualitätssicherung

in medizinischen Laboratorien e.V.

Düsseldorf/Berlin, Germany, 18.04.2019

Corrected version: 29 July 2019 (See Table 3, page 8, program 344; table 5, page 14,

program 391; table 5, page 15, program 370)


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

IQVD GmbH 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/


Summary of sample properties and target values and

Mailing of Participation Documents

INSTAND External Quality Assessment Schemes – March 2019

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 2019. Today you receive the summary of sample properties and target values.

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

certificate certificate of participation listing and evaluation of the results

Since the EQA term March 2019, INSTAND e.V. has established the "EQAS (RV) Online system" for result entry for all EQA schemes in virology, except the EQA schemes for virus resistance determination.

This enables you to get direct access to your participation documents via the button "Evaluation" after login on the INSTAND website https://rv-online.instandev.de/ .

For download are available:

certificate (button "Certificate Download")

certificate, certificate of participation, listing and evaluation of results (button "Evaluation Download")

NEW: individual summary of results (button "General overview Download")

Please note: The "individual summary of results" is only available online for download and is not part of the participation documents sent out by mail.

Please see Annex 1 for "Overview of the function and operation of RV Online" (page 16) and for "Download of the evaluation documents" (page 32).

For the forthcoming EQA scheme terms, participants having yet not used the RV Online system are kindly advised to follow the information in Annex 1.

In Tables 1 and 2, the EQA schemes having been performed in March 2019 are highlighted in bold. For these highlighted EQA schemes, the corresponding participation documents (certificate, certificate of participation and listing and evaluation of the results) will be sent out by mail together with this summary of sample properties and target values.

https://rv-online.instandev.de/


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) Hepatitis E virus (380)* HIV-1 (RNA) (360) Parvovirus B19 (367) West Nile virus (391)*

Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in March 2019 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) 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) Zika virus (403)

Legend to Tables 1 and 2: $ From 2019, 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 has increased 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 in 2019, 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 March 2019 are highlighted in bold (Tables 1 and 2). For these highlighted EQA

schemes, the corresponding participation documents (certificate, certificate of participation and listing and evaluation of the results) will be sent out by mail together with this summary of sample properties and target values. The participation documents of the following EQA schemes for drug resistance determination will be sent out later by mail.

EQA schemes in Tables 1 and 2 marked in italics were not performed in March 2019.


Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme March 2019.

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.

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

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

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

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 – March 2019 Summary of sample properties and target values

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

351071 positive avidity: high negative

past CMV infection (two healthy blood donors)

anti-CMV IgG anti-CMV IgM

351072

positive avidity: no avidity / not done negative

negative healthy blood donors (pool)

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

350070§

positive not evaluated§ negative

serum from patient G-D25 with a past / acute primary

dengue virus infection (DENV-1)

traveller returned from Sri Lanka,

clinical signs at onset of disease: fever; limb pains

blood collected 18 and 30 months after onset of disease

anti-Dengue IgG

anti-Dengue IgM

Dengue NS1-Ag

350071

negative negative positive

1 : 15.8

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)


350072

positive positive/borderline 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 and 9 weeks after onset of disease


350073

negative negative negative

serum of a healthy blood donor without signs of an acute, recent or past dengue virus infection; negative for anti-CHIKV, anti-DENV, anti-TBEV, anti-WNV, anti-YF and anti-ZIKV

Non-marked samples derive from independent preparations.

* 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).

§ Sample 350070: The question concerning persisting anti-Dengue-IgM will be commented in the forthcoming report.


Table 3 (contd.): EQA Schemes Virus Immunology – March 2019 Summary of sample properties and target values



Hanta-viruses*

(Ab)

serum

355*

conform to

B 2

anti-Puumala IgG anti-Puumala IgM

355069 positive negative

serum from patient G-H30

with a past Puumala virus infection,

probably acquired in Saxony, Germany, anamnesis concerning a stay abroad outside Europe excluded;

at onset of disease hospitalization necessary; flu-like symptoms, fever;

Blood collected approx. 1 year and 6 months after onset of disease

anti-Dobrava IgG anti-Dobrava IgM


serum from patient G-H13,

follow-up serum, the serum for sample 355070 and 355071 derives from the same patient,

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. 3 years and 11 months after onset of disease

anti-Dobrava IgG anti-Dobrava IgM


serum from patient G-H13,

follow-up serum, the serum for sample 355070 and 355071 derives from the same patient,

with a past Dobrava-Belgrade virus infection,

for anamnestic details please see sample 355070.

blood collected approx. 7 years and 2 months after onset of disease

anti-Hanta IgG anti-Hanta IgM

355072 negative negative

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

hanta virus infection


* 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 IgG/ anti-HAV total

343141 positive 1 : 180 anti-HAV IgG positive healthy blood donor

anti-HAV IgG/ anti-HAV total

343142 negative negative healthy blood donors (pool)

anti-HAV IgM 343143 positive 1 : 20 acute hepatitis A

anti-HAV IgM 343144 negative negative healthy blood donors (pool)

Hepatitis B virus

(prog. 1)

(HBsAg anti-HBs anti-HBc)

serum

344

manda-tory:

B 3

HBsAg 344421 positive 6.0 - 14.00 IU/ml (9.78 IU/ml target value)

(a) 1 : 450 chronic hepatitis B

HBsAg 344422 negative 0.0 – 0.08 IU/ml (0.0 IU/ml target value)


HBsAg 344423 positive 1.5 – 3.5 IU/ml (2.49 IU/ml target value)

(a) 1 : 1 800

chronic hepatitis B

HBsAg 344424 positive 3.0 – 7.00 IU/ml (4.96 IU/ml target value)

(a) 1 : 900

manda-tory:

B 2

anti-HBs 344425 positive 25 – 250 IU/l (141 IU/l target value)

1 : 380 anti-HBs positive healthy blood donor

anti-HBs 344426 negative <10 IU/l


anti-HBs 344427 positive 25 - 250 IU/l (135 IU/l target value)

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

anti-HBs 344428 positive 25 - 250 IU/l (141 IU/l target value)

1 : 1 375 anti-HBs positive healthy blood donor

manda-tory:

B 2

anti-HBc 344429 positive (b) 1 : 200 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)

anti-HBc 344430 negative negative healthy blood donors (pool)

anti-HBc 344431 positive (b) 1 : 600 chronic hepatitis B (negative for HBeAg, anti-HBc-IgM negative)

anti-HBc 344432 negative negative healthy blood donors (pool)


a, b: Marked samples derive from corresponding stock materials diluted in consecutive steps. Evaluation corrected on 29 July 2019





Hepatitis B virus

(prog. 2)

(anti-HBc-IgM

HBeAg anti-HBe)

serum

345

manda-tory:

B 2

anti-HBc-IgM 345211 positive 1 : 160 acute hepatitis B

anti-HBc-IgM 345212 negative negative healthy blood donors (pool)

manda-tory:

B 3

HBeAg 345213 positive (c) 1 : 700

chronic hepatitis B

HBeAg 345214 positive (c) 1 : 350

manda-tory:

B 2

anti-HBe 345215 positive (d) 1 : 72 chronic hepatitis B (negative for HBeAg)

anti-HBe 345216 positive (d) 1 : 120

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

346141* negative negative



346142** positive positive

1 : 10 chronic hepatitis C (subtype 3a)



1 : 20 chronic hepatitis C (subtype 4a)



1 : 80 chronic hepatitis C (subtype 1b)

HIV-1/ HIV-2 (Ab)

serum

335

manda-tory:

B 2

anti-HIV-1 335141 positive (e) 1 : 75 HIV-1 infection

anti-HIV-1/2 335142 negative negative healthy blood donors (pool)

anti-HIV-1 335143 positive (e) 1 : 300 HIV-1 infection

anti-HIV-1 335144 positive (e) 1 : 150

HIV-1 p24 Ag

serum

337

manda-tory:

B 3

p24 Ag 337071 positive / borderline (ee) 1 : 100 000 HIV-1 infection (spiked serum pool of negative blood donors; HIV-1 heat inactivated) p24 Ag 337072 positive (ee) 1 : 25 000


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


EQA Schemes Virus Genome Detection by PCR/NAT

March 2019

Summary of sample properties and target values

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 (contd.): EQA Schemes Virus Genome Detection – March 2019 Summary of sample properties and target values

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

364041 positive (a) 1 : 300 3 273 589 2 052 348

364042 negative 1 : 100 0.0 0.0

364043 positive (a) 1 : 30 000 28 340 20 361

364044 positive (a) 1 : 3 000 334 349 198 169

Chikungunya virus&

(RNA)

cell lysates

392&

conform to

B 3

392033 positive (Martinique)

(b) 1 : 1 500 (inactivated)

Quantitative results in copies/ml were

not reported

-----

392034 positive (Martinique)

(b) 1 : 13 500 (inactivated)

-----

392035 negative ---- -----

392036 positive (S27)

1 : 13 500 (inactivated)

-----

CMV (DNA)

spiked plasma

365

manda-tory:

B 3

For evaluation of results

in copies/ml or IU/ml: see notice 1, page 10

365141 positive (c) 1 : 71.4 503 362 921 870

365142 positive (d) 1 : 11 428.6 25 231 30 500

365143 positive (d, e) 1 : 114 285.7 2 307 3 162

365144 positive (c) 1 : 714.3 62 271 94 219

CMV (DNA)

training program

spiked plasma

368 conform

to

B 3

368029 positive (c) 1 : 7 142.9 8 296 11 338

368030 positive (d) 1 : 1 142 857.1 261 454

368031 positive (c) 1 : 71 428.6 869 944

368032 positive (d, e) 1 : 114 285.7 3 398 4 097

HAV (RNA)

spiked plasma

377

manda-tory:

B 3

377141 positive (f) 1 : 2 000 ----## ----##

377142 positive (f) 1 : 4 000 ----## ----##

377143 positive (f) 1 : 1 000 ----## ----##

377144 negative ---- ----## ----##

HBV (DNA)

plasma

361

manda-tory:

B 3

361141 positive (genosubtype D1)

(g) 1 : 10 000 Results in copies/ml:

not accepted or

not evaluated (see notices 2 and

3, page 10)

26 306


(g, h) 1 : 316 230 900


(g) 1 : 31 623 8 483


(g) 1 : 100 000 2 768

HBV (DNA)

training program

plasma

378

conform to

B 3


(g) 1 : 10 000 000 Results in copies/ml:

not accepted or

not evaluated (see notices

2 and 3, page 10)

30.9


(g) 1 : 3 162 300 100


(g, h) 1 : 316 230 874


(g) 1 : 1 000 000 283


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

e, h: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBAEK Section B 3) and the corresponding training program.

& The EQA programs Virus Genome Detection – Chikungunya virus (392), Dengue Viruses (369), West Nile Virus (391) and Zika Virus (403) are performed in cooperation with Bernhard-Nocht-Institut, Hamburg (Nationales Referenzzentrum für tropische Infektionserreger, Abteilung für Virologie und WHO Collaborating Centre for Arbovirus and Haemorrhagic Fever Reference and Research: Prof. Dr. Stephan Günther, Prof. Dr. Dr. Jonas Schmidt-Chanasit und Dr. Petra Emmerich).

## The evaluation interval for each positive sample (quantitative results) is set by the EQA scheme adviser (ET) taking into account the results of the INSTAND Expert Laboratories.



Program Group RiliBAE

K Sample

Sample properties




copies/ml IU/ml

HCV (RNA)

plasma

362

manda-tory:

B 3

362141 positive (genotype 3) (i) 1 : 500 Results in copies/ml:

not accepted or


2 and 3, page 10)

20 333

362142 positive (genotype 3) (i) 1 : 1 581 6 575

362143 positive (genotype 3) (i) 1 : 50 226 737

362144 positive (genotype 3) (i, j) 1 : 5 000 2 260

HCV (RNA)

training program

plasma

379

conform to

B 3

379029 positive (genotype 3) (i) 1 : 50 000 Results in copies/ml:

not accepted or


2 and 3, page 10)

244

379030 positive (genotype 3) (i) 1 : 15 810 754

379031 positive (genotype 3) (i, j) 1 : 5 000 2 083

379032 positive (genotype 3) (i) 1 : 158 100 77.4

HDV (RNA)

plasma

400

conform to

B 3

400033 positive (k) 1 : 900 ----## 7 960

400034 negative ---- ----## 0.0

400035 positive (k) 300 ----## 25 227

400036 positive (k) 1 : 2 700 ----## 2 165

HEV (RNA)

spiked plasma*

suspension of feces**

380

conform to

B 3

380049* positive (l) 1 : 60 ----# 10 500

380050** positive (m) 1 : 50 ----# 16 099

380051* positive (l) 1 : 6 ----# 188 123

380052** positive (m) 1 : 500 ----# 466

HIV-1 (RNA)

spiked plasma

360

manda-tory:

B 3

360141 positive (group M/ subtype F) (heat inactivated)

(n) 1 : 4 235.1 12 385

Results in IU/ml: not accepted

or not evaluated (see notices

4 and 5, page 10)


(n) 1 : 13 390 4 334


(n, o) 1 : 42 351.3 1 269


(n) 1 : 1 339 36 828

HIV-1 (RNA)

training program

spiked plasma

382

conform to

B 3


(n) 1 : 423 513.4 126

Results in IU/ml: not accepted

or not evaluated (see notices

4 and 5, page 10)


(n, o) 1 : 42 351.3 1 231


(n) 1 : 1 339 000 41.8


(n) 1 : 133 900 394


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

j, o: Marked samples represent overlapping samples deployed in the respective main EQA scheme (mandatory according to RiliBAEK

Section B 3) and the corresponding training program

# The quantitative results are not evaluated due to the low number of analyses.




Program Group RiliBAE

K Sample

Sample properties




copies/ml IU/ml

JC virus (DNA)

suspension of urine

394

conform to

B 3

394033 positive 1 : 33 154 888 15 972

394034 positive 1 : 66 205 193 16 011

394035 negative 1 : 1 000 0.0 0.0

394036 positive 1 : 66 38 854 3 937

Parvovirus B19

(DNA)

plasma

367

manda-tory:

B 3

367141 positive (genotype 1)

(p) 1 : 79 000 429 454 218 935

367142 negative ---- 0.0 0.0


1 : 300 000 106 461 62 256


(p) 1 : 790 000 49 181 24 198


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


Table 5: EQA Schemes Virus Genome Detection incl. Typing

March 2019 – Summary of sample properties and target values

Program Group RiliBAEK Sample

Sample properties

qualitative type

(species, if applicable)

dilution Target value of all

methods copies/ml

Dengue viruses& (RNA)

cell lysates

369&

conform to

B 3

369041 positive DENV-2 (inactivated)

(q) 1 : 300

Quantitative results in copies/ml were not

reported


(q) 1 : 100

369043 negative ---- ----


1 : 900

Norovirus (RNA)

suspension of feces

381

conform to

B 3

381050 positive genogroup II 1 : 500 ----##

381051 negative ---- 1 : 20 ----##

381052 positive genogroup II 1 : 500 ----##

381053

not evaluated (positive - low concentrated sample)

not evaluated (genogroup II)

1 : 500 not evaluated

Para- influenza-

viruses (RNA)

cell lysates

388

conform to

B 3

388041 positive PIV-2 (r) 1 : 500 ----##

388042 positive PIV-3 1 : 500 ----##

388043 negative ---- ---- ----##

388044 positive PIV-2 (r) 1 : 2 500 ----##

West Nile virus& (RNA)

cell lysates*

plasma**

391&

conform to

B 3

391059* positive WNV-2 (inactivated)

(s) 1 : 50 000 ----##

391060** positive WNV-1 (inactivated)

1 : 2 000 ----##


(s) 1 : 5 000 ----##

391062* negative ---- ---- ----##

391063** positive WNV-2 (inactivated)

1 : 5 000 ----##


1 : 2 000 ----##

Zika virus& (RNA)

plasma

403&

conform to

B 3

403025§ = 403028

positive Asian linage (inactivated)

(t) 1 : 3 000 ----##

403026 negative ---- ---- ----##

403027 positive Asian linage (inactivated)

(t) 1 : 300 ----##

403028 = 403025§

positive Asian linage (inactivated)

(t) 1 : 3 000 ----##


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

§ The samples 403025 and 403028 are identical.

& 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).


Evaluation corrected on 29 July 2019


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

March 2019 – Summary of sample properties and target values

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

370107

positive

for avian influenza A(H5N8) virus

A/DE-SH/Reiherente/AR8444/

2016

allantoic fluid (inactivated)

(1 : 400 diluted)

370108

positive

for seasonal influenza B virus

B/Colorado/06/2017 (vaccine strain)

infected MDCK cells (lysate)

(1 : 60 diluted)

370109

positive

for seasonal influenza A(H1N1 pdm09)

virus

A/Michigan/45/2015 (vaccine strain)

infected MDCK-cells (lysate)

(1 : 200 diluted)

370110 negative ---- not-infected MDCK

cells (lysate)

370111

positive

for seasonal influenza A(H3N2) virus

A/Singapore/INFIMH-16-0019/2016

(vaccine strain)


(1 : 60 diluted)

370112

positive

for seasonal influenza B virus

B/Phuket/3073/2013 (vaccine strain)


(1 : 100 diluted)


* The EQA program for influenza A and B viruses, incl. influenza A(H1N1) pdm09 virus and avian influenza A virus (different subtypes), is performed in cooperation with Nationales Referenzzentrum für Influenza, Robert Koch-Institut, Berlin,

Dr. Ralf Dürrwald and Dr. Barbara Biere and Nationales Referenzlabor für Aviäre Influenza, Bundesforschungsinstitut für Tiergesundheit, Friedrich-Loeffler-Institut, Insel Riems, PD Dr. Timm C. Harder.

Evaluation corrected on 29 July 2019


ANNEX 1

Overview of the function and operation of

RV Online (the secure area for our participants)

This manual contains detailed and practical instructions for the online management of your data on our website INSTAND e.V. You have the following possibilities:

NEW: user-based login

Creation of multiple user accounts for one laboratory number

Data transfer from the old online system

Ordering

Entry of measured values for EQA schemes in virology


Table of contents

1. Initial step 17

2. Transferring an existing user account from RV Web 18

3. Transferring further participant numbers 20

4. Creating a new user account 22

5. Adding additional laboratories 24

6. User administration 25

7. Registering EQA tests (ordering) 26

8. Entering values for virological EQA schemes 28

8.1 Menu of the entry mask 28

8.2 Selection of the EQA scheme 28

8.3 Selection of the parameter (Attention: formerly test category) 28

8.4 Selection of the reagent and test name of the applied test system 29

8.5 Result entry 29

8.6 Result entry of a second test system 30

8.7 Selection of a further parameter (Attention: formerly test category) 30

9. Correcting results 30

10. Download of the evaluation documents 31


1. Initial step

Go to the Internet site www.instand-ev.de

Click on > EQAs Online > Ordering online and entering results.

Click on the link “To ordering online and entering results”.

Please continue directly with point 8 (page 14) if you have already a user account and wish to enter your EQAS results.


2. Transferring an existing user account from RV Web

With the change to our new online system, logging in is now user based and no longer institute based as was previously the case. Each user can be assigned multiple laboratory numbers (previously: “participant number”). If you have multiple participant numbers, you will need to complete this process for each of your participant numbers. (You will receive a start code for each participant number by post.)

First log in using your current login details (participant number, password).

On the next page you will be asked to enter your start code.

Click on “Continue”.

Enter your participant

number and old

password and then click

on “Log in”.


Update your user data and create a new, personal password in the following form. Then accept the terms and conditions and click on “Continue”. This user is specified as the administrator. Other users can be can added (see Point 6).

You will then receive an e-mail to verify your user account. This enables us to protect your data from unauthorized access.

Click on the link in the e-mail to generate the following message:

After confirming “OK” you can log in with your e-mail address and your new password. Note: Once this is done, you will only be able to log in using your e-mail address and password!


3. Transferring further participant numbers

See Point 2 in the manual for details on transferring the first participant number.

It is important to transfer each of your participant numbers to the new program.

(You will receive a start code for each participant number by post.)

Once you have transferred the first participant number, you can transfer further participant numbers as follows:

Enter the start code corresponding to the participant number.

Click on “Continue”.

If your e-mail address is already registered with INSTAND and you would like to be the administrator of these laboratory numbers, click on:

Enter the next

participant number and

corresponding

password here and

then click on “Log in”.


Enter your existing login details (e-mail address and password).

Now you can manage multiple labs with one account. If you would like to change to a different laboratory number, simply click on the symbol “change” next to the laboratory number.


4. Creating a new user account

NOTE! Please DON’T create a new user account if you already have an account on RV Web!

First click on “Register”.

Completely fill in the registration form. Fields marked with an (*) cannot be left blank. Confirm your entries by clicking on “Submit registration”.

After registering you will receive an e-mail with an activation link. Click on this link to verify the user account. This enables us to protect your data from unauthorized access.

Now you can log in using your e-mail address and password.


If you have not yet been assigned a laboratory, you will be asked immediately after logging in whether you would like to create a laboratory. Confirm this by clicking on “Yes”.

Enter the master data of your laboratory (institute) as well as any additional addresses for certificates or invoices.

Make sure to save your master data.


5. Adding additional laboratories

If, as the administrator, you would like to add an additional lab to your user account, please proceed as follows:

Log in with your login details.

Under master data, select “Add laboratory”.

Enter the master data for the additional lab. It will be assigned a new participant/laboratory number.

Now you can manage multiple laboratories with one account. If you would like to change to a different laboratory number, just click on the word “change” next to the laboratory number.


6. User administration

In the new “RV Online” system, the administrator is able to create additional users with different authorizations. Please note: additional users have to be created for each laboratory number.

Click on Master data > Laboratory administration > User administration. Here additional users can be added and given specific authorizations.

The authorizations represent the following possibilities: Administrator: Account cannot be deleted (all rights).

Can add new users.

User administration: Can be appointed by the administrator.

Can add new users.

Order: User can order and cancel EQA tests.

Value entry: User can enter and adjust measurement values.

Download certificate: User can look at and print out certificates (under development).

Once you have managed the authorizations of the respective user, click on “Save”.

The newly added user will receive a temporary password, which will be sent to the specified e-mail address.

The temporary password is used to log in for the first time. In a subsequent step, the user is requested to create a new personal password.

If the user is already registered, they will only receive an e-mail with information about which laboratory they are assigned to.


7. Registering EQA tests (ordering)

All of the buttons are located under the tab “Welcome” in the upper right-hand corner under the INSTAND logo.

Use the button “Registration”.

Alternatively you can use the tab labelled “Registration”.

Both will take you to the overview of orders.

Use the dropdown menu to select the year and the EQA test you wish to order (1). You will find all of our EQA tests listed according to topic (2).

(1)

(2)


Here you can individually enter your order quantity for each date.

Check “Subscription” to activate this order for the next year. This will remain in place until you wish to unsubscribe. To do this, uncheck the box next to the corresponding order (subscription will end the following year).

Proceed in this manner for all other EQA tests that you would like to order.

Click on “Continue”. This will bring up a list of your orders.

Click on “Order” to place your order. You will receive order confirmation by e-mail.

Orders can only be modified (cancelled) before the respective registration deadline. Once this registration deadline has passed, orders can no longer be changed.


8. Entering values for virological EQA schemes

All buttons are located under the “Welcome” tab in the upper right-hand corner under the INSTAND logo. 8.1 Menu of the entry mask

By clicking on “Result Entry”, you can enter, add and adjust your results from the time the samples have been sent until the submission deadline.

Figure 1: Screen after log in on INSTAND EQAS Online

8.2 Selection of the EQA scheme

Select the name of the EQA scheme, for which you would like to enter your results (i.e. „Virus Immunology – HIV-1/HIV-2 (Ab)”; Figure 2).

Figure 2: List of the EQA schemes available for result entry

8.3 Selection of the parameter (Attention: formerly test category)

Select the parameter (formerly test category), for which you would like to enter your results (i.e. “Screening test”; Figure 3).

Figure 3: Entry mask for Virus Immunology – HIV-1/HIV-2 (Ab)

Result Entry


8.4 Selection of the reagent and test name of the applied test system

First, select the reagent and test name of the applied test system, before entering your results of this parameter, (Figure 4). The mask for result entry opens automatically after selection of the test name (Figure 5). Please specify the lot number of your applied test and specify the name of the used device.

Figure 4: Selection of the reagent and test name of the applied test system

Figure 5: Entry mask after selection of the applied test system

8.5 Result entry

Enter the results of the used test system. Required results are marked with an orange bar. If applicable, please enter additionally your device value “Result (device)” with the corresponding device unit “Unit (device)” (Figure 6).

Figure 6: Entry mask after entering from results inclusively device values

Click on “Save and back to overview” to save your values with us. Subsequently, you can enter data for further groups / EQA test results.

On the overview page you can immediately see which EQA test has yet to be entered (red light) or has partially been entered (yellow light), or you can manually set the group to “completed” (green light).


8.6 Result entry of a second test system

Please use the “plus symbol”, shown at the corresponding parameter (formerly test category), for result entry of a second test system (Figure 7) and enter the results according to the instructions given below (see 8.3-8.5).

Figure 7: Extension of the mask for result entry of a second test system by using the „plus symbol“

Figure 8: Result entry of the second test system starting with selection of the used reagent and test name

8.7 Selection of a further parameter (Attention: formerly test category)

Select a further parameter (formerly test category) for entering the next results (i.e. “Confirmation test”; Figure 3) and enter the results according to the instructions given below (see 8.3-8.6).

9. Correcting results

You can change the entered values up until midnight on the day of the submission deadline. After the submission deadline this is no longer possible.

Open the protocol sheet and click on the value to be corrected. You will be asked whether you really wish to change the value. The button “Unlock” only needs to be clicked on if changes are to be made to the manufacturer, reagents or unit.

Please save and print out all changes in order to more easily track changes.


10. Download of the evaluation documents

All of the buttons are located under the tab “Welcome” in the upper right-hand corner under the INSTAND logo.

By clicking on “Evaluation”, you can see a list of the EQA schemes you have submitted values for.

In this list you can also see the state of the evaluation:

grey: results have been submitted

green: evaluation has been completed and documents are available

orange: evaluation has been completed and documents are available, but not all parameters are passed

You can download your evaluation documents including the certificate, certificate of participation and listing

and evaluation of the results by clicking on the button.

Furthermore, you can download just the certificates ( ) or the individual summary of results ( ). Please note: The individual summary of results is only available online for download and is not part of the submission of evaluation documents by mail.

By selecting the checkbox you can choose several documents for the download.