Product no. 5091 HIV, antibodies and antigen detection

1 / 1

External Quality Assessment Scheme

HIV, antibodies and antigen detection Round 1, 2020 Specimens Please find enclosed 3 human plasma samples S001, S002 and S003, each 0.7 mL. Caution Quality control specimens derived from human blood must be handled with the same care as patient samples, i.e. as potential transmitters of serious diseases. The specimens may contain infectious viruses. The specimens have not been heated or inactivated. Examinations HIVAb, HIVAg, HIVAgAb, primary tests HIVAb, HIVAg, confirmatory tests Clinical interpretation Storage and use The samples should be stored at 2 … 8 °C, and used as soon as possible, preferably within a week. The samples are ready for use. Analyse as patient samples. Result reporting Please enter the results and methods via LabScala. If you can’t find your instrument or reagent from the registry, please contact the EQA Coordinator. All reported examinations will be scored. S001: LQ773620011

S002: LQ773620012

S003: LQ773620013

2020-03-03 INSTRUCTIONS

Product no. 5091 LQ773620011-013/DE, US UN3373 Subcontracting: Sample preparation, Sample pretesting

If the kit is incomplete or contains damaged specimens, please report immediately to [email protected]. ____________________________

The results should be reported no later than March 26, 2020. _________________________

The expected results of the round are published in LabScala in the View Reports section by March 31, 2020. Inquiries EQA Coordinator Marsa Järvenpää [email protected] Labquality Kumpulantie 15 FI-00520 HELSINKI Finland Tel. + 358 9 8566 8200 Fax + 358 9 8566 8280 [email protected] www.labquality.fi

HIV, antibodies and antigen detection, March, 1-2020

Copyright © Labquality Oy

31.03.2020 1/21

History Test nr. Own success rate Difference AVR success rateRound 2019-3 1-1 100 % 1 % 99 %Round 2019-3 1-2 100 % 1 % 99 %Round 2019-2 1-1 100 % 1.1 % 98.9 %Round 2019-2 1-2 100 % 1.1 % 98.9 %Round 2019-1 1-1 100 % 1 % 99 %Round 2019-1 1-2 75 % -24 % 99 %Round 2018-4 1-1 100 % 1.9 % 98.1 %Round 2018-4 1-2 100 % 1.9 % 98.1 %Round 2018-3 1-1 100 % 1.5 % 98.5 %Round 2018-3 1-2 100 % 1.5 % 98.5 %Round 2018-2 1-1 100 % 2.2 % 97.8 %Round 2018-2 1-2 100 % 2.2 % 97.8 %

Summary Own score Max score Own success rate Difference AVR success rateSample S001 2 2 100 % 3.6 % 96.4 %Sample S002 2 2 100 % 1.5 % 98.5 %Sample S003 2 2 100 % 3.3 % 96.7 %Average: 100 % 2.8 % 97.2 %

Client report

No of participants No of responded participants Response percentageHIV, antibodies and antigen detection, March, 1-2020 242 233 96.3 %

Summary Result 1

xxxxx



31.03.2020 2/21

Sample S001 Result 1 |

Sample S001 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 95.5 % 259HIVAb (1/2), primary test - - - - 100 % 13HIVAgAb (combo), primary test 2 2 100 % 2 % 98 % 250HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 100 % 12HIV-1 Ab, confirmatory test - - - - 100 % 4HIV-2 Ab, confirmatory test - - - - 100 % 3HIVAg (p24), confirmatory test - - - - - 2

Total: 2 2 100 % 3.6 % 96.4 % 545

Clinicalinterpretation

Interpretation Further action Interpretationcount

Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate

Difference AVRsuccess

rateHIVAgAb negative 2 0 %Not yet reported, primary test(s)reactive, referred

176 100 %

Would be referred to anotherlaboratory for further examination

132 - -

New sample requested 38 - -HIVAb positive, confirmed 5 100 %

New sample requested 1 - -

xxxxx



31.03.2020 3/21


1 - -

HIVAgAb positive, confirmed 14 100 %Would be referred to anotherlaboratory for further examination

9 - -

New sample requested 6 - -HIV-1 Ab positive, confirmed 17 100 %


3 - -

New sample requested 1 - -HIV-2 Ab positive, confirmed 1 50 %HIVAb reactive, reported withoutconfirmation

21 50 %


8 - -

New sample requested 3 - -Laboratory does not give clinicalinterpretation

23 -


4 - -

New sample requested 1 - -Total: 259 - - - - 95.5 %

HIVAb (1/2),primary test

Interpretation Methodics Interpretationcount

Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 13 100 %

Advia Centaur, HIV 1/O/2 Enhanced(EHIV), Siemens

2

CMIA HIV combo, Abbott 1Determine HIV 1/2, antibodies, Alere 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo RapidTest

1

SD BIOLINE HIV-1/2 3.0, Abbott 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 13 - - - - 100 %

OWN DEVICE: FSM MERKEZ 15

HIVAgAb(combo),primary test


Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 4 0 %

ARCHITECT HIV Ag/Ab Combo,Abbott

3

Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Test does not give a clear result 1 0 %VIDAS HIV Duo Ultra, bioMerieux 1

Positive 245 2 2 100 % 0 % 100 %

Abbott Alinity i HIVAg/Ab combo 23Access HIV-1/2, Beckman Coulter 2Advia Centaur, HIV Ag/Ab Combo(CHIV), Siemens

6


101

Elecsys HIV duo, Roche 7Enzygnost HIV Integral 4 Assay,Siemens

4

Genscreen ULTRA HIV AgAb,Bio-Rad

7

GS HIV Combo Ag/Ab EIA, Bio-Rad 1HIV Combi PT, Roche 77LIAISON XL MUREX HIV Ab / Ag,Diasorin

2

Siemens Atellica HIV Ag/Ab Combo 3UniCel Dxl 800, Beckman Coulter 1

xxxxx



31.03.2020 4/21

VIDAS HIV Duo Quick, bioMerieux 7VIDAS HIV Duo Ultra, bioMerieux 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

2

Total: 250 2 2 100 % 2 % 98 %

HIVAg (p24),primary test


Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -

LIAISON XL HIV Ab / Ag, Diasorin 1Positive 1 -

Elecsys HIV duo, Roche 1Total: 2 - - - -

HIVAb,confirmatorytest


Methodicscount

Ownscore

Maxscore

Ownsuccess

rate



Geenius HIV 1/2 confirmatory assay,Bio-Rad

1

Inno-Lia HIV I/II, Innogenetics 1recomLine HIV-1& HIV-2 IgG,Microgen Diagnostik

1

HIV-1 Positive 9 100 %Geenius HIV 1/2 confirmatory assay,Bio-Rad

2

Inno-Lia HIV I/II, Innogenetics 7Total: 12 - - - - 100 %

HIV-1 Ab,confirmatorytest


Methodicscount

Ownscore

Maxscore

Ownsuccess

rate



Geenius HIV 1/2 confirmatoryassay, Bio-Rad

1

Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2

Total: 4 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 3 100 %


1

Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1

Total: 3 - - - - 100 %

HIVAg (p24),confirmatorytest


Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateTest does not give a clear result 1 -

VIDAS P24 II confirmary,bioMerieux

1

Positive 1 -Inno-Lia HIV I/II, Innogenetics 1

Total: 2 - - - -

xxxxx



31.03.2020 5/21


Sample S002 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 98.7 % 259HIVAb (1/2), primary test - - - - 100 % 13HIVAgAb (combo), primary test 2 2 100 % 2 % 98 % 247HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 100 % 5HIV-1 Ab, confirmatory test - - - - - 1HIV-2 Ab, confirmatory test - - - - - 1

Total: 2 2 100 % 1.5 % 98.5 % 528



Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate


rateHIVAb negative 29 100 %

New sample requested 1 - -HIVAgAb negative 207 100 %

New sample requested 8 - -Would be referred to anotherlaboratory for further examination

4 - -

Not yet reported, primary test(s)reactive, referred

3 0 %


2 - -

Laboratory does not give clinicalinterpretation

20 -

xxxxx



31.03.2020 6/21

Total: 259 - - - - 98.7 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




2

CMIA HIV combo, Abbott 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo RapidTest

1

SD BIOLINE HIV-1/2 3.0, Abbott 2VIDAS HIV Duo Ultra, bioMerieux 1Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 13 - - - - 100 %




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 242 2 2 100 % 0 % 100 %


6


100


4


7


2

Siemens Atellica HIV Ag/Ab Combo 3UniCel Dxl 800, Beckman Coulter 1VIDAS HIV Duo Quick, bioMerieux 7VIDAS HIV Duo Ultra, bioMerieux 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Positive 5 0 %ARCHITECT HIV Ag/Ab Combo,Abbott

3

HIV Combi PT, Roche 2Total: 247 2 2 100 % 2 % 98 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 2 -

Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1

Total: 2 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


xxxxx



31.03.2020 7/21



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -

Inno-Lia HIV I/II, Innogenetics 1Total: 1 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -


xxxxx



31.03.2020 8/21


Sample S003 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 95.5 % 258HIVAb (1/2), primary test - - - - 92.9 % 14HIVAgAb (combo), primary test 2 2 100 % 0 % 100 % 248HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 91.7 % 12HIV-1 Ab, confirmatory test - - - - 100 % 4HIV-2 Ab, confirmatory test - - - - 100 % 3HIVAg (p24), confirmatory test - - - - - 2

Total: 2 2 100 % 3.3 % 96.7 % 543



Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate


rateHIVAb negative 1 0 %Indeterminate (tests don’t giveclear results)

2 0 %


1 - -

New sample requested 2 - -Not yet reported, primary test(s)reactive, referred

180 100 %


xxxxx



31.03.2020 9/21


137 - -

HIVAb positive, confirmed 3 100 %New sample requested 1 - -

HIVAgAb positive, confirmed 14 100 %New sample requested 5 - -Would be referred to anotherlaboratory for further examination

9 - -

HIV-1 Ab positive, confirmed 16 100 %Would be referred to anotherlaboratory for further examination

2 - -

New sample requested 1 - -HIVAb reactive, reported withoutconfirmation

20 50 %


8 - -


22 -


3 - -




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateTest does not give a clear result 1 0 %

VIDAS HIV Duo Ultra, bioMerieux 1Positive 13 100 %


2


1


1

Total: 14 - - - - 92.9 %




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 248 2 2 100 % 0 % 100 %


6


103


4


7


2


2

xxxxx



31.03.2020 10/21

Total: 248 2 2 100 % 0 % 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 2 -


Total: 2 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate



recomLine HIV-1& HIV-2 IgG,Microgen Diagnostik

1

Positive 2 100 %Geenius HIV 1/2 confirmatoryassay, Bio-Rad

1

Inno-Lia HIV I/II, Innogenetics 1HIV-1 Positive 9 100 %


2

Inno-Lia HIV I/II, Innogenetics 7Total: 12 - - - - 91.7 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 4 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 3 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -


1


Total: 2 - - - -

xxxxx



31.03.2020 11/21

History Test nr. Own success rate Difference AVR success rateRound 2019-3 1-1 100 % 1 % 99 %Round 2019-3 1-2 100 % 1 % 99 %Round 2019-2 1-1 100 % 1.1 % 98.9 %Round 2019-2 1-2 100 % 1.1 % 98.9 %Round 2019-1 1-1 100 % 1 % 99 %Round 2019-1 1-2 75 % -24 % 99 %Round 2018-4 1-1 100 % 1.9 % 98.1 %Round 2018-4 1-2 100 % 1.9 % 98.1 %Round 2018-3 1-1 100 % 1.5 % 98.5 %Round 2018-3 1-2 100 % 1.5 % 98.5 %Round 2018-2 1-1 100 % 2.2 % 97.8 %Round 2018-2 1-2 100 % 2.2 % 97.8 %

Summary Own score Max score Own success rate Difference AVR success rateSample S001 2 2 100 % 3.6 % 96.4 %Sample S002 2 2 100 % 1.5 % 98.5 %Sample S003 2 2 100 % 3.3 % 96.7 %Average: 100 % 2.8 % 97.2 %

Client report


Summary Result 2

xxxxx



31.03.2020 12/21


Sample S001 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 95.5 % 259HIVAb (1/2), primary test - - - - 100 % 13HIVAgAb (combo), primary test 2 2 100 % 2 % 98 % 250HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 100 % 12HIV-1 Ab, confirmatory test - - - - 100 % 4HIV-2 Ab, confirmatory test - - - - 100 % 3HIVAg (p24), confirmatory test - - - - - 2

Total: 2 2 100 % 3.6 % 96.4 % 545



Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate


rateHIVAgAb negative 2 0 %Not yet reported, primary test(s)reactive, referred

176 100 %


132 - -

New sample requested 38 - -HIVAb positive, confirmed 5 100 %


xxxxx



31.03.2020 13/21


1 - -

HIVAgAb positive, confirmed 14 100 %Would be referred to anotherlaboratory for further examination

9 - -

New sample requested 6 - -HIV-1 Ab positive, confirmed 17 100 %


3 - -

New sample requested 1 - -HIV-2 Ab positive, confirmed 1 50 %HIVAb reactive, reported withoutconfirmation

21 50 %


8 - -


23 -


4 - -




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




2


1


1

Total: 13 - - - - 100 %

OWN DEVICE: FSM MERKEZ16



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 4 0 %


3

Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Test does not give a clear result 1 0 %VIDAS HIV Duo Ultra, bioMerieux 1

Positive 245 2 2 100 % 0 % 100 %


6


101


4


7


2

Siemens Atellica HIV Ag/Ab Combo 3UniCel Dxl 800, Beckman Coulter 1

xxxxx



31.03.2020 14/21

VIDAS HIV Duo Quick, bioMerieux 7VIDAS HIV Duo Ultra, bioMerieux 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

2

Total: 250 2 2 100 % 2 % 98 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -

LIAISON XL HIV Ab / Ag, Diasorin 1Positive 1 -

Elecsys HIV duo, Roche 1Total: 2 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1

Inno-Lia HIV I/II, Innogenetics 1recomLine HIV-1& HIV-2 IgG,Microgen Diagnostik

1

HIV-1 Positive 9 100 %Geenius HIV 1/2 confirmatory assay,Bio-Rad

2




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 4 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 3 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateTest does not give a clear result 1 -


1


Total: 2 - - - -

xxxxx



31.03.2020 15/21


Sample S002 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 98.7 % 259HIVAb (1/2), primary test - - - - 100 % 13HIVAgAb (combo), primary test 2 2 100 % 2 % 98 % 247HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 100 % 5HIV-1 Ab, confirmatory test - - - - - 1HIV-2 Ab, confirmatory test - - - - - 1

Total: 2 2 100 % 1.5 % 98.5 % 528



Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate


rateHIVAb negative 29 100 %

New sample requested 1 - -HIVAgAb negative 207 100 %

New sample requested 8 - -Would be referred to anotherlaboratory for further examination

4 - -


3 0 %


2 - -


20 -

xxxxx



31.03.2020 16/21

Total: 259 - - - - 98.7 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




2

CMIA HIV combo, Abbott 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo RapidTest

1

SD BIOLINE HIV-1/2 3.0, Abbott 2VIDAS HIV Duo Ultra, bioMerieux 1Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 13 - - - - 100 %




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 242 2 2 100 % 0 % 100 %


6


100


4


7


2


1

Positive 5 0 %ARCHITECT HIV Ag/Ab Combo,Abbott

3

HIV Combi PT, Roche 2Total: 247 2 2 100 % 2 % 98 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 2 -


Total: 2 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


xxxxx



31.03.2020 17/21



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -


xxxxx



31.03.2020 18/21


Sample S003 results Responded Own score Max score Own success rate Difference AVR success rate CountClinical interpretation - - - - 95.5 % 258HIVAb (1/2), primary test - - - - 92.9 % 14HIVAgAb (combo), primary test 2 2 100 % 0 % 100 % 248HIVAg (p24), primary test - - - - - 2HIVAb, confirmatory test - - - - 91.7 % 12HIV-1 Ab, confirmatory test - - - - 100 % 4HIV-2 Ab, confirmatory test - - - - 100 % 3HIVAg (p24), confirmatory test - - - - - 2

Total: 2 2 100 % 3.3 % 96.7 % 543



Furtheractioncount

Ownscore

Maxscore

Ownsuccess

rate


rateHIVAb negative 1 0 %Indeterminate (tests don’t giveclear results)

2 0 %


1 - -

New sample requested 2 - -Not yet reported, primary test(s)reactive, referred

180 100 %


xxxxx



31.03.2020 19/21


137 - -

HIVAb positive, confirmed 3 100 %New sample requested 1 - -

HIVAgAb positive, confirmed 14 100 %New sample requested 5 - -Would be referred to anotherlaboratory for further examination

9 - -

HIV-1 Ab positive, confirmed 16 100 %Would be referred to anotherlaboratory for further examination

2 - -

New sample requested 1 - -HIVAb reactive, reported withoutconfirmation

20 50 %


8 - -


22 -


3 - -




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate



VIDAS HIV Duo Ultra, bioMerieux 1Positive 13 100 %


2


1


1

Total: 14 - - - - 92.9 %




Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 248 2 2 100 % 0 % 100 %


6


103


4


7


2


2

xxxxx



31.03.2020 20/21

Total: 248 2 2 100 % 0 % 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 2 -


Total: 2 - - - -



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate



recomLine HIV-1& HIV-2 IgG,Microgen Diagnostik

1

Positive 2 100 %Geenius HIV 1/2 confirmatoryassay, Bio-Rad

1

Inno-Lia HIV I/II, Innogenetics 1HIV-1 Positive 9 100 %


2

Inno-Lia HIV I/II, Innogenetics 7Total: 12 - - - - 91.7 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 4 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate




1


Total: 3 - - - - 100 %



Methodicscount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 1 -


1


Total: 2 - - - -

xxxxx



31.03.2020 21/21

Report Info

PARTICIPANTS

Altogether 242 laboratories from 19 countries participated in this EQA round.

REPORT INFO

The results are divided into groups according to the method stated by the laboratory and presented in laboratory-specific tables. Accepted results are marked with green color and laboratory’sown result with a black radio button . In the scoring report you will find summaries of overall success rate and sample specific success rates (%). Sample specific interpretations are shown in piediagrams as percentages and the total interpretation and methodic counts in the tables. If you have not reported any results you will get a note: “You have not responded in time, only globalreport is available.”

For information on report interpretation and performance evaluation, please see the "EQAS Interpretation guidelines" in LabScala User instructions. In case you have any questions regarding thereports, please contact the EQA Coordinator.

SCORING

The round is scored based on test results and clinical interpretations when 60% or more of the participants report the expected result and when at least three results are reported.

The following general rules are applied:

Correct/expected test result 2/2 pointsFalse/deviating test result 0/2 pointsCorrect/expected clinical interpretation 4/4 pointsPositive results reported without confirmatory testing 2/4 pointsFalse/deviating clinical interpretation 0/4 points

The performance of the laboratory is assessed by the Own success rate (%). The target is 100%. The examination-specific scores obtained by the laboratory in the round are converted to Ownsuccess rate per sample (scores/maximum scores*100). The Laboratory's Own success rate is the average of the sample success rates.

The success rate for the entire round (AVR success rate) is calculated from the total number of scores given to the results per sample (all scores/maximum scores*100). The AVG success rate of theentire round is the average of the sample success rates. The difference in the Laboratory's Own success rate (%) to the corresponding numbers for the entire round is shown in the table.

xxxxx



31.03.2020 1/10

GLOBAL REPORT


Summary

Summary AVR success rateSample S001 96.4 %Sample S002 98.5 %Sample S003 96.7 %Average: 97.2 %



31.03.2020 2/10

Sample S001 |

Sample S001 results Responded AVR success rate CountClinical interpretation 95.5 % 259HIVAb (1/2), primary test 100 % 13HIVAgAb (combo), primary test 98 % 250HIVAg (p24), primary test - 2HIVAb, confirmatory test 100 % 12HIV-1 Ab, confirmatory test 100 % 4HIV-2 Ab, confirmatory test 100 % 3HIVAg (p24), confirmatory test - 2

Total: 96.4 % 545



Furtheractioncount

AVRsuccess

rate

InterpretationScore

FurtheractionScore

HIVAgAb negative 2 0 % 0Not yet reported, primary test(s)reactive, referred

176 100 % 4

Would be referred to another laboratoryfor further examination

132 100 % 1

New sample requested 38 100 % 1HIVAb positive, confirmed 5 100 % 4

New sample requested 1 100 % 1



31.03.2020 3/10


1 100 % 1

HIVAgAb positive, confirmed 14 100 % 4Would be referred to another laboratoryfor further examination

9 100 % 1

New sample requested 6 100 % 1HIV-1 Ab positive, confirmed 17 100 % 4


3 100 % 1

New sample requested 1 100 % 1HIV-2 Ab positive, confirmed 1 50 % 2HIVAb reactive, reported withoutconfirmation

21 50 % 2


8 100 % 1

New sample requested 3 100 % 1Laboratory does not give clinicalinterpretation

23 - -


4 100 % 1

New sample requested 1 100 % 1Total: 259 95.5 %



Methodicscount

AVR successrate

InterpretationScore

Positive 13 100 % 2Advia Centaur, HIV 1/O/2 Enhanced (EHIV),Siemens

2

CMIA HIV combo, Abbott 1Determine HIV 1/2, antibodies, Alere 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo Rapid Test 1SD BIOLINE HIV-1/2 3.0, Abbott 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 13 100 %

HIVAgAb (combo),primary test


Methodicscount

AVR successrate

InterpretationScore

Negative 4 0 % 0ARCHITECT HIV Ag/Ab Combo, Abbott 3Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Test does not give a clear result 1 0 % 0VIDAS HIV Duo Ultra, bioMerieux 1

Positive 245 100 % 2Abbott Alinity i HIVAg/Ab combo 23Access HIV-1/2, Beckman Coulter 2Advia Centaur, HIV Ag/Ab Combo (CHIV),Siemens

6

ARCHITECT HIV Ag/Ab Combo, Abbott 101Elecsys HIV duo, Roche 7Enzygnost HIV Integral 4 Assay, Siemens 4Genscreen ULTRA HIV AgAb, Bio-Rad 7GS HIV Combo Ag/Ab EIA, Bio-Rad 1HIV Combi PT, Roche 77LIAISON XL MUREX HIV Ab / Ag, Diasorin 2Siemens Atellica HIV Ag/Ab Combo 3UniCel Dxl 800, Beckman Coulter 1VIDAS HIV Duo Quick, bioMerieux 7VIDAS HIV Duo Ultra, bioMerieux 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

2

Total: 250 98 %



Methodicscount

AVR successrate

Interpretation Score



31.03.2020 4/10

Negative 1 - -LIAISON XL HIV Ab / Ag, Diasorin 1

Positive 1 - -Elecsys HIV duo, Roche 1

Total: 2

HIVAb,confirmatory test


Methodicscount

AVR successrate

InterpretationScore

Positive 3 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad

1

Inno-Lia HIV I/II, Innogenetics 1recomLine HIV-1& HIV-2 IgG, MicrogenDiagnostik

1

HIV-1 Positive 9 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad

2

Inno-Lia HIV I/II, Innogenetics 7Total: 12 100 %

HIV-1 Ab,confirmatory test


Methodicscount

AVR successrate

InterpretationScore


1


Total: 4 100 %



Methodicscount

AVR successrate

InterpretationScore

Negative 3 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad

1


Total: 3 100 %

HIVAg (p24),confirmatory test


Methodicscount

AVR successrate

InterpretationScore

Test does not give a clear result 1 - -VIDAS P24 II confirmary, bioMerieux 1

Positive 1 - -Inno-Lia HIV I/II, Innogenetics 1

Total: 2



31.03.2020 5/10

Sample S002 |

Sample S002 results Responded AVR success rate CountClinical interpretation 98.7 % 259HIVAb (1/2), primary test 100 % 13HIVAgAb (combo), primary test 98 % 247HIVAg (p24), primary test - 2HIVAb, confirmatory test 100 % 5HIV-1 Ab, confirmatory test - 1HIV-2 Ab, confirmatory test - 1

Total: 98.5 % 528



Furtheractioncount

AVRsuccess

rate

InterpretationScore

FurtheractionScore

HIVAb negative 29 100 % 4New sample requested 1 - -

HIVAgAb negative 207 100 % 4New sample requested 8 - -Would be referred to another laboratoryfor further examination

4 - -


3 0 % 0


2 - -


20 - -



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Total: 259 98.7 %



Methodicscount

AVR successrate

InterpretationScore

Negative 13 100 % 2Advia Centaur, HIV 1/O/2 Enhanced (EHIV),Siemens

2

CMIA HIV combo, Abbott 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo Rapid Test 1SD BIOLINE HIV-1/2 3.0, Abbott 2VIDAS HIV Duo Ultra, bioMerieux 1Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 13 100 %



Methodicscount

AVR successrate

InterpretationScore

Negative 242 100 % 2Abbott Alinity i HIVAg/Ab combo 23Access HIV-1/2, Beckman Coulter 2Advia Centaur, HIV Ag/Ab Combo (CHIV),Siemens

6


1

Positive 5 0 % 0ARCHITECT HIV Ag/Ab Combo, Abbott 3HIV Combi PT, Roche 2

Total: 247 98 %



Methodicscount

AVR successrate


Negative 2 - -Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1

Total: 2



Methodicscount

AVR successrate

InterpretationScore


1

Inno-Lia HIV I/II, Innogenetics 4Total: 5 100 %



Methodicscount

AVR successrate

InterpretationScore

Negative 1 - -Inno-Lia HIV I/II, Innogenetics 1

Total: 1



Methodicscount

AVR successrate

InterpretationScore

Negative 1 - -Inno-Lia HIV I/II, Innogenetics 1

Total: 1



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Sample S003 |

Sample S003 results Responded AVR success rate CountClinical interpretation 95.5 % 258HIVAb (1/2), primary test 92.9 % 14HIVAgAb (combo), primary test 100 % 248HIVAg (p24), primary test - 2HIVAb, confirmatory test 91.7 % 12HIV-1 Ab, confirmatory test 100 % 4HIV-2 Ab, confirmatory test 100 % 3HIVAg (p24), confirmatory test - 2

Total: 96.7 % 543



Furtheractioncount

AVRsuccess

rate

InterpretationScore

FurtheractionScore

HIVAb negative 1 0 % 0Indeterminate (tests don’t give clearresults)

2 0 % 0


1 100 % 1

New sample requested 2 100 % 1Not yet reported, primary test(s)reactive, referred

180 100 % 4

New sample requested 40 100 % 1



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137 100 % 1

HIVAb positive, confirmed 3 100 % 4New sample requested 1 100 % 1

HIVAgAb positive, confirmed 14 100 % 4New sample requested 5 100 % 1Would be referred to another laboratoryfor further examination

9 100 % 1

HIV-1 Ab positive, confirmed 16 100 % 4Would be referred to another laboratoryfor further examination

2 100 % 1

New sample requested 1 100 % 1HIVAb reactive, reported withoutconfirmation

20 50 % 2


8 100 % 1

New sample requested 3 100 % 1Laboratory does not give clinicalinterpretation

22 - -


3 100 % 1

New sample requested 1 100 % 1Total: 258 95.5 %



Methodicscount

AVR successrate

InterpretationScore

Test does not give a clear result 1 0 % 0VIDAS HIV Duo Ultra, bioMerieux 1

Positive 13 100 % 2Advia Centaur, HIV 1/O/2 Enhanced (EHIV),Siemens

2

CMIA HIV combo, Abbott 1Determine HIV 1/2, antibodies, Alere 1Elecsys HIV duo, Roche 1Laboquick Anti-HIV 1/2, Koroglu 1LIAISON XL HIV Ab / Ag, Diasorin 1Murex HIV-1.2.O, Diasorin 1One rapid diagnostic test, Artron 1OnSite HIV 1/2 Ab Plus Combo Rapid Test 1SD BIOLINE HIV-1/2 3.0, Abbott 2Vitros, HIV Combo, Ortho ClinicalDiagnostics

1

Total: 14 92.9 %



Methodicscount

AVR successrate

InterpretationScore

Positive 248 100 % 2Abbott Alinity i HIVAg/Ab combo 23Access HIV-1/2, Beckman Coulter 2Advia Centaur, HIV Ag/Ab Combo (CHIV),Siemens

6


2

Total: 248 100 %



Methodicscount

AVR successrate


Negative 2 - -Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1



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Total: 2



Methodicscount

AVRsuccess

rate

InterpretationScore

Test does not give a clear result 1 0 % 0recomLine HIV-1& HIV-2 IgG, MicrogenDiagnostik

1


1

Inno-Lia HIV I/II, Innogenetics 1HIV-1 Positive 9 100 % 2


2

Inno-Lia HIV I/II, Innogenetics 7Total: 12 91.7 %



Methodicscount

AVR successrate

InterpretationScore


1


Total: 4 100 %



Methodicscount

AVR successrate

InterpretationScore


1


Total: 3 100 %

HIVAg (p24),confirmatory test


Methodicscount

AVR successrate

InterpretationScore

Negative 1 - -VIDAS P24 II confirmary, bioMerieux 1

Positive 1 - -Inno-Lia HIV I/II, Innogenetics 1

Total: 2



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Report Info

PARTICIPANTS

Altogether 242 laboratories from 19 countries participated in this EQA round.

REPORT INFO

The results are divided into groups according to the method stated by the laboratory and presented in laboratory-specific tables. Accepted results are marked with green color and laboratory’sown result with a black radio button . In the scoring report you will find summaries of overall success rate and sample specific success rates (%). Sample specific interpretations are shown in piediagrams as percentages and the total interpretation and methodic counts in the tables. If you have not reported any results you will get a note: “You have not responded in time, only globalreport is available.”

For information on report interpretation and performance evaluation, please see the "EQAS Interpretation guidelines" in LabScala User instructions. In case you have any questions regarding thereports, please contact the EQA Coordinator.

SCORING

The round is scored based on test results and clinical interpretations when 60% or more of the participants report the expected result and when at least three results are reported.

The following general rules are applied:

Correct/expected test result 2/2 pointsFalse/deviating test result 0/2 pointsCorrect/expected clinical interpretation 4/4 pointsPositive results reported without confirmatory testing 2/4 pointsFalse/deviating clinical interpretation 0/4 points

The performance of the laboratory is assessed by the Own success rate (%). The target is 100%. The examination-specific scores obtained by the laboratory in the round are converted to Ownsuccess rate per sample (scores/maximum scores*100). The Laboratory's Own success rate is the average of the sample success rates.

The success rate for the entire round (AVR success rate) is calculated from the total number of scores given to the results per sample (all scores/maximum scores*100). The AVG success rate of theentire round is the average of the sample success rates. The difference in the Laboratory's Own success rate (%) to the corresponding numbers for the entire round is shown in the table.

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External Quality Assessment Scheme

HIV, antibodies and antigen detection Round 1, 2020 Specimens Samples of this EQA round were human plasma. The anti-HIV positive specimen S001 was undiluted. The anti-HIV positive specimen S003 consisted of one single anti-HIV positive donation diluted in 1:10 with one single anti-HIV negative donation plasma. The anti-HIV negative specimen S002 consisted of one single anti-HIV negative donator plasma. Based on the pre-testing and the results obtained in the round, the samples were homogeneous, stable and suitable for the external quality assessment scheme. The materials were sent without any temperature control packaging. The accepted results were as follows: Sample S001 (LQ773620011) HIVAb HIV-1 Positive HIVAg Positive Sample S002 (LQ773620012) HIVAb Negative HIVAg Negative Sample S003 (LQ773620013) HIVAb HIV-1 Positive HIVAg Negative Pre-test methods: Abbott Determine HIV-1/2, Biolytical laboratories INSTI HIV-1 / HIV-2, DiaSorin Murex HIV Ag/Ab Combination, Fujirebio INNOTEST HIV Antigen mAb, Fujirebio INNOTEST HIV Antigen mAb Neutralization Reagents, Bio-Rad New LAV Blot I, Bio-Rad New LAV Blot II. Report info Please see the description of the data analysis on the last page of the laboratory-specific reports and global reports. Comments It is important to read the Final report first, because it contains important information of the samples and results in each round. Sample S001 was HIV-1 antibody and antigen positive. There were four negative and one “Test does not give a clear result” results reported by three different HIVAgAb (combo) test. In clinical interpretations one participant reported the sample as HIV-2Ab positive. Twenty-one (21) laboratories reported the sample as HIVAb reactive without confirmation. Twenty-three (23) participants did not give clinical interpretation. The overall success rate for sample S001 was 96.4%. Sample S002 was HIV antibody and antigen negative. There were five positive HIVAgAb (combo) test results reported by two different methods. Three participants have possibly mixed up the samples (or results) S001 and S002. Some of these false test results led to false clinical interpretation. There were three “Not yet reported, primary test reactive, referred” interpretations reported. Twenty (20) participants did not give clinical interpretation. The overall success rate for sample S002 was 98.5%.

2020-04-03 FINAL REPORT

Product no. 5091 Subcontracting: Sample preparation, Sample pretesting Samples sent 2020-03-03 Round closed 2020-03-26 Expected results 2020-03-30 Final report 2020-04-03 Request for correction Typing errors in laboratory’s result forms are on laboratory’s responsibility. Labquality accepts responsibility only for result processing. Requests must be notified by writing within three weeks from the date of this letter. Authorized by EQA Coordinator Marsa Järvenpää [email protected] Expert Henrikki Brummer-Korvenkontio, Finnish Institute for Health and Welfare, Helsinki Labquality Oy Kumpulantie 15 FI-00520 HELSINKI Finland Tel. + 358 9 8566 8200 Fax + 358 9 8566 8280 [email protected] www.labquality.fi

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Sample S003 was HIV-1 antibody positive and antigen negative. One “Test does not give a clear result” was reported for both HIVAb (1/2) primary and HIVAb confirmatory tests. One “HIVAb negative” and two “Indeterminate (tests don’t give clear results) interpretations were reported. Twenty (20) laboratories reported the sample as HIVAb reactive without confirmation. Twenty-two (22) laboratories did not give clinical interpretation. The overall success rate for sample S003 was 96.7%. Exceptions in scoring No exceptions. Annex Pre-test results (Annex 1). End of report Copyright © Labquality Oy Labquality does not permit any reproduction for commercial purposes of any portion of the material subject to this copyright. Labquality prohibits any use of its name, or reference to Labquality EQA program, or material in this report in any advertising, brochures or other commercial publications. Labquality EQA data do not necessarily indicate the superiority of instruments, reagents, testing equipments or materials used by participating laboratories. Use of Labquality EQA data to suggest superiority or inferiority of equipments or materials may be deceptive and misleading. Proficiency test results are handled confidentially. Labquality will not issue any statements to third parties of the performance of laboratories in external quality assessment schemes unless otherwise agreed.

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Annex 1. Pre-test results. POC/Rapid tests

Sample Determine HIV 1/2, antibodies (Abbott)

INSTI HIV-1 / HIV-2 (Biolytical laboratories)

S001 Positive Positive

S002 Negative Negative

S003 Positive Positive

Laboratory tests (EIA)

Sample Murex HIV

Ag/Ab Combination

HIVAgAb test result

INNOTEST HIV Antigen mAb

HIVAg (p24) test result

HIVAg-neutralization

test result

S001

S002

S003

Cut off

2.491, 2.318

0.067, 0.064

2.245, 2.210

0.214, 0.233

+ -

+

0.377

0.063

0.136

+ -

+

Confirmatory tests HIV-1

Sample Bío-Rad New LAV Blot I

Visible HIV specific protein bandsConfirmatory test

result

S001 gp160, gp120, p68, p55*, p52, gp41,

p34, p24*, p17* +

S002

No visible protein bands -

S003

gp160, gp120, p68*, gp41 +

*Weak reaction Interpretation according to WHO criteria.

Documents

Product no. 5091 HIV, antibodies and antigen detection