Product no. 5091 HIV, antibodies and antigen detection ...
Transcript of Product no. 5091 HIV, antibodies and antigen detection ...
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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
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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
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HIV, antibodies and antigen detection, March, 1-2020
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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
HIV, antibodies and antigen detection, March, 1-2020
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Would be referred to anotherlaboratory for further examination
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 %
Would be referred to anotherlaboratory for further examination
3 - -
New sample requested 1 - -HIV-2 Ab positive, confirmed 1 50 %HIVAb reactive, reported withoutconfirmation
21 50 %
Would be referred to anotherlaboratory for further examination
8 - -
New sample requested 3 - -Laboratory does not give clinicalinterpretation
23 -
Would be referred to anotherlaboratory for further examination
4 - -
New sample requested 1 - -Total: 259 - - - - 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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
ARCHITECT HIV Ag/Ab Combo,Abbott
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
HIV, antibodies and antigen detection, March, 1-2020
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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
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
LIAISON XL HIV Ab / Ag, Diasorin 1Positive 1 -
Elecsys HIV duo, Roche 1Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 3 100 %
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
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 4 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 - - - - 100 %
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 3 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 - - - - 100 %
HIVAg (p24),confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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
HIV, antibodies and antigen detection, March, 1-2020
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Sample S002 Result 1 |
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
Clinicalinterpretation
Interpretation Further action Interpretationcount
Furtheractioncount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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 %
Would be referred to anotherlaboratory for further examination
2 - -
Laboratory does not give clinicalinterpretation
20 -
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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Total: 259 - - - - 98.7 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 13 100 %
Advia 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 RapidTest
1
SD BIOLINE HIV-1/2 3.0, Abbott 2VIDAS HIV Duo Ultra, bioMerieux 1Vitros, HIV Combo, Ortho ClinicalDiagnostics
1
Total: 13 - - - - 100 %
OWN DEVICE: FSM MERKEZ 15
HIVAgAb(combo),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 242 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
ARCHITECT HIV Ag/Ab Combo,Abbott
100
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 76LIAISON XL MUREX HIV Ab / Ag,Diasorin
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 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 2 -
Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 5 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 4Total: 5 - - - - 100 %
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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HIV-1 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
Inno-Lia HIV I/II, Innogenetics 1Total: 1 - - - -
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
Inno-Lia HIV I/II, Innogenetics 1Total: 1 - - - -
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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Sample S003 Result 1 |
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
Clinicalinterpretation
Interpretation Further action Interpretationcount
Furtheractioncount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateHIVAb negative 1 0 %Indeterminate (tests don’t giveclear results)
2 0 %
Would be referred to anotherlaboratory for further examination
1 - -
New sample requested 2 - -Not yet reported, primary test(s)reactive, referred
180 100 %
New sample requested 40 - -
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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Would be referred to anotherlaboratory for further examination
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 %
Would be referred to anotherlaboratory for further examination
8 - -
New sample requested 3 - -Laboratory does not give clinicalinterpretation
22 -
Would be referred to anotherlaboratory for further examination
3 - -
New sample requested 1 - -Total: 258 - - - - 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateTest does not give a clear result 1 0 %
VIDAS HIV Duo Ultra, bioMerieux 1Positive 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: 14 - - - - 92.9 %
OWN DEVICE: FSM MERKEZ 15
HIVAgAb(combo),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 248 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
ARCHITECT HIV Ag/Ab Combo,Abbott
103
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 78LIAISON XL MUREX HIV Ab / Ag,Diasorin
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
2
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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Total: 248 2 2 100 % 0 % 100 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 2 -
Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateTest does not give a clear result 1 0 %
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 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
2
Inno-Lia HIV I/II, Innogenetics 7Total: 12 - - - - 91.7 %
HIV-1 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 4 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 - - - - 100 %
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 3 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 - - - - 100 %
HIVAg (p24),confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
VIDAS P24 II confirmary,bioMerieux
1
Positive 1 -Inno-Lia HIV I/II, Innogenetics 1
Total: 2 - - - -
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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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
No of participants No of responded participants Response percentageHIV, antibodies and antigen detection, March, 1-2020 242 233 96.3 %
Summary Result 2
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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Sample S001 Result 2 |
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
HIV, antibodies and antigen detection, March, 1-2020
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Would be referred to anotherlaboratory for further examination
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 %
Would be referred to anotherlaboratory for further examination
3 - -
New sample requested 1 - -HIV-2 Ab positive, confirmed 1 50 %HIVAb reactive, reported withoutconfirmation
21 50 %
Would be referred to anotherlaboratory for further examination
8 - -
New sample requested 3 - -Laboratory does not give clinicalinterpretation
23 -
Would be referred to anotherlaboratory for further examination
4 - -
New sample requested 1 - -Total: 259 - - - - 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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 MERKEZ16
HIVAgAb(combo),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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
ARCHITECT HIV Ag/Ab Combo,Abbott
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
HIV, antibodies and antigen detection, March, 1-2020
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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
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
LIAISON XL HIV Ab / Ag, Diasorin 1Positive 1 -
Elecsys HIV duo, Roche 1Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 3 100 %
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
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 4 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 - - - - 100 %
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 3 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 - - - - 100 %
HIVAg (p24),confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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
HIV, antibodies and antigen detection, March, 1-2020
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Sample S002 Result 2 |
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
Clinicalinterpretation
Interpretation Further action Interpretationcount
Furtheractioncount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
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 %
Would be referred to anotherlaboratory for further examination
2 - -
Laboratory does not give clinicalinterpretation
20 -
xxxxx
HIV, antibodies and antigen detection, March, 1-2020
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31.03.2020 16/21
Total: 259 - - - - 98.7 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 13 100 %
Advia 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 RapidTest
1
SD BIOLINE HIV-1/2 3.0, Abbott 2VIDAS HIV Duo Ultra, bioMerieux 1Vitros, HIV Combo, Ortho ClinicalDiagnostics
1
Total: 13 - - - - 100 %
OWN DEVICE: FSM MERKEZ16
HIVAgAb(combo),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 242 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
ARCHITECT HIV Ag/Ab Combo,Abbott
100
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 76LIAISON XL MUREX HIV Ab / Ag,Diasorin
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 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 2 -
Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 5 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 4Total: 5 - - - - 100 %
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HIV-1 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
Inno-Lia HIV I/II, Innogenetics 1Total: 1 - - - -
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
Inno-Lia HIV I/II, Innogenetics 1Total: 1 - - - -
xxxxx
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Sample S003 Result 2 |
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
Clinicalinterpretation
Interpretation Further action Interpretationcount
Furtheractioncount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateHIVAb negative 1 0 %Indeterminate (tests don’t giveclear results)
2 0 %
Would be referred to anotherlaboratory for further examination
1 - -
New sample requested 2 - -Not yet reported, primary test(s)reactive, referred
180 100 %
New sample requested 40 - -
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Would be referred to anotherlaboratory for further examination
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 %
Would be referred to anotherlaboratory for further examination
8 - -
New sample requested 3 - -Laboratory does not give clinicalinterpretation
22 -
Would be referred to anotherlaboratory for further examination
3 - -
New sample requested 1 - -Total: 258 - - - - 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateTest does not give a clear result 1 0 %
VIDAS HIV Duo Ultra, bioMerieux 1Positive 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: 14 - - - - 92.9 %
OWN DEVICE: FSM MERKEZ16
HIVAgAb(combo),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 248 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
ARCHITECT HIV Ag/Ab Combo,Abbott
103
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 78LIAISON XL MUREX HIV Ab / Ag,Diasorin
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
2
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Total: 248 2 2 100 % 0 % 100 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 2 -
Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
Total: 2 - - - -
HIVAb,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateTest does not give a clear result 1 0 %
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 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
2
Inno-Lia HIV I/II, Innogenetics 7Total: 12 - - - - 91.7 %
HIV-1 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
ratePositive 4 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 - - - - 100 %
HIV-2 Ab,confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 3 100 %
Geenius HIV 1/2 confirmatoryassay, Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 - - - - 100 %
HIVAg (p24),confirmatorytest
Interpretation Methodics Interpretationcount
Methodicscount
Ownscore
Maxscore
Ownsuccess
rate
Difference AVRsuccess
rateNegative 1 -
VIDAS P24 II confirmary,bioMerieux
1
Positive 1 -Inno-Lia HIV I/II, Innogenetics 1
Total: 2 - - - -
xxxxx
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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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GLOBAL REPORT
No of participants No of responded participants Response percentageHIV, antibodies and antigen detection, March, 1-2020 242 233 96.3 %
Summary
Summary AVR success rateSample S001 96.4 %Sample S002 98.5 %Sample S003 96.7 %Average: 97.2 %
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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
Clinicalinterpretation
Interpretation Further action Interpretationcount
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
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Would be referred to another laboratoryfor further examination
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
Would be referred to another laboratoryfor further examination
3 100 % 1
New sample requested 1 100 % 1HIV-2 Ab positive, confirmed 1 50 % 2HIVAb reactive, reported withoutconfirmation
21 50 % 2
Would be referred to another laboratoryfor further examination
8 100 % 1
New sample requested 3 100 % 1Laboratory does not give clinicalinterpretation
23 - -
Would be referred to another laboratoryfor further examination
4 100 % 1
New sample requested 1 100 % 1Total: 259 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
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
Interpretation Methodics Interpretationcount
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 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
Interpretation Score
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Negative 1 - -LIAISON XL HIV Ab / Ag, Diasorin 1
Positive 1 - -Elecsys HIV duo, Roche 1
Total: 2
HIVAb,confirmatory test
Interpretation Methodics Interpretationcount
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
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Positive 4 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 100 %
HIV-2 Ab,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Negative 3 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 100 %
HIVAg (p24),confirmatory test
Interpretation Methodics Interpretationcount
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
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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
Clinicalinterpretation
Interpretation Further action Interpretationcount
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 - -
Not yet reported, primary test(s)reactive, referred
3 0 % 0
Would be referred to another laboratoryfor further examination
2 - -
Laboratory does not give clinicalinterpretation
20 - -
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Total: 259 98.7 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
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 %
HIVAgAb (combo),primary test
Interpretation Methodics Interpretationcount
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
ARCHITECT HIV Ag/Ab Combo, Abbott 100Elecsys 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 76LIAISON 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
1
Positive 5 0 % 0ARCHITECT HIV Ag/Ab Combo, Abbott 3HIV Combi PT, Roche 2
Total: 247 98 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
Interpretation Score
Negative 2 - -Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
Total: 2
HIVAb,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Negative 5 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 4Total: 5 100 %
HIV-1 Ab,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Negative 1 - -Inno-Lia HIV I/II, Innogenetics 1
Total: 1
HIV-2 Ab,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Negative 1 - -Inno-Lia HIV I/II, Innogenetics 1
Total: 1
HIV, antibodies and antigen detection, March, 1-2020
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31.03.2020 7/10
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
Clinicalinterpretation
Interpretation Further action Interpretationcount
Furtheractioncount
AVRsuccess
rate
InterpretationScore
FurtheractionScore
HIVAb negative 1 0 % 0Indeterminate (tests don’t give clearresults)
2 0 % 0
Would be referred to another laboratoryfor further examination
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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Would be referred to another laboratoryfor further examination
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
Would be referred to another laboratoryfor further examination
8 100 % 1
New sample requested 3 100 % 1Laboratory does not give clinicalinterpretation
22 - -
Would be referred to another laboratoryfor further examination
3 100 % 1
New sample requested 1 100 % 1Total: 258 95.5 %
HIVAb (1/2),primary test
Interpretation Methodics Interpretationcount
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 %
HIVAgAb (combo),primary test
Interpretation Methodics Interpretationcount
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
ARCHITECT HIV Ag/Ab Combo, Abbott 103Elecsys 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 78LIAISON 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: 248 100 %
HIVAg (p24),primary test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
Interpretation Score
Negative 2 - -Elecsys HIV duo, Roche 1LIAISON XL HIV Ab / Ag, Diasorin 1
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Total: 2
HIVAb,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVRsuccess
rate
InterpretationScore
Test does not give a clear result 1 0 % 0recomLine HIV-1& HIV-2 IgG, MicrogenDiagnostik
1
Positive 2 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1HIV-1 Positive 9 100 % 2
Geenius HIV 1/2 confirmatory assay,Bio-Rad
2
Inno-Lia HIV I/II, Innogenetics 7Total: 12 91.7 %
HIV-1 Ab,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Positive 4 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot I 2
Total: 4 100 %
HIV-2 Ab,confirmatory test
Interpretation Methodics Interpretationcount
Methodicscount
AVR successrate
InterpretationScore
Negative 3 100 % 2Geenius HIV 1/2 confirmatory assay,Bio-Rad
1
Inno-Lia HIV I/II, Innogenetics 1New LAV Blot II 1
Total: 3 100 %
HIVAg (p24),confirmatory test
Interpretation Methodics Interpretationcount
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.