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OraQuick HIV Self-Test
OraQuick HIV Self-Test is a visually read, qualitative immunochromatographic test for the detection of antibodies to HIV-1 and HIV-2.
Manufacturer: OraSure Technologies Inc (Bethlehem, PA)
Detects: HIV-1 and HIV-2
Quality Standards: WHO PQ
WHO PQ Number: PQDx 0159-055-01 (self-test); PQDx 0159-055-00 (professional use)
WHO Listing Dates: 20 July 2017 (self-test); 8 April 2016 (professional use)
Two systematic reviews and meta-analyses comparing HIV self-testing to standard HIV testing services have been published. Johnson et al (2017) found that HIV self-testing is associated with increased uptake and frequency of testing, while Figueroa et al (2018) found that self-testers can reliably and accurately conduct HIV rapid diagnostic tests, as compared with trained healthcare workers.
Summary of WHO PQ product performance evaluation |
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|---|---|
Reference standard | Not specified |
Sample type | Oral Fluid |
Number of specimens | 596 |
Evaluator | WHO at the Institute of Tropical Medicine (Antwerp, Belgium) |
Evaluation Period | 2015 |
Performance characteristics in comparison with an agreed reference standard: oral fluid specimens (N=596) |
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|---|---|---|
Initial (95% CI) | Final (95% CI) | |
Sensitivity % | *99.1% (94.8% – 100%) | Repeat testing was not conducted |
Specificity % | 100% (99.0% – 100%) | Repeat testing was not conducted |
Invalid rate % | 0.1% | |
Inter-reader variability % | 0.4% |
*For patients not on antiretroviral therapy (ART)
Note: Product performance evaluation for the OraQuick HIV 1/2 Self-Test was considered from the professional use product, OraQuick HIV 1/2 Rapid Antibody Test, which was prequalified in 2016.