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INSTI HIV Self Test
INSTI HIV Self Test is a qualitative immunoassay that uses blood to detect HIV-1 and HIV-2 antibodies.
Manufacturer: bioLytical Laboratories Inc (Richmond, Canada)
Detects: HIV-1 and HIV-2
Quality Standards: WHO PQ
WHO PQ Number: PQDx 0002-002-01 (self test); PQDx 0002-002-00 (professional use)
WHO Listing Dates: 27 November 2018 (self-test); 29 August 2013 (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 | Clinically derived samples |
Number of specimens | 1079 |
Evaluator | WHO at the Institute of Tropical Medicine (Antwerp, Belgium) |
Evaluation Period | Not specified |
Performance characteristics in comparison with an agreed reference standard |
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|---|---|---|
Initial (95% CI) | Final (95% CI) | |
Sensitivity % | 100% (99.1% – 100%) | 100% (99.1% – 100%) |
Specificity % | 99.7% (98.9% – 100%) | 99.7% (98.9% – 100%) |
Invalid rate % | 0% | |
Inter-reader variability % | 0% |
Note: Product performance evaluation for the INSTI HIV Self-Test was considered from the previous assessment of the professional use product, INSTI HIV-1/HIV-2 Antibody Test, which was prequalified in 2013.
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