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SURE CHECK HIV Self Test
SURE CHECK HIV Self-Test is a qualitative, single-use in-vitro diagnostic self-test for detection of antibodies to HIV-1 and HIV-2 in fingerstick whole blood.
Manufacturer: Chembio Diagnostic Systems, Inc. (Medford, USA)
Detects: HIV-1 and HIV-2
Quality Standards: WHO PQ
WHO PQ Number: PQDx 0054-006-01 (self test); PQDx 0054-006-00 (professional use)
WHO Listing Dates: 29 November 2019 (self test); 8 December 2014 (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 | Serum/plasma specimens |
Number of specimens | 1118 |
Evaluator | WHO |
Evaluation Period | Third quarter of 2014 |
Performance characteristics in comparison with an agreed reference standard |
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|---|---|---|
Initial (95% CI) | Final (95% CI) | |
Sensitivity % | 99.8% (98.8% – 100%) | 99.8% (98.8% – 100%) |
Specificity % | 99.9% (99.2% – 100%) | 99.9% (99.2% – 100%) |
Invalid rate % | 0% | |
Inter-reader variability % | 0% |
Note: Product performance evaluation for the SURE CHECK HIV Self-Test were considered from the previous assessment of professional use product, SURE CHECK HIV 1/2 Assay, which was prequalified in 2014.
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