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.