The Mylan HIV Self Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the detection of HIV-1 and HIV-2 antibodies in whole blood.

Manufacturer:  Atomo Diagnostics Pty Ltd (Leichardt, Australia; Muizenberg, South Africa)

Detects: HIV-1 and HIV-2

Quality Standards: WHO PQ

WHO PQ Number: PQDx 0320-090-00

WHO Listing Dates: 3 July 2019

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.