Global pharmaceutical company Mylan N.V. and medical device manufacturer Atomo Diagnostics announced that the Mylan HIV Self Test, a handheld in vitro HIV rapid diagnostic test for self-testing, has received Prequalification approval by the World Health Organization (WHO PQ).
The WHO PQ process includes a rigorous evaluation of the test’s technical performance and manufacturing sites. Prequalification signifies that the product meets global standards of quality, safety and performance and is a signal to global funders and Ministries of Health that the product can be procured. The Mylan HIV Self Test detects the presence or absence of HIV antibodies through a fingerstick. It uses one-fifth the volume of blood necessary for other tests and provides a result in just 15 minutes.
Linda-Gail Bekker, Executive Director of the Desmond Tutu HIV Foundation and a former president of the International AIDS Society, stated,
“HIV self-testing can be a game-changer in helping us meet the ambitious UNAIDS 90-90-90 targets, which require that 90% of all HIV positive people know their status by 2020. Having more high-quality and user-friendly HIV self-tests on the market, like the Mylan HIV Self Test that has been Prequalified by the World Health Organization, will give us a powerful tool in expanding diagnosis and treatment of vulnerable and previously untested populations.”
The convenience and discretion afforded by self-testing enables individuals to test in the comfort and privacy of their own home, making the test an effective way of reaching hard-to-reach populations. In September 2018, Mylan announced a partnership with Atomo Diagnostics, the manufacturer of the test, covering more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS), and Latin America.