Mylan HIV Self Test receives prequalification approval by WHO

Mylan HIV Self Test receives prequalification approval by WHO

Today, Atomo Diagnostics and partner Mylan have jointly 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.

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