Prequalification tells global funders and Ministries of Health that the product meets global standards of quality, safety, and performance.
A handheld in-vitro HIV rapid diagnostic test for self-testing, developed by Mylan N.V. and Atomo Diagnostics, has been given Prequalification approval by the World Health Organization (WHO). Prequalification tells global funders and Ministries of Health that the product meets global standards of quality, safety, and performance.
The Mylan HIV Self Test detects the presence or absence of HIV type 1 and type 2 antibodies through a fingerstick using the built-in safety lancet. It uses 1/5 the volume of blood necessary for other tests and provides the result in just 15 minutes. The convenience of at-home testing broadens access to testing and treatment for hard-to-reach populations. People who are at higher risk of HIV are less likely to be tested, according to WHO. Self-testing aims to close that gap.
The test has been proven to be 99.7% accurate, with 99.6% sensitivity and 99/6% specificity, according to Mylan. The all-in-1 device aims to remove the need for multiple test components by integrating them into the device platform.
It is currently estimated that 9.4 million—or 25%— of people with HIV do not know their status, and many countries are searching for ways to make testing more widely available and reduce that number. Currently, 59 countries have adopted HIV self-testing policies.
In a statement, Linda-Gail Bekker, Executive Director of the Desmond Tutu HIV Foundation and a former president of the International AIDS Society, said: “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.”
Bekker added that high-quality and user-friendly self-tests can be a powerful tool in expanding diagnosis and treatment for vulnerable populations.
Mylan announced its partnership with Atomo Diagnostics in September 2018. The partnership gave exclusive commercialization rights to the test in more than 100 companies across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS), and Latin America.
WHO Prequalification aims to ensure that diagnostics, medicines, vaccines, and immunization-related equipment and devices meet global standards of quality, safety, and efficacy. The prequalification process includes a transparent assessment including dossier review, consistency testing, and performance evaluation, and site visits to manufacturers.
A positive result using the Mylan HIV Self Test would still need to be confirmed by a health care provider, and may not identify a very recent HIV infection before the antibodies have developed.
Mylan and Atomo Diagnostics Announce WHO Prequalification Approval for Mylan HIV Self Test. Mylan N.V. http://investor.mylan.com/news-releases/news-release-details/mylan-and-atomo-diagnostics-announce-who-prequalification. Published July 8, 2019. Accessed July 9, 2019.