The World Health Organization recently gave Mylan N.V., partnered with Atomo Diagnostics, the pre-qualification green light to continue with the handheld in-vitro HIV rapid diagnostic test for self-testing device. With its pre-qualification status, it lets Ministries of Health and worldwide funders know the product meets international standards of performance, quality and safety.
The self-test will determine if there are any HIV type 1 or type 2 antibodies using a fingerstick method that is built into the safety lancet. It uses one-fifth of the blood volume other tests need and can provide results in as little as 15 minutes.
At-home testing kits expand the access hard-to-reach populations, making it far more convenient for these individuals to get tested and treated. People who are at significant risk of catching HIV are not as likely to be tested for the disease. Self-testing kits are looking to eliminate the gap.
The Mylan N.V testing device is roughly 99.7 percent accurate with 99.6 percent rating for both specificity and sensitivity. A Mylan representative said the device eliminates the need for several test components, as it’s an all-in-one device.
About 25 percent of people (9.4 million individuals) do not know they have HIV, and countries have been looking for ways to improve the availability of testing to decrease the number. 59 countries currently have HIV self-testing policies in place.
Desmond Tutu HIV Foundation Executive Director and former International AIDS Society President Linda-Gail Bekker said HIV testing is a huge game-changer that helps in meeting the 90/90/90 targets the UNAIDS has set forth. Basically, 90 percent of the people who are HIV positive will need to know that by 2020.
According to Bekker, user-friendly, high-quality tests are very potent tools in increasing the vulnerable population’s diagnosis and treatment.
The companies’ partnership became in September 2018, which led to special commercialization rights to the test in over 100 companies around the Middle East, Africa, Asia, Latin America and the Commonwealth of Independent States.
With the WHO pre-qualification, the device must go through a translucent assessment such as consistency testing, dossier review, performance evaluation, and on-site manufacturer visits. If a person gets a positive result from the Mylan HIV Self Test, they must have a healthcare professional confirm the results and have not had a recent HIV infection before the antibodies appeared.
Written by Mark Riegel, MD
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