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.
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.
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.
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.
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.
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.
to Bekker, user-friendly, high-quality tests are very potent tools in
increasing the vulnerable population’s diagnosis and treatment.
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.