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July 28, 2021 01:06pm
By Jill Murphy, Associate Editor
The test has been proven to be 99.7% accurate, with 99.6% sensitivity and 99/6% specificity, according to Mylan.
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
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.
A version of this article was originally published by Pharmacy Times. View the full article atPharmacyTimes.com.