Over-the-counter HIV test earns CE mark

HIV Self Test
INSTI HIV Self Test--Courtesy of bioLytical

The INSTI HIV Self Test from bioLytical Laboratories has been given CE marking by EU regulators.

According to an announcement, the test will be available commercially, at some retailers and e-commerce platforms, by the end of this  year in the U.K., France and other European countries.

Rather than after 15- to 20-minute wait, as many self-test kits require, the INSTI kit claims to offer “instant results.” The announcement claims that users need only one drop of blood to detect HIV antibodies, and results are over 99% accurate.


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The INSTI HIV Self Test is the over-the-counter version of the INSTI HIV-1/HIV-2 Antibody Test. That test is approved by the FDA, Health Canada, is prequalified with WHO, and has a European CE mark.

The test is a rapid, flow-through in vitroqualitative immunoassay which detects HIV Type 1 and Type 2 antibodies.

"The current point of care INSTI HIV-1/HIV-2 test is already a market leader in both France and the UK, and we are pleased to offer our Self Test to the many individuals who wish to test themselves in the privacy of their own home without the anxiety of waiting to learn their status," said Stan Miele, chief commercial officer of bioLytical, in the announcement.

The announcement noted that as of 2014, within the WHO European Region there were an estimated 2.5 million people living with HIV, of which approximately half were unaware of their status. The UNAIDS 90-90-90 initiative has a goal that by 2020, 90% of those living with HIV will know their status, 90% of those will receiving antiretroviral therapy (ART) and of those on ART, 90% will be virologically suppressed.

The announcement said bioLytical’s self-test kit will play a role in achieving the first 90 milestone.

- here's the press release


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