Essential medicines and health products

In lead-up to World AIDS Day, WHO prequalifies second HIV self-test

prequalified HIV self-test

Produced by bioLytical (Canada), the INSTI HIV SELF TEST can be used on one drop of finger stick whole blood. The test result can be read immediately, and studies show that it is very accurate (99.8%).

WHO assesses in vitro diagnostic tests for priority conditions according to quality, safety and performance requirements. When these standards are found to have been met, WHO includes the product on its prequalification list, which can be used as a reference for quality-assured medical products by countries and other large buyers of such products. Prequalification is a precondition for international procurement agencies, such as as the Global Fund to Fight AIDS, TB and Malaria, PEPFAR, UNITAID, UNICEF and Médecins Sans Frontières.

Self-testing for HIV has been recommended by WHO since 2016. Evidence shows that it is safe and accurate and highly acceptable to populations. Self-testing can be done in the privacy of one’s home and does not need sophisticated laboratory equipment. For that reason, it has the potential to reach many more people, including first-time testers, people with undiagnosed HIV or those at ongoing risk who are in need of frequent retesting.

It is hoped that HIV self-testing will help achieve the first of the United Nations 90–90–90 targets for HIV, one of which is that 90% of all people with HIV know their status by 2020.