OraSure’s HIV self-test gets WHO prequalification


US-based point-of-care (POC) diagnostics developer OraSure Technologies has obtained prequalification from the World Health Organisation (WHO) for its OraQuick HIV Self-Test (HIVST).

OraQuick HIVST is a POC test developed to enable detection of both HIV-1 and HIV-2 antibodies using an oral swab, providing results within 20 minutes at home, outreach testing settings, or at community-based screening events.

Designed to ensure global quality, safety and efficacy standards of a product, the WHO prequalification is expected to allow government organisations that implement HIVST pilots and programmes to access funding for the test.

The prequalification of the product is based on results that indicated 100% sensitivity and more than 99% specificity compared to a fourth-generation laboratory test.

OraSure Technologies president and CEO Douglas Michels said: “We believe this easy-to-use and reliable self-test product is a critical tool for meeting the UNAIDS’s 90/90/90 diagnosis and treatment targets set for 2020 and will be vital to improving the health and wellness of those living with HIV on a global scale.

"This easy-to-use and reliable self-test product is a critical tool for meeting the UNAIDS’s 90/90/90 diagnosis and treatment targets set for 2020 and will be vital to improving the health and wellness of those living with HIV on a global scale."

“The prequalification also reaffirms that our HIV self-test meets the stringent technical and quality standards that we place on all of our products.”

To date, more than 40 million OraQuick self-tests are reported to have been used by healthcare professionals and individuals.

The firm has recently signed an agreement with the Bill and Melinda Gates Foundation to decrease the test’s price in 50 developing countries for rapid adoption and deployment.

The test is currently in use in the UNITAID/PSI HIV Self-Testing Africa (STAR) project aimed at improving access to simple HIV self-tests in Malawi, Zambia and Zimbabwe.