Rapid, point-of-care HIV test receives WHO Prequalification

The OraQuick HIV Self-Test, a point-of-care test developed by OraSure Technologies, Inc. that detects HIV-1 and HIV-2 antibodies within 20 minutes, has been Prequalified by WHO, according to a press release.

“We are pleased to offer the first rapid HIV Self-Test to have received WHO Prequalification,” Douglas A. Michels, president and CEO of OraSure Technologies, said in the release. “WHO Prequalification enables government organizations implementing HIV Self-Test pilots and programs to access funding for the OraQuick HIV Self-Test.”

Based on the same platform used for other OraQuick tests, like the In-Home HIV Test and the Rapid HIV 1/2 Antibody Test, the OraQuick HIV Self-Test (HIVST) enables rapid detection of HIV antibodies with an oral swab. HIVST can be used at home, outreach testing settings or community-based screening events. More than 40 million tests have been used worldwide, the company said.
According to WHO Prequalification data, the test demonstrated 100% sensitivity and more than 99% specificity in the detection of HIV antibodies compared with a fourth-generation laboratory test. The WHO Prequalification process requires careful examination of HIVST’s technical performance to confirm that the test meets global standards of quality, safety and efficacy.

“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,” Michels said. “The Prequalification also reaffirms that our HIV Self-Test meets the stringent technical and quality standards that we place on all of our products.”

Disclosure: Michels is president and CEO of OraSure Technologies.

The OraQuick HIV Self-Test, a point-of-care test developed by OraSure Technologies, Inc. that detects HIV-1 and HIV-2 antibodies within 20 minutes, has been Prequalified by WHO, according to a press release.

“We are pleased to offer the first rapid HIV Self-Test to have received WHO Prequalification,” Douglas A. Michels, president and CEO of OraSure Technologies, said in the release. “WHO Prequalification enables government organizations implementing HIV Self-Test pilots and programs to access funding for the OraQuick HIV Self-Test.”

Based on the same platform used for other OraQuick tests, like the In-Home HIV Test and the Rapid HIV 1/2 Antibody Test, the OraQuick HIV Self-Test (HIVST) enables rapid detection of HIV antibodies with an oral swab. HIVST can be used at home, outreach testing settings or community-based screening events. More than 40 million tests have been used worldwide, the company said.
According to WHO Prequalification data, the test demonstrated 100% sensitivity and more than 99% specificity in the detection of HIV antibodies compared with a fourth-generation laboratory test. The WHO Prequalification process requires careful examination of HIVST’s technical performance to confirm that the test meets global standards of quality, safety and efficacy.

“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,” Michels said. “The Prequalification also reaffirms that our HIV Self-Test meets the stringent technical and quality standards that we place on all of our products.”

Disclosure: Michels is president and CEO of OraSure Technologies.