FDA clears OraSure in-home rapid HIV test kit

4 July 2012 (Last Updated July 4th, 2012 18:30)

The US Food and Drug Administration (FDA) has cleared OraSure Technologies' OraQuick in-home HIV test to help people learn whether or not they have been infected with the HIV virus.

The US Food and Drug Administration (FDA) has cleared OraSure Technologies' OraQuick in-home HIV test to help people learn whether or not they have been infected with the HIV virus.

The self-administered OraQuick in-home HIV test, an over-the-counter (OTC) version of the company's OraQuick Advance HIV-1/2 antibody test, is designed to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).

The OraQuick test places the collected oral fluid sample into a developer, provided as part of the kit, to provide test results within 20 to 40 minutes.

The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods, according to the FDA.

Clinical studies for self-testing have demonstrated that the OraQuick in-home HIV Test has an expected performance of 92% for test sensitivity, as well as 99.98% for test specificity.

OraSure Technologies president and CEO, Douglas Michels, said the in-home HIV oral test allows individuals to learn their HIV status in the comfort of their home and obtain referral to care if needed.

"This new in-home rapid test - the same test doctors have used for years - will help individuals at risk for HIV, who otherwise may not test in a professional or clinical setting," Michels added.

The OraQuick in-home HIV test is expected to be available for purchase in October 2012 at more than 30,000 retail outlets and online.