The blinded, multi-visit user, unobserved final phase study, enrolling 5,800 patients, were subjected with unsupervised oral fluid self-testing using an investigational OTC version of the OraQuick Advance Rapid HIV-1/2 test.
The performance of the OraQuick HIV test in the unobserved OTC setting was compared with FDA-approved laboratory HIV test results.
The study showed the identification of more than 100 previously undiagnosed individuals with HIV.
OraSure Technologies president and CEO Douglas Michels said the latest CDC figures show the status quo for testing is inadequate and additional options to capture undiagnosed individuals infected with HIV must be brought to the market.
"An easy-to-use, private, and accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support," Michels said.
