OraSure Technologies has received FDA approval for its OraQuick In-Home HIV Test for sale directly to consumers. Although other HIV tests have been approved earlier, they all required the user to send back the acquired sample to a laboratory for results. The OraQuick is the first testing option with results available directly at home in as little as 20 minutes. Moreover, it is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over the counter.
The OraQuick In-Home HIV Test is an over-the-counter version of the company’s OraQuick ADVANCE HIV 1/2 Antibody Test, which has been available for much longer. The HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab. Each test kit includes detailed information on HIV and HIV testing, and a support center is available 24/7 that will, amongst other things, arrange referrals in case of a positive test result. The test is expected to be available for purchase this October.
Press release: OraSure Receives FDA Approval of OraQuick(R) In-Home HIV Test…
Product page: OraQuick ADVANCE HIV 1/2 Antibody Test…