US approves HIV home test kit

An HIV home test kit has been approved for marketing in the US. The ‘OraQuick’ kit from US diagnostics firm OraSure, is already in use by clinics, but until now the company has not been allowed to market it for home use.

Users collect an oral sample by swabbing their gums and putting the swab into a buffer solution. The kit then provides a result in 20–40 minutes.

The Food and Drug Administration says that the test should not be considered conclusive. It gets the answer right 92% of the time when the user is infected and 99.98% when they aren’t. Despite this shortcoming, the FDA adds: ‘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.’

OraSure is planning to launch the home test version of the kit in October.