At-Home HIV Test Awaits Final FDA Approval

A recent study found that nearly 240,000 HIV positive carriers in the United States are not aware they have the disease, however that problem may soon be easily fixable with a new at-home HIV test that is currently awaiting final Food and Drug Administration (FDA) approval.

Known as OraQuick, the test only requires a mouth swab which can then deliver HIV test results in as little as 20 minutes.

An FDA advisory panel recently agreed that while the test is less accurate than a professionally-administered test the benefits of the test outweigh any possible incorrect results that may occur.

OraQuick received a unanimous vote from the 17 member strong FDA advisory panel and the organization is expected to announce its final decision later in the year.

According to OraSure the test is 99% accurate when administered by professionals who have been able to use the test since 2004. A recent at-home trial of non-professional users found the test to be 93% accurate when administered at home.

At those rates the test would still miss 3,800 cases per year based on current numbers, however it could potentially identify upwards of 45,000 cases and prevent 4,000 new transmissions each year if enough people choose to take the test.

On average 50,000 new HIV transmissions are estimated to have occurred each year for the last two decades.

It has been a big month for HIV prevention and testing, last week a separate FDA advisory panel voted to allow the first drug known to help prevent against HIV.

While the FDA does not have to agree with its advisory panels in most cases the organization follows their suggestions.