Known as the OraQuick In-Home HIV test, the test was developed by OraSure Technologies, Inc.
“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,” the FDA said in a new release.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”
The FDA says clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with the kit, one negative result could be expected.
“A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result,” the FDA said. “Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.”
FDA officials noted that the OraSure in-home test is the first HIV test that allows users to learn their results at home immediately without interacting with a lab or medical professionals.
The officials said the new test’s potential for identifying large numbers of people who don’t know they are infected outweighs concern by some that people who test positive should have immediate access to counseling and medical advice.
Experts estimate that one-fifth of the people infected with HIV are unaware of their status and often contribute to the infection of others.