Known as the OraQuick In-Home HIV test, the test was developed by OraSure Technologies, Inc.
â€śThe test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,â€ť the FDA said in a new release.
â€śKnowing your status is an important factor in the effort to prevent the spread of HIV,â€ť said Dr. Karen Midthun, director of the FDAâ€™s Center for Biologics Evaluation and Research. â€śThe 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.â€ť
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.
â€śA 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,â€ť the FDA said. â€śSimilarly, 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.â€ť
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 testâ€™s potential for identifying large numbers of people who donâ€™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.