HealthDay News — The FDA has approved the OraQuick In-Home HIV test (OraSure Technologies), the first over-the-counter test to detect antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2), which are known to cause AIDS, the agency announced.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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 test allows users to swab the upper and lower gums and obtain results about their HIV-status within 40 minutes. However, a positive result does not mean the test user is necessarily infected with HIV, but that additional testing should be done by a medical professional, the FDA said.
Similarly, a negative result does not guarantee that the test user is not infected with HIV, particularly if possible exposure to the virus has come within the prior three months.
Clinical trial results show the test has a 92% sensitivity, and a 99.98% specificity, which translates to one false negative result in every 12 tests among individuals with HIV and one false-positive result in every 5,000 tests among uninfected individuals.
The CDC estimates some 1.2 million people in the United States are infected with HIV, with about 50,000 people newly infected each year. Furthermore, about one in five people with HIV are not aware that they have contracted the disease, according to the FDA.
A clinical version of the test for use in professional settings was approved in 2004.