(CNN) - The first over-the-counter rapid HIV test will soon be available for use at home. The U.S. Food and Drug Administration gave its approval today (Tuesday). The OraQuick In Home HIV Test is a self-administered kit that detects the presence of the virus that causes AIDS.
To use the kit, participants swab the upper and lower gums of their mouth, then place the sample into a developer vial. The results are available within 20 to 40 minutes.
A positive result does not mean one is infected, but additional testing should be done at a medical facility.
The Centers for Disease Control and Prevention estimates that 1-point-2-million people in the U.S. are living with HIV infection. About one in five don't know they are infected.
The FDA approved another in-home test in 1996, however those samples needed to sent away to a lab for results. The rapid test kit is expected to be available in stores and online in early October.