The U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test—the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to HIV virus types 1 (HIV-1) and 2 (HIV-2), according to a release.

The test allows individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths; then, they place that sample into a developer vial and obtain test results within 20 to 40 minutes.

A positive result does not mean that an individual is definitely infected with HIV; instead, it means that additional testing should be done in a medical setting to confirm the test result. 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.

The CDC estimates that 1.2 million people in the United States are living with HIV.