FDA approves self-administered HIV test

The FDA has approved the first over-the-counter, self-administered HIV test to detect antibodies to HIV-1 and HIV-2.

The OraQuick In-Home HIV Test allows individuals to collect a sample of oral fluid by swabbing the gums, placing the sample into a developer vial and obtaining results in 20 to 40 minutes, according to an FDA press release. A positive result should encourage people to obtain additional testing in a medical setting to confirm the results. In addition, negative results do not definitely mean a person does not have HIV.

“Knowing your status is an important factor to prevent the spread of HIV,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “The availability of a home-use HIV test kid provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

Study results of the OraQuick In-Home HIV Test have shown that the test has a 92% test sensitivity and 99.98% specificity.

"As HIV medical providers and researchers on the front lines of the HIV pandemic, we strongly support expanded access to HIV testing to improve early detection of HIV infection," Judith Aberg, MD, chair of the HIV Medicine Association, said in a press release. "We believe the rapid antibody HIV test recently approved by the Food and Drug Administration for sale over the counter holds great promise as a self-directed tool for people to learn their HIV status."

The FDA has approved the first over-the-counter, self-administered HIV test to detect antibodies to HIV-1 and HIV-2.

The OraQuick In-Home HIV Test allows individuals to collect a sample of oral fluid by swabbing the gums, placing the sample into a developer vial and obtaining results in 20 to 40 minutes, according to an FDA press release. A positive result should encourage people to obtain additional testing in a medical setting to confirm the results. In addition, negative results do not definitely mean a person does not have HIV.

“Knowing your status is an important factor to prevent the spread of HIV,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “The availability of a home-use HIV test kid provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

Study results of the OraQuick In-Home HIV Test have shown that the test has a 92% test sensitivity and 99.98% specificity.

"As HIV medical providers and researchers on the front lines of the HIV pandemic, we strongly support expanded access to HIV testing to improve early detection of HIV infection," Judith Aberg, MD, chair of the HIV Medicine Association, said in a press release. "We believe the rapid antibody HIV test recently approved by the Food and Drug Administration for sale over the counter holds great promise as a self-directed tool for people to learn their HIV status."