First at-home HIV test approved by FDA

OraQuick In-Home HIV Test
OraQuick In-Home HIV TestFDA

The US Food and Drug Administration on Tuesday approved the first over-the-counter test for HIV that people can take in the privacy of their homes. The test, called OraQuick In-Home HIV Test, will become available in October, but the company hasn’t yet determined how much it will cost.

It works by detecting the presence of antibodies to human immunodeficiency virus type 1 and type 2 and is 92 percent reliable; one false negative result occurs for every 12 test results in HIV-infected individuals. A single false positive occurs for every 5,000 test results in those who aren’t infected with the virus.

“A negative test result does not mean that an individual is definitely not infected with HIV,” according to the FDA in a press statement, “particularly when exposure may have been within the previous three months.”

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Where the test may prove the most useful is for high-risk individuals who forgo blood tests to screen for the AIDS-causing virus. Blood tests are more accurate, missing HIV infections far less than 1 percent of the time.

The new in-home test detects HIV antibodies via a saliva sample and provides a result within 20 to 40 minutes. Any positive result, said the FDA, should be confirmed with additional testing in a medical setting.

The federal Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with an HIV infection. About one in five are not aware they are infected, and about 50,000 new HIV infections occur every year.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.

OraSure Technologies, manufacturer of the in-home test, plans to offer a live consumer support phone line and a website to provide information on HIV and guidance to those with positive test results.

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