Skip to main content

The Globe and Mail

FDA approves over-the-counter HIV home test kit

Yvonne Cruz holds an OraQuick Advance HIV test at a World AIDS Day event in Chicago. The oral test's manufacture, Ora Sure Technologies, claims the test is 99 per cent accurate and provides results in 20 minutes.

John Gress/Reuters

The United States announced Tuesday that it had authorized the first over-the-counter home testing kit for HIV, the virus that leads to acquired immune deficiency syndrome (AIDS).

Under the testing procedure, the OraQuick In-Home HIV test kit will allow purchasers to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, the Food and Drug Administration (FDA) announced.

The sample is placed into the kit's developer vial and results should be available within 20 to 40 minutes.

Story continues below advertisement

The FDA noted that a positive result from the test does not mean a person is definitely infected with HIV (human immunodeficiency virus), but rather that an additional test should be done in a medical setting to confirm the 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 FDA said in a statement.

The home testing kit has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods, according to the FDA.

The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection – of which about one in five are not aware they are infected.

There are about 50,000 new HIV infections every year and many of those infections are transmitted from people who are unaware of their HIV status.

"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.

"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," she added.

Story continues below advertisement

Clinical studies for self-testing have shown that the OraQuick home HIV test has an expected performance of 92 per cent for test sensitivity, the percentage of results that will be positive when HIV is present, said the FDA statement.

"This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals," it added.

Similar testing indicates that one false positive would be expected out of every 5,000 test results in uninfected individuals, according to the FDA, which is responsible for regulating medication in the United States.

Report an error

The Globe invites you to share your views. Please stay on topic and be respectful to everyone. For more information on our commenting policies and how our community-based moderation works, please read our Community Guidelines and our Terms and Conditions.

We’ve made some technical updates to our commenting software. If you are experiencing any issues posting comments, simply log out and log back in.

Discussion loading… ✨