FDA approves rapid at-home HIV test kit

The FDA has approved for home use the rapid HIV test OraQuick already in use at clinics and testing centers throughout the nation. (Photo courtesy OraSure Technologies Inc)

The U.S. Food and Drug Administration approved Tuesday the rapid OraQuick In-Home HIV Test for over-the-counter sales for the first time.

“The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,” the FDA said in a release.

Experts estimate one-fifth of those infected with HIV are unaware of their status. The Centers for Disease Control and Prevention estimates 1.2 million Americans are living with HIV, and that there are 50,000 new HIV infections annually, primarily transmitted from people unaware of their HIV status. As such, increasing access to the HIV screener has become a cornerstone of the fight against the disease.

The newly approved test, which allows users to swab their gums in order to detect the presence of antibodies to HIV in 20 to 40 minutes, will soon bring into homes a tool that clinics have been using since 2004.

“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 in a press release, Tuesday. “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.”

Clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with this kit, one negative could be expected, which raised alarm among HIV/AIDS activists.

“Shortly after my first post on this product, I managed to corner an OraSure executive backstage at the NYC AIDS Walk, where I grilled him about the possible abuses of the product by parents and partners and about the potential for self-harm upon a positive result,” wrote AIDS activist and gay blogger Joe Jervis in a blog post on Tuesday. “He told me that the company had considered all of that and had the position that those hopefully rare occurrences were outweighed by the potential for getting many more people on the necessary treatments.”

The FDA release addressed those concerns as well on Tuesday.

“A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result,” the release read. “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 OraSure test is the first test that allows users to learn their results at home immediately, without interacting with professionals, which some experts say may not be ideal. The Home Access Health Corporation’s ‘Home Access HIV-1 Test System’ was given FDA approval in 1996, and continues to be available to consumers widely in stores and pharmacies around the nation. The system differs from the approved oral-swab OraSure test, as the test performed is a self-collected fingerstick blood sample that is mailed to the Home Access Health Corporation’s College of American Pathologist accredited laboratory for testing. The results are also given to the consumer via trained HIV professionals, with immediate counseling available.

“We believe that an individual’s access to HIV testing in the privacy of their own home is critical to knowing their HIV status,” said Home Access Health Corporation president Mary Vogt, calling differences in accuracy between the two tests “significant.” “It’s our hope that FDA’s approval of another at-home testing option will add to the body of knowledge surrounding risk factors for HIV, increase overall testing, and reduce the rates of transmission of this dangerous virus.”

Home Access Health Corporation has provided the following side-by-side comparison of the two tests:

Home Access provided the above side-by-side comparison of the two tests to media outlets. (Source: Home Access Health Corporation)