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First at-Home HIV Test Nears Approval

OraQuick Mouth-Swab Test: Results in 20 Minutes; False Assurance an Issue


There's another catch to the OraQuick in-home test: the "window period." The test detects anti-HIV antibodies, but these antibodies appear many weeks after infection.

A recent study suggests that rapid HIV tests such as OraQuick will be accurate two months after infection. OraSure says that to be safe, people should assume the OraQuick test will miss any new HIV infection contracted in the past three months.

This means that people with any HIV risk behavior -- such as unprotected sex or needle sharing -- will need regular retesting, as is true with any HIV test. And confirmatory testing at a doctor's office or free clinic is strongly advised for those who test positive but also for those who test negative despite high-risk behavior.

Is America Ready for Home HIV Testing?

HIV testing has been controversial ever since it began in 1985. In those days, before HIV drugs were developed for treatment, a positive test result was considered a death sentence.

Stigma was enormous. Children with HIV were kicked out of school. Adults with HIV lost their jobs. It took great courage for a person with HIV to tell anyone about it.

And because a positive test had such a dramatic impact, HIV testing was done only along with counseling, both before and after the result was known.

While these safeguards were necessary, they threw up barriers to testing. The hassle is one reason why so many people at risk of HIV infection never get tested -- or don't get regular HIV tests.

In 1989 and again in 1990, the FDA was approached by companies that wanted to sell HIV tests over the counter. But according to an FDA briefing document, "the state of technology and public-health thinking at that time was not conducive to such a claim."

In other words, America wasn't ready for a home HIV test. But in 1996, the FDA approved two kits that allowed people to gather blood or mouth-swab samples and send them off to a lab for testing. Test results, counseling, and referral to medical care were available by phone.

These tests did not have much of an impact on HIV testing by people at risk of infection. So the FDA was happy to listen to OraSure when the company suggested it could expand access to testing with an at-home test.

The result, after three rounds of ever-more-realistic testing, was still not a slam dunk. Concerned that the test might falsely assure too many people with HIV that they were not infected, the FDA asked today's expert panel to consider all the issues involved.

The panel's unanimous vote today suggests that the U.S. has entered a new era of HIV testing.


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