FDA Panel Recommends In-Home HIV Testing Kit Be Approved

The first over-the-counter HIV testing kit to offer quick in-home results may soon find its way to medicine cabinets near you.

This week, a 17-member Food and Drug Administration (FDA) advisory panel unanimously recommended the FDA approve the OraQuick In-Home HIV Test, which requires only an oral sample taken by swabbing the mouth, and delivers results in 20 minutes. This test is in contrast to the only other approved over-the-counter HIV test, the Home Access Express HIV-1 Test System, which requires blood samples that must be mailed to a lab.

Reuters reported that the panel believed that the benefits of the device outweighed questions about the accuracy of the home test compared to tests given in a doctor's office or clinic:

FDA officials said the OraQuick In-Home test showed a high degree of effectiveness in detecting HIV infection. But some research data suggested the test lacked sufficient sensitivity to avoid false negative results.

False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.

Some panel members argued for strongly worded labeling about false results and procedures to link those who telephone a company hotline with questions with healthcare professionals.

U.S. health officials told the panel that home-testing could help get needed healthcare to HIV-positive individuals earlier. At present, only 62 percent of those with HIV are linked to the healthcare services and just 28 percent have access to drugs capable of suppressing the infection.

According to WebMD, another concern is the price, which has yet to be set but is believed will be more than the $20 professional version but less than $60. This raises concerns that these tests may not be accessible for people of lower incomes.

Yet, advocates for at-home tests believe that this might be a step in the right direction in terms of bridging the HIV testing gap in the U.S. It's estimated that almost 240,000 Americans are HIV positive and don't know it. Past reports suggest that some people would be more willing to submit to HIV testing if they could do it in the privacy of their own homes.

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