FDA approves OTC HIV test

News that the Food and Drug Administration has approved an over-the-counter test for home use for the detection of HIV attracted wide interest in the print and online media.

NBC Nightly News reported, “The FDA has approved a new over-the-counter test for HIV that can be used at home and gets results in about a half an hour.”

The Los Angeles Times reported, “The test, manufactured by OraSure, already had been approved for medical clinics. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies beginning in October.”

The test “works by detecting antibodies in a swab from the gums.”

The AP reported, “FDA stressed in its approval announcement that the test is not 100 percent accurate in identifying people with the virus.”

Research “conducted by … Orasure showed” the test “detected HIV in those carrying the virus only 92 percent of the time, though it was 99.9 percent accurate in ruling out HIV in patients not carrying the virus.”

Individuals “who test negative should get re-tested after three months, because it can take several weeks for detectable antibodies to HIV to appear, according to Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention’s HIV unit.”

In a front-page story, the New York Times reported, “Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a ‘positive step forward’ and one that could help bring the 30-year-old epidemic under control.”

Meanwhile, “Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the FDA approval ‘wonderful because it will get more people into care.'”

The FDA, however, “does not intend for the home test to replace medical testing, but instead to provide another way for people to find out their HIV status, said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.”

The Wall Street Journal reported that Dr. Midthun said “Knowing your status is an important factor in the effort to prevent the spread of HIV.”

According to Dr. Midthun, “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.”

Bloomberg News reported that “Regulators urged people who receive a positive result with the at-home kit to confirm the finding with their doctors and a laboratory-based test.”

The Boston Globe “Daily Dose” blog reported that “OraSure Technologies … 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.”

The NPR “Shots” blog pointed out that “there’s already an approved home HIV test kit, but it requires consumers to stick a finger to collect a few drops of blood and then send the sample in to a laboratory and wait for results.”

The MSNBC “Vitals” blog reported that earlier this year, “despite concerns about learning of the serious diagnosis at home, an FDA panel unanimously agreed that the benefits of the home test outweigh the risks.”

The Philadelphia Inquirer pointed out, “This marks the first FDA approval for a rapid, over-the-counter diagnostic test that screens for infectious disease.”

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