First Home-Use DIY HIV Test Approved by FDA
Good news for those who wants to test themselves for Human Immunodeficiency Virus (HIV).
On Tuesday, July 3, 2012, the FDA approved the first do-it-yourself (DIY) HIV test that would give people their results in the privacy and comfort of their own home.
“Knowing your status is an important factor in the effort to prevent the spread of HIV. 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,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said.
The HIV test, called OraQuick(R) In-Home HIV Test, involves swabbing the gums, placing the swab into a vial, and then seeing preliminary results within 20 minutes. If positive, the test device will reveal two reddish-purple lines in a small window indicating signs that the body’s immune system has geared up to battle against HIV.
It is also worth noting that the the HIV test uses oral fluid, which is not the same as saliva. Its results are considered preliminary, and should be confirmed by a blood test.
OraSure Technologies, Inc., the company who manufactured the product, had an initial trial with the device. In nearly 5,700 people who took the at-home version of the HIV test, 114 thought they were HIV-positive but only 106 of them actually were. That means that positive results were accurate 93 percent of the time. Negative results were accurate 99.98 percent of the time, the company claims.
The company said that the new home-use HIV test will be sold in supermarkets and pharmacies beginning in October this year at more than 30,000 retail outlets nationwide, as well as online. The company has not said how much the test will cost, only that it will be more than the $18 cost for the professional kit.
Doug Michels, president of OraSure, acknowledged that pricing was a “fine balance,” but said his company’s product was not designed to replace other options.
The test, which looks for signs of HIV in oral fluid, is already being used since 2004 at hospitals and doctors’ offices where medical professionals administer it.
Tests for the HIV, which causes AIDS, have become increasingly simpler and quicker to use since their introduction in the 1980s. In 2002, the FDA approved the first on-the-spot tests for clinics. In 2005, the FDA began exploring the possibility of approving a home test.