A government advisory panel is considering whether to allow the use of the first HIV test a person can take entirely at home, alone.
The possible availability of the test, which relies on a swab on the inside of the mouth, has raised concerns about the potential psychological impact on people who learn they have the virus with no doctors or counselors present.
The test, called OraQuick Advance, is made by OraSure Technology, of Bethlehem, Pa. It is already widely available in health clinics and doctor’s offices, and the FDA is considering permitting it to be sold over the counter.
A person takes the test by taking a mouth swab and then inserting the swab in a vial of fluid that comes with the test. Twenty minutes later, the device would indicate whether it detects the presence of HIV-1 or HIV-2 antibodies inside cells picked up by the swab.
The test will not detect the virus if the person only recently acquired HIV, the virus that causes AIDS, because it takes several weeks for the antibodies to appear.
The company has not decided at what price it would sell the kits to consumers, company officials said. The company sells the kits for between $12 and $17 to clinics and doctors, he said.
The test is accurate more than 99 percent of the time, the company says. Still, a positive result from the test should be confirmed through an additional test by doctors or public health officials.
The FDA’s Blood Products Advisory Committee will consider Thursday whether to recommend the product for over-the-counter sales. The FDA has the final say, but it usually follows its committees’ advice.
FDA briefing documents posted on the Internet said these kits could lead to more people knowing whether they have HIV, which could mean earlier treatment of the infection. People afraid or unwilling to take the test, particularly those with no symptoms, may more readily test themselves with a kit they can use privately.
But the documents also note concerns about someone learning they probably have HIV when they are alone, with no health professional or counselor nearby. Company officials said they would develop instructions with the kit for someone who receives a positive result that would probably include a telephone number and web site address.
One other home test, made by Home Access Health Corp., is approved for sale in the United States by the FDA. People taking this test must take a sample from themselves and mail it to a lab for results.
Some companies market unapproved HIV tests for home use; the FDA says it is impossible to know if they are reliable.
About one million people in the United States have HIV. The Centers for Disease Control estimates nearly 300,000 people have the virus but don’t know it.