WASHINGTON – 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 (search), 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.
The FDA's Blood Products Advisory Committee on Thursday discussed issues that would be raised by approving the test for over-the-counter sales.
But FDA officials said they would not yet ask the panel of independent experts whether to recommend approval of the product, saying they were first seeking advice on appropriate standards for these kinds of products.
The FDA usually follows the advice of its committees but has the final say whether to authorize products for over-the-counter sales.
A person takes the OraQuick 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.
FDA scientist Elliot Cowan told panelists that the availability of anonymous HIV testing could lead to a greater number of people who have the virus knowing it, potentially leading them to seek treatment earlier than they would have otherwise.
Still he noted concerns about a person's reaction to learning he or she probably has HIV at a time when no health professional or counselor is immediately accessible.
In that vein, "the biggest issue that has come up repeatedly is suicidal tendencies," Cowan said.
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.
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.