Supporters of home kits say more people will get tested and get treatment sooner, if infected. However, concerns have been raised about whether a doctor or counselor should be nearby if people find out they are HIV-positive.
If approved, the test would become the first FDA-approved test a person can take without the presence of a health care worker, or the requirement of mailing a sample to a lab.
OraSure Technology has not decided the cost of the kit. The company sells the kits for between $12 and $17 to clinics and doctors.
Ron Spair, the company's chief financial officer, says the test is accurate more than 99 percent of the time, adding a positive result from the test should be confirmed through an additional test by doctors or public health officials.
On Nov. 3, FDA's Blood Products Advisory Committee, will consider whether to recommend the product for over-the-counter sales. The FDA makes the final decision following the advice of its advisory committees.
To take the test, a person swabs the inside of their mouth, between their cheek and gum, to insert their saliva into a vial of fluid that comes with the kit. Twenty minutes later, an indicator will light up if the test detects the presence of HIV-1 or HIV-2 antibodies.
About 1 million people in the United States are believed to have HIV. The Centers for Disease Control and Prevention estimates nearly 300,000 people have the virus but do not know it.
