It is estimated that about 240,000 people carrying HIV in the nation don't know their condition, according to official reports; and testing is a chief means of slowing infections.
The test procedure involve taking an oral fluid sample collected by swabbing the upper and lower gums inside a person's mouth, placing the sample into the kit's developer vial and then waiting for the result 20 to 40 minutes.
The kit, which detects both type 1 and type 2 HIV antibodies, could identify large numbers of previously undiagnosed infections, according to the FDA.
The FDA noted that a positive result from the test does not mean a person is definitely infected with HIV, and similarly a negative result does not mean that an individual is not infected, but rather that an additional test should be done in a medical setting to confirm the result.
The Centers for Disease Control and Prevention estimates there are about 50,000 new HIV infections every year and many of those infections are transmitted from people who are unaware of their HIV status.
"Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. (Agencies)
VietNamNet/Xinhuanet