The new test can quickly and reliably detect antibodies to HIV-1, the HIV virus that causes infection in most cases in the U.S. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. The new test is not approved for home use.

"This test will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be take to block their newborns from being infected with HIV," said FDA Deputy Commissioner Dr. Lester M. Crawford. "It will also be a critical resource in helping identify HIV infection in health-care and emergency workers who are accidentally exposed to HIV-infected blood while doing their job."

To perform the test, a fingerstick sample of blood is collected from an individual and transferred to a vial where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the test gives a reactive test result, that result must be confirmed with an additional specific test. The new test has not been approved to screen blood donors.

FDA currently categorizes the new test as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Under CLIA, new tests are categorized as either moderate or high complexity. This designation means that the new test can only be given in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. If the test manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions.

The Centers for Disease Control and Prevention (CDC) has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) are working with state and other health officials to make the test widely available and to offer technical assistance and counseling training for its use.