First-of-its-kind rapid HIV test kit approved

FDA Consumer, July-August, 2004

The FDA recently approved the use of oral fluid samples with a rapid HIV diagnostic test kit that provides screening results in about 20 minutes with over 99 percent accuracy. The approval of the OraQuick Rapid HIV-1/2 Antibody Test for use with oral fluid represents a significant new use for a test that was approved previously for use on blood samples. The test can quickly and reliably detect antibodies to HIV-1, can be stored at room temperature, and requires no specialized equipment.

The person being tested for HIV-1 takes the device, which has an absorbent pad at one end, and places the pad above the teeth and against the outer gum. He or she gently swabs completely around the outer gums, both upper and lower, one time around. The tester then takes the device and inserts it into a vial containing a solution. 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.

The original version of this rapid test, manufactured by OraSure Technologies Inc. of Bethlehem, Pa., was approved in 2002 for the detection of antibodies to HIV-1 in blood. In March 2004, the FDA approved the test for detection in blood of HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States).

The Centers for Disease Control and Prevention (CDC) has estimated that one-fourth of the approximately 900,000 people infected with HIV in the United States 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 have worked with state and other health officials to make the test widely available and to offer technical assistance and training for its use.

As with all HIV screening tests, if the OraQuick test is positive, that result must be confirmed with an additional, more specific test.

The OraQuick test has not been approved to screen blood donors. And although the test is approved to detect antibodies to HIV-1 and HIV-2 when used on blood, the recent FDA approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1.