Secretary Thompson Announces FDA Approval of Rapid HIV Test Approval

Secretary Thompson announced Friday FDA approval of the use of oral swabs with a rapid HIV diagnostic test kit. The OraQuick Rapid HIV-1/2 Antibody Test provides screening results with over 99 percent accuracy in as little as 20 minutes.

About 850,000 to 950,000 Americans are currently living with HIV and a quarter of these don't even know they are infected. Approximately 30% of people being tested for HIV in public clinics did not come back a few weeks later for the standard test results. This new test will return results in approximately 20 minutes. This oral test also provides another important option for people who might be afraid of a blood test and will greatly reduce the risk of transmitting HIV to health care workers since they will not be exposed to blood.

The test works as follows:

• The person being tested for HIV places an absorbent pad above the teeth and against the outer gum.
• They gently swab completely around their outer gums, both upper and lower.
• Then, the device is inserted into a vial containing a solution.
• The test device will reveal the presence of HIV-1 antibodies by displaying two reddish-purple lines in a small window on the device in as little as 20 minutes.

Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services (CMS) have worked with state and other health officials to make the test widely available and to offer technical assistance and counseling training for its use.

In November of 2002, the FDA approved the OraQuick test for detection of the HIV-1 antibody in blood. On March 19, 2004, FDA approved this test for the detection of HIV-2 - a variant of HIV prevalent in parts of Africa but rarely found in the US - in blood. The OraQuick test is manufactured by OraSure Technologies, Inc.