Bulletin of Dental Education

FDA Approves First Oral Fluid-Based Rapid HIV Test Kit

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The FDA has approved the use of oral fluid samples with a rapid HIV diagnostic test kit that provides screening results with over 99 percent accuracy in as little as 20 minutes. Until now, all rapid HIV tests required the use of blood in order to get such rapid results.

The original version of this rapid test—the OraQuick Rapid HIV-1/2 Antibody Test, manufactured by OraSure Technologies, Inc.—was approved November 7, 2002 for detection of antibody to HIV-1 in blood. On March 19, 2004, the FDA approved the test for detection of HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States) in blood. This latest approval represents another significant new use for the test. As when used on blood, this test can quickly and reliably detect antibodies to HIV-1, and it can be stored at room temperature and requires no specialized equipment.

“This oral test provides another important option for people who might be afraid of a blood test,” said HHS Secretary Tommy G. Thompson. “It will improve care for these people and improve the public health as well.”

To perform the test, the person being tested takes the device, which has an exposed absorbent pad at one end, and places the pad above the teeth and against the outer gum. The person then gently swabs completely around the outer gums, both upper and lower, one time around. The tester 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.

Although the results of rapid screenings will be reported in point-of-care settings, as with all screening tests for HIV, if the OraQuick test gives a reactive test result, that result must be confirmed with an additional more specific test. 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) have worked with state and other health officials to make the test widely available and to offer technical assistance and training for its use.

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