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Vital Signs

FDA Approves First “Bloodless” Rapid HIV Test

When rapid HIV diagnostic tests, which deliver results in about 20 minutes, were first approved for use in the U.S., they were hailed as a major breakthrough in increasing early detection of the HIV virus and preventing the spread of AIDS by people who are unaware that they are HIV-positive. According to Department of Health and Human Services Secretary Tommy G. Thompson, “Before the approval of [rapid tests], many people being tested for HIV in public clinics did not return for the results of standard tests [which usually took a week to provide results]. Where the rapid test is available, those tested get their results within minutes.”

Now this important advance in AIDS screening has been taken one step further. On March 26, the Food and Drug Administration (FDA) approved the first oral fluid-based rapid HIV test kit. Previously, all rapid HIV tests required the use of blood samples in order to get such fast results. The oral test, designed for use in point-of-care settings, has two distinct advantages. It provides a new option for people who may have avoided being screened because they were afraid of blood testing, and it reduces health care workers’ risk of being accidentally exposed to the HIV virus through needlesticks.

The test, called the OraQuick® Rapid HIV-1/2 Antibody Test, works by having the person being tested swab his/her gums with the testing device, which has an absorbent pad at one end. Then the health care worker inserts the device into a vial containing a solution. In 20 minutes, the test will indicate if HIV-1 antibodies are present by displaying two reddish-purple lines in a small window on the device. If the OraQuick test indicates a positive reading, that result must be confirmed with an additional, more specific test.

The new rapid oral HIV test is manufactured by OraSure Technologies, Inc., of Bethlehem, Pa., which also produced the first blood-based rapid HIV test to receive FDA approval. For more information, visit the company’s Web site at www.orasure.com.