FDA approves new HIV test kit

FDA Consumer, Jan-Feb, 2003

The FDA has approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes.

Using a drop of blood collected from a finger-stick, the OraQuick Rapid HIV-1 Antibody Test can quickly and reliably detect antibodies to HIV-1, the virus involved in most AIDS cases in the United States. Unlike other antibody tests for HIV, OraQuick can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings.

Health and Human Services Secretary Tommy G. Thompson says that many HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results. "With this new test," he says, "in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."

To perform the test, a blood sample is collected from a person 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.

People who take the rapid tests will get the results directly from their doctor's office or clinic. As with all screening tests for HIV, if the OraQuick test indicates that HIV antibodies are present, the result must be confirmed with an additional specific test. The OraQuick test has not been approved to screen blood donors. The test is manufactured by OraSure Technologies Inc. of Bethlehem, Pa.

The Centers for Disease Control and Prevention (CDC) has estimated that one-quarter of the approximately 900,000 HIV-infected people 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 are working with other officials to make the test widely available.