By Liz Kresse
November 18, 2002

FDA Approves a Rapid Test for HIV

By Liz Kresse

On November 7, the Food and Drug Administration (FDA) approved an HIV diagnostic test that provides results in as little as 20 minutes with an accuracy rate of 99.6 percent. Standard HIV tests take two days to two weeks to provide results, a time lag that discourages thousands of people each year from returning to find out their results. In addition to encouraging people to get tested who do not want to wait days or weeks for results, other perceived benefits of the new rapid test include enabling doctors to identify pregnant HIV-infected women going into labor who were not tested during pregnancy so that steps can be taken immediately to prevent mother-to-infant transmission and helping to identify HIV infection in health-care and emergency workerThe new test is called the OraQuick Rapid HIV-1 Antibody Test and is manufactured by OraSure Technologies, Inc. The test involves a fingerstick sample of blood which is transferred to a vial where it is mixed with a developing solution. The test device is then inserted into the vial. Within 20 minutes to an hour, the test will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. As with all screening tests for HIV, a positive results must be confirmed with an additional specific test. Unlike other HIV antibody tests, the new test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional medical settings. The test is expected to cost less than $20 and to be available within 45 days.