Expected to also have major public health impact
A critical new weapon is available in the struggle to deliver appropriate and timely post-exposure prophylaxis to health care workers who have percutaneous blood exposures. The Food and Drug Administration (FDA) has approved a new rapid HIV diagnostic test kit that provides results with 99.6% accuracy in as little as 20 minutes.
"It will be a critical resource in helping identify HIV infection [for] health care and emergency workers who are accidentally exposed to HIV-infected blood while doing their job," says Lester Crawford, MD, deputy commissioner at the FDA.
The newly approved HIV test is marketed under the brand name OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies Inc., Bethlehem, PA). Using a drop of blood, the new test can quickly and reliably detect antibodies to HIV. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings. To perform the test, a fingerstick sample of blood is collected from an individual 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 about 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.
The FDA currently categorizes the OraQuick test as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Under CLIA, new tests are categorized as either moderate or high complexity. This designation means that the OraQuick test only can be given in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. If the test manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions. The OraQuick test has not been approved to screen blood donors.
Still, while enabling rapid post-exposure prophylaxis decisions, the new test also is expected to have a considerable public health impact. "This test will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be take to block their newborns from being infected with HIV," Crawford says.
In addition, every year, thousands of people are tested in local clinics, but never return to get their test results. That problem should be reduced with the new test, allowing those HIV-infected to immediately seek confirmatory testing and take infection control precautions. Although the results of rapid screenings will be reported immediately, if the OraQuick test gives a reactive test result, the results must be confirmed with an additional specific test, the FDA states.
The Centers for Disease Control and Prevention (CDC) estimates that one fourth 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 & Medicaid Services are working with state and other health officials to make the test widely available and offer technical assistance and counseling training for its use.