OraSure Announces U.S. Launch of OraQuick Rapid Saliva-Based HIV Test
OraSure Technologies on Wednesday said it plans to start shipping next month its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test to sites around the country, the AP/Seattle Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 10/20). The test, which produces results in 20 minutes, works with blood from a finger stick or oral fluid collected from the gums of a patient's mouth using a treated swab. In June, FDA approved the test for HIV-1 and HIV-2 in doctors' offices and HIV counseling centers in addition to certified laboratories, expanding the product's use of the test to approximately 180,000 sites. OraSure had expected to launch the test in August (Kaiser Daily HIV/AIDS Report, 6/28). The launch of the test was delayed after a clinical trial produced a higher rate of unconfirmed positive results than data obtained through company testing, according to the AP/Post-Intelligencer. The company conducted another study using more than 12,000 test readings, and that trial mirrored the use of the test in the field. The results from that study, as well as data from several independent studies, "clearly indicate that the test is operating within its specifications," according to OraSure, the AP/Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 10/20). "We believe it is the most versatile and comprehensive rapid HIV test available and are committed to making the test available to the widest possible range of customers in the United States and abroad," OraSure President Douglas Michels said. The product was scheduled to be introduced Thursday at the United States Conference on AIDS in Philadelphia (OraSure release, 10/20).
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