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BETHLEHEM, Pa. -- OraSure Technologies, Inc., the market leader in oral fluid diagnostics, announces that its OraQuick Rapid HIV-1 Antibody Test was reported to produce substantially fewer false-positive results than traditional lab-based HIV tests or other Food and Drug Administration (FDA) approved rapid HIV tests when used in a laboratory setting. This information is based on the results from clinical trials submitted to the FDA and published by the Centers for Disease Control and Prevention (CDC) in its study, "Rapid HIV-1 Antibody Testing during Labor and Delivery for Women of Unknown HIV Status: A Practical Guide and Model Protocol," released on Jan. 30, 2004.
The protocol was developed in order to offer guidance to clinics, laboratories, hospital administrators, and policymakers who are planning and implementing a rapid HIV testing program during labor and delivery for women of unknown HIV status. The document can be viewed on the CDC Web site (http://www.cdc.gov/hiv/rapid_testing/rt-labor&delivery.htm). The CDC recommends that rapid HIV testing be routinely offered to women whose HIV status is unknown during labor and delivery to provide the opportunity to reduce mother-to-child transmission of the virus even among women who do not seek care until labor begins.
"The data highlighted in the protocol indicate that the use of the OraQuick device during labor and delivery will provide rapid and accurate HIV results while minimizing the number of false-positive results compared to other available rapid HIV tests," said Mike Gausling, president and CEO of OraSure Technologies. "We are extremely pleased with our role in the CDC HIV testing labor and delivery protocol, and we look forward to working in conjunction with government partners to make rapid HIV testing available to all who need it."
OraQuick is the first rapid, point-of-care test approved by the FDA to detect antibodies to HIV-1 in fingerstick and venipuncture whole blood specimens in approximately 20 minutes. OraSure received FDA approval of the OraQuick test for fingerstick whole blood on Nov. 7, 2002, and for venipuncture whole blood on Sept. 5, 2003. On Jan. 31, 2003, OraSure received a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver for the test, permitting its use by more than 180,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices.
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV-1. In addition, the company supplies oral-fluid testing solutions for drugs of abuse testing.