Print this page    •   Back to Web version of article

Policy & Politics
FDA Expands Use of OraQuick Rapid HIV Test to 180,000 Sites, Including Doctors' Offices, Clinics

June 28, 2004

FDA announced on Friday that Bethlehem, Pa.-based OraSure Technologies' OraQuick Rapid HIV-1/2 Test can be used 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, the AP/New York Times reports (AP/New York Times, 6/26). 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. On Wednesday, the company announced that FDA had approved the OraQuick Rapid HIV-1/2 Test for use in detecting HIV-2 antibodies in oral samples. Although FDA already had approved the test to detect HIV-1 and HIV-2 in blood samples, it had approved the oral version of the test only for HIV-1 (Kaiser Daily HIV/AIDS Report, 6/25). The test previously was approved for use primarily in government-approved laboratories. However, following last week's approval of the test for detecting HIV-2 antibodies in oral fluid, the company "immediately" sought an FDA waiver to allow the oral fluid test to be used in clinics and doctors' offices, the Allentown Morning Call reports. OraSure President and CEO Douglas Michels said, "We believe this waiver represents the final step needed to make our new OraQuick HIV-1/2 Test the most versatile and comprehensive rapid HIV test available to the widest possible range of customers in the United States." The test is expected to go on the market in mid-August, according to the Morning Call (Shope, Allentown Morning Call, 6/26). HHS Secretary Tommy Thompson on Friday also announced that the federal government has allocated $4.8 million to the HHS Substance Abuse and Mental Health Administration to support expanded testing for HIV/AIDS among injection drug users and their sex partners, according to an HHS release (HHS release, 6/25).

Back to other news for June 28, 2004

Search the Newsroom archive

Reprinted with permission from You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at The Kaiser Daily HIV/AIDS Report is published for, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.

This article was provided by Henry J. Kaiser Family Foundation. You can find this article online by typing this address into your Web browser:

General Disclaimer: is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.