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Article: New HIV test licensed. (from Epitope Corp., HIV antibodies)
- Article from:
- FDA Consumer
- Article date:
- March 1, 1995
CopyrightCOPYRIGHT 1995 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The first test system using oral fluid samples to detect the presence of HIV antibodies received FDA approval last Dec. 23. HIV is the virus that causes AIDS.
It is approved for screening only. Blood tests are still required before a diagnosis of HIV can be made. The system, consisting of a device to collect oral fluid and a test for analyzing the presence of antibodies in oral fluid, is not as accurate as the approved HIV-antibody tests used with blood.
The collection part of the test system includes a specially treated cotton pad on a stick that is placed between the lower gum and cheek to collect a sample of oral fluid. The pad is then placed in a plastic ...