What is the significance of the Food and Drug Administrations (FDA) approval of the OraQuick rapid HIV test for oral fluid on March 26, 2004?
The FDA has approved the OraQuick Advance HIV1/2 Antibody Test for use with oral fluid and for use on plasma specimens. Until now, the test, manufactured by OraSure Technologies, Inc., was approved only for whole blood specimens. This is the only rapid HIV test to be approved in the US by the FDA for use with oral fluid. What is the difference between the OraQuick Advance Rapid HIV 1/2 Antibody Test for oral fluid and the OraQuick Rapid HIV-1 Antibody Test for blood approved by the Food and Drug Administration in November 2002? The FDA approved the new version of the test for the detection of HIV-2 antibodies and for use with additional types of specimens. Until now, the OraQuick rapid HIV antibody test required a whole blood specimen, either from a fingerstick or a tube of blood. The OraQuick Advance test can now be used with oral fluid specimens taken from the mouth, with plasma, and with whole blood. Additionally, the new version of the test can be performed in a wider range of oper
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