CDC Selects OraSure's OraQuick Rapid HIV-1/2 Test for MIRIAD Project
This article was originally published in The Gray Sheet
Executive Summary
OraSure Technologies is hoping that the Centers for Disease Control and Prevention's inclusion of the OraQuick rapid HIV-1/2 test in a maternal AIDS intervention study will raise the product's visibility among U.S. public hospitals.
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Firm files premarket approval application for the rapid HIV test, designed to detect antibodies within 20 minutes in oral fluid, whole blood, serum or plasma (1"The Gray Sheet" May 1, 2000, p. 17). The PMA covers serum and whole blood only. OraSure expects to file for use with oral fluid in the fourth quarter, upon completion of related trials
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Abbott/Murex
The only rapid HIV test available on the U.S. market, the Abbott Murex Single Use Diagnostic System HIV-1 test, resumes availability after a seven months hiatus, FDA Center for Biologics Evaluation and Research announces May 10. Production was halted in October 2000 after a failure to meet certain panel and negative control specifications. After adding supplemental testing to ensure the product met its quality control specifications, CBER determined that five consecutive lots of the SUDS HIV-1 tests Abbott submitted could be released for clinical use