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In Brief: Abbott Labs

This article was originally published in The Gray Sheet

Executive Summary

Abbott Labs: Begins shipments April 26 of the HIVAG-1 Monoclonal ELISA in vitro blood donor screening test, the second HIV-1 p24 antigen screening system to reach the market since the agency's August 1995 recommendation that blood banks screen for p24. Like Coulter's ELISA antigen screen that cleared FDA in March ("The Gray Sheet" March 18, p. 10), the Abbott test is intended to reduce the "window" period between HIV infection and detection. The Abbott test is priced competitively with the Coulter test, Abbott says. Prior to the Coulter test's approval, Abbott's polyclonal-based HIVAG-1 test for use in diagnosis and monitoring applications was the only HIV-1 antigen test system on the market...
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