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Abbott Determined To Improve Image Of HIV Tests After Regulatory Setbacks

This article was originally published in The Gray Sheet

Executive Summary

Applications submitted by African countries for Abbott's Determine rapid HIV diagnostic test will be evaluated by health care consulting firm Axios International at the end of April, Abbott said March 27.

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CDC selects firm's rapid HIV-1/2 test under treatment investigational device exemption granted by FDA, OraSure announces March 15. CDC is focusing use of test in public hospitals in five U.S. cities for delivery room testing, as well as emergency departments and outpatient clinics. No rapid HIV test currently is marketed in the U.S.; the agency authorized continued use of the investigational test by CDC because it addresses a serious and life-threatening condition for which no alternatives exist. Abbott's SUDS HIV-1 rapid test was temporarily withdrawn from the market due to quality control issues (1"The Gray Sheet" Oct. 23, 2000, p. 24). Trinity Biotech's Feb. 5 premarket approval application for Uni-Gold rapid HIV test is pending at FDA

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