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Abbott Investigating SUDS HIV-1 Test Production Problems, Exhausts Supply

This article was originally published in The Gray Sheet

Executive Summary

Production of Abbott Laboratories' single-use diagnostic system (SUDS) HIV-1 rapid test could resume within the next 30 days, the firm says following a halt in production due to a failure to meet certain panel and negative control specifications.

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OraSure's OraQuick

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 Abbott's SUDS HIV-1 rapid test was temporarily withdrawn from the market due to quality control issues (1"The Gray Sheet" Oct. 23, 2000, p. 24).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

OraSure's OraQuick

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 Abbott's SUDS HIV-1 rapid test was temporarily withdrawn from the market due to quality control issues (1"The Gray Sheet" Oct. 23, 2000, p. 24).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

Trinity Biotech's Uni-Gold

Rapid HIV test investigational device exemption allows use in cases of needlestick injury and high-risk pregnancy, to provide data for a future PMA supplement. A Feb. 5 PMA is pending for broader use of the test, which provides results in under 15 minutes. No rapid HIV test is currently marketed in the U.S. following temporary withdrawal of Abbott's SUDS HIV-1 rapid test due to quality control issues (1"The Gray Sheet" Oct. 23, 2000, p. 24)

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