Trinity Biotech's Uni-Gold
This article was originally published in The Gray Sheet
Executive Summary
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)