OraSure OraQuick
This article was originally published in The Gray Sheet
Executive Summary
Rapid HIV-1 antibody test is granted CLIA waived status - expanding its availability to about 100,000 U.S. sites, including physician offices and HIV counseling centers. PMA approval of the 20-minute, whole-blood fingerprick test in November limited use to the roughly 38,000 domestic CLIA-approved labs that perform moderate complexity testing. The formal CLIA waiver application submission to FDA, one day before approval Jan. 31, included data confirming that 102 untrained users could administer the test. "Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are at high risk of HIV is vital to the public health," HHS Secretary Tommy Thompson states. Clinical trials showed 99.6% sensitivity and 100% specificity (1"The Gray Sheet" Jan. 6, 2003, p. 28)...