Nucleic amplification testing (NAT) has been performed on virtually all blood collected in the United States since early 1999. The testing has been focused on HIV‐1 and HCV. HBV NAT versions are being developed for implementation in the future. The impetus for implementing HCV NAT came from the European plasma fractionators whose regulations were changed to require HCV NAT‐screened products. Strong impetus in the United States also came from FDA Commissioner, David Kessler, MD, who at a September 1994 workshop urged the industry to develop sensitive NAT assays so that all recipients of blood and blood components could be assured of the safest components possible. Because of the short timeframe associated with the European requirement (in place as of July 1999), and because commercial tests were not automated (and actually not even ready for commercialization), pooled testing using manual (first‐generation) technology was adopted. NAT is performed under an investigational new drug (IND) application approved by the FDA. Two test system vendors, Gen‐Probe (San Diego, CA) and Roche Molecular Systems (RMS, Pleasanton, CA), are approved under separate IND applications. The two major goals of the NAT IND applications, independent of their sponsors, have been to show the feasibility of
Transfusion – Wiley
Published: Jan 1, 2000
Keywords: ; ; ;
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