NAT for screening blood and plasma for viruses have been rapidly developed and implemented for the detection of HCV and HIV‐1. The US FDA has had to develop regulatory policies under conditions not previously encountered, namely the development, improvement, and application of new test technologies occurring at such unprecedented speed that nearly all blood and plasma donations would need to be tested while the methods were still in clinical trials. This rapid pace of development can be clearly seen to extend into the future; NAT procedures for additional viruses and modifications of NAT for greater sensitivity and the rapid detection of many viruses simultaneously are currently under development. It had been clear for several years that the increased sensitivity for detecting HCV and HIV‐1 by NAT would give an added level of safety to the nation's blood and plasma supply and that widespread use at the earliest possible date, even if conducted under investigational exemptions before approval of licenses for NAT systems, would be desirable. Furthermore, the expectation in the late 1990s that NAT screening of plasma for HCV would be required by European regulatory authorities, and the fact that substantial volumes of plasma collected in the United
Transfusion – Wiley
Published: Sep 1, 2002
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