A workshop on the implementation of NAT to screen donors of blood and plasma for viruses, sponsored by the FDA, was held on December 14, 1999, in Bethesda, MD. Participants included representatives from companies that are testing donations of blood and plasma under investigational new drug exemptions (INDs), representatives of blood and plasma trade organizations, foreign regulatory and public health officials, and FDA staff members. The goal of the workshop was to discuss the issues and progress in implementing NAT to detect viruses in blood and plasma, including HCV, HIV‐1, HBV, and parvovirus B19. An earlier workshop, in 1998, had addressed many aspects of NAT screening for HCV. At the present workshop, industry representatives reported a projection that >99 percent of whole blood and source plasma collected in the United States would be tested in minipools by NAT for both HCV and HIV‐1 by the end of 1999. In actuality, 99 percent of source plasma and >95 percent of whole blood were being tested by NAT for both HCV and HIV‐1 by the end of 1999. In the United States at the present time, pool sizes for NAT screening of source plasma range from 96 to 1200 units
Transfusion – Wiley
Published: Jan 1, 2000
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