Article
Sensitivity of HCV RNA and HIV RNA blood screening assays.
Transfusion - 1 May 2002
Lelie P Nico, van Drimmelen Harry A J, Cuypers H Theo M, Best Susan J, Stramer Susan L, Hyland Catherine, Allain Jean-Pierre, Moncharmont Pierre, Defer Christine, Nübling Micha, Glauser Andreas, da Silva Cardoso Marcia, Viret Jean-François, Lankinen Mervi H, Grillner Lena, Wirthmüller Urs, Coste Joliette, Schottstedt Volkmar, Masecar Barbara, Dax Elizabeth M
Abstract excerpt
BACKGROUND: The FDA requirement for sensitivity of viral NAT methods used in blood screening is a 95-percent detection limit of 100 copies per mL, whereas the NAT screening system should have a sensitivity of at least 5000 copies per mL per individual donation. According to the Common Technical Specifications of the European Directive 98/79/EC for in vitro diagnostics, viral standard dilutions (calibrated against...
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