IMPROVED COBAS AMPLICOR(TM) VIRAL ASSAYS AS A BASIS FOR MINIPOOL SCREENING OF VIRUSES IN BLOOD OR PLASMA

Background: Serological screening assays have greatly reduced the risk of transmitting viral infections by transfusion. Testing for viral nu cleic acids should further reduce the residual transmission risk. Mate rial and Methods: With some modification, COBAS AMPLICOR(TM) Hepatitis -C (HCV) and COBAS AMPLICOR Human Immunodeficiency Virus-1 (HIV-1) tes t kits could serve as the basis of new systems for screening pools com posed of samples from individual units of blood or plasma. Results: Th e new generation of COBAS AMPLICOR HCV and HIV-1 Tests provides equiva lent amplification of all HCV and HIV-1 Group M genotypes, respectivel y. Sensitivities of 100 copies per mi for HCV and 50 copies per mi for HIV-1 have been demonstrated. A sensitivity of 100 copies per ml for HIV-1 should be achieved with simple modifications to the test paramet ers. Conclusions: Testing pools of approximately 96 units with assays exhibiting these sensitivities should further reduce the window period between exposure to virus and detection of infection, thereby reducin g the frequency of potentially infectious units in the blood supply. A utomation could allow operations in distributed facilities and provide rapid turn around of results, enabling release of most negative units within 48 h of collection.