HCV and HIV Tests for Screening Donated Blood

In vitro tests are designed for the direct detection of hepatitis C virus (HCV) RNA and HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion. Both tests have been cleared by the US Food and Drug Administration (FDA).

Both tests are run on the Cobas AmpliScreen system of Roche Diagnostics (Basel, Switzerland) also cleared by the FDA. The system's Data Output Management System is a computerized data collection system intended for use with the Cobas AmpliScreen. Both tests are based on Roche's polymerase chain reaction (PCR)-based nucleic acid technology (NAT).

The tests are designed to detect HIV-1 and HCV RNA in donations of blood and blood components during the time between infection and detection, known as the "window period.” Earlier detection of these viruses can further reduce the potential of infectious blood being transfused. During a US three-year study, the tests identified 3 HIV-1 positive and 43 HCV positive donations that would otherwise have entered the US blood supply. Roche is now working on a PCR NAT-based test for screening donated blood for the presence of the West Nile virus.




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