The FDA-cleared COBAS AmpliScreen System is intended for use in laboratories testing human plasma specimens with COBAS AmpliScreen Tests, which are pending FDA approval. RNA tests for HCV and HIV-1 reduce the number of days between the time a person contracts HIV or HCV and when the viruses can be detected using serological tests.
     The system combines the Hamilton Microlab AT plus 2 pipettor and the COBAS Amplicor automated bench top analyzer to automate the sample pooling amplification and detection steps of the PCR process.
     The system is designed for use with the COBAS AmpliScreen HCV Test, version 2.0 and the COBAS AmpliScreen HIV-1 Test, version 1.5. Both tests are qualitative in vitro tests for the direct detection of Hepatitis C virus RNA and Human Immunodeficiency virus (HIV-1) RNA in human plasma using PCR nucleic acid amplification and nucleic acid hybridization.
     The COBAS AmpliScreen System, along with the COBAS AmpliScreen HCV Test, version 2.0 and the COBAS AmpliScreen HIV-1 Test, version 1.5, have been used by America’s Blood Centers since 1999 under Investigational New Drug Applications (INDs) to screen blood donations for the presence of the HCV and HIV-1 RNA viruses.
Roche Diagnostics
www.roche-diagnostics.com
Keywords: infectious disease, HIV, HCV, molecular diagnostics, blood banking