Issue Stories
Automated PCR plasma screening for HCV and HIV-1
Cobas AmpliScreen system has received a 510(k) clearance
The FDA-cleared Cobas Ampli Screen 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. The tests are qualitative in vitro tests for the direct detection of Hepatitis C virus RNA and Human Immunodeficiency virus (HIV-1) RNA. Roche Diagnostics www.CLPmag.com Keywords: infectious disease, HIV, HCV, molecular diagnostics, blood banking
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