The first FDA-approved HCV RNA viral load test for use as an aid in the diagnosis of active HCV infections.
The combination of error-prone RNA replication with a high rate of virus production results in extreme genetic variability of hepatitis C virus (HCV). A quantitative HCV RNA test must thus be able to tolerate sequence mismatches for accurate and reliable results.
References:
1. cobas® HCV Package Insert 07175418001-01EN ver 1.0.