A quantitative hepatitis C virus (HCV) RNA test must be able to tolerate sequence mismatches for accurate and reliable results. The combination of error-prone RNA replication and a high rate of virus production results in extreme genetic variability of HCV. Clinicians rely on regular HCV viral load assessment to achieve an optimal treatment outcome.
The cobas® HCV quantitative nucleic acid test delivers robust, clinically relevant assay performance based on the proprietary dual-probe assay design from Roche. cobas® HCV is designed to deliver high sensitivity to meet the requirements of current and future chronic hepatitis C therapies combined with an efficient workflow for laboratories.
The innovative, state-of-the-art dual-probe HCV viral load assay precisely distinguishes true signals from background noise leading to more accurate quantification of viral loads.
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.
1. World Health Organization (WHO). World Hepatitis Day. http://www.who.int/campaigns/hepatitis-day/2016/event/en. Accessed July 2016.
cobas® HCV Test Innovation ReviewView Full Table
cobas® HCV Test Innovation Review
Key improvements in simplicity and functionality
|cobas 6800/8800 Systems||Benefits
|CLIA complexity categorization
||Increases flexibility with personnel
|Tests per package
|Onboard open reagent stability
cobas® HCV Test Performance SummaryView Full Table
cobas® HCV Test Performance Summary
Gold Standard Performance with additional benefits
|cobas® 6800/8800 Systems|
||cobas® 6800/8800 systems
|Intended use||1. Diagnosis of chronic HCV infection
2. Monitoring patients on HCV therapy
3. Assessment of SVR
|CLIA complexity categorization||Moderate|
|Linear range||15- 1.E+08 IU/mL|
|Analytical sensitivity (LOD by probit analysis)|
|EDTA plasma (IU/mL)||
|Packaging||HCV test-specific reagent (96 tests/kit)|
|Genotypes covered||Genotypes 1-6|
|Primer and probe design||Dual probe|
|Sample types||Serum, EDTA & PPT Plasma|
|Sample size||650 uL|
|Contamination control with AmpErase||Yes|