Table 5.: Commercial Qualitative and Quantitative HCV Molecular Assays (Modified from Ghani et al. Hepatology 2009)

Qualitative Assay Application LOD Technique Type Amplification
AmpliScreen 2.0 (Roche Molecular System) Blood screening < 50 UI/ml Semi-automated rtPCR Target
Amplicor HCV 2.0 (Roche Molecular System) To Confirm active infection 60 UI/ml in serum 50 UI/ml in EDTA Manual rtPCR Target
Cobas Amplicor Monitor HCV 2.0 (Roche Molecular System) To Confirm active infection 50 UI/ml in EDTA 60 UI/ml in serum Semi-automated rtPCR Target
Versant HCV RNA (Siemens Healthcare Diagnotics) To Confirm active infection/ Blood screening 5 IU/mll Semi-automated TMA Target
Procleix HIV/HCV assay (Gen Probe) To Confirm active infection/ Blood screening <50 IU/ml Manual TMA Target
Procleix Ultrio assay (Gen Probe) To Confirm active infection/ Blood screening <50 IU/ml Automated TMA Target
Quantitative Assay LOD and Dynamic Range (IU/L) 1 IU/L conversion Technique Type Amplification
Amplicor HCV Monitor 2.0 (Roche Molecular System) 600 (600-500,000) 0.9 copies/ml Manual competitive rtPCR Target
Cobas Amplicor Monitor HCV 2.0 (Roche Molecular System) 600 (600-500,000) 2.4 copies/ml Semi-automated competitive rtPCR/ automated Target
Cobas AmliPrep/Cobas TaqMan HCV (Roche Molecular System) 15(43—69,000,000) 2.7 copies/ml Semi-automated compeitive rtPCR Target
Versant HCV RNA 3.0 Quantitative assay (Siemens Health Care Diagnostics) 520 (615-700,000) 5.2 copies/ml Semi-automated branched DNA Assay Signal
LCx HCV RNA Quantitative assay (Abbott Laboratories) 23 (25-2,300,000) 4.3 copies/ml Semi-automated Competitive rtPCR Target
SuperQuant (National Genetic Institute) 100 (600-1,470,000) 3.4 copies/ml Semi-automated Competitive rtPCR Target
Abbott RealTime (Abbott Molecular Diagnostics) 12 (12-100,000,000) Not available Automated rtPCR Target