Table 2.
Assay | Distributor | Technology | Detection limits (IU/mL) | Genotypes | Approval status |
Qualitative HCV RNA detection assays | |||||
AmplicorTM HCV 2.0 | Roche molecular Systems | PCR | 50 | All | FDA, CE |
VersantTM HCV | Siemens Medical Solutions Diagnostics | TMA | 5-10 | All | FDA, CE |
Quantitative HCV RNA detection | |||||
AmplicorTM HCV Monitor 2.0 | Roche molecular Systems | PCR | 500 to approximately 5.105 | All | CE |
HCV SuperQuantTM | National Genetics institute | PCR | 30 to 107 | All | U.S only |
VersantR HCV RNA 3.0 | Siemens Medical Solutions Diagnostics | bDNA | 615 to 8.106 | All | FDA, CE |
CobasR AmpliPrep/High pure system/CobasR TaqManR | Roche molecular Systems | Real-time PCR | 15 to 107 | All | FDA, CE |
Abbot RealTimeTM HCV | Abbot Diagnostics | Real-time PCR | 10 to 107 | All | FDA, CE |
Artus HCV QS-RGQ assay | Qiagen | Real-time PCR | 34 to 108 | All | CE |
VersantRR HCV 1.0 kPCR assay | Siemens | Real-time PCR | 10 to approximately 107 | - | CE |
HCV: hepatitis C virus; TMA: Transcription-mediated amplification of RNA; bDNA: Branched DNA hybridization assay.