Assay | Vendor | Technology (target region) | IVD Approval Status | Dynamic Range (IU/mL) | LLOQ (IU/mL) | LLOD* (IU/mL) |
---|---|---|---|---|---|---|
COBAS® Ampliprep/ COBAS® TaqMan ® v2.0 Test | Roche Molecular Systems | Real-time PCR, (5'UTR) | FDA, CE | 15 to 1.00 × 108 | 15 | 15 |
COBAS® TaqMan ® for use with the High Pure System Test, v2.0 | Roche Molecular Systems | Real-time PCR, (5'UTR) | FDA, CE | 25 to 3.91 × 108 | 25 | 20 |
Abbott RealTime HCV Test | Abbott Diagnostics | Real-time PCR, (5'UTR) | FDA, CE | 12 to 1.00 × 108 [27] | 12 | 12 |
Versant HCV RNA Test, 1.0 (kPCR) | Siemens | Real-time PCR, (pol gene) | CE | 15 to 1.00 × 108 | 15 | 15 |
Artus Hepatitis C Test (QS-RGQ) | Qiagen | Real-time PCR (target proprietary) | CE | 65 to 1 × 106 [9] | 35 | 21 |