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Table 1 Commercially available quantitative real-time PCR-based hepatitis C virus RNA assays

From: Molecular diagnostics in the management of chronic hepatitis C: key considerations in the era of new antiviral therapies

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
  1. IVD: In vitro diagnostic. LLOQ: Lower limit of quantification. LLOD: Lower limit of detection (also referred to as analytical sensitivity). PCR: polymerase chain reaction. FDA: Food and Drug Administration. CE: European Community. HCV: Hepatitis C virus.
  2. * LLOD shown is the overall analytical sensitivity, the LLOD by genotype and by matrix (plasma vs. serum) may be lower than the number shown.