Skip to main content

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.