VERSANT HCV RNA 1.0 Assay (kPCR)

The VERSANT® HCV RNA 1.0 Assay (kPCR)* is a real-time kinetic polymerase chain reaction (kPCR) assay for quantitative detection of human hepatitis C virus (HCV) RNA in plasma or serum of HCV-infected individuals. The assay is intended to be used in conjunction with clinical presentation and other laboratory markers of disease status to aid in the management of HCV-infected individuals undergoing antiviral therapy.

• Referenced to the WHO 3rd Hepatitis C Virus (HCV) RNA International Standard (60/100) for IU/mL
• Conversion factor: 1 IU/mL = 4.3 copies/mL
• Lot-to-lot reproducibility ensured with Gold Standard Master Calibrators (secondary standards to WHO standard)

• 15-100,000,000 IU/mL (64.5 – 430,000,000 copies/mL)
• LOD = 15 IU/mL (64.5 copies/mL)

• 2 log IU/mL – 23.8 to 30.4% (0.11 - 0.13 log SD)
• 3-4 log IU/mL – 22.8 to 23.6% (0.10 log SD)
• 5-8 log IU/mL – 26.5 to 35.6% (0.11 - 0.15 log SD)

Catalog No.      Description
10469013          VERSANT HCV-1 RNA 1.0 (kPCR) Kit, IVDD Box 1 (96 tests) *
10469014          VERSANT HCV-1 RNA 1.0 (kPCR) Kit, IVDD Box 2 (96 tests) *
10286026          VERSANT Sample Preparation 1.0 Reagents Box 1 (96 tests) *
10286027          VERSANT Sample Preparation 1.0 Reagents Box 2 (96 tests) *

 

^{*IVDD, CE marked. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirements.}