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VERSANT HCV RNA 1.0 Assay (kPCR)

Highly Sensitive Viral Load Assay for the Atellica MDX 160 Molecular System

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.
 

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