VERSANT HBV DNA 1.0 Assay (kPCR)
Highly Sensitive Viral Load Assay for the Atellica MDX 160 Molecular System
The VERSANT HBV DNA 1.0 Assay (kPCR) is a real-time polymerase chain reaction (PCR) assay for quantitative detection of human hepatitis B virus (HBV) DNA in plasma or serum of HBV-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 HBV-infected individuals undergoing antiviral therapy.
- Referenced to the WHO 2nd Hepatitis B Virus (HBV) DNA International Standard (NIBSC 97/750) for IU/mL
- Conversion factor: 1 IU/mL = 1.4 copies/mL
- 13-700,000,000 IU/mL
- Limit of detection (LOD) = 13 IU/mL
- 2 log IU/mL – 30.3 to 34.6% (0.13 - 0.16 log SD)
- 3-4 log IU/mL – 22.3 to 29.1% (0.10 - 0.13 log SD)
- 5-9 log IU/mL – 20 to 30.9% (0.09 - 0.13 log SD)
Catalog No. Description
10282480 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 1 (48 tests) *
10282481 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 2 (48 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.
The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.