VERSANT HBV DNA 1.0 Assay (kPCR)
Highly Sensitive Viral Load Assay for the Atellica MDX 160 Molecular System
Performance to Meet Your Needs
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
Total Precision (including lot-to-lot variation)
- 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 Healthineers organization for further details.