VERSANT HBV DNA 1.0 Assay (kPCR)Highly Sensitive Viral Load Assay for the Atellica MDX 160 Molecular System

• Efficient and reproducible extraction, amplification, and detection of HBV-1 DNA
• Up to 41 patient samples per run
• Results in about 4 hours and 30 minutes

• Quality extraction of nucleic acids ensures accuracy
• Highly sensitive and specific assay performance provides confidence
• Outstanding precision across a wide dynamic quantitation range produces reliable results
• Excellent quantitation of all genotypes (A-H) provides clinicians with the information they need to manage therapy
   

• Primary-tube sampling supports a variety of tube types and sizes
• Positive patient sample identification with barcode ID
• Flexible run sizes with 4 runs per kit over 4 weeks
• Sample input requirement of 500 μL (with dead volume depending on sample tube size)
   

• Ultrasensitive kinetic PCR technology
• Maximum stability and reproducibility with calibrators and controls made from rDNA
• No contamination monitoring needed due to amplicon contamination control with UNG (Uracil N-glycosylase)
• Enhanced sensitivity and specificity with BLACK HOLE QUENCHER reagent (Biosearch Technologies)
• Non-competitive internal control to monitor extraction and PCR efficiency
• Targets the highly conserved overlapping region within the HBV surface antigen (S) and pol (P) genes
• Detects all genotypes A-H

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.