ValiQuant™ HBV Quantification Panel

The ValiQuant HBV DNA Quantification Panel provides a standard across multiple test methods, enabling clinical laboratories and diagnostic manufacturers to assess molecular diagnostic test procedures (including the DNA extraction step) for the quantitative and qualitative determination of human hepatitis B virus (HBV) DNA. The product can be used for training and proficiency testing of laboratory personnel. This product is for Research Use Only. Not for Use in Diagnostic Procedures.

Summary

The ValiQuant HBV DNA Quantification Panel members were produced by making quantitative dilutions of HBV positive human source materials into normal human plasma (NHP).

This panel was designed and developed to meet the need for highly standardized and controlled nucleic acid testing of HBV viral load. The panel helps to ensure that the nucleic acid testing procedures for HBV DNA are properly validated, and allows the monitoring of training and proficiency for operators who utilize the HBV DNA assay being evaluated. In order to meet global standardization and harmonization requirements, the panel has been calibrated against the World Health Organization (WHO) International Standard for HBV DNA.

Principles of the Procedure

The ValiQuant HBV DNA Quantification Panel members have been carefully formulated to mimic naturally occurring human specimens containing HBV DNA.  Additionally, the intact virus format of the ValiQuant HBV DNA Quantification Panel allows for verification of an effective viral DNA extraction procedure. As such, the test methodology must include an extraction step that releases the viral DNA and makes it available for amplification and/or hybridization, as appropriate to the test

This product contains 0.05% sodium azide and 0.05% gentamicin sulfate as preservatives.


The target concentrations given are manufacturing targets and may not represent actual results reported by the HBV RNA quantitative assay.


 

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Panel Configurations

Description Catalog Number
ValiQuantTM HBV DNA Quantification Panel 95-0150
Configurations Quantity
HBV DNA 5E1 1.2mL
HBV DNA 5E2 1.2mL
HBV DNA 5E3 1.2mL
HBV DNA 5E4 1.2mL
HBV DNA 5E5 1.2mL
HBV DNA 5E6 1.2mL
HBV DNA 5E7 1.2mL

It is recommended that the ValiQuant HBV DNA Quantification Panel be stored at -20°C or lower to ensure consistent results until the expiration date. Discard any unused material after the first use.