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HBV Sequencing Assay

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View Ordering Information
Product Name Quantity Order # Additional Information
HBV Sequencing Amplification Reagent Kit
 03N03-090
HBV Sequencing Control Kit (4 Pos + 4 Neg) 03N03-080
HBV Sequencing m2000 System ROW Combined Application CD-ROM 05N62-010
mSample Preparation System DNA 06K12-024

Background

Hepatitis B is a significant cause of worldwide morbidity and mortality

  • HBV infection is a major cause of chronic liver disease
  • More than two billion have been infected
  • 600,000 deaths per year
  • More than 350 million chronic carriers
  • 25%-40% of persons with chronic HBV disease die from cirrhosis or HCC (hepatocellular carcinoma)
  • Highest rates found in developing countries. In areas of Africa and Asia, widespread infection may occur in infancy and childhood

Recent advancements in antiviral therapy, based on the development of new and more powerful nucleous(t)ide analogues, have dramatically improved chronic hepatitis B management. The primary goal of Hepatitis B therapy is to suppress HBV DNA to the lowest level.

Description

The Abbott HBV Sequencing assay targets the polymerase (pol) region of the HBV viral genome.

  • Sequencing-based assay for the detection of both HBV genotype and drug resistance in one test
  • Variable low and high throughput automation options:
    • Sample Preparation m2000sp or m24sp
    • PCR m2000rt or Perkin Elmer 9700 Thermal Cycler or equivalent
    • Sequencing (Applied Biosystems 4 and 16 capillary systems.  ABI SeqScape Software version 2.5 or later)
    • On-line reporting
Feature Summary Table
Instrumentation m2000/m24 System and ABI Sequencer
Kit Configuration
 Sequencing Kits (48 tests) Control Kit (4 control reactions)
Technology Real-Time PCR and Sanger Sequencing
Genotype Detection
 A, B, C, D, E, F, G, H
Sample Type
 Serum and Plasma
Input Volume
 0.5 mL
Standardization WHO HBV International Standard
External Controls
 Negative Control
Positive Control (inactivated HBV virion in plasma)

HBV Sequencing Assay

m2000sp

m2000rt

DNA Sequencers/Applied BioSystems

 

Intended Use

Abbott HBV Sequencing is an in vitro assay for determining the DNA sequence of the reverse transcriptase (RT) region of the polymerase (Pol) gene of the Hepatitis B Virus (HBV). The test is intended for use as an aid in the management of patients with chronic HBV.

 

The Abbott HBV Sequencing assay is not intended for use in the screening of blood, plasma, or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

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