Abbott HBV Sequencing Assay

CE Marked

For In Vitro Diagnostic Use

The Abbott HBV Sequencing assay detects both HBV genotype and drug resistance in one test.

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Description
 

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

Variable low and high throughput automation options include:

  • Sample preparation with the 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)
  • Online reporting

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.

 
Design
 

The Abbott HBV Sequencing assay target region
The Abbott HBV Sequencing target region

 
 
Specifications
 
 
 
Abbott HBV Sequencing
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 World Health Organization HBV International Standard
External Controls Negative Control
Positive Control (inactivated HBV virion in plasma)

Ordering Info

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