Abbott Sequencing Hepatitis B Assay Kit
Abbott Sequencing Hepatitis B Assay Kit
Description :
For In Vitro Diagnostic Use
The Abbott HBV Sequencing assay detects both HBV genotype and drug resistance in one test.
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.
