Hepatitis B Virus (HBV) Genotype

CPT: 87912
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Test Details

Synonyms

  • HBV PreCore Mutations
  • HBV Subtype

Use

The HBV genotype assay classifies the virus present in the sample into one of eight recognized genotypes (A-H) via sequence analysis of the DNA polymerase gene. Disease progression and response to therapy may be influenced by genotype. In addition, the HBV genotype assay identifies and reports sequence polymorphisms in the basal core promotor (BCP) and coding regions of the HBV precore gene that result in either decreased levels, or complete absence, of HBeAg expression in chronically infected patients.

Limitations

This assay may not be successful when the HBV viral load is <500 IU/mL.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

Methodology

Polymerase chain reaction (PCR) amplification and DNA sequencing

Specimen Requirements

Specimen

Plasma or serum, frozen

Volume

1.2 mL

Minimum Volume

600 μL

Container

Gel-barrier tube, yellow-top (ACD) tube, lavender-top (EDTA) tube or PPT.

Collection

Centrifuge sample within six hours of collection, transfer plasma/serum to a polypropylene screw-cap tube and freeze. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Storage Instructions

Freeze.

Causes for Rejection

Quantity not sufficient for analysis; heparin/SPS plasma (wrong anticoagulant); gross hemolysis; specimen not frozen

For Providers

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