Hepatitis B Virus (HBV) Genotyping Plus Drug Resistance

CPT: 87900; 87912
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Test Details

Synonyms

  • HBV Genotype, PreCore and Resistance
  • HBV Resistance Testing

Use

Data generated in the genotyping assay is subsequently analyzed for mutations in the reverse transcriptase gene of HBV associated with resistance to therapeutic agents, and if identified an interpretation of their clinical significance provided.

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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