Ordering Recommendation

Determine antiviral drug resistance by DNA sequencing.

Mnemonic
HBVGENO
Methodology

Polymerase Chain Reaction/Sequencing

Performed

Tue, Fri

Reported

Within 10 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), serum separator tube, or plasma preparation tube.

Specimen Preparation

Separate serum or plasma from cells within 24 hours. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

Ambient: 72 hours; Refrigerated: 1 week; Frozen: 6 weeks

Reference Interval

None

Interpretive Data

Both the HBV RT polymerase and the HBsAg encoding regions are sequenced. Resistance and surface antigen mutations are reported. In addition, the major HBV genotypes are identified. Mutations in viral sub-populations below 20 percent of total may not be detected.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

This test may be unsuccessful if the HBV viral load is less than log 3.0 or 1,000 IU/mL of plasma.

Hotline History
N/A
Components
Component Test Code* Component Chart Name LOINC
2001568 HBV Surface Antigen Mutations by Seq 32366-7
2001569 Hepatitis B Genotype by Seq 32366-7
2001570 HBV RT Polymerase Mutations by Seq 49883-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Adefovir
  • Entecavir
  • HBsAg mutations
  • HBV drug resistance testing
  • HBV Genotype
  • HBV Genotyping
  • HBV Resistance
  • HBV Resistance Sequencing
  • HBV Sequencing
  • Hepatitis B Drug Resistance Panel
  • Lamivudine
  • Telbivudine
  • Tenofovir
Hepatitis B Virus Genotype by Sequencing