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Test ID FHBG Hepatitis B Virus Genotyping

Method Name

Polymerase Chain Reaction/Sequencing

Reporting Name

Hepatitis B Virus Genotype

Specimen Type

Plasma EDTA


Specimen Required


Draw blood in lavender (EDTA) tube(s). Spin down and send 2 mL plasma frozen in a plastic vial.

 

Required: 1. Viral Load

               2. Viral Load Date

 

Note: Red-top serum and serum gel tube(s) are acceptable.

 

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


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 42 days
  Refrigerated  7 days
  Ambient  72 hours

Reference Values

Interpretive Information: Hepatitis B Virus Genotype

 

HBV genotype and resistance interpretation is provided by SeqHepB software from Evivar Medical. The following mutations are reported: reverse transcriptase L80I/V, Il69T, V173L, L180M, A181S/T/V, T184A/C/F/I/G/S/M/L, S202C/G/I, M204I/V, N236T, M250I/L/V; surface antigen P120T, D144A, G145R.

 

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% of total may not be detected.

 

This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

Day(s) Performed

Tuesday, Friday

Performing Laboratory

ARUP Laboratories

CPT Code Information

87912

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FHBG Hepatitis B Virus Genotype 32366-7

 

Result ID Test Result Name Result LOINC Value
Z3195 Hepatitis B Genotype 32366-7
Z3196 HBV Surface Antigen Mutations 32366-7
Z3197 HBV RT Polymerase Mutations Unable to Verify

Test Classification

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.

Report Available

10 to 21 days

NY State Approved

Yes