Test Catalog

Test Id : FHBG

Hepatitis B Virus Genotyping

Method Name
A short description of the method used to perform the test

Polymerase Chain Reaction/Sequencing

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Hepatitis B Virus Genotype

Aliases
Lists additional common names for a test, as an aid in searching

HBsAg mutations

HBV drug resistance testing

HBV Genotype

HBV Resistance

HBV Resistance Sequencing

HBV Sequencing

Hepatitis B Drug Resistance Panel

Lamirudine

Telbivudine

Adefovir

Entecavir

HBV Genotyping

HBVGENO

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis: NA
Thawing: Warm OK; Cold OK
Lipemia: NA
Icterus: NA
Other: Heparinized specimens

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

10 to 21 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

ARUP Laboratories

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determine by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purpose.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87912

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports