Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations
Test Summary
This test is used to:
1. Identify HBV genotype (A-H) for epidemiology or prognostic purposes.
2. Detect hepatitis B virus (HBV) mutations associated with resistance to antiviral agents.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL plasma collected in a PPT potassium EDTA (white-top) tube
Minimum Volume
0.3 mL
Instructions
This test can only be performed reliably on specimens with a viral load of at least 600 IU/mL. For unknown viral loads order test code 16694, HBV DNA, Quantitative PCR w/Reflex to HBV Genotype.
Serum: Collect blood in sterile tubes with no anticoagulants; plastic serum separator tubes (SSTs) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-capped, aliquot tubes and store refrigerated or frozen. Ship frozen.
Plasma: Collect blood in sterile tubes containing EDTA anticoagulant; either 0.15% solution v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (plasma preparation tube or PPT tube with plasma separator-gel, preferred). Store whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-capped aliquot tubes and store at -18° C or colder. If blood is collected in a PPT tube, centrifuge preferably within 2 hours of collection as before but it is not necessary to transfer plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport and storage. The PPT is plastic and hence plasma can be stored and shipped frozen in the original tube. Avoid repeated freezing and thawing of specimen. Ship frozen.
Serum: Collect blood in sterile tubes with no anticoagulants; plastic serum separator tubes (SSTs) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-capped, aliquot tubes and store refrigerated or frozen. Ship frozen.
Plasma: Collect blood in sterile tubes containing EDTA anticoagulant; either 0.15% solution v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (plasma preparation tube or PPT tube with plasma separator-gel, preferred). Store whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-capped aliquot tubes and store at -18° C or colder. If blood is collected in a PPT tube, centrifuge preferably within 2 hours of collection as before but it is not necessary to transfer plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport and storage. The PPT is plastic and hence plasma can be stored and shipped frozen in the original tube. Avoid repeated freezing and thawing of specimen. Ship frozen.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
Results obtained from immunosuppressed patients should be interpreted with caution.
Other Acceptable Specimens
Serum • Plasma collected in an EDTA (lavender-top) tube
Unacceptable Specimens
Unspun PPT tube
Order Code
HBVGEN
EPIC (Premier) Code
LAB3055
Includes
N/A
CPT Code
- 87912
Billing Code
- 671005
CPT Statement
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thurdays; Report available: 8 - 12 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL plasma collected in a PPT potassium EDTA (white-top) tube
Minimum Volume
0.3 mL
Instructions
This test can only be performed reliably on specimens with a viral load of at least 600 IU/mL. For unknown viral loads order test code 16694, HBV DNA, Quantitative PCR w/Reflex to HBV Genotype.
Serum: Collect blood in sterile tubes with no anticoagulants; plastic serum separator tubes (SSTs) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-capped, aliquot tubes and store refrigerated or frozen. Ship frozen.
Plasma: Collect blood in sterile tubes containing EDTA anticoagulant; either 0.15% solution v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (plasma preparation tube or PPT tube with plasma separator-gel, preferred). Store whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-capped aliquot tubes and store at -18° C or colder. If blood is collected in a PPT tube, centrifuge preferably within 2 hours of collection as before but it is not necessary to transfer plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport and storage. The PPT is plastic and hence plasma can be stored and shipped frozen in the original tube. Avoid repeated freezing and thawing of specimen. Ship frozen.
Serum: Collect blood in sterile tubes with no anticoagulants; plastic serum separator tubes (SSTs) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-capped, aliquot tubes and store refrigerated or frozen. Ship frozen.
Plasma: Collect blood in sterile tubes containing EDTA anticoagulant; either 0.15% solution v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (plasma preparation tube or PPT tube with plasma separator-gel, preferred). Store whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-capped aliquot tubes and store at -18° C or colder. If blood is collected in a PPT tube, centrifuge preferably within 2 hours of collection as before but it is not necessary to transfer plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport and storage. The PPT is plastic and hence plasma can be stored and shipped frozen in the original tube. Avoid repeated freezing and thawing of specimen. Ship frozen.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
Results obtained from immunosuppressed patients should be interpreted with caution.
Other Acceptable Specimens
Serum • Plasma collected in an EDTA (lavender-top) tube
Unacceptable Specimens
Unspun PPT tube
Result Information
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thurdays; Report available: 8 - 12 days