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Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations
Test Code10529
Alias/See Also
LAB1336
CPT Codes
87912
Preferred Specimen
1 mL plasma collected in a PPT potassium EDTA (white-top) tube
Minimum Volume
0.3 mL
Other Acceptable Specimens
Plasma collected in: EDTA (lavender-top) tube • Serum collected in: SST® (red-top/plastic) or no additive (red-top) tube
Instructions
Plasma: Collect blood in sterile tube 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 transport tube and store at -18° C or colder.
Serum: Collect blood in sterile tube with no anticoagulants; plastic Serum Separator Tubes (SST®) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile plastic transport tube and store refrigerated or frozen. Ship frozen.
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.
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.
Serum: Collect blood in sterile tube with no anticoagulants; plastic Serum Separator Tubes (SST®) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile plastic transport tube and store refrigerated or frozen. Ship frozen.
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.
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.
Transport Container
Transport tube
Transport Temperature
Frozen
Specimen Stability
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: 30 days
Refrigerated: 7 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Unspun PPT tube
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Mon, thurs
Report Available
4-8 days
Limitations
Results obtained from immunosuppressed patients should be interpreted with caution.
Reference Range
See Laboratory Report
Clinical Significance
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.
1. Identify HBV genotype (A-H) for epidemiology or prognostic purposes.
2. Detect hepatitis B virus (HBV) mutations associated with resistance to antiviral agents.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |