Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations : 10529

Message
This test can only be performed reliably on specimens with a viral load of at least 600 IU/mL.


Test Code
HBVG or 10529


Alias/See Also
Hepatitis B Drug Resistance Panel


CPT Codes
87912

Instructions
Lavender (EDTA) or serum separator tube.


Transport Container
Centrifuge the serum separator tube within 2 hours of collection and transport. Centrifuge the lavender top tube within 2 hours of collection and transfer 1 mL plasma to a standard transport tube. (Min: 0.3 mL)


Transport Temperature
Refrigerated.


Specimen Stability
After separation from cells: Room temperature: 72 hours; Refrigerated: 7 days; Frozen: 30 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Unspun specimens.


Methodology
Polymerase Chain Reaction (PCR), Sequencing

Setup Schedule
Monday & Thursday


Report Available
8 days (From receipt at performing laboratory)


Limitations
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.


Reference Range
By 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.


Performing Laboratory
Quest Diagnostics



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.