Hepatitis B Virus DNA, Quantitative, Real-Time PCR

Test Code
8369

CPT Codes
87517

Preferred Specimen
3 mL plasma collected in EDTA (lavender-top) tube

Minimum Volume
1 mL

Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) • Serum

Instructions
Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer’s instructions for collection tube handling.

Transport Temperature
Frozen

Specimen Stability
Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 84 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received room temperature

Methodology
Real-Time Polymerase Chain Reaction

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Tues-Sat a.m.; Report available: Next day

Limitations
Results obtained from immunosuppressed patients should be interpreted with caution.

Reference Range
Hepatitis B Virus DNA Not Detected IU/mL
Hepatitis B Virus DNA Not Detected Log IU/mL


Clinical Significance
This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from this test must be interpreted within the context of all relevant clinical and laboratory finding.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153




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.