Hepatitis B Virus DNA, Quantitative PCR with Reflex to HBV Genotype

Test Code

16694

CPT Codes
87517

Includes

If HBV DNA Quantitative result is ≥ 600 IU/mL, then Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations will be performed at SJC-IFD, at an additional charge (CPT code: 87912).

Preferred Specimen

2 mL plasma collected in each of two separate EDTA (lavender-top) tubes

Minimum Volume

1.4 mL

Other Acceptable Specimens

Plasma collected in each of two PPT potassium EDTA (white-top) tubes • Serum (x2)

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: 30 days

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

Unspun PPT tube • Heparinized samples

Methodology
Real-Time PCR • Polymerase Chain Reaction • Sequencing

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: Mon-Sat; Report available: 1-2 days (If genotyping performed additional days required)

Limitations

Due to the character limitations of some clients' LIS systems, viral load values greater than 10 million are reported using scientific exponential notation. For example, a result of 10 million (10,000,000) is reported as 10.0E6 IU/mL or copies/mL. If your LIS will accept the number of characters required for viral loads greater than 10 million, please contact your local service representative to have this reporting convention changed.

Reference Range

See Laboratory Report

Clinical Significance

This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical 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 cobas® HBV Test is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.

Reportable range is 10 to 1,000,000,000 IU/mL (1.00 to 9.00 Log IU/mL).
(1.00 Log IU/mL to 9.00 Log IU/mL).

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.