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Hepatitis B Virus DNA, Quantitative, Real-Time PCR

Test Code

8369

CPT Code(s)

87517

Preferred Specimen(s)

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

Minimum Volume

1 mL

Alternative Specimen(s)

Plasma collected in: PPT potassium EDTA (white-top) tubes • Serum

Collection Instructions

Plasma: Separate plasma from whole blood (EDTA tube) within 24 hours from the time of collection.
Serum: Separate serum from a serum separator tube within 24 hours from the time of collection.
Note: This test requires a separately collected sample.

Specimen Container

Plastic screw-cap vial

Transport Temperature

Frozen

Specimen Stability

Room temperature: 72 hours
Refrigerated: 7 days
Frozen: 42 days

Reject Criteria

Unspun whole blood samples greater than 24 hours from collection

Methodology

Real-Time Polymerase Chain Reaction

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.

Performing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

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(s)

Hepatitis B Virus DNA <20 IU/mL
Hepatitis B Virus DNA <1.30

LogIU/mL

This test was performed using the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0

To convert International Units/mL to copies/mL, use the following conversion factor:
1 IU/mL = 5.82 copies/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.

LOINC®' Code(s)

The Result and LOINC information listed below should not be used for electronic interface maintenance with Quest Diagnostics. Please contact the Quest Diagnostics Connectivity Help Desk for more information at 800-697-9302.

NOTE: The codes listed in the table below are not orderable Test Codes.

Result
Code
Result NameLOINC CodeComponent Name
35222AHepatitis B Virus DNA42595-9Hepatitis B virus DNA
35222BHepatitis B Virus DNA48398-2Hepatitis B virus DNA

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided 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 payer being billed.

LOINC assignment is based on a combination of test attributes, including the method used by the performing laboratory. For tests not performed by Quest Diagnostics, codes are assigned by the performing laboratory.

* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.