Hepatitis B Virus DNA, Quantitative, Real-Time PCR

Test Code

8369

CPT Code(s)

87517

Test Code

8369

CPT Code(s)

87517

In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

Hepatitis B Virus DNA, Quantitative, Real-Time PCR - 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).

Test Resources

Clinical Focus

Viral Hepatitis: Laboratory Support for Diagnosis and Management

Test Details

Methodology

Real-Time Polymerase Chain Reaction

Assay Category

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.

Reference Range(s)

Hepatitis B Virus DNA	Not Detected (IU/mL)
Hepatitis B Virus DNA	Not Detected (Log IU/mL)

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Real-Time Polymerase Chain Reaction

Assay Category

Reference Range(s)

Hepatitis B Virus DNA	Not Detected (IU/mL)
Hepatitis B Virus DNA	Not Detected (Log IU/mL)

LOINC® Codes, Performing Laboratory

Service Area must be determined

Preferred Specimen(s)

3 mL plasma collected and separated from an EDTA (lavender-top) tube

Alternative Specimen(s)

Serum • PPT potassium EDTA (white-top) tube

Minimum Volume

1 mL

Collection 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 Container

Transport tube

Transport Temperature

Frozen

Specimen Stability

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

Reject Criteria

Unspun whole blood sample >24 hours from collection

Setup Schedule

Service Area must be determined

Preferred Specimen(s)

3 mL plasma collected and separated from an EDTA (lavender-top) tube

Alternative Specimen(s)

Serum • PPT potassium EDTA (white-top) tube

Minimum Volume

1 mL

Collection Instructions

Transport Container

Transport tube

Transport Temperature

Frozen

Specimen Stability

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

Reject Criteria

Unspun whole blood sample >24 hours from collection

Setup Schedule

Service Area must be determined

In-home collection may be available in your area for purchase through Quest Mobile.

Test Details

Clinical Significance

Test Resources

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 guidance 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.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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