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HBV DNA Quantitation by PCR

HBV Quant, Hepatitis B Virus DNA, Quantitative by PCR

Test Codes

EPIC: LAB6397, Beaker: IHBVG

Department

Molecular Pathology

Specimen Collection Criteria

Collect: Plasma OR Serum.

• Plasma: One Lavender-top EDTA tube.
• Serum: One Gold-top SST tube.
• Preferred: 2 mL; Minimum: 0.650 mL.
• Separate samples must be submitted when multiple tests are ordered.

Physician Office/Draw Specimen Preparation

Centrifuge to separate plasma or serum from cells within 24 hours of collection.

Collect enough whole blood to allow for a minimum of 1 mL of serum or plasma. Whole blood collected in SST or EDTA tubes are stable for up to 24 hours at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to centrifugation.

After centrifugation, transfer all available plasma/serum to a sterile plastic transport tube and refrigerate (2-8°C or 36-46°F). Plasma or serum samples may be stored refrigerated (2-8°C or 36-46°F) for up to 6 days.

Preparation for Courier Transport

Transport:

• Uncentrifuged whole blood can be transported at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) if processed within 24 hours of collection.
• Centrifuged/processed plasma or serum can be transported refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Specimens not centrifuged within 24 hours of collection.
• Specimens collected in Green-top heparin tubes or White-top PPT tubes.
• Specimens not maintained refrigerated or frozen following separation.
• Specimens exposed to repeated freeze/thaw cycles.
• Specimens with less than 0.650 mL plasma/serum.
• Unlabeled tubes.

In-Lab Processing

Specimens must be centrifuged with plasma or serum separated from cells within 24 hours of collection. After centrifugation, please ensure that all available plasma or serum is transferred to a sterile plastic transport tube.

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 6 days – Centrifuged plasma or serum only
Frozen (-20°C/-4°F or below): 12 weeks – Centrifuged plasma or serum only

Specimen Storage in Department Prior to Disposal:

Frozen (-20°C/-4°F or below): 4 weeks

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

At least once per week.
Results available in 7–10 days.

Reference Range

HBV DNA not detected. The analytical sensitivity is 6.6 IU/mL (plasma) and 3.5 IU/mL (serum).

The reportable range is 10-1,000,000,000 IU/mL. Results exceeding 1,000,000,000 IU/mL will not be diluted and will be reported as greater than 1,000,000,00 IU/mL.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)-Roche COBAS® 6800 HBV Test (FDA Approved).

Clinical Utility

• The test is intended for use as an aid in the management of patients with chronic 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 findings. This test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.
  
• The lower limit of reporting in this assay is less than 10 IU/mL. A result reported as “detected” less than 10 IU/mL indicates the presence of HBV DNA concentrations below the level of quantitation of the assay.

Epidemiology

The Centers for Disease Control and Prevention (CDC) estimates that in the United States 3,192 to 20,700 persons become infected with HBV each year. Approximately 80% of acute hepatitis B cases reported to CDC during 2019 occurred among persons aged 30–59 years. A total of 1,427 patients with acute hepatitis B were hospitalized with 0.42 deaths per 100,000 population in 2019.

Transmission

The virus is blood-borne and is transmitted efficiently by exposure to blood. HBV is also commonly transmitted sexually and through perinatal transmission. Infections with HBV in the United States mostly occur in adults who are exposed through sexual or blood contact with a chronically infected person.

CPT Codes

87517

Contacts

Last Updated

10/7/2023