• Test Code:
    3290
  • Department:
  • Test Synonyms:
    Hepatitis B Viral DNAHBV PCR
  • CPT Code(s):
    87517
Background:

Hepatitis B virus (HBV) is one of several viruses known to cause viral hepatitis.  Over 2 billion people throughout the world have been infected with HBV and over 350 million of them are chronically infected carriers.  Hepatitis B is a major cause of liver disease in the United States with 47-70% of cases attributed to people born outside the US.  However, targeted screening programs have shown prevalence rates in excess of 15% in certain high-risk immigrant populations.  Patients with chronic HBV infection are at high risk of long-term complications of infection including chronic hepatitis, cirrhosis, and hepatocellular carcinoma.  Serologic and molecular markers are commonly used as diagnostic and/or prognostic indicators of acute or chronic HBV infection.

Clinical Utility:
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.

Methodology:

The Abbott RealTime HBV assay quantitates HBV viral DNA by PCR amplification of target HBV DNA. The assay is standardized against the WHO International Standard for Hepatitis B Virus DNA (NIBSC). The viral load results are reported in International Units (IU/mL).

Reportable Range:
10-1,000,000,000 IU/mL

Specimen Requirements:

  • 5-10 mL of blood in purple (EDTA) tube and stored at 2-25°C.  Specimen must be centrifuged and separated within 6 hours.  Freeze plasma for transport to lab.
  • Alternatively, serum from a red top tube may be prepared, frozen, and submitted for the assay.
  • Pediatric Minimum is 800µL of plasma or serum.
  • Contact Client Services for shipping materials and procedures at (855) 535-1522.
A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES.  Please include detailed clinical information.

Test Performed (Days):

Wednesday

Turn Around Time:

7-10 days

Shipment Sensitivity Requirements:

Ship plasma/serum on dry ice.  Ship via overnight express, using the FedEx priority overnight label provided.

References:

Abbott RealTime HBV with Optional Aplification Reagent Extened Use package insert 51-608261/R1 (2N40-91).

Additional Info:

The Knight Cancer Institute at Oregon Health & Science University is a pioneer in the field of precision cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down just the cells that enable cancer to grow. This breakthrough has made once-fatal forms of the disease manageable and transformed how cancer is treated. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle – an honor earned only by the nation's top cancer centers. It is headquarters for one of the National Cancer Institute's largest research collaboratives, SWOG, in addition to offering the latest treatments and technologies as well as hundreds of research studies and clinical trials.

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