Nucleic Acid Test for HBV Helps Estimate Therapy Progress

A nucleic acid test for hepatitis B virus (HBV) measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides healthcare professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

The test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual's response to therapy. The baseline level of hepatitis B virus should decrease with successful treatment. The test is used with other clinical findings, such as results from biochemical and serological testing.

Called the Cobas TaqMan HBV test, and manufactured by Roche Diagnostic Division (Basel, Switzerland), the nucleic acid test has been approved by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA). "Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "The Cobas TaqMan test gives healthcare providers a new and sensitive tool for this process.”

HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization (WHO; Geneva, Switzerland). A vaccine for HBV has been available in the United States since 1982.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70% of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

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Roche Diagnostics
U.S. Food and Drug Administration
World Health Organization