First Rapid Test for HCV Antibodies Approved

The first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older was approved June 25 by the U.S. Food and Drug Administration (FDA).

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis—it is not approved for HCV screening of the general population.

OraQuick, manufactured by Bethlehem, Pa.-based OraSure Technologies Inc., is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain test results.

“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

Source: FDA news release


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