FDA Approves Rapid Test for Antibodies to Hepatitis C Virus
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FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

ROCKVILLE, Md -- June 29, 2010 -- The US Food and Drug Administration (FDA) has approved the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals aged 15 years and older.

The 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. The test does not require an instrument for diagnosis, as it is done on a test strip. It takes about 20 minutes to obtain results from the test.

"Approval of [the rapid antibody test] 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, FDA's Center for Devices and Radiological Health, Rockville, Maryland. "Getting faster treatment is an important public health step to control this dangerous disease."

The HCV rapid antibody test is not approved for HCV screening of the general population.

SOURCE: US Food and Drug Administration

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