June 25, 2010
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HCV rapid antibody test approved

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The FDA has approved a rapid antibody test that detects hepatitis C, the first of its kind in the United States.

The OraQuick(R) HCV Rapid Antibody Test (OraSure Technologies) detects HCV antibodies in venous whole blood specimens.

“The OraQuick HCV test efficiently identifies previously undiagnosed HCV-infected individuals who are at risk,” said Eugene R. Schiff, MD, of the University of Miami School of Medicine. “We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection.”

OraQuick(R) HCV provides results in 20 minutes.

In the United States, there are an estimated 4.1 million Americans that are or have been infected with HCV.

According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80% of HCV-positive individuals show no signs or symptoms.