FDA Approves Hepatitis C Virus Test

Hepatitis C virus (VA.gov)

OraSure Technologies Inc. in Bethlehem, Pennsylvania says that the U.S. Food and Drug Administration (FDA) has approved its OraQuick HCV Rapid Antibody Test to detect hepatitis C virus (HCV) antibodies with a fingerstick whole blood sample. The test, says the company, provides results in 20 minutes.

OraSure says the OraQuick HCV test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus approved so far by the FDA. The test was designed for use by health care providers and not for testing by patients themselves.

The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.

Accorder to the Centers for Disease Control and Prevention, HCV infection is a disease of the liver, and the most common chronic bloodborne infection in the United States, with some 3.2 million persons chronically infected. The most common means of HCV transmission in the U.S. is by injection drug use.

*     *     *