FDA Hepatitis Update - Rapid blood test for antibodies to the hepatitis C virus (HCV) approved

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Hepatitis Update - Rapid blood test for antibodies to the hepatitis C virus (HCV) approved

	 You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

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On June 25, 2010, the Food and Drug Administration (FDA) approved the first rapid blood test in the U.S. for antibodies to the hepatitis C virus (HCV) in whole blood specimens (from venipuncture), for individuals 15 years and older. The OraQuick HCV Rapid Antibody Test, a test strip for the detection of antibodies to the hepatitis C virus, is indicated for testing individuals who are at risk for infection with HCV, and people with signs or symptoms of hepatitis.

No additional instrumentation is required for diagnosis, and results are available in about twenty minutes. The test is categorized as Moderate Complexity under CLIA, meaning it can only be administered in professional medical settings that satisfy the technical requirements for moderate complexity testing.

Results are presumptive, meaning that a positive test result should be followed up by a confirmatory test using traditional HCV testing methods to make a definitive diagnosis.

Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation in the United States. CDC estimates that in the United States 3.2 million people are living with chronic Hepatitis C.  Many do not know they are infected. Each year an estimated 17,000 people become infected with Hepatitis C.  Approximately 75 to 85 percent of those who become infected with the hepatitis C virus develop chronic infection.

HCV is transmitted primarily through exposure to infected blood, and intravenous drug use is the most common means of transmission in the United States. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is manufactured by OraSure Technologies Inc., Bethlehem, PA.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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