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ABBOTT PARK, Ill. -- Abbott announced the availability of a fully automated hepatitis C virus (HCV) test in the United States for its widely-used AxSYMÂ® automated immunoassay instrument system. With results within 23 minutes, the AxSYMÂ® Anti-HCV test provides laboratories with a quick and efficient test. The presence of antibodies to HCV indicate that an individual may have been infected with HCV in the past or have an ongoing infection.
"With more than 34 years of experience in hepatitis diagnostics, Abbott is a leader in this field, developing and introducing many of the world's first hepatitis assays," said William E. Brown, PhD, vice president, diagnostic assays and systems development for Abbott. "Not only is the AxSYM Anti-HCV test sensitive and specific, but also it has been designed and developed to detect the known genotypes of HCV."
Last year in the United States, Abbott introduced two fully automated tests for the hepatitis A virus on the AxSYM system -- AxSYMÂ® HAVAB-M 2.0 assay and AxSYMÂ® HAVABÂ® 2.0. Abbott has also submitted an application to the U.S. Food and Drug Administration (FDA) for its AxSYM hepatitis B tests, which are currently available outside of the United States. Abbott's hepatitis tests are used everyday for blood screening and diagnostic testing.
According to the Center for Disease Control and Prevention (CDC), an estimated 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected. Often called the "silent epidemic," many individuals infected with the virus have no signs or symptoms of the disease until chronic infection or chronic liver disease has developed. Additionally, there is no vaccine to prevent HCV.
A Microparticle Enzyme Immunoassay (MEIA) test, the AxSYM Anti-HCV test is designed for the qualitative detection of antibodies to HCV in human serum or plasma and is not intended for use in blood, plasma or tissue screening.