Fourth generation Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis C Virus in human plasma (EDTA, Heparin and Citrate) and sera.
The kit may be used for the screening of blood units of HCV-infected patients.
For “in vitro” diagnostic use only
Introduction
The World Health Organization (WHO) define Hepatitis C infection as follows: “Hepatitis C is a viral infection of the liver which had been referred to as parenterally transmitted "non A, non B hepatitis" until identification of the causative agent in 1989. The discovery and characterization of the hepatitis C virus (HCV) led to the understanding of its primary role in post transfusion hepatitis and its tendency to induce persistent infection.
HCV is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million persons are newly infected each year. HCV is spread primarily by direct contact with human blood. The major causes of HCV infection worldwide are use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. No vaccine is currently available to prevent hepatitis C and treatment for chronic hepatitis C is too costly for most persons in developing countries to afford. Thus, from a global perspective, the greatest impact on hepatitis C disease burden will likely be achieved by focusing efforts on reducing the risk of HCV transmission from nosocomial exposures (e.g. blood transfusions, unsafe injection practices) and high-risk behaviours (e.g. injection drug use).