Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis C Virus in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HCV-infected patients.

Regulatery Status: CE
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Product Catalog No: CVAB Pack Size: 96 Wells

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Summary

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 posttransfusion 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).

Test Principle

Microplates are coated with HCV-specific antigens derived from “core” and “ns” regions encoding for conservative and immunodominant antigenic determinants (Core peptide, recombinant NS3, NS4 and NS5 peptides). The solid phase is first treated with the diluted sample and HCV Ab are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound HCV antibodies, IgG and IgM as well, are detected by the addition of polyclonal specific anti hIgG&M antibodies, labelled with peroxidase (HRP). The enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of anti HCV antibodies present in the sample. A cut-off value let optical densities be interpreted into HCV antibody negative and positive results.

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References
  1. CDC. Public Health Service inter-agency guidelines for screening donors of blood, plasma, organs, tissues, and semen for evidence of hepatitis B and hepatitis C. MMWR 1991;40(No. RR-4):1-17.
  2. Alter MJ. Epidemiology of hepatitis C. Hepatology 1997;26:62S-5S.
  3. McQuillan GM, Alter MJ, Moyer LA, Lambert SB, Margolis HS. A population based serologic study of hepatitis C virus infection in the United States. In Rizzetto M, Purcell RH, Gerin JL, Verme G, eds. Viral Hepatitis and Liver Disease, Edizioni Minerva Medica, Turin, 1997, 267-70.
  4. Dufour MC. Chronic liver disease and cirrhosis. In Everhart JE, ed. Digestive diseases in the United States: epidemiology and impact. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 1994; NIH publication no. 94-1447, 615- 45.
  5. Alter MJ, Hadler SC, Judson FN, et al. Risk factors for acute non-A, non-B hepatitis in the United States and association with hepatitis C virus infection. JAMA 1990;264:2231-35.
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