Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgM antibodies to Hepatitis C Virus in human plasma and sera. The kit is mainly intended for the follow-up of HCV chronic patients submitted to anti-viral pharmaceutical treatment.

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

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Summary

Antiviral drugs, such as Interferon taken alone or in combination with Ribavirin, can be used for the treatment of persons with chronic viral hepatitis C.

Treatment with interferon alone is effective in about 10% to 20% of patients. Interferon combined with Ribavirin is effective in about 30% to 50% of patients. Ribavirin does not appear to be effective when used alone.

Active production of HCV antigens in the liver of chronic patients generates spikes of IgM antibodies production and release of liver specific enzymes, similar to what happen in HBV chronic patients. The presence of anti viral IgM is usually correlated to a phase of sufferance and cellular damage of the liver.

During the pharmaceutical treatment HCV IgM may represent a marker for the follow-up of the efficiency of the drug itself, monitoring the balance between its effectiveness and the side effects, that often may be heavy for the patient.

Test Principle

Microplates are coated with HCV immunodominant synthetic antigens (core peptide, recombinant NS3, NS4 and NS5 peptides).

In the 1st incubation, the solid phase is treated with diluted samples and anti HCV IgM are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti-HCV IgM are detected by the addition of anti hIgM antibody, labeled 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 IgM antibodies present in the sample.

The presence of IgM in the sample may therefore be quantitated by means of a calibration curve able to determine the content of the antibody in arbU/ml.

Neutralization of IgG anti-HCV, carried out directly in the well, is performed in the assay in order to block interferences due to this class of antibodies in the determination of IgM.

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References
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