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.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Hepatitis E Virus in human plasma and sera. The kit may be used for the determination of the acute phase of infection where IgM antibodies are generated before the other immunoglobulins and for the follow-up of HEV-infected patients. For “in vitro” diagnostic use only. Microplates are coated with HEV-specific recombinant antigens encoding for conservative and immunodominant determinants of all the 4 subtypes. The solid phase is first treated with the diluted sample and anti HEV IgM are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti-HEV IgM are detected by the addition of polyclonal specific anti hIgM 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 HEV IgM present in the sample. A cut-off value let optical densities be interpreted into anti-HEV IgM negative and positive results. Neutralization of IgG anti-HEV and Rheumatoid Factor, carried out directly in the well, is performed in the assay in order to block such kind of interferences.

Third generation Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgG antibodies to Hepatitis E Virus in human plasma and sera. The kit is intended for the follow-up of HEV-infected patients. For “in vitro” diagnostic use only. Microplates are coated with HEV-specific recombinant antigens encoding for conservative and immunodominant determinants of all the 4 subtypes. The solid phase is first treated with the diluted sample and anti HEV IgG are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti-HEV IgG are detected by the addition of polyclonal specific anti hIgG 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 HEV IgG present in the sample. A cut-off value let optical densities be interpreted into anti-HEV IgG negative and positive results.

Third generation Enzyme ImmunoAssay (ELISA) for the qualitative determination of total antibodies to Hepatitis E Virus (HEV) in serum and plasma. The kit is intended for the follow-up of HEV-infected patients and the screening of blood units. In addition, due to the assay configuration of the product, the kit may be used also in testing total antibodies to HEV in serum and plasma derived from other not-human recipients for zoonotic studies. For “in vitro” diagnostic use only. Microplates are coated with highly specific synthetic antigen encoding for conservative and immunodominant determinants of HEV. The solid phase is first treated with the sample where anti HEV total antibodies (mostly IgG, IgM and IgA) are captured, if present, by the antigens. After washing out all the other components of the sample, in the second incubation bound anti HEV total antibodies are detected by the addition of the same HEV highly specific synthetic antigen 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 HEV antibodies present in the sample. After blocking the enzymatic reaction, its optical density is measured by an ELISA reader. The version ULTRA is particularly suitable for automated screenings.

Enzyme ImmunoAssay (ELISA) for the determination of IgM class antibodies to Hepatitis Delta Virus or HDV in human plasma and sera with the "capture" system. The kit is intended for the classification of the viral infective agent and the follow-up of HDV infected patients. For "in vitro" diagnostic use only. Microplates are coated with a monoclonal anti-hIgM antibody that in the 1st incubation “captures” specifically this class of antibodies. After washing out all the other components of the sample, in the 2nd incubation bound anti HDV IgM are detected by the addition of recombinant HDV antigen immunocomplexed with a specific antibody, labeled with peroxidase (HRP). After washing, the enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of IgM antibodies present in the sample.

Third generation Enzyme ImmunoAssay (ELISA) for the determination of Hepatitis Delta Virus or HDV in human plasma and sera. The kit is intended for the follow-up of HDV infected patients. For "in vitro" diagnostic use only. HDV Ag, if present in the sample, is captured by a specific monoclonal antibody, in the 1st incubation. A detergent is added to the sample in order to dissolve the specific antigen from HDV particles. In the 2nd incubation, after washing, a tracer, composed of a second anti HDV Ag antibody, labeled with peroxidase (HRP), is added to the microplate and binds to the captured HDV Ag. The concentration of the bound enzyme on the solid phase is proportional to the amount of HDV Ag in the sample and its activity is detected by adding the chromogen/substrate in the 3rd incubation. The presence of HDV Ag in the sample is determined by means of a cut-off value that allows for the semi quantitative detection of the antigen.

Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis Delta Virus or HDV in human plasma and sera with a “two-steps” methodology. The kit is used for the follow-up of patients infected by HDV. For "in vitro" diagnostic use only. Anti-HDV antibodies, if present in the sample, compete with a virus-specific polyclonal IgG, labeled with peroxidase (HRP), for a fixed amount of rec-HDV coated on the microplate. The test is carried out with a two steps incubation competitive system. First the sample is added to the plate and specific anti HDV antibodies bind to the adsorbed antigen. After washing, an enzyme conjugated polyclonal antibody to HDV is added and binds to the free portion of the antigen coated. After washing a chromogen/substrate mixture is dispensed. The concentration of the bound enzyme on the solid phase becomes inversely proportional to the amount of anti-HDV antibodies in the sample and its activity is detected by the added chromogen/substrate. The concentration of HDV-specific antibodies in the sample is determined by means of a cut-off value that allows for the semi quantitative detection of anti-HDV antibodies.

Hepatitis C Virus or HCV is an enveloped RNA virus recently classified in the family of Flaviviridae. The genome encodes for structural components, a nucleocapsid protein and two envelope glycoproteins, and functional constituents involved in the virus replication and protein processing. The nucleocapsid-encoding region seems to be the most conservative among the isolates obtained all over the world. THCV accounts for about 95% of hepatitis infections in recipients of blood transfusion and 50% of cases of sporadic NANB hepatitis. HCV commonly gives origin to asymptomatic hepatitis and chronicity develops in a high number of cases, sometime evolving in severe forms of illness, as hepato-carcinoma. The determination of antibody to HCV has become mandatory in the screening of blood units to prevent post-transfusion hepatitis. It is also currently used to follow-up risk individuals and patients under treatment with interferon. Conformation of any positive result is strongly recommended in the clinical laboratory practice before considering the patient truly positive for anti HCV antibodies.

Enzyme ImmunoAssay (ELISA) for the determination of Hepatitis B Virus "e" Antigen and Antibody in human plasma and sera. The kit is intended for the follow-up of acute infection and of chronic patients under therapy. For "in vitro" diagnostic use only. HBeAg, if present in the sample, is captured by a specific monoclonal antibody, in the 1st incubation. In the 2nd incubation, after washing, a tracer, composed of a mix of two specific anti HBeAg monoclonal antibodies, labeled with peroxidase (HRP), is added to the microplate and binds to the captured HBeAg.

In the screening of blood units for Hepatitis B surface Antigen or HBsAg some false positivity may happen, leading to a misinterpretation of the assay results and a misclassification of the blood unit and the donor. To confirm the positivity of a screened sample or to confirm the presence of an ongoing HBV infection in a hospitalized patient, a confirmatory test has to be run. A simple procedure based on an immunoreaction of neutralization is used in combination with the HBsAg assay. The device has to be used in combination with the product code SAG1.CE for the determination of HBsAg in human sera and plasma.

Enzyme ImmunoAssay (ELISA) for both the quantitative and qualitative determination of antibodies to the Surface Antigen of Hepatitis B Virus in human plasma and sera. For "in vitro" diagnostic use only. After washing, captured antibodies are detected by an HBsAg, labelled with peroxidase (HRP), that specifically binds the second available binding site of these antibodies. The enzyme specifically bound to wells, by acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of HBsAb in the sample and can be detected by an ELISA reader. The amount of antibodies may be quantitated by means of a standard curve calibrated against the W.H.O reference preparation. Samples are pre treated in the well with an specimen diluent able to block interference present in vaccinated individuals.

Enzyme ImmunoAssay (ELISA) for both the quantitative and qualitative determination of antibodies to the Surface Antigen of Hepatitis B Virus in human plasma and sera. For "in vitro" diagnostic use only. After washing, captured antibodies are detected by an HBsAg, labelled with peroxidase (HRP), that specifically binds the second available binding site of these antibodies. The enzyme specifically bound to wells, by acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of HBsAb in the sample and can be detected by an ELISA reader. The amount of antibodies may be quantitated by means of a standard curve calibrated against the W.H.O reference preparation. Samples are pre treated in the well with an specimen diluent able to block interference present in vaccinated individuals.

Enzyme ImmunoAssay (ELISA) for the determination of IgM class antibodies to Hepatitis A Virus in human plasma and sera with the "capture" system. The kit may be used for the identification of the viral agent causing hepatitis in the patient and the follow up of the acute phase of the infection. For "in vitro" diagnostic use only. The assay is based on the principle of "IgM capture" where IgM class antibodies in the sample are first captured by the solid phase coated with anti hIgM antibody. After washing out all the other components of the sample and in particular IgG antibodies, the specific IgM captured on the solid phase are detected by the addition of a purified preparation of inactivated HAV, labelled with an antibody conjugated with peroxidase (HRP). After incubation, microwells are washed to remove unbound conjugate and then the chromogen/substrate is added. In the presence of peroxidase the colorless substrate is hydrolysed to a colored end-product, whose optical density may be detected and is proportional to the amount of antibodies to HAV present in the sample.

Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis A Virus in human plasma and sera. The kit is used for the follow-up of patients infected by HAV. For "in vitro" diagnostic use only. The assay is based on the principle of competition where the antibodies in the sample compete with an anti-HAV specific antibody, labeled with HRP, for a fixed amount of antigen on the solid phase. A purified and inactivated HAV is coated to the microwells. The patient’s serum/plasma is added to the microwell and antibodies to HAV are captured by the solid phase. After washing, the enzyme conjugate is added and binds to the free HAV antigen, if still present. The plate is washed to remove unbound conjugate and then the chromogen/substrate is added. In the presence of peroxidase the colorless substrate is hydrolysed to a coloured end-product, whose optical density may be detected and is inversely proportional to the amount of antibodies to HAV present in the sample. An additive is added to the sample directly into the well to block interferences able to mask the presence of antibodies, mostly appearing in the follow up of vaccination.

Fourth generation Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis C Virus in human plasma/sera & for the screening of blood units and follow-up of HCV-infected patients. For "in vitro" diagnostic use only. 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.

Fourth generation Enzyme Immunoassay (ELISA) for the one-step determination of Hepatitis B surface Antigen or HBsAg in human plasma and sera & for the screening of blood units. Able to detect HBsAg mutants and find application in the follow-up of HBV-infected patients. For "in vitro" diagnostic use only. The World Health Organization (WHO) defines Hepatitis B Virus infection as follows: "Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. Hepatitis means inflammation of the liver, and the most common cause is infection with one of 5 viruses, called hepatitis A,B,C,D, and E. All of these viruses can cause an acute disease with symptoms lasting several weeks including yellowing of the skin and eyes (jaundice); dark urine; extreme fatigue; nausea; vomiting and abdominal pain. It can take several months to a year to feel fit again. Hepatitis B virus can cause chronic infection in which the patient never gets rid of the virus and many years later develops cirrhosis of the liver or liver cancer.

Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis B core Antigen in human plasma and sera. The kit is for use in screening of blood units and the follow-up of HBV-infected patients. For "in vitro" diagnostic use only. The assay is based on the principle of competition where the antibodies in the sample compete with a monoclonal antibody for a fixed amount of antigen on the solid phase. A purified recombinant HBcAg is coated to the microwells. The patient’s serum/plasma is added to the microwell together with an additive able to block interferences present in the sample. In the second incubation after washing, a monoclonal antibody, conjugated with Horseradish Peroxidase (HRP) and specific for HBcAg is added and binds to the free rec-HBcAg coated on the plastic. After incubation, microwells are washed to remove any unbound conjugate and then the chromogen/substrate is added. In the presence of peroxidase enzyme the colorless substrate is hydrolyzed to a colored end-product. The color intensity is inversely proportional to the amount of antibodies to HBcAg present in the sample.