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Micro-plates are coated by strips with ANA recombinant or purified Antigens specific: Ro/SSA52,RoSSA60, La/SSB, RNP-68, Sm, Scl-70, Jo-1, CENP-B. Microplates are coated by strips with ANA recombinant or purified Antigens specific: Ro/SSA52,RoSSA60, La/SSB, RNP-68, Sm, Scl-70, Jo-1, CENP-B. Position Autoantigen Composition A SSA60 Rec Ag B SSA52 Rec Ag C SSB Rec Ag D RNP-68 Rec Ag E Sm Native Ag F Scl-70 Rec Ag G Jo-1 Rec Ag H CENP-B Rec Ag In the 1st incubation, the solid phase is treated with diluted samples and anti nuclear IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti nuclear IgG are detected by the addition of anti hIgG 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 nuclear IgG antibodies present in the sample. The presence of IgG in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples.

ANA Screening IgG - Enzyme Immunoassay (ELISA) for the qualitative determination of IgG antibodies to anti Nuclear antigens in human serum and plasma Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgG auto-antibodies to dsDNA, histones, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, centromere and other antigens extracted from the HEp-2 nucleus, in human plasma and sera. For in vitro diagnostic use only. Autoimmunity is the failure of an organism to recognize its own constituent parts as self, which allows an immune response against its own cells and tissues. Any disease that results from such an aberrant immune response is termed an Autoimmune Disease. Rheumatoid autoimmune diseases are often associated with auto-antibodies to Nuclear Antigens. We can to distinguish between Anti Nuclear Antibodies (ANA), associate with autoimmune systemic diseases as SLE (Systemic Lupus Erythematosus), RA (Reumatoid Arthritis), Scleroderma, MCDT (Mixed Connective Tissue Disease) and Sjogren's Syndrome; and Extractable anti Nuclear Antibodies (ENA), associate with autoimmune systemic disease as Polymyositis, SLE, MCDT and Sjogren's Syndrome.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Cytomegalovirus in plasma and sera. For "in vitro" diagnostic use only.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Cytomegalovirus in plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with native Cytomegalovirus antigens, highly purified by sucrose gradient centrifugation and inactivated. The solid phase is first treated with the diluted sample and IgG to Cytomegalovirus are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti Cytomegalovirus 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 Cytomegalovirus IgG antibodies present in the sample. A Calibration Curve, calibrated against the1st W.H.O international standard , makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme Immuno Assay (ELISA) for the determination of IgM class antibodies to Cytomegalovirus or CMV in human plasma and sera with the "capture" system. The kit is intended for the follow-up of CMV infected patients and the monitoring of the risk of neonatal defects due to CMV infection during pregnancy. 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, in the 2nd incubation bound anti CMV IgM are detected by the addition of a complex composed of native CMV antigens and CMV specific monoclonal antibodies, labeled with peroxidase (HRP). After incubation, microwells are washed to remove unbound conjugate and then the chromogen/substrate is added. In the presence of bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to Cytomegalovirus present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

The device code: (COXBM.CE) Enzyme Immuno Assay (ELISA) for the determination of IgM antibodies to Coxsackievirus B (CoxB) in human plasma and sera.

Enzyme Immuno Assay (ELISA) for the determination of IgG antibodies to Coxsackievirus type B (CoxB) in human plasma and sera. For “in vitro” diagnostic use only. Coxsackievirus belongs to a group of viruses called enteroviruses in particular they are Picornaviruses.They are present in two main groups, A and B. Most Coxsackievirus infections are not serious. They typically cause only mild signs and symptoms, such as fever, rash, sore throat, joint pain and headache. Symptoms usually last about a week.

The device code: (COXBM.CE) Enzyme Immuno Assay (ELISA) for the determination of IgM antibodies to Coxsackievirus B (CoxB) in human plasma and sera.

Enzyme Immuno Assay (ELISA) for the determination of IgM antibodies to Coxsackievirus B (CoxB) in human plasma and sera. For “in vitro” diagnostic use only. Coxsackievirus belongs to a group of viruses called enteroviruses and are present in two main groups, A and B. Most Coxsackievirus infections are not serious. They typically cause only mild signs and symptoms, such as fever, rash, sore throat, joint pain and headache. Symptoms usually last about a week. Coxsackievirus infection occurs most often in young children. Group A viruses are associated with aseptic meningitis, colds, acute hemorrhagic conjunctivitis and acute myocardiopathies and group B are associated with acute myocarditis and a polio-like paralysis.

The device code: (CPA.CE) Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgA antibodies to Chlamydia Pneumoniae in human plasma and sera. The product is intended for the follow-up of patients showing respiratory pathologies referabl Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgA antibodies to Chlamydia Pneumoniae in human plasma and sera. The product is intended for the follow-up of patients showing respiratory pathologies referable to Chl. Pneumoniae infection. Micro-plates are coated with a preparation of native C.pneumoniae. In the 1st incubation, the solid phase is treated with diluted samples and anti-C.pneumoniae IgA are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-CP IgA are detected by the addition of anti hIgA 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-CP IgA antibodies present in the sample. The presence of IgA in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples. Neutralization of IgG anti-CP, 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 IgA.

The device code: (CPG.CE) Enzyme ImmunoAssay (ELISA) for the quantitative determination of IgG antibodies to Chlamydia pneumoniae in human plasma and sera. The kit is intended for the follow up of patients undergoing a Chlamydia pneumoniae infection. Download Full Document(IFU) Enzyme ImmunoAssay (ELISA) for the quantitative determination of IgG antibodies to Chlamydia pneumoniae in human plasma and sera. The kit is intended for the follow up of patients undergoing a Chlamydia pneumoniae infection. Micro-plates are coated with a preparation of native C.pneumoniae. In the 1st incubation, the solid phase is treated with diluted samples and anti-C.pneumoniae IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-C.pneumoniae IgG are detected by the addition of anti hIgG 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-C.pneumoniae IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (Uarb/ml) as no international standard is available.

The device code: (CPM.CE) Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Chlamydia Pneumoniae in human plasma and sera. The product is intended for the follow-up of patients showing respiratory pathologies referable to Chl.p Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Chlamydia Pneumoniae in human plasma and sera. The product is intended for the follow-up of patients showing respiratory pathologies referable to Chl. pneumoniae infection. Micro-plates are coated with a preparation of native C.pneumoniae. In the 1st incubation, the solid phase is treated with diluted samples and anti-C.pneumoniae IgM are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-CP 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-CP IgM antibodies present in the sample. The presence of IgM in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples.Neutralization of IgG anti-CP, 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.

The device code: (CTA.CE) Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgA antibodies to Chlamydia Trachomatis in human plasma and sera. The product is intended for the follow-up of patients showing pathologies referable to Chl. Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgA antibodies to Chlamydia Trachomatis in human plasma and sera. The product is intended for the follow-up of patients showing pathologies referable to Chl. Trachomatis infection. Micro-plates are coated with a species-specific polypeptide derived from C.trachomatis major outer membrane antigen.In the 1st incubation, the solid phase is treated with diluted samples and anti-C.trachomatis IgA are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti-C.trachomatis IgA are detected by the addition of anti hIgA antibody, 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-C.trachomatis IgA antibodies present in the sample. IgA in the sample are then determined by a cut-off value able to discriminate between the negative and the positive population.Interferences due to IgG are blocked by means of a Neutralizing Reagent directly added to the sample in the well.

Enzyme ImmunoAssay (ELISA) for the quantitative determination of IgG antibodies specific to Chlamydia trachomatis in human plasma and sera. The kit is intended for the follow up of patients undergoing a Chlamydia trachomatis infection. Micro-plates are coated with an immunodominant species-specific polypeptide derived from Chlamydia trachomatis major outer-membrane antigen (MOMP), that makes the assay very specific for C.trachomatis (no cross reaction with C.pneumoniae).In the 1st incubation, the solid phase is treated with diluted samples and anti-C.trachomatis IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-C.trachomatis IgG are detected by the addition of anti hIgG antibody, 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-C.trachomatis IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (Uarb/ml) as no international standard is available.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Chlamydia Trachomatisin human plasma and sera. Micro-plates are coated with a species-specific polypeptide derived from C.trachomatis major outer membrane antigen.In the 1st incubation, the solid phase is treated with diluted samples and anti-CT IgM are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti-CT 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-CT IgM antibodies present in the sample. The presence of IgM in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples.Neutralization of IgG anti-CT, 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.

Enzyme ImmunoAssay (ELISA) for the qualitative/semiquantitative determination of IgG antibodies to Dengue virus in human plasma and sera.The product is intended mostly for the follow-up of Dengue virus infection.The product is supplied for research purpose only.Micro-plates are coated with an highly purified Dengue virus antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti Dengue virus IgG are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti Dengue virus IgG are detected by the addition of anti hIgG 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 Dengue virus IgG antibodies present in the sample.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgM antibodies to Dengue Virus in human plasma and sera. Micro-plates are coated with higly purified Dengue Virus antigen.In the 1st incubation, the solid phase is treated with diluted samples and anti Dengue Virus IgM are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti Dengue Virus 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 Dengue Virus IgM antibodies present in the sample. Neutralization of IgG anti-DV, carried out directly in the well in the 1st incubation, is performed in the assay in order to block interferences due to this class of antibodies in the determination of IgM.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Epstein Barr Virus Early Antigen in human plasma and sera. For “in vitro” diagnostic use only. Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt’s lymphoma and nasopharyngeal carcinoma, or NPC.A member of the family Herpesviridae, it has a worldwide distribution, such that 80 to 90% of all adults have been infected.Primary infections usually occur during the first decade of life.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgM class antibodies to Epstein Barr Virus Early Antigen (Ea) in human plasma and sera. The kit is intended for the classification of the viral infective agent and the follow-up of EBV infected patients. For “in vitro” diagnostic use only.Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt’s lymphoma and nasopharyngeal carcinoma, or NPC.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgM class antibodies to Epstein Barr Virus Nuclear Antigen (EBNA) in human plasma and sera.The kit is intended for the classification of the viral infective agent and the follow-up of EBV infected patients.For “in vitro” diagnostic use only.Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt’s lymphoma and nasopharyngeal carcinoma, or NPC.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Epstein Barr Virus Nuclear Antigen in human plasma and sera. For "in vitro" diagnostic use only.Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt's lymphoma and nasopharyngeal carcinoma, or NPC. A member of the family Herpesviridae, it has a worldwide distribution, such that 80 to 90% of all adults have been infected. Primary infections usually occur during the first decade of life. While childhood infections are mostly asymptomatic, 50 to 70% of young adults undergoing primary EBV infections show mild to severe illness. EBV may cause a persistent, latent infection which can be reactivated under immunosoppression or in AIDS affected patients. As humoral responses to primary EBV infections are quite rapid, the level and class of antibodies raised in most cases allow classification as to whether the patient is still susceptible, has a current or recent primary infection, had a past infection or may be having reactivated EBV infection.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgA antibodies to Epstein Barr Virus Capsidic Antigen in human plasma and sera. For “in vitro” diagnostic use only. Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt’s lymphoma and nasopharyngeal carcinoma, or NPC. A member of the family Herpesviridae, it has a worldwide distribution, such that 80 to 90% of all adults have been infected.Primary infections usually occur during the first decade of life.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Epstein Barr Virus Capsidic Antigen in human plasma and sera. For "in vitro" diagnostic use only. Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt's lymphoma and nasopharyngeal carcinoma, or NPC. A member of the family Herpesviridae, it has a worldwide distribution, such that 80 to 90% of all adults have been infected. Primary infections usually occur during the first decade of life. While childhood infections are mostly asymptomatic, 50 to 70% of young adults undergoing primary EBV infections show mild to severe illness. EBV may cause a persistent, latent infection which can be reactivated under immunosoppression or in AIDS affected patients.

Enzyme ImmunoAssay (ELISA) for the quantitative or qualitative determination of IgM class antibodies to Epstein Barr Virus (EBV) Capsidic Antigen 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 EBV infected patients. For "in vitro" diagnostic use only. Epstein Barr Virus or EBV is the principal etiological agent of infectious mononucleosis, as well as a contributory factor in the etiology of Burkitt's lymphoma and nasopharyngeal carcinoma, or NPC. A member of the family Herpesviridae, it has a worldwide distribution, such that 80 to 90% of all adults have been infected. Primary infections usually occur during the first decade of life. While childhood infections are mostly asymptomatic, 50 to 70% of young adults undergoing primary EBV infections show mild to severe illness.

The device ENA6PRO.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the qualitative determination of IgG autoantibodies against Ro/SSA, La/SSB, RNP-68, Sm, Scl-70, Jo-1 in human plasma and sera. For in vitro diagnostic use only. Microplates are coated by strips with ENA recombinant or purified Antigens specific: Ro/SSA, La/SSB, RNP-68, Sm, Scl-70, Jo-1. In the 1st incubation, the solid phase is treated with diluted samples and anti nuclear IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti nuclear IgG are detected by the addition of anti hIgG antibody, 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 nuclear IgG antibodies present in the sample. The presence of IgG in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples.Controls are included to provide an internal check of the analytical system.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgG auto-antibodies to SSA, SSB, Sm, RNP68, Scl-70, Jo-1, in human plasma and sera. For in vitro diagnostic use only. Autoimmunity is the failure of an organism to recognize its own constituent parts as self, which allows an immune response against its own cells and tissues. Any disease that results from such an aberrant immune response is termed an Autoimmune Disease. Rheumatoid autoimmune diseases are often associated with auto-antibodies to Nuclear Antigens. We can to distinguish between Anti Nuclear Antibodies (ANA), associate with autoimmune systemic diseases as SLE (Systemic Lupus Erythematosus), RA (Reumatoid Arthritis), Scleroderma, MCDT (Mixed Connective Tissue Disease) and Sjogren's Syndrome; and Extractable anti Nuclear Antibodies (ENA), associate with autoimmune systemic disease as Polymyositis, SLE, MCDT and Sjogren's Syndrome.

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.

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 B core Antigen in human plasma and sera. The kit may be used for the 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.

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 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: 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.

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.

Third generation Enzyme Immunoassay for the determination of Hepatitis B surface Antigen or HBsAg in human serum and plasma A mouse monoclonal antibody specific for HBsAg is fixed to the surface of microwells. Patient’s serum/plasma is added to the microwell together with a second mouse monoclonal antibody, conjugated with Horseradish Peroxidase (HRP) and directed against a different epitope. The specific immunocomplex, formed in the presence of HBsAg in the sample, is captured by the solid phase. At the end of the one-step incubation, microwells are washed to remove unbound serum proteins and HRP conjugate. The chromogen/substrate is then added and, in the presence of captured HBsAg immunocomplex, the colorless substrate is hydrolyzed by the bound HRP conjugate to a colored end-product. After blocking the enzymatic reaction, its optical density is measured by an ELISA reader. The color intensity is proportional to the amount of HBsAg present in the sample.

Third generation Enzyme Immunoassay for the determination of Hepatitis B surface Antigen or HBsAg in human serum and plasma. 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.

Fourth generation Enzyme Immunoassay (ELISA) for the one-step determination of Hepatitis B surface Antigen or HBsAg in human plasma and sera. The kit may be used for the screening of blood units, is 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.

Fourth generation 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. 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.

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 IgM antibodies to Hepatitis C Virus in human plasma and sera. The kit is intended for the follow-up of HCV chronic patients submitted to anti-viral pharmaceutical treatment. For "in vitro" diagnostic use only. 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 determined by means of a cut-off value able to discriminate between negative and positive samples. 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.

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.

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.

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 qualitative determination of antibodies to Hepatitis E Virus in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HEV-infected patients. For "in vitro" diagnostic use only. Microplates are coated with HEV-specific synthetic antigens encoding for conservative and immunodominant determinants derived from Mexican and Burma virus strains. The solid phase is first treated with the diluted sample and HEV Ab are captured, if present, by the antigens. 2nd incubation bound HEV 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 HEV antibodies present in the sample. A cut-off value let optical densities be interpreted into HEV antibody negative and positive results.

Third generation Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgG antibodies to Hepatitis E Virus in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HEV-infected patients. For "in vitro" diagnostic use only. Microplates are coated with HEV-specific synthetic antigens encoding for conservative and immunodominant determinants derived from Mexican and Burma virus strains. 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.

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 follow-up of HEV-infected patients. For "in vitro" diagnostic use only. Microplates are coated with HEV-specific synthetic antigens encoding for conservative and immunodominant determinants derived from Mexican and Burma virus strains. The solid phase is first treated with the diluted sample and anti HEV IgM are captured, if present, by the antigens adsorbed on wells. After washing out all the other components of the sample, in the 2nd incubation bound anti HEV IgM antibodies are detected by the addition of polyclonal specific anti hIgM antibodies, 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. A cut-off value let optical densities be interpreted into HEV antibody 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.

Epidemiological evidence indicates that an infectious agent transmitted through intimate contact, intravenous drug use or use of infected blood or blood products leads to Acquired Immunodeficiency Syndrome (AIDS). This disease affects T-cell mediated immunity, resulting in severe lymphopenia and a reduced subpopulation of helper T-lymphocytes. Destruction of this T-lymphocyte population by the virus causes an immune deficiency, resulting in a reduced or deficient response to subsequent infections. Consequently, infections become more severe and may cause death. At present, there is no successful treatment for AIDS. The etiological agent has been identified as a retrovirus, human immunodeficiency virus type 1 (HIV-1). A closely related, but distinct type of immunodeficiency virus, designated HIV-2, has also been isolated. This virus causes a disease that is indistinguishable from AIDS. Serological cross-reactivity between HIV-1 and HIV-2 has been shown to be highly variable from sample to sample. This variability requires the inclusion of antigens to both HIV-1 and HIV-2 for the screening of antibodies to HIV-1 and HIV-2. The presence of anti-HIV-1 and/or anti-HIV-2 and/or HIV p24 antigen in the blood indicates potential infection with HIV-1 and/or HIV-2 and consequently this blood should not be used for transfusion or for manufacture of injectable products.

Enzyme ImmunoAssay (ELISA) for the determination of HIV specific p24 antigen in the screening of blood units. The test is not recommended for the follow up of AIDS patients. For "in vitro" diagnostic use only. The kit is an enzyme-linked immunosorbent assay (ELISA) for the determination of HIV specific p24 antigen (p24 Ag). If this antigen is present in the sample, a monoclonal antibody, labeled with biotin and added to the sample, will bind the p24 Ag. A second monoclonal antibody, coated on the plate, will bind the immunocomplex formed in solution. After washing StreptoAvidin, labeled with peroxidase (HRP), is added to detect any biotin residual, specifically captured by the plate. After washing, a substrate/chromogen solution is added; the intensity of the color developed by the bound enzyme will be proportional to the amount of p24 Ag in the sample. Results are evaluated against a cut-off value able to discriminate negative from positive individuals.

H.Pylori Ag antigen STOOL EXTRACTION KIT

Enzyme Immunoassay (ELISA) for the one-step qualitative/quantitative determination of Helicobacter pylori Antigen (HP Ag) in human stools. The kit may be used for the the follow-up of HP-infected patients and their pharmacological treatment. For "in vitro" diagnostic use only. Stools from patients are used as a source of sample for the determination of HP antigen. Microplates are coated with a cocktail of affinity purified mouse monoclonal antibodies directed to the most specific Helicobacter pylori antigens. In the 1st incubation, the solid phase is treated with the sample, previously extracted from stools, and simultaneously with a mixture of monoclonal antibodies to Hp, conjugated with peroxidase (HRP). After washing out all the other components of the sample, in the 2nd incubation the bound enzyme specifically present on the solid phase generates an optical signal that is proportional to the amount of H.pylori antigens present in the sample.

Enzyme Immunoassay for the quantitative determination of IgA antibodies to Helicobacter pylori cytotoxin associated gene A Antigen or CagA-Ag in sera/plasma. The product is intended for the follow-up of patients showing gastrointestinal pathologies referable to H.pylori infection. For "in vitro" diagnostic use only. Microplates are coated with Helicobacter pylori specific CagA-Ag synthetic antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti CagA-Ag IgA are captured, if present, by the antigens.

Enzyme Immunoassay for the quantitative determination of IgG antibodies to Helicobacter pylori cytotoxin associated gene A Antigen or CagA-Ag in sera/plasma. The product is intended for the follow-up of patients showing gastrointestinal pathologies referable to H.pylori infection. For "in vitro" diagnostic use only. Microplates are coated with Helicobacter pylori specific CagA-Ag synthetic antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti CagA-Ag IgG are captured, if present, by the antigens.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgA antibodies to Helicobacter pylori in human plasma and sera. The product is intended for the follow-up of patients showing gastrointestinal pathologies referable to H.pylori infection.For "in vitro" diagnostic use only. Microplates are coated with H.pylori immunodominant antigens derived from tissue culture of a virulent strain. In the 1st incubation, the solid phase is treated with diluted samples and anti-HP IgA are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti-HP IgA are detected by the addition of anti hIgA antibody, labeled with peroxidase (HRP).

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Helicobacter pylori in human plasma and sera. The product is intended for the follow-up of patients showing gastrointestinal pathologies potentially correlated to HP infection. For "in vitro" diagnostic use only. Microplates are coated with H.pylori immunodominant antigens derived from tissue culture of a virulent strain. In the 1st incubation, the solid phase is treated with diluted samples and anti-HP IgG are captured, if present, by the antigens.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Helicobacter pylori in human plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with H.pylori immunodominant antigens derived from tissue culture of a virulent strain. In the 1st incubation, the solid phase is treated with diluted samples and anti-HP IgM are captured, if present, by the antigens.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Herpes Simplex Virus type 1 and 2 in human plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with native inactivated HSV1 and HSV2. The solid phase is first treated with the diluted sample and IgG to HSV are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti HSV 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 HSV IgG antibodies present in the sample. A Calibration Curve, calibrated against an internal Gold Standard, makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Herpes Simplex Virus types 1&2 in human plasma and sera with the "capture" system. The devise is intended for the follow-up of HSV infected patients and for the monitoring of risk of neonatal defects due to HSV infection during pregnancy. 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 HSV1&2, labeled with a specific 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 bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to HSV1&2present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Herpes Simplex Virus type 1 in human plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with native inactivated HSV1. The solid phase is first treated with the diluted sample and IgG to HSV are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti HSV1 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 HSV1 IgG antibodies present in the sample. A Calibration Curve, calibrated against an internal Gold Standard, makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Herpes Simplex Virus types 1 in human plasma and sera with the "capture" system. The device is intended for the follow-up of HSV1 infected patients and for the monitoring of risk of neonatal defects due to HSV infection during pregnancy.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 preparation of inactivated HSV1, labeled with a HSV1 specific 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 bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to HSV1 present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Herpes Simplex Virus type 2 in human plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with synthetic HSV2 specific glycoprotein G or gG. The solid phase is first treated with the diluted sample and IgG to HSV2 are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti HSV2 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 HSV2 IgG antibodies present in the sample. A Calibration Curve, calibrated against an internal Gold Standard, makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Herpes Simplex Virus types 2 in human plasma and sera with the "capture" system. The devise is intended for the follow-up of HSV2 infected patients and for the monitoring of risk of neonatal defects due to HSV infection during pregnancy. 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 preparation of inactivated HSV2, labeled with a HSV2 specific 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 bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to HSV2 present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

Third generation Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Human T-cell Lymphotropic Virus type I&II or HTLV I&II Ab. The kit may be used for the screening of blood units and the follow-up of HTLV I&II-infected patients. Microplates are coated with HTLV I&II-specific peptides (gp46-I, gp46-II and p21-I). The solid phase is first treated with the diluted sample and anti HTLV I&II Ab are captured, if present, by the antigens coated on the microplate. After washing out all the other components of the sample, in the 2nd incubation bound anti HTLV I&II 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 HTLV I&II antibodies present in the sample. A cut-off value let optical densities be interpreted into anti HTLV I&II antibody negative and positive results.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of antibodies to Human T-cell Lymphotropic Virus type I&II or HTLV I&II Ab. The kit may be used for the screening of blood units and the follow-up of HTLV I&II-infected patients. For "in vitro" diagnostic use only. HTLV I&II are retroviruses not related genetically to HIV1&2; however, they have similar routes of transmission and can have extremely long period of latency prior to manifestation of disease.HTLV I is endemic in southern Japan, the Caribbean and the US and many other scattered population trough the world.HTLV II is endemic in some native American populations but is detected mostly in intravenous drug users and their sexual partners. HTLV I&II are transmitted transplacentally, parenterally, by sexual contacts and by infected blood.ELISA has been applied to the diagnosis of HTLV I&II serology by detecting specific antibodies in plasma and sera.

The device CENPB.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Centromere B autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant Centromere B antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-CENPB IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-CENPB are detected by the addition of anti hIgG antibody, 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-CENPB IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device JO1.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Jo-1 autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant Jo-1 antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti Jo-1 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti Jo-1 IgG are detected by the addition of anti hIgG 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 Jo-1 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device SCL70.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Scl-70 autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant Scl-70 antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-SCL70 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-SCL70 are detected by the addition of anti hIgG 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-SCL70 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device SM.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Sm autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of purified Sm antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-Sm IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-Sm are detected by the addition of anti hIgG 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-Sm IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device SSA52.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against SSA-52KD autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of Recombinant SSA 52KDa antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-SSA52 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation the bound anti-SSA52 IgG are detected by the addition of anti hIgG 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-SSA52 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device SSA60.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against SSA-60KD autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant SSA 60KDa antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-SSA60 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-SSA60 are detected by the addition of anti hIgG 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-SSA60 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

The device SSB.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against SSB autoantigens in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant SSB antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-SSB IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-SSB are detected by the addition of anti hIgG 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-SSB IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

Enzyme ImmunoAssay (ELISA) for the quantitative determination of IgG autoantibodies to RNP-68KDa in human plasma and sera. For in vitro diagnostic use only. Microplates are coated with a preparation of recombinant U1-snRNP 68 antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti U1-snRNP 68 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti U1-snRNP 68 are detected by the addition of anti hIgG 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 U1-snRNP 68 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.

Enzyme Immunoassay (ELISA) for the determination of antibodies to Plasmodium species in human sera and plasma. The kit is intended for the screening of blood units and the identification of people that came into contact with the protozoa and developed an immunological response. The kit is for in vitro diagnostic use only and the test has to be carried out by professional people, opportunely trained.Plasmodium species are obligate intracellular protozoa related to Babesia and Toxoplasma. Plasmodium species reproduce sexually in mosquitoes; mosquitoes transmit the resulting sporozoites into humans where the organisms reproduce asexually.

Enzyme ImmunoAssay (ELISA) for the semi-quantitative determination of IgG antibodies to Measles Virus in human plasma and sera. The product is intended mostly for the follow-up of anti Measles Virus vaccination and can also be useful for the follow up of infected individuals. Micro-plates are coated with Measles Virus native antigens derived from tissue culture of a virulent strain. In the 1st incubation, the solid phase is treated with diluted samples and anti Measles Virus IgG are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti Measles Virus IgG are detected by the addition of anti hIgG 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 Measles Virus IgG antibodies present in the sample. IgG in the sample may therefore be semi quantitated in arbU/ml by means of its S/Co value and a calibration curve.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgM antibodies to Measles Virus in human plasma and sera. The product is intended mostly for the identification of the pathogen in patients undergoing an exanthematic infection. Micro-plates are coated with Measles Virus native antigens derived from tissue culture of a virulent strain. In the 1st incubation, the solid phase is treated with diluted samples and anti Measles Virus IgM are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti Measles Virus 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 Measles Virus IgM antibodies present in the sample. Neutralization of IgG anti-measles, 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.

Enzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to groups ACWY Meningococcus in human plasma and sera. The product is intended for the follow-up of patients administered with a meningococcal vaccine, containing the polysaccharides from groups A, C, Y and W135. Micro-plates are coated with a preparation of purified capsular polysaccharides formed by serogroups A, B, C, Y and W135. In the 1st incubation, the solid phase is treated with diluted samples and anti-Meningococcus IgG are captured, if present, by the antigens.After washing out all the other components of the sample, in the 2nd incubation bound anti-Men IgG are detected by the addition of anti hIgG 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-Men IgG antibodies present in the sample. A cut-off value permits to transform the optical density values detected in positive or negative results due to the presence of absence of anti-Men IgG.

Enzyme ImmunoAssay (ELISA) for the qualitative and/or semi quantitative determination of IgG antibodies to Mycobacterium tuberculosis. The kit may be used for the follow up of patients undergoing tuberculosis. Mycobacterium tuberculosis (MTB) is a fastidious, slowly-growing, strictly aerobic bacterium with a complex cell wall composed of peptide-glycans and many complex long-chain lipids.Tuberculosis remains one of the most common and deadly diseases throughout the world. In the past 10 years there has been a resurgence of tuberculosis in old-world countries, also due to new infections (HIV) and immigration.

Parvovirus B19 IgG Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Parvovirus B19 in human plasma and sera. For “in vitro” diagnostic use only. The B19 virus, generally referred to as parvovirus B19 was the first (and until 2005 the only) known human virus in the family of parvoviruses, genus erythrovirus. Parvovirus B19 is a non-enveloped, icosahedral virus that contains a single-stranded linear DNA genome.

Parvovirus B19 IgM Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgM antibodies to Parvovirus B19 in human plasma and sera. For “in vitro” diagnostic use only. The B19 virus, generally referred to as parvovirus B19 was the first (and until 2005 the only) known human virus in the family of parvoviruses, genus erythrovirus. Parvovirus B19 is a non-enveloped, icosahedral virus that contains a single-stranded linear DNA genome. It is classified as erythrovirus because of its capability to invade red blood cell precursors in the bone marrow. Three genotypes (with subtypes) have been recognised.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Rubella Virus in human plasma and sera. For "in vitro" diagnostic use only. Microplates are coated with native Rubella Virus, highly purified by sucrose gradient centrifugation and inactivated. The solid phase is first treated with the diluted sample and IgG to Rubella Virus are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti Rubella 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 Rubella Virus IgG antibodies present in the sample. A Calibration Curve, calibrated against the 1st W.H.O international standard for anti-Rubella immunoglobulin code RUBI-1-94, makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Rubella Virus in human plasma and sera with the "capture" system. The devise is intended for the follow-up of Rubella Virus infected patients and for the monitoring of risk of neonatal defects due to Rubella Virus infection during pregnancy. 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 Rubella Virus, labeled with a specific monoclonal 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 bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to Rubella Virus present in the sample.A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Treponema pallidum (Tp) in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of Tp-infected patients. For "in vitro" diagnostic use only. Microplates are coated with purified Treponema pallidum synthetic antigens, derived from immunodominant protein of the bacterium. The solid phase is first treated with the diluted sample and captures antibodies if present. After the washing step, the specifically bound antibodies are detected with an anti-human IgG&M antibody, labeled with peroxidase (HRP). A substrate/chromogen solution is added and the intensity of the color developed by the bound enzyme is proportional to the amount of anti-Tp antibodies in the sample. Results are evaluated against a cut-off value able to discriminate Treponema pallidum antibody negative individuals from positive ones.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Treponema pallidum (Tp) in human plasma and sera. The kit is intended for the follow-up of Tp-infected patients. For "in vitro" diagnostic use only. Microplates are coated with Tp immunodominant synthetic antigens (recombinant p47, p17 and TmpA).In the 1st incubation, the solid phase is treated with diluted samples and anti-Tp IgM are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti-Tp 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-Tp IgM antibodies present in the sample. The presence of IgM in the sample may therefore be determined by means of a cut-off value able to discriminate between negative and positive samples. Neutralization of IgG anti-Tp, 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.

Third generation Enzyme Immuno Assay (ELISA) for the determination of antibodies to Tripanosoma cruzi (Tc) in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of Tc-infected patients. For “in vitro” diagnostic use only. Tripanosomes are flagellar protozoa known to infect humans and cause the Chaga’s disease (T.cruzi) and the Sleeping Sickness (T.brucei). Chaga’s disease is mainly spread in south America countries but is known to be present also in south USA and some African regions.

The device TG.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Thyroglobulin in human plasma and sera. For in vitro diagnostic use only. Autoimmunity is the failure of an organism to recognize its own constituent parts as self, which allows an immune response against its own cells and tissues. Any disease that results from such an aberrant immune response is termed an Autoimmune Disease. Thyroid autoantibodies are frequently found in patients with autoimmune thyroid disease. The two most common of these autoantibodies are antibodies to Thyroglobulin and Thyroid peroxidase. Antibodies to Thyroglobulin and Thyroid Peroxidase will be found in cases of Hashimoto's disease, myxedema and Grave's Disease.

The device code TORCHM.CE is intended to be used for the first screening of women in pregnancy, and in other “risk patients” in order to point out those samples that are positive for IgM to any of the TORCH infectious agents (Toxoplasma gondii, Rubella virus, Cytomegalovirus and Herpes Simplex virus). In case the assay turns out to be positive, the clinician then on such patient will go throughout specific TORCH tests able to determine which TORCH pathogen is involved in the infection.For “in vitro” diagnostic use only. TORCH microorganisms are ubiquitous human pathogens, whose infections continue to be an important health problem in certain patient populations, such as pregnant women, newborns, graft recipients of solid organs or bone marrow, and AIDS patients. In these last groups, Toxoplasma and CMV are a major cause of morbidity and mortality. The screening of TORCH specific IgM antibodies, even if does not indicate which microorganism is involved, is of great value in the first diagnosis of acute/primary infections or reactivation of a latent one, particularly in the absence of typical clinical symptoms, as usually happens for CMV and for Toxoplasma. Recently developed IgM capture ELISA’s for TORCH, taking advantage of specific synthetic antigens or highly purified native ones, provide the clinician with an highly specific and reliable diagnostic test, not affected by Rheumatoid Factor, for the monitoring of such “risk” populations.

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Toxoplasma gondii in plasma and sera.The solid phase is first treated with the diluted sample and IgG to T. gondii are captured, if present, by the antigens. After washing out all the other components of the sample, in the 2nd incubation bound anti Toxoplasma gondii IgG are detected by the addition of polyclonal specific anti human IgG 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 Toxoplasma gondii IgG antibodies present in the sample. A Calibration Curve, calibrated against the W.H.O 3nd international standard , makes possible a quantitative determination of the IgG antibody in the patient.

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Toxoplasma gondii or T.gondii in human plasma and sera with the "capture" system. The devise is intended for the follow-up of T.gondii infected patients and for the monitoring of risk of neonatal defects due to T.gondii infection during pregnancy. 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 preparation of inactivated T.gondii, labeled with a specific monoclonal 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 IgM antibodies to T.gondii present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.

The device TPO.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Thyroid Peroxidase in human plasma and sera. For in vitro diagnostic use only. Autoimmunity is the failure of an organism to recognize its own constituent parts as self, which allows an immune response against its own cells and tissues. Any disease that results from such an aberrant immune response is termed an Autoimmune Disease. Thyroid autoantibodies are frequently found in patients with autoimmune thyroid disease. The two most common of these autoantibodies are antibodies to Thyroglobulin and Thyroid peroxidase. Antibodies to Thyroglobulin and Thyroid Peroxidase will be found in cases of Hashimoto's disease, myxedema and Grave's Disease.

Enzyme ImmunoAssay (ELISA) for the qualitative determination of antibodies to West Nile Virus in human plasma and sera. The product is intended mostly for the follow-up of West Nile Virus infection. For “in vitro” diagnostic use only. West Nile Virus is an arbovirus and is transmitted to people through complex life cycles involving birds and mosquitoes. Each infection is most often not trasmitted from person to person. Most peolple who are infected with west Nile Virus will not have any symptoms.

Real-Time PCR for the BKV genome Quantification The BKV DNA Quantitation Real-Time PCR kitcoded BKVDNAQT.CE is intended for the quantitative detection of the BK Virus DNA in human plasma and urine with a simultaneous control of the amplification/extraction reaction through an Internal Control (IC). The kit has been adapted for the use on the Real-Time Thermacyclers ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) or Miniopticon® (Software CFX manager version 1.6, Biorad™**) or MX3000P® (Software MxPro version 4.01, Stratagene™***).

Real -Time PCR for detection of Chlamydia Trachomatis The Chlamydia trachomatis DNA Real-Time PCR kit coded CTDNA.CE is intended for the qualitative detection of Chlamydia trachomatis DNA in human urethral/cervical swabs and urine with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC). The kit has been adapted for the use on the Real-Time Thermacyclers and ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) or Miniopticon® (Software CFX manager version 1.6 , Biorad™**) or MX3000P (Software MxPro version 4.01, Stratagene™***). Importante note: The CTDNA.CE kit it is able to detect the Swedish C.trachomatis variant.

Real -Time PCR for the CMV genome Quantitation The CMV DNA Quantitation (QT) Real-Time PCR kit coded CMVDNAQT.CE is intended for the quantitative detection of Cytomegalovirus DNA in human sample (blood, plasma, amniotic fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Real -Time PCR for the CMV genome Quantitation The EBV DNA Quantitation (QT) Real-Time PCR kit coded EBVDNAQT.CE is intended for the quantitative detection of Epstein-Barr Virus DNA in human plasma and whole blood collected in EDTA with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Real -Time PCR for detection of Enterovirus spp The Enterovirus RNA Real-Time PCR kit coded ENTERORNA.CE is intended for the qualitative detection of Enterovirus RNA in human plasma and CSF samples (Cerebral Spinal Fluid) with a simultaneous control of the amplification reaction through an Internal Control (IC).

Real -Time PCR for detection of HBV genome The HBV DNA Quantitation Real-Time PCR kitcoded HBVDNAQT.CE is intended for quantitative detection of Hepatitis B Virus DNA in human plasma with a simultaneous control of the amplification reaction through an Internal Control (IC). The kit is intended for use in conjunction with clinical observation and laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment. The kit has been adapted for the use on the Real-Time Thermacyclers ABI 7500 Sequence Detection System® (Applied Biosystems™*) software SDS 1.3.1 or Miniopticon® software CFX Manager ver.1.6 (Biorad™**) or MX3000P® software MxPro 4.01(Stratagene™*** ).

Real -Time PCR for detection of HBV genome The HDV Quantitation Real-Time PCR kit coded DRNA.CE is intended for the quantitative detection of Hepatitis D Virus RNA in human serum with a simultaneous control of the amplification reaction through an Internal Control (IC).

Kit for the Reverse Transcription of Hepatitis D Virus (HDV) RNA The HDV RNA Retrotrascription kit coded RNART.HDV.CE is intended for the reverse transcription to cDNA of Hepatits delta virus RNA. Reverse transcription polymerase chain reaction (RT-PCR) is aimed to the generation of many copies of a cDNA from an RNA molecule using the enzyme Reverse Transcriptase. The resulting cDNA can be use as template of a real-time PCR using the DRNA.CE kit (Gentaur)

Real -Time PCR for the HHV6 A-B genome Quantification The HHV6 DNA Quantitation Real-Time PCR kit coded HHV6DNAQT.CE is intended for the quantitative detection of the Herpesvirus 6 DNA in human plasma/blood with a simultaneous control of the amplification/extraction reaction through an Internal Control (IC).

Real -Time PCR for the HHV8 genome Quantification The HHV8 DNA Quantitation (QT) Real-Time PCR kit coded HHV8DNAQT.CE is intended for the quantitative detection of Human herpesvirus 8 DNA in human plasma/blood with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Real -Time PCR for the HSV1 genome Quantification The HSV1 DNA Quantitation (QT) Real-Time PCR kit coded HSV1DNAQT.CE is intended for the quantitative detection of Human herpes simplex virus 1 DNA in human plasma and CSF (cerebrospinal fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Real -Time PCR for the HSV2 genome Quantification The HSV2 DNA Quantitation (QT) Real-Time PCR kit coded HSV2DNAQT.CE is intended for the quantitative detection of Human herpes simplex virus 2 DNA in human plasma and CSF (cerebrospinal fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Real -Time PCR for the JCV genome Quantification The JCV DNA Quantitation Real-Time PCR kit coded JCVDNAQT.CE is intended for the quantitative detection of the JC Virus DNA in human plasma ,urine and cerebrospinal fluid (CSF) with a simultaneous control of the amplification/extraction reaction through an Internal Control (IC).

Real-Time PCR for detection of Legionella Pneumophila genome Legionella pneumophila, a gram negative non spore forming motile bacillus, is the etiologicagent of Legionellosis. Clinical symphtoms can range in severity from a mild, febrile illness(Pontiac fever) to a rapid and potentially fatal pneumonia (Legionnaires' disease). L. pneumophila is a common cause of nosocomial and travel-acquired pneumonia and with thebacterial species Mycoplasma pneumoniae and Clamydia pneumoniae is one of the top three cause of sporadic, community acquired pneumonia. The first strain of legionella were isolated in 1943 and classified as Riccktesia like organism, and the genus was established in 1979 after a large outbreak of pneumonia among members of the American legion that occurred 3 years earlier. After this, a large spectrum of legionella species was classified,actually genus includes 50 species and 16 serogrups of L. pneumophila were classified. Legionellae are ubiquitous in natural and artificial water environments worldwide, and survive in a range of environmental conditions.

Kit for the Reverse Transcription of viral RNA and m-RNA with Random Hexamers The RNA Retrotrascription kit coded RNART.CE is intended for the reverse transcription to cDNA of highly purified RNA coming from Virus (vRNA) with Random Hexamers. Reverse transcription polymerase chain reaction (RT-PCR) is aimed to the generation of many copies of a cDNA from an RNA molecule using the enzyme Reverse Transcriptase. The resulting cDNA can be use as template of a traditional or real-time PCR.

Real -Time PCR for detection of Toxoplasma Gondii The Toxoplasma gondii DNA Real-Time PCR kit coded TOXODNA.CE is intended for the qualitative detection of Toxoplasma Gondii DNA in human samples (plasma and amniotic fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).

Qualitative Real -Time PCR for detection of Trypanosoma cruzi The Trypanosoma cruzi DNA Real-Time PCR kit coded TCRUZIDNA.CE is intended for the qualitative detection of Trypanosoma cruzi DNA in human blood samples with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC). The kit has been adapted for the use on the Real-Time Thermacyclers and ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) or Miniopticon® (Software CFX manager version 1.6 , Biorad™**) or MX3000P (Software MxPro version 4.01, Stratagene™***).

Real -Time PCR for the VZV genome Quantification The VZV DNA Quantitation (QT) Real-Time PCR kit coded VZVDNAQT.CE is intended for the quantitative detection of Varicella-Zoster virus DNA in human plasma and CSF (cerebrospinal fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC).