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The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis.

The MESACUP Test PR-3 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with proteinase III antigen. Incubation allows the anti-PR-3 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the PR-3 bound antibodies. Following another washing step, The bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate, The intensity of the color generated is proportional to the serum concentration of anti-PR-3 antibodies, Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-PR-3 antibody in patient samples.

The MESACUP TEST MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidase (MPO) antibodies in human serum. The MESACUP TEST MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis.

The MESACUP Test MPO is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with myeloperoxidase antigen. Incubation allows the anti-MPO antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the MPO bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-MPO antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two callbrators to measure the amount of anti-MPO antibody in patient samples.

The MESACUP-2 Test CENP-B is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-CENP-B antibodies in human serum. The MESACUP-2 Test CENP-B is intended for in vitro diagnostic use as an aid in the diagnosis of CREST syndrome and related connective tissue diseases.

The MESACUP-2 Test CENP-B is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with CENP-B antigen. Incubation allows the anti-CENP-B antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the CENP-B bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-Jo-1 antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-CENP-B antibody in patient samples.

The MESACUP-2 TEST Jo-1 is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Jo-1 antibodies in human serum as an aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases.

The MESACUP-2 Test Jo-1 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with Jo-1 (histidyl-tRNA synthetase) antigen. Incubation allows the anti-Jo-1 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the Jo-1 bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-Jo-1 antibodics. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-Jo-1 antibodies in patient samples.

The MESACUP-2 TEST Mitochondria M2 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Mitochondrial antibodies in human serum as an aid in the diagnosis of primary biliary cirrhosis.

The MESACUP-2 Test Mitochondria M2 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with mitochondria M2 antigens. Incubation allows the antimitochondria M2 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the mitochondria M2 bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H3O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-mitochondria M2 antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-mitochondria M2 antibodies in patient samples.

The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

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The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

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