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The HY • TEC™ Specific and Total IgE EIA System is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific and/or total IgE concentrations in human serum. The assay is to be used with the HY . TECTM 288 instrument for in-vitro diagnostic use. Measurement of specific allergen antibodies and total IgE may aid in the diagnosis of asthma, allergies and other pulmonary disorders.

The HY . TEC 288 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The new modified MCS (Modified Classification System) Specific/Total IgE assay includes the current set of five calibrators (100, 17.5, 3.5, 0.70 and 0.35 IU/mL) and a new zero calibrator. The HY . TEC allergy system is standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. The HY · TEC reagents have been optimized to provide a fast, sensitive sandwich immunoassay with a dynamic range from 0.05 to 100 IU/mL. An allergen-coated paper disc is incubated with a serum sample. Non-specific proteins are removed by washing and the disc is incubated with enzyme-labeled monoclonal anti human IgE conjugate. Following a second wash, substrate color is developed. The results are read spectrophotometrically against a calibration curve; results are reported in both IU/mL and Classes. The HY . TEC MCS Specific/Total IgE assay requires only three hours of total incubation time and completes assay runs within six hours for the maximum assay size of 288 tests.

The HY . TECTM Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200 is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific IgE concentrations in human serum. The assay system is for in-vitro diagnostic use. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

The EVO RSP 200 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The EVO RSP 200 Automated EIA System for Specific IgE performs the same functions as the HY . TEC 480 Automated EIA System. The specific IgE assay for both systems, the HY .TEC 480 and the EVO RSP 200, is the same (utilizes same reagents and procedures) except for the following: A zero calibrator is being added to the current set of five calibrators (0.35, 0.7, 3.5, 17.5 and 100 IU/mL) for the EVO Specific IgE assay. The incubation times and temperatures have been changed. The HY . TEC 480 and EVO RSP 200 allergy systems are standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. An allergen-coated paper disc is incubated with a serum sample. Non-specific proteins are removed by washing and the disc is incubated with enzyme-labeled monoclonal anti human IgE conjugate. Following a second wash, substrate color is developed. The results are read spectrophotometrically against a calibration curve; results are reported in both IU/mL and Classes.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to ß-2 Glycoprotein-I (ß-2 GPI) antibodies in human serum Uses: The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. This device can be used with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum. Uses: The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-B-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only.

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These assays (RIA&EIA) are to be used to detect antibodies (IgE) in a single serum specimen. The results of the latex assay can be used as an aid in diagnosis of allergy to latex.

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