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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemilyminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IqE) 11/234.

The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS™ Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.

NOVEOS™ Immunoassay Analyzer: The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory. NOVEOS™ Specific IgE (sIgE) Assay: The NOVEOS™ Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS™ Specific IgE Assay is to be used with the NOVEOS™ Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS™ Immunoassay Analyzer is a high-throughput, highly automated immunoassay platform that employs magnetic microbeads as the solid phase. The immunoassay reaction takes place in individual reaction chambers in the reaction rotor, with other rotors containing patient samples and reagents. Liquids are moved by robotic pipettors. The reaction is quantitated by a combination of chemiluminescence and fluorescence measurements compared to a calibration curve, all performed by the analyzer with the NOVEOS software.

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 IgG autoantibodies to tissue transglutaminase (tTg) in human serum. Uses: The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.

Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi. Uses: The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine. This device can be used with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only. Prescription Use (Per 21 CFR 801.109)

Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum. Uses: The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only. Prescription use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.