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ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semiquantitative measurement of IgA or IqG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgAllgG ImmunoCAP is intended to be used with the instrument ImmunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. ImmunoCAP/UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP/UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the ImmunoCAP/UniCAP Specific IgA system. ImmunoCAP/UniCAP Specific IgA assay is to be used with the instrument ImmunoCAP/UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

The Pharmacia ImmunoCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. ImmunoCAP System is comprised currently of an instrument family, ImmunoCAP 100/250/1000 and individual assay products - Fluoro enzyme immunoassays reagents for the measurement of Immunoglobulin IgE, IgG, IgA, with ImmunoCAP Allergens/Antigens (solid phase components which contain the specific allergen/antigens to which antibodies are going to be measured), and Software Accessories. ImmunoCAP instruments are designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP cariers are loaded into the instrument and the process, which takes about 2.5 hours, is started. A laboratory report is automatically printed when the process is ended. ImmunoCAP instruments can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs. Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the instrument system software. ImmunoCAP® System Information Data Manager (IDM) is intended to be used with a Windows-based PC operating up to five ImmunoCAP instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer. ImmunoCAP Specific IgA is a fluoro enzyme immunoassay for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component (ImmunoCAP carrier). Specific IgA antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Gliadin, which are covalently coupled to the ImmunoCAP carrier solid phase. After washing away non-specific IgA, enzyme labeled antibodies against IgA (ImmunoCAP/UniCAP Specific IgA Conjugate) is added to form a complex. After incubation, unbound enzyme-anti-IgA is washed away and the bound complex is incubated with a development agent. After stopping the reaction, the response of the eluate is measured. The response is directly proportional to the concentration of IgA in the serum sample. The modification consists of a change from polyclonal Rabbit anti-human IgA antibodies to Mouse monoclonal anti-human IgA antibodies in the reagent ImmunoCAP/UniCAP Specific IgA Conjugate. No other reagents have been changed.

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. The system includes reagents (Conjugate, Calibrators, Curve Controls, Specific IgE ImmunoCAP and Allergen ImmunoCAP Carriers, Development Kit, Washing Solution) and ImmunoCAP instruments with built-in software. The assay principle involves allergen coupled to ImmunoCAP reacting with specific IgE in the patient sample, followed by incubation with enzyme labeled antibodies against IgE. After washing, the bound complex is incubated with a developing agent, and the fluorescence of the eluate is measured. The fluorescence response is transformed to concentrations using a calibration curve. The modification is a minor change to the calibrator system to extend the technical measuring range below 0.35 kUx/l by adding a 0 kU/l Calibrator and removing the 50 kU/l Calibrator, keeping 6 calibrators in total (0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l).