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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).

The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.

Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.

The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).

Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones present in the patient sample bind to the antigen. In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution. The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.

Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies. The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.

The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma. The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The Varelisa ß2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa B2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma. The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The Varelisa B .- Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.