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The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. 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 allergist/immunologist offices.

The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.

Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric.

The IgE assay is intended for use in the quantitative determination of Total Immunoglobulin E (lgE) concentration in human serum and plasma (lithium heparin, K2-EDTA, K3-EDTA, K3-EDTA) on Beckman Coulter AU/DxC AU clinical chemistry analyzers. The determination aids in the diagnosis of IgEmediated allergic disorders in conjunction with other clinical findings. For in vitro diagnostic use only.

The Total Immunoglobulin E (IgE) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's AU/DxC AU clinical chemistry analyzers. Each reagent kit contains one buffer reagent (R1), one antibody reagent (R2), and a six-level lot matched calibrator set. The IgE reagent test system utilizes a turbidimetric immunoassay methodology. The AU analyzer measures the change in absorbance at 800 nm to calculate and express the concentration of immunoglobulin E in the test sample based on a stored calibration curve. The IgE assay is traceable to the World Health Organization (WHO) 3rd International Standard 11/234.

For in vitro diagnostic use in the quantitative determination of total IgE in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems.

The ADVIA Centaur Total IgE (tlgE) assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies to IqE. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Total IgE (tlgE) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator 80 is a set of 2 level calibrators for the assay. Siemens Healthcare Diagnostics recommends the use of commercially available quality control materials with at least 2 levels (low and high).

ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000. 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. ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum and 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. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

The general ImmunoCAP reagents include ImmunoCAP Specific or Total IgE Conjugate, ImmunoCAP Specific or Total IgE Curve Control, ImmunoCAP Specific or Total IgE Calibrators, Specific or Total IgE anti-IgE, Allergen ImmunoCAP carriers (only for determination of Specific IgE), Development solution, Stop Solution and Washing Solution. The method specific reagents consist of individual purified allergen (native or recombinant), covalently coupled to a support in a plastic housing (only for determination of Specific IgE). Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total 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. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000. ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.

ImmunoCAP Total IgE reagents and control are modular in concept and are available individually. For a complete listing of reagents needed to perform the ImmunoCAP Total IgE assay, please consult the ImmunoCAP Total IgE Directions for Use. Phadia 100. Phadia 250. Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed. Anti-IgE, covalently coupled to ImmunoCAP, reacts with the total IgE in the patient sample. After washing, enzyme labeled antibodies against IgE are added to form a complex. Following incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The fluorescence is directly proportional to the concentration of IgE in the sample. The higher the response, the more IgE is present in the sample. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. Dimension Vista™ Protein 1 Control L. M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Dimension Vista™ IGE Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB). Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

Quantia IqE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies. Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use. Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunodobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies. Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with the Quantia Ferritin, the Quantia Myoglobin and the Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin. reference K040879 and also cleared for use with quantex Myoglobin K042982) For in vitro diagnostic use. Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay. For in vitro diagnostic use.

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Lacrytest is a rapid immunoassay for the detection of total IgE in tears, Semi-quantitative detection of total IgE In tears (< 2.5 KIU/liter, 2.5 - 10 kIU/liter, 10 - 40 klU/liter, and > 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.

Lacrytest (marked CE) allows the rapid and specific determination of total IgE in tears (in vivo/in vitro). This test is a simple and rapid immuno-chromatographic test, which enables the identification of allergic conjunctivitis in one single step. Its main advantage is that it can be done in vivo without being invasive. The speed and simplicity of this unique test enables a better and faster treatment of the patient. Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear samples is required: Lacrytest uses monoclonal and polyclonal antibodies to detect total IgE in tears. Lacrytest gives results from just one teardrop, and is placed in contact with the patient's eye for less than three minutes, causing minimum discomfort when compared to the Schirmer assay. Doctors do not have to take tear sample, and an indicator appears on the strip when enough tear fluid has been absorbed. The test strip is then soaked with sterile water and the evaluation of amount of total IgE detected. The results appear in the form of easily visible red-violet lines in the presence of total IgE levels greater than 2,5 KUI/L (the detection limit). These results are stable and can be archived. The test can be used in the laboratory, in the doctor's surgery or on a home visit.