"Export use Only" Total-IgE Rapid Test is a one-step qualitative immunoassay for the detection of elevated levels of immunoglobulin E (total IgE) in human serum or plasma. This human IgE rapid test is an aid for diagnosis of allergic reactions and autoimmune disorders. Materials provided with the Total-IgE Rapid Test Kits: 1. Testing Device 2. Sample Dropper 3. Test Instructions Materials required, not provided: 1. Specimen collection container 2. Clock or timer 3. Centrifuge IgE Rapid Test Background Information An elevated concentration of IgE in serum is a common symptom associated with allergic pathologies; it may also becaused by autoimmune diseases and some infections. Rapid detection of elevated levels of IgE using the Diagnostic Automation Total- IgE Test will help in the diagnosis and treatment of IgE-mediated allergic and autoimmune disorders. IgE Rapid Test Principle The test utilizes the sandwich immunodetection principle. Dye conjugated polyclonal antibody against human IgE and immobilized mouse monoclonal anti-human IgE antibody bind to IgE in the sample specimen to produce a distinctive visual pattern registering IgE concentrations of 80 IU/ml and higher. In the test procedure, patient serum or plasma is added to the sample well "S" of the test device with the aid of a sample dropper. Labeled antibodydye conjugate binds to the human IgE molecules present in the specimen forming an antigen- antibody-dye complex. When the total IgE concentration is at or above the sensitivity level of the test, a visual test band forms in the test zone "T". For additional details please refer to the instructions for use. For a complete list of Rapid Tests, ELISA tests, IFA Kits, Serology Tests, and available testing Instrumentation, please visit our website home page or contact our Customer Service Representatives at 818-591-3030.