CDIA™ Total IgE Rapid Test - Creative Diagnostics

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CDIATM Total IgE Rapid Test (DTS214)

Intended Use

IgE Rapid Test is a qualitative immunoassay for the detection of elevated levels of immunoglobulin E (total IgE) in human serum or pla sma. The immunochromatographic “sandwich” detection method employs a unique combination of monoclonal and polyclonal antibodies against human IgE that allows the detection of elevated serum IgE levels in five minutes.
  • Serum, Plasma
  • Cassette
  • 80 IU/ml

Product Introduction

General Description

An elevated concentration of IgE in serum is a common symptom associated with allergic pathologies; it may also be caused by autoimmune diseases and some infections. Rapid detection of elevated levels of IgE using the IgE Rapid Test will help in the diagnosis and treatment of IgE-mediated allergic and autoimmune disorders.
The IgE Rapid Test is an immunochroma tographic assay which utilizes immobilized and dye-conjugated monoclonal and polyclonal anti- bodies against human IgE to selectively identify elevated IgE levels with a high degree of sensitivity.

Principle Of The Test

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 antibody-dye 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 " as immobilized antibody captures the IgE-dye complex and forms a n antibody-antigen-antibody-dye "sandwich."  Proper test performance is verified by a visible control band which forms as immobilized reagents in the control zone capture free dye conjugate in the migrating solution. A pink-rose band in the control zone "C" indicates the test is functioning properly.

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