INTENDED USE

A rapid test for the qualitative detection of human IgE antibodies in whole blood, serum or plasma specimen.

SUMMARY

Immunoglobulin E (IgE) is a type of antibody (or immunoglobulin (Ig) “isotype”) that has only been found in mammals. IgE is synthesised by plasma cells. Monomers of IgE consist of two heavy chains (ε chain) and two light chains, with the ε chain containing Ig-like constant domains (Cε1-Cε4). IgE’s main function is immunity to parasites such as helminthes like Schistosoma mansoni, Trichinella spiralis, and Fasciola hepatica. IgE is utilized during immune defense against certain protozoan parasites such as Plasmodium falciparum. IgE also has an essential role in type I hypersensitivity, which manifests in various allergic diseases, such as allergic asthma, most types of sinusitis, allergic rhinitis, food allergies, and specific types of chronic urticaria and atopic dermatitis. IgE also plays a pivotal role in responses to allergens, such as: anaphylactic drugs, bee stings, and antigen preparations used in desensitization immunotherapy. Although IgE is typically the least abundant isotype—blood serum IgE levels in a normal (“non-atopic”) individual are only 0.05% of the Ig concentration, compared to 75% for the IgGs at 10 mg/ml, which are the isotypes responsible for most of the classical adaptive immune response—it is capable of triggering the most powerful inflammatory reactions.

PRINCIPLE

The IgE Rapid Test is a qualitative, lateral flow immunoassay for the detection of human IgE antibody in whole blood, serum or plasma specimens. In this test, mouse anti-human IgE is coated in the test line region of the test. During testing, IgE present in whole blood, serum or plasma specimen reacts with mouse anti-human IgE coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-IgE on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for IgE, while its absence indicates a negative result for that infection. To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.