Histamine ELISA

Intended Purpose
Enzyme immunoassay for the quantitative determination of histamine in human EDTA plasma and urine. The Histamine ELISA is useful as an aid for diagnosis of allergic disorders by assessing the patient's health status using the physiological marker histamine. Of clinical interest in the histamine determination is the quantification of the histamine release from basophilic leukocytes in allergies of the "immediate type" as well as of the histamine quantity which is present in various body fluids (plasma, urine), after allergen administration. Patient population includes adults suspected to be affected by allergies. The Histamine ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for professional laboratory use only. The test kit is not for self-testing. The Histamine ELISA is NOT intended for near-patient testing.

Clinical significance
Histamine ((2-(imidazol-4-yl)ethylamine); ß-imidazolethylamine) was named after the Greek word for tissue histos and is the most important mediator substance in humans and appears primarily in the initial phase of the anaphylactic reaction (allergy of the immediate type). It is considered to be a major mediator of numerous pathological processes and to regulate several essential processes in allergy and autoimmune diseases.[1-4] Histamine plays a central role in stimulating the development of allergy-related inflammatory diseases by regulating the maturation and activation of leukocytes and controlling their migration to target sites where they cause chronic inflammation. Histamine also exerts a number of other immunoregulatory functions by modulating the functions of various cells.[4-6] The clinical interest of histamine determination lies once in the quantification of histamine release from basophilic leukocytes in allergies of the immediate type, as well as the amount of histamine present in the various body fluids (plasma, urine) after allergen administration has occurred.[7,8]

For concrete data please consult the Instruction for Use in the download box on the top right side.