Tissue Transglutaminase Ab IgG ELISA

INTENDED PURPOSE

Anti-Tissue-Transglutaminase IgG is an ELISA test system for the quantitative measurement of IgG class autoantibodies to tissue transglutaminase (tTG) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
Autoantibodies against tissue transglutaminase (tTG) during a gluten containing diet are the most obvious serologic feature of coeliac disease (CD). Determination of serum levels of IgG against tTG is the first choice in suspected CD. In subjects with either primary or secondary humoral IgA deficiency, at least one additional test measuring IgG class CD-specific antibodies is recommended. The clinical relevance of a positive anti-tTG result should be confirmed by histology of the small intestinal mucosa.

PRINCIPLE OF THE TEST

Human recombinant tissue transglutaminase is bound to microwells. The determination is based on an indirect enzyme linked immune reaction with the following steps: Specific antibodies in the patient sample bind to the antigen coated on the surface of the reaction wells. After incubation, a washing step removes unbound and unspecifically bound serum or plasma components. Subsequently, added enzyme conjugate binds to the immobilised antibody-antigen- complexes. After incubation, a second washing step removes unbound enzyme conjugate. After addition of substrate solution the bound enzyme conjugate hydrolyses the substrate forming a blue col- oured product. Addition of an acid stops the reaction generating a yellow end-product. The intensity of the yellow color correlates with the concentration of the antibody-antigen-complex and can be measured photometrically at 450 nm.