Background
This CLIA is designed, developed, and produced for the quantitative measurement of human tTG-IgA in serum samples. The assay utilizes a two-site “sandwich” technique with one antigen and one antibody that bind to different epitopes and paratopes of tTG-IgA.
Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. An acridinium ester antibody and a biotin antigen are added. The magnetic particles capture the biotin antigen as well as an immuno complex in the form of “magnetic particles – biotin tTG-IgA antigen –tTG-IgA– acridinium ester tTG-IgA antibody”.
The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel and light generated by the reaction is measured with the ECL100 or ECL25 analyzer. The relative light units (RLU) are proportional to the concentration of tTG-IgA in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum tTG-IgA concentration.
