Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti‑TSH receptor determination is used as an aid in the differential diagnosis of Graves’ disease.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Competition principle. >> Total duration of assay: 27 minutes
1st incubation: 50 µL of serum sample are incubated with pretreatment buffer solution (PT1) and pretreatment reagent buffer (PT2) consisting of a pre‑formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti‑porcine TSH receptor mouse monoclonal antibody. TRAb in patient’s sera are allowed to interact with the TSH receptor complex.
▪ 2nd incubation: After addition of buffer solution, TRAb are allowed to further interact with the TSH receptor complex.
▪ 3rd incubation: After addition of streptavidin-coated microparticles and a human thyroid stimulating monoclonal autoantibody (M22) labeled with aruthenium complex, bound TRAb are detected by their ability to inhibit the binding of labeled M22. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
▪ The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M. Application of a voltage to the electrode then induces
chemiluminescent emission which is measured by a photomultiplier.
▪ Results are determined via a calibration curve which is instrumentspecifically generated by 2‑point calibration and a master curve provided via the reagent barcode or e‑barcode.
For Elecsys 2010 and cobas e 411.
Each package contains 100 assays.