Establishment and Analytical Performance of Light-Initiated Chemiluminescence Assay Method for Detecting Thyrotropin Receptor Antibody

Aim: To evaluate double-antibody competitive light-initiated chemiluminescence assay method for detecting the thyrotropin receptor antibody. Materials & methods: The optimal working concentrations of competitive antibody and rTSHR were confirmed by checkerboard titration. Assay performance was assessed by precision, linearity, accuracy, limit of blank and clinical evaluation. Results: The coefficient of variation for repeatability and intermediate precision was 3.9-5.9 and 0.9-1.3%, respectively. The correlation coefficient was 0.999 by least squares linear fitting in linearity evaluation. The relative deviation ranged from -5.9 to 4.1%, and the limit of blank of the method was 0.13 IU/l. Compared with the Roche cobas system (Roche Diagnostics, Mannheim, Germany), the relationship between the two assays was shown to be significantly correlative. Conclusion: The light-initiated chemiluminescence assay method for detecting thyrotropin receptor antibody is a rapid, novel and accurate method for thyrotropin receptor antibody measurement.Graves' disease is common in daily life. Patients often experience rapid heartbeat and weight loss. Blood tests (especially serum autoantibody levels) are meaningful in diagnosis and treatment. In this study, we used a new and useful approach to test blood markers. Compared with other methods, this new technique could perform better in terms of time and expense. Based on a full assessment, we believe that this new method will play an important role in clinical application.