Consistency evaluation of magnetic particle chemiluminescence assay and electrochemiluminescence assay for the detection of thyroid-stimulating hormone receptor antibodies#br#
1.Department of Ultrosound Medicine, the Third Hospital, Hebei Medical University, Hebei Province, Shijiazhuang 050051, China;
2.Department of Nuclear Medicine, the Third Hospital, Hebei Medical University, Hebei Province, Shijiazhuang 050051, China
Abstract：Objective To study the difference between the content of serum thyrotropin receptor antibody (TRAb) detected by magnetic particle chemical luminescence assay (CLIA) and electrochemical luminescence assay (ECLIA), to explore the feasibility and practicality of CLIA to detect TRAb. Methods A total of 118 serum samples were collected from the outpatient and inpatient departments of the Endocrinology Department of the Third Hospital of Hebei Medical University from November to December 2020. Serum samples were detected simultaneously by two methods. Among them, there were 70 cases of thyroid-related diseases, and 48 people with physical examination and non-thyroid diseases. The correlation, deviation analysis, negative-positive coincidence rate of the two detection methods were compared, and the precision, linear range and reference interval of CLIA method for detecting TRAb were verified. Results The overall correlation between CLIA and ECLIA in detecting TRAb was good (r = 0.969); Bland-Altman deviation analysis showed that the results of the two methods for detecting TRAb were in good agreement at low concentrations (0-5 IU/L), but with the increase of TRAb concentration, the deviation gradually increased; the positive coincidence rate, negative coincidence rate and total coincidence rate of the two were 86.84%, 100%, and 95.76%, respectively, and the Kappa value was 0.8995 (P ＜ 0.01). The intra-assay CVs of low and high TRAb values detected by CLIA were 2.68% and 0.92%, respectively, and the inter-assay CVs were 5.70% and 1.48%, respectively; the linearity was good between 0.25 and 40 IU/L, and R2 = 0.9987. Conclusion In this study, it is believe that CLIA and ECLIA have good consistency, and CLIA can be used as a reliable method for clinical detection of serum TRAb levels.
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