Analytical and clinical performance of newly developed immunoassay for detecting thyroid-stimulating immunoglobulin, the Immulite TSI assay.

Graves' disease (GD) is caused by autoantibodies against the thyrotropin receptor (TRAb), and among the three types of TRAbs, only the stimulating type (TSI) is known to be associated with GD. In this study, we evaluated the analytical performance of a new fully automated chemiluminescent TSI immunoassay, namely, the Immulite TSI assay, and compared the diagnostic efficacy of the assay with the Elecsys Anti-TSH receptor (TSHR) assay. Precision was evaluated using two levels of quality control reagents, and linearity was evaluated across the expected analytical measurement range (0.18-37.35 IU/L) at five levels using clinical samples. A comparative evaluation between the two assays was performed using 187 clinical samples, and the concordance of qualitative results was also assessed. The repeatability and total imprecision (% coefficient of variation) of the Immulite TSI assay were 3.19% and 3.46% at 0.93 IU/L, and 3.76% and 5.42% at 19.3 IU/L, respectively. The linearity of this assay ranged from 0.16 to 6.17 IU/L. A high degree of correlation was observed between quantitative values from each assay (correlation coefficient = 0.819). Moderate agreement between methods was observed with an overall qualitative agreement of 93.0%. Among 13 cases with discordant qualitative results, the Immulite TSI assay generated more favorable results consistent with clinical diagnoses of patients than the Elecsys Anti-TSHR assay. The Immulite TSI assay showed reliable analytical performance and good correlation with the Elecsys Anti-TSHR assay and we expect this method will be helpful for clinicians to evaluate patients with hyperthyroidism.