Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine , Seoul , Republic of Korea.
Department of Laboratory Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine , Seoul , Republic of Korea.
Scand J Clin Lab Invest. 2019 Oct;79(6):443-448. doi: 10.1080/00365513.2019.1658216. Epub 2019 Aug 27.
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.
格雷夫斯病（GD）是由针对促甲状腺激素受体（TRAb）的自身抗体引起的，在三种 TRAb 中，只有刺激型（TSI）与 GD 相关。在这项研究中，我们评估了一种新的全自动化学发光 TSI 免疫分析的分析性能，即 Immulite TSI 分析，并且比较了该分析与 Elecsys 抗 TSH 受体（TSHR）分析的诊断效果。使用两种质控试剂评估了精密度，使用临床样本在五个水平上评估了预期分析测量范围（0.18-37.35 IU/L）内的线性度。使用 187 个临床样本进行了两种分析的比较评估，并评估了定性结果的一致性。Immulite TSI 分析的重复性和总不精密度（%变异系数）分别为 0.93 IU/L 时 3.19%和 3.46%，19.3 IU/L 时 3.76%和 5.42%。该分析的线性范围为 0.16-6.17 IU/L。每个分析的定量值之间观察到高度相关性（相关系数=0.819）。两种方法之间观察到中度一致性，总体定性一致性为 93.0%。在 13 例定性结果不一致的病例中，Immulite TSI 分析产生的结果比 Elecsys Anti-TSHR 分析更符合患者的临床诊断，更有利。Immulite TSI 分析表现出可靠的分析性能，与 Elecsys Anti-TSHR 分析具有良好的相关性，我们预计该方法将有助于临床医生评估甲状腺功能亢进症患者。
