两种方法检测促甲状腺激素受体抗体的定量对比研究
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南京医科大学第一附属医院

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R581

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江苏省临床医学研究中心支撑体系建设(BL2014084)


A quantitative comparison of two methods for thyrotropin receptor antibody
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    摘要:

    目的 评价电化学发光法和放射受体分析法测量促甲状腺素受体抗体(Thyrotropin receptor antibody,TRAb)一致性和相关性,并进行定量比较,评估两种方法在临床使用过程中是否可以互换使用。方法 选取2018年09月至2018年11月之间122份血清样本,TRAb分别用全自动电化学发光法和放射受体分析法测定,进行Kappa、Passing-Bablok和Bland Altman分析。结果 全自动电化学发光和放射受体分析测量的TRAb结果Kappa值为0.841,一致性好;Spearman's相关系数为0.91,高度相关。Passing-Bablok回归方程为电化学发光测量值= -0.9+1.8×放射测量值,提示全自动电化学发光测量TRAb水平比放射受体分析法高80%-0.9 IU/L。Bland-Altman分析提示两种方法测定之间的绝对差值在测定范围内随TRAb测量值的增加而增加。结论 全自动电化学发光法和放射受体分析法测定的TRAb水平高度相关,一致性好,但在定量比较中,放射受体分析法和全自动电化学发光法测量值之间存在比例差异,不建议在甲状腺功能亢进的诊治随访过程中交换使用测量来评估病情缓解情况。

    Abstract:

    Objective To evaluate the consistency and correlation of TRAb measured by automated electrochemiluminescence immunoassay and radioreceptor assay, and whether two methods can be used interchangeably in clinical work through quantitative analysis. Methods 122 serum samples from patients for TRAb measurement were assayed measuring with automated electrochemiluminescence immunoassay and radioreceptor assay simultaneously between September to November 2018. Kappa, Passing-bablok and Bland Altman analyses were performed and the proportional differences between two methods were assayed. Results The Kappa value of TRAb measured between two methods was 0.84, and the Spearman's correlation coefficient was 0.91, which was highly correlated. The Passing-bablok regression formula for TRAb mesurement was automated electrochemiluminescence immunoassay level = -0.9 +1.8× radioreceptor assay level, indicating that on average the TRAb levels measured with automated electrochemiluminescence immunoassay were 80% - 0.9 IU/L higher than radioreceptor assay levels. Bland Altman suggested that the absolute difference between the two methods increased with increasing TRAb levels. Conclusion The TRAb levels measured with automated electrochemiluminescence immunoassay and radioreceptor assay are highly correlated and consistent, but there is a proportion difference between them in quantitative comparison. In the process of hyperthyroidism, the two methods are inappropriate to evaluate the remission interchangeably.

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  • 收稿日期:2020-10-31
  • 最后修改日期:2021-11-11
  • 录用日期:2022-01-24
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