建立甲状腺刺激阻断性抗体的变异源模型及其参考区间

Analysis of source of variation for thyroid stimulating blocking antibody and the establishment of its reference interval

目的分析甲状腺刺激阻断性抗体的变异来源,并建立其参考区间。方法本研究为回顾性研究。收集2018年12月在北京协和医院进行体检的120名表观健康个体的剩余血清,进行甲状腺刺激阻断性抗体(TSBAb)检测,基于检测结果建立多因素方差模型并计算标准差比(SDR),以判断TSBAb的变异来源以及是否需要按照变异源建立亚组参考区间。采用Box-Cox转换算法改善数据分布,并使用基于正态分布的方法建立TSBAb的参考区间和90%的可信区间(CI)。结果纳入个体的甲状腺相关自身抗体及甲状腺超声结果均为阴性。TSBAb年龄、性别、促甲状腺激素受体抗体(TRAb)水平的SDR分别为0.068、0.003和0.075,均<0.3, 且3个变异源在多因素方差分析中各水平差异无统计学意义(P>0.05)。不需要依据这3个因素建立亚组参考区间。TSBAb参考区间的上限和下限及其90%CI分别为3.63(3.39~3.88)和9.40(8.81~10.03)μg/L。结论 TSBAb不受年龄、性别以及TRAb水平的影响,且本研究建立的参考区间稳定可靠,信度高。

Objective To analyze the sources of variations of thyroid stimulation-blocking antibody(TSBAb)and establish a reference interval for TSBAb.Methods This study was a retrospective study.The remaining serum of 120 apparently healthy individuals who underwent physical examination in Peking Union Medical College Hospital in December 2018 was collected for thyroid stimulating blocking antibody(TSBAb)detection.A multi-factor variance model was established.The standard deviation ratio(SDR)was calculated to evaluate the sources of TSBAb variations and whether the reference intervals for subgroups should be established.Box-cox transformation algorithm was used to improve the data distribution.The TSBAb reference interval and a 90%confidence interval were established using the method based on normal distribution.Results The results of thyroid-related autoantibodies and thyroid ultrasound for the participants were negative.The SDR values of age,gender and TRAb for TSBAb were 0.068,0.003 and 0.075 respectively,which are all less than 0.3.In the multivariate analysis of variance,the differences among the three sources of variation at each level were not statistically significant(P>0.05).There was no need to establish reference intervals for subgroups based on these three factors.The reference interval of TSBAb and the 90%CI were 3.63(3.39-3.88)and 9.40(8.81-10.03)μg/L,respectively.Conclusions TSBAb is not affected by age,gender or TRAb level.The reference interval established in this study was stable and reliable.