摘要
目的研究磁微粒化学发光法(CLIA)检测血清促甲状腺激素受体抗体(TRAb)含量与电化学发光法(ECLIA)的差异,探讨CLIA检测TRAb的可行性和实用性。方法收集2020年11月至12月河北医科大学第三医院内分泌科门诊及住院部送检患者血清样本118份,用两种方法同时检测血清样本,其中甲状腺相关疾病70例,健康查体及非甲状腺疾病人群48例。比较两种检测方法的相关性、偏差分析、阴阳性符合率,并对CLIA法检测TRAb的精密度、线性范围及参考区间进行验证。结果CLIA与ECLIA检测TRAb整体相关性良好(r=0.969);Bland-Altman偏差分析显示两种方法检测TRAb结果在低浓度值部分(0~5 IU/L)一致性良好,但随着TRAb浓度的升高,偏差也逐渐增大;二者的阳性符合率、阴性符合率和总符合率分别为86.84%、100%、95.76%,Kappa值为0.8995(P<0.01)。CLIA法检测TRAb低值和高值批内CV分别为2.68%和0.92%,批间CV分别为5.70%和1.48%;0.25~40 IU/L线性良好,R^(2)=0.9987。结论本研究认为CLIA和ECLIA法一致性较好,CLIA法可以作为临床上检测血清TRAb含量的可靠方法。
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 R^(2)=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.
作者
隋鑫
解朋
黄建敏
高建青
景建敏
魏玲格
吴炜杰
于宏伟
SUI Xin;XIE Peng;HUANG Jianmin;GAO Jianqing;JING Jianmin;WEI Lingge;WU Weijie;YU Hongwei(Department of Ultrosound Medicine,the Third Hospital,Hebei Medical University,Hebei Province,Shijiazhuang 050051,China;Department of Nuclear Medicine,the Third Hospital,Hebei Medical University,Hebei Province,Shijiazhuang 050051,China)
出处
《中国医药导报》
CAS
2022年第6期25-28,共4页
China Medical Herald
基金
河北省重点研发计划项目(18277719D)。
关键词
电化学发光法
磁微粒化学发光法
促甲状腺激素受体抗体
Electrochemical luminescence assay
Magnetic particle chemical luminescence assay
Thyrotropin receptor antibody
