全自动电化学发光免疫分析法检测血清TRAb的方法学评价

Methodological Evaluation of Fully Automated Electrochemiluminescence Immunoassay for Determination of Serum Thyrotropin Receptor Antibody

目的:对电化学发光免疫分析(ECLIA)检测血清促甲状腺激素受体抗体(TRAb)进行方法学评价。方法:采用ECLIA分别检测62例GD患者、65例非GD患者以及41例健康对照者血清中TRAb的含量,评估ECLIA检测TRAb的精密度、回收率、诊断敏感性和特异性及与ELISA的相关性。结果:ECLIA检测TRAb的批内、批间变异系数分别为0.78%～3.30%、1.25%～5.42%;回收率为96.8%～101.5%;对GD诊断的敏感性和特异性分别为95.1%、96.2%;与ELISA检测的相关性良好(r=0.9815,P<0.01)。结论:ECLIA检测TRAb的精密度、准确性均符合临床诊断要求,对GD诊断的敏感性、特异性都很高,且操作简便,检测实现仪器的自动化,能很好地满足临床检测的需要。

Objective To evaluate an automatic immunological analyzer for the determination of serum thyrotropin receptor antibody（TRAb） by electrochemiluminescence immunoassay（ECLIA） technique.Methods The TRAb concentrations were simultaneously analyzed by ECLIA in 62 patients with Graves＇ disease（GD）,65 with thyroid diseases without diagnosis of GD and 41 healthy controls.The methodology of ECLIA assay,including precision,recovery,sensitivity,specificity and its correlation to ELISA assay,was fully evaluated.Results The intra-and inter-precision,recovery of ECLIA assay were 0.78%~3.30%,1.25%~5.42% and 96.8%~101.5%,respectively.The diagnostic sensitivity and specificity for GD were 95.1% and 96.2%,separately.There is a good correlation between ECLIA and ELISA for detection of the serum TRAb（r=0.9815,P0.01）.Conclusion The ECLIA assay is a new immunological technique with advantage of high precision and accuracy for the determination of TRAb concentration.The method also shows good specificity,sensitivity in GD diagnosis.Furthermore,the ECLIA assay exhibits a convenient,fast and suitable for automation analysis.The method can be applied for clinical application.