电化学发光免疫法与放射免疫法检测血清皮质醇的对比研究

Comparison of electrochemiluminescent immunoassay and radioimmunoassay for detection of cortisol in human serum

目的 采用电化学发光免疫（ECLIA）法与放射免疫（RIA）法测定血清皮质醇水平,对其结果进行对比分析.方法 采用简单随机抽样法抽取我院健康体检者、门诊和住院患者共188例血清样本,利用ECLIA法和RIA法同时进行检测并进行统计学分析.将质控血清进行两两对比分析,计算两种方法批内、批间差异系数（CV）,评价其精确性;将质控血清加入低、中、高（100.2、201.9、310.7 nmol/L）已知浓度的皮质醇血清中,测定回收率.对样本测定结果的相关性作回归性分析.结果 ECLIA法检测血清皮质醇表达水平的灵敏度和特异度均高于RIA法.ECLIA法检测的批内与批间CV均低于RIA法,但两种方法回收率相当.两种方法检测结果具有高度相关性（r=0.991,P＜ 0.01）.结论 在检测血清皮质醇水平上,两种方法各有优势,ECLIA法自动化程度高,RIA法技术成熟、价格低廉.随着技术的发展,ECLIA法要更具优势,但ECLIA法在检测皮质醇方面是否可以完全替代RIA法,还有待进一步的探讨.

Objective To investigate the difference between electrochemiluminescent immunoassay （ECLIA） and radioimmunoassay （RIA） in the detection of serum cortisol.Methods A total of 188 patients were selected from healthy outpatients and inpatients.The serum cortisol of the patients and quality control serum cortisol were detected by ECLIA and RIA.The detection accuracy of the methods in the two batches and the coefficient of variation （CV） of within-batch and between-batch were calculated.To evaluate the precision of the test,quality control serum was added to low,medium,and high concentrations of serum cortisol for the evaluation of recovery rate and detection accuracy.The correlation between results was analyzed by regression.Results The sensitivity and specificity of the ECLIA method was higher than those of the RIA method.The CV of the ECLIA method was also lower than that of the RIA method,and the recovery rate of the ECLIA method was higher than that of the RIA method.The two methods showed good correlation and highly correlated results （r=0.991,P〈0.01）.Conclusions The two methods have their own advantages in the detection of serum cortisol.The degree of automation of ECLIA is high,whereas the RIA method is mature and inexpensive.Although ECLIA is the current and future development trend,RIA retains a certain advantage in terms of sensitivity and specificity.The two methods provide different reference intervals.RIA remains an indispensable method for clinical cortisol testing.