毛细管电泳法检测血清蛋白电泳的性能评估  

Evaluation of the performance of capillary electrophoresis for detection of serum protein electrophoresis

作　　者：安崇文[1] 李海霞[1] 焦莉莉[1] AN Chongwen;LI Haixia;JIAO Lili(Department of Clinical Laboratory,First Hospital of Peking University,Beijing 100034,China)

机构地区：[1]北京大学第一医院检验科,北京100034

出　　处：《国际检验医学杂志》2020年第21期2645-2649,共5页International Journal of Laboratory Medicine

摘　　要：目的评估毛细管电泳法(CE)检测血清蛋白电泳(SPE)的性能。方法应用美国临床和实验室标准化协会(CLSI)EP5-A2、EP15-A2、C28-A3c、EP9-A2方法评价CE检测SPE的精密度、正确度、生物参考区间与琼脂糖凝胶电泳法(AGE)的偏差、样本的稳定性及对M蛋白的筛查情况。结果CE检测SPE的批内、批间精密度均符合要求。正确度验证显示测定国内、国外、厂家提供的评价物质的结果符合验证要求。与AGE比较,清蛋白、α1球蛋白、α2球蛋白、β球蛋白、γ球蛋白平均相对偏差为-7.79%、124.61%、-18.24%、11.33%、14.87%,α1球蛋白、α2球蛋白在参考区间处的预期偏差存在明显差异,结果一致性较差,无可比性。生物参考区间验证α2球蛋白、β1球蛋白、γ球蛋白未能通过评估,证明厂家提供的美国人参考区间不适合我国人群。该院检验科不可接受直接转移该参考区间。稳定性试验显示,β2球蛋白区在室温和4℃避光保存平均偏差呈负增长趋势,分别为-69.16%^-3.69%和-41.62%^-0.49%;CE检测M蛋白的灵敏度为0.753,特异度为0.988,ROC曲线下面积为0.870,与AGE比较,差异有统计学意义(P<0.05)。结论CE检测SPE与AGE比较存在一定差异,应用CE检测SPE是筛查和定量M蛋白的一种好方法。Objective To evaluate the performance of capillary electrophoresis(CE)for the detection of serum protein electrophoresis(SPE).Methods The precision,accuracy,biological reference interval,deviation from agarose gel electrophoresis(AGE),stability of samples and screening of M protein were evaluated by the American clinical and laboratory standardization association(CLSI)EP5-A2,EP15-A2,C28-A3c and EP9-A2 guidelines.Results The precision of the within-run and the between-run of CE system met the requirements for the detection of SPE.The accuracy verification showed that the results of the determination of evaluation substances provided by domestic,foreign and manufacturers met the verification requirements.The average relative deviations of albumin,α1 globulin,α2 globulin,βglobulin,γglobulin were-7.79%,124.61%,-18.24%,11.33%and 14.87%,compared with AGE method.There was significantly different in expected deviations ofα1 globulin andα2 globulin at reference interval,and the results was inconsistent and not comparable.Biological reference interval validation ofα2 globulin,β1 globulin,γglobulin failed to pass the evaluation,which proved that the American the reference interval provided by the manufacturer was not suitable for Chinese population.The laboratory in the hospital can not accept the direct transfer of the reference interval.The stability test showed that the average deviation of theβ2 globulin region in the dark at room temperature and 4℃refrigerator showed a negative growth trend,which ranged from-69.16%to-3.69%and ranged from-41.62%to-0.49%.The sensitivity,specificity and area under ROC curve of CE method for detecting M protein were 0.753,0.988 and 0.870 respectively,and the differences between CE method and AGE method were statistically significant(P<0.05).Conclusion The CE method for detecting SPE is a certain difference compared with AGE method.It is a good method to screen and quantify M protein by CE method.

关 键 词：血清蛋白电泳 毛细管电泳法 M蛋白 

分 类 号：R446.112[医药卫生—诊断学]