以半胱氨酸蛋白酶抑制剂C为例介绍蛋白质量值传递标准化方法  

Introduction on protein value-transfer procedure using cystatin C as an example

作　　者：康娟 

机构地区：[1]北京市医疗器械检验所医疗器械检验与安全性评价北京市重点实验室,北京101111

出　　处：《检验医学》2016年第12期1081-1086,共6页Laboratory Medicine

基　　金：北京市科技计划项目(Z101102052610002)

摘　　要：目的以国内半胱氨酸蛋白酶抑制剂C(Cys C)标准物质定值为例介绍采用免疫比浊法进行蛋白质量值传递的原理和方法。方法在使用颗粒增强透射免疫比浊法(PETIA)的开放系统中,以国际标准物质ERM-DA471稀释液作为校准品建立定标曲线,测定国内候选标准物质的系列稀释液;在使用颗粒增强散射免疫比浊法(PENIA)的封闭系统中,采用试剂盒配套校准品定标,分别测定ERM-DA471和国内候选标准物质的系列稀释液。所有复溶稀释都通过称重法完成。按照数学模型,进行理论相对浓度和测定相对浓度的多点线性拟合,得到过原点的回归直线,由斜率换算出候选标准物质的浓度。结果 PETIA和PENIA测定候选标准物质的结果分别为4.41 mg/L和4.52 mg/L,变异系数(CV)分别为1.3%和1.5%。结论该蛋白质量值传递方法通过称重稀释、多点拟合等方式,提高了蛋白质量值传递的可靠性,具有一定的借鉴意义。Objective To introduce protein value-transfer principle and procedure by immunoassay usingcystatin C(Cys C) national standard as an example. Methods In open system of particle-enhanced turbidimetryimmunoassay(PETIA),ERM-DA471 dilutions were used as calibrators,and candidate national standard dilutionswere used as samples. Whereas,in closed system of particle-enhanced nephelometry immunoassay(PENIA),the manufacturer's calibrators must be used,and the dilutions of ERM-DA471 and candidate national standard wereboth determined as samples. All reconstitutions and dilutions were controlled by weighing. Based on mathematicalprinciples,the national standard concentration was deduced from the slope of regression line passing through thezero obtained by plotting testing results against theory dilutions. Results The concentrations for Cys C in candidatenational standards were 4.41 mg/L and 4.52 mg/L by PETIA and PENIA,and the coefficients of variation(CV)were 1.3% and 1.5%,correspondingly. Conclusions This procedure is expected to improve the protein valuetransferreliability by weighing dilutions and multipoint fitting.

关 键 词：半胱氨酸蛋白酶抑制剂C 量值传递 免疫比浊法 蛋白质 

分 类 号：R446.1[医药卫生—诊断学]