不同方法检测血清特定蛋白的结果一致性研究

摘要

目的 分析不同检测系统、方法间特定蛋白检测结果的差异；探讨以欧洲标准局参考物质(ERM) DA470k/IFCC赋值的定值血清能否替代ERM-DA470k/IFCC应用于临床检测以促进特定蛋白检测结果一致性.方法 方法学评价.选取2012年6月于复旦大学附属中山医院体检中心进行健康体检的表面健康人群(27 ～ 73岁,男47名,女53名)血清标本100份.我们使用罗氏和德赛试剂在日立7600全自动生化仪、西门子试剂在西门子BNⅡ特定蛋白仪和贝克曼试剂在贝克曼IMMAGE特定蛋白仪检测100份血清标本、ERM-DA470k/IFCC以及ERM-DA470k/IFCC赋值的定值血清标本中的IgA、IgG、IgM、补体3c(C3c)、补体4(C4)、转铁蛋白(TRF)和前白蛋白(PA)含量.以ERM-DA470k/IFCC为校准品对混合血清进行定值.同类方法间特定蛋白检测结果比较使用T检验和Wilcoxon非参数检验,不同方法间结果比较使用方差分析和Friedman非参数检验.两组数据相关性分析采用一元线性回归分析.结果 两种免疫散射比浊检测方法之间、两种免疫透射比浊检测方法之间以及4种免疫比浊法之间特定蛋白检测结果均存在统计学差异(P＜0.05).2种免疫透射比浊检测方法之间除C3c以外其余项目的R2均＞0.97,相关性较好.2种免疫散射比浊检测方法之间除IgM结果的R2＞ 0.96外,其余项目结果的R2均在0.90 ～0.94,相关性相对略差.不同免疫比浊法IgA、IgG和IgM结果间相关性较好,R2均＞0.95;C3c、C4、TRF和PA结果间相关性相对略差,R2为0.90～0.97.以ERM-DA470k/IFCC标定值为基准,对各检测系统的特定蛋白检测结果进行修正后,检测值可趋于一致(P＞0.05)；定值血清也可以取得相似的效果.结论 不同检测系统(方法)间特定蛋白检测结果存在明显差异.ERM-DA470k/IFCC和定值血清能够修正不同检测系统(方法)间特定蛋白检测结果,使检测值趋于一致.%Objective To analyze differences of serum proteins measurements by different methods in different systems and investigate whether the assigned serum valued by ERM-DA470k/IFCC can replace ERM-DA470k/IFCC in clinical measurements to promote the harmonization of serum proteins measurements.Methods Serum specimen was collected from 100 medical examination persons in Zhongshan Hospital (Jun 2012; age:27-73; 47 male and 53 female).Serum IgA,IgG,IgM,C3c,C4,TRF and PA of health persons,ERM-DA470k/IFCC and the assigned valued by ERM-DA470k/IFCC were measured by Hitachi 7600 (Roche and DiaSys reagents),Siemens BN Ⅱ (Siemens reagent) and Beckman IMMAGE (Beckman reagent),respectively.ERM-DA470k/IFCC was used as a calibrator to value the mixed serum.Serum proteins results obtained from the same methods were compared by T test and Wilcoxon test,and analysis of variance and Firendman test were used to compare results from different methods.The correlation of two groups was analyzed by linear regression.Results The differences of serum proteins results measured by two immunonephelometries,two immunoturbidimetries and all assays were statistically significant (P ＜0.05),respectively.The serum proteins results measured by two immunoturbidimetries showed good correlation (R2 were all above 0.97 except for C3c).In contrast,the serum proteins results measured by two immunonephelometries show poor correlation (R2 were all ranged from 0.90 to 0.94) except for IgM (above 0.96).The serum IgA,IgG and IgM results measured by different methods show good correlation (R2 were all above 0.95) Based on certified values of ERM-DA470k/IFCC,serum protein results measured by different methods could be harmonized,and got similar results from the assigned serum (P ＞ 0.05).Conclusions There is significant difference of serum proteins results detected by different methods.The ERM-DA470k/IFCC and certified serum can make serum protein results obtained from different methods harmonized.