应用CLSI评价方案分析超敏C-反应蛋白不同测定方法的结果偏倚

Bias of measurement results of different methods determining high sensitivity C-reactive protein according to the guideline approved by CLSI

目的分析超敏C-反应蛋白(Hs-CRP)不同测定方法的结果偏倚。方法依据美国临床实验室标准化研究所(CLSI)批准的EP9-A文件,3种实验方法分别与比较方法组成3个比对组,对每组比对数据作散点图、偏倚图,计算线性方程和相关系数,进行偏倚评估。结果各比对组中,每2种方法均相关良好(r2=0.991 8、0.986 8、0.996 7);在Hs-CRP为3 mg/L时,预期相对偏倚分别为6.4%、32.3%、24.4%。结论检测Hs-CRP时,免疫增强透射比浊法不同试剂结果基本相符;免疫增强透射比浊法与免疫增强散射比浊法结果偏倚较大;独立检测Hs-CRP浓度的方法与同时检测Hs-CRP及CRP浓度的方法相比,前者可减少Hs-CRP检测结果的偏差。

Objective To analyze the bias of measurement results using different methods determining high sensitivity C-reactive protein （Hs-CRP）. Methods According to the EP9-A file approved by Clinical Laboratory Standardization Institute（CLSI） , three test methods were compared with the comparison method, which formed three comparison groups. The comparison data in each group were presented in scatter figures and bias figures showing the linear equations and correlation coefficients while the biases of measurement results were evaluated. Results In each comparison group, the measurement results using the test method were well correlated with the results using the comparison method （r^2=0. 991 8,0.986 8,0. 996 7）. While Hs-CRP was 3 mg/L, three predicted relative biases were respectively 6.4%, 32.3% and 24.4%. Conclusions The measurement results of Hs-CRP by the particle- enhanced immunoturbidimetric assay using different reagent kits were coincided with each other. The bias of Hs-CRP measurement results between the particle-enhanced immunoturbidimetric assay and the particle-enhanced immunonephelometric assay was considerable. Comparing the method determining independently Hs-CRP with that determining simultaneously both Hs-CRP and CRP, the former can reduce the bias of Hs-CRP measurement results.