摘要
目的评价基于微流控技术的血清淀粉样蛋白A和C-反应蛋白检测试剂的分析性能,以判断其是否能满足临床需求。方法参照CLSI EP方案对检测试剂的精密度、准确度、线性范围和干扰试验等技术指标进行测定。结果血清淀粉样蛋白A检测试剂测定高、低浓度样本的批内变异系数分别为0.54%和1.79%,批间变异系数分别为0%和1.20%,C-反应蛋白检测试剂测定高、低浓度样本的批内变异系数分别为0.30%和2.28%,批间变异系数分别为0.17%和0%;两者方法学比对实验结果分别为Y=-0.0609+0.9871X,R^(2)=0.9975和Y=0.3354+0.9857X,R^(2)=0.9990,允许误差均大于预期偏差可信区间的上限,偏倚均可接受;血清淀粉样蛋白A检测试剂的线性范围为3~100.0 mg/L,C-反应蛋白检测试剂的线性范围为3~150.0 mg/L。结论基于微流控技术的血清淀粉样蛋白A和C-反应蛋白检测试剂分析性能可满足临床实验室需求。
Objective To evaluate the analytical performance of serum amyloid A protein and C-reactive protein detection reagents based on microfluidic technology,so as to determine whether they can meet clinical requirements.Methods The precision,accuracy,linear range,interference test and other technical indicators of the detection reagent were determined according to the CLSI EP scheme.Results The intra-batch coefficients of variation of high and low concentration samples were 0.54%and 1.79%,and the inter-batch coefficients of variation were 0%and 1.20%,respectively,for the serum amyloid A detection reagent;the intra-batch coefficients of variation of high and low concentration samples were 0.30%and 2.28%,and the inter-batch coefficients of variation were 0.17%and 0%,respectively,for the C-reactive protein detection reagent;the experimental results of the methodological comparison of the two methods were Y=-0.0609+0.9871X,R^(2)=0.9975 and Y=0.3354+0.9857X,R^(2)=0.9990,respectively,and the allowable errors were greater than the upper limit of the expected bias confidence interval,and the biases were acceptable;the linear range of the serum amyloid A detection reagent was 3~100.0 mg/L,and the linear range of the C-reactive protein detection reagent was 3~150.0 mg/L.Conclusion The analytical performance of serum amyloid A and C-reactive protein detection reagents based on microfluidic technology can meet the needs of clinical laboratories.
作者
沃燕波
WO Yan-Bo(Ali Biotechnology Taizhou Co.,Ltd.,Taizhou 225300,China)
出处
《实验室检测》
2024年第7期108-111,共4页
Laboratory Testing
关键词
血清淀粉样蛋白A
C-反应蛋白
微流控
分析性能评价
serum amyloid A protein
C-reactive protein
microfluidic technology
analyze performance evaluation
