散射比浊法检测CRP的方法学评价研究

摘要

目的 评价西门子BNII全自动特定蛋白分析仪检测CRP的分析性能.方法 根据CLSI系列文件(EP15-A、EP9-A2、EP7-A2)和其他相关文献的实验方案,对BNII全自动特定蛋白分析仪CRP检测的精密度、准确度、比对实验、干扰等方面进行分析,并将结果与厂商声明的性能或公认的质量标准进行比较.结果 CRP含量在13.84 mg/L和55.6 mg/L时批内不精密度(CV)分别为3.32%和3.58%,小于厂家声明的CV为4.0%和5.7%;两个浓度校准品检测结果与靶值的相对偏倚分别为6.06%和6.16%,均少于1/2 CLIA'88水平(12.5%);与罗氏Modular全自动生化分析仪的免疫透射比浊法比较,相关系数为0.999 5,线性回归方程为y=0.952 7x+0.355 2,预期偏差可接受;干扰实验结果显示F-Bil 0.2 g/L、C-Bil 0.4 g/L、Hb 4.82 g/L、乳糜835浊度对CRP检测时干扰差异无统计学意义.结论 西门子BNII全自动特定蛋白分析仪CRP检测的主要分析性能符合质量目标要求.%Objective To evaluate the performance of CRP dectected by DADE BNH automatic special protein auto-analyzer. Methods The precision, accuracy, comparability and interference analysis were performed according to CLSI protocols (EP15-A, EP9-A2, EP7-A2) and other literatures. The results were compared with manufacturer' s statement or international standards. Results The intra-assay inaccuracy (CV) of CRP at 13.84 mg/L and 55.6 mg/L was 3.32％ and 3.58％ respectively, which was less than the CV provided by manufacture (4.0％ and 5.7％).The relative bias between the results detected for calibrator at two levels and given value from SIEMENS was 6.06％and 6.16％, less than 1/2 CLIA' 88 standard (12.5％). The nephelometry was correlated with Roche Modular automatic biochemical analyzer (r=0.999 5, y=0.952 7x+0.355 2). The bias was acceptable between the two systems. Interference analysis showed the interference was limited when F-Bil at 0.2 g/L, hemoglobin at 4.82 g/L, chyle at 835 FTU.Conclusion The major performances of CRP detected by DADE BNII automatic special protein autoanlayzer was according with acceptable standards.