散射比浊法检测CRP的方法学评价研究

Performance evaluation and analysis of CRP tested by nephelometry

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13.84mg/L和55.6mg/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1/2CLIA’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0.9995,线性回归方程为y=0.9527x+0.3552,预期偏差可接受;干扰实验结果显示F-Bil0.2g/L、C-Bil0.4g/L、Hb4.82g/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 BNII 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.