参照NCCLS EP9-A2文件探讨实验室可用的试剂性能评估方案

Discussion on available reagent performance evaluation scheme according to NCCLS EP9-A2

目的参照美国国家临床实验室标准化委员会(NCCLS)EP9-A2文件探讨实验室可用的试剂性能评估方案。方法选取3个不同厂家的高密度脂蛋白胆固醇测定试剂盒,进行性能评估实验并比较分析,观察其精密度、线性、抗干扰能力以及临床比对结果。结果 3个不同厂家试剂盒的批内精密度和线性比较,差异无统计学意义(P>0.05),抗干扰能力选择性清除法最优,三者间临床样本的测定结果相关性差。结论 3个不同厂家的高密度脂蛋白胆固醇测定试剂性能各有优劣,可满足临床基本需求。各实验室可根据自身需求选择不同的方法。

Objective To discuss the available reagent performance evaluation scheme according to NCCLS EP9-A2. Methods The determined reagent of high-density lipoprotein cholesterol （ HDLC ） produced by 3 different manufactories were selected for conducting the performance evaluation experiment and comparative analysis. Tile precision, linearity, anti-interference ability and clinical comparison results were observed. Results The intra-batch precision and linearity had no statistical difference among 3 reagent samples produced＇by 3 different manufactories. The selective clearance method was best in the ability of anti-interference. The detected results of clinical samples had poor correlation among 3 reagents. Conclusion Each performance among 3 different methods has the advantages and disadvantages, and all of them can meet the clinical basic needs. Each laboratory should choose different methods according to oneself needs.