应用NCCLS EP10-A2文件评价亮氨酸氨基肽酶试剂性能

摘要

Objective:Evaluation of Leucine aminopeptidase (LAP) kit for clinical application performance using Clinical and Laboratory Standards Institute (NCCLS) EP 10-A2.Methods: According to the NCCLS Document EP10-A2, samples at high, medium and low concentrations were measured by a special order in 5 days. The bias,the total imprecision, intercept, slope rate, non linearity, carryover contamination and drift were calculated.Results:The bias of the high, medium and low specimens of LAP were 0.1, 0.2 and 0.7 mg/dl respectively, the total imprecision of the three concentrations were 0.76%, 0.51% and 0.53% respectively, the intercept, slope rate,non linearity.carryover contamination and drift was-0.273, 1.006, -0.032, 0.000, -0.005 respectively,which did not show significant difference(P>0.01).Conclusions: Both the bias and precision of LAP kit were good, the linearity was also good, the reagent had low carryover contamination and good stability, can meet clinical application requirement.%目的：利用NCCLS EP 10-A2文件对亮氨酸氨基肽酶（LAP）试剂盒的临床应用性能进行初步评价。方法：按照美国临床实验室标准化委员会（NCCLS）颁布的EP10-A2文件，连续5天按特定顺序测定高、中、低浓度样本的LAP，计算测定结果的偏差、总不精密度、截距、斜率、非线性、携带污染和漂移。结果：高、中、低浓度LAP样本偏差分别为0.71，0.16和0.05 U/L；总不精密度分别为2.42%，2.29%和1.22%；截距、斜率、非线性、携带污染、漂移分别为1.178、0.986、1.080、0.000、-0.080，差异均无统计学意义（P>0.01）。结论：LAP试剂盒准确度和精密度良好，线性良好，携带污染率较低，稳定性较好，性能指标可满足临床应用要求。