应用NCCLS EP10-A2文件评价亮氨酸氨基肽酶试剂性能

Application of NCCLS EP10-A2 document evaluation of leucine aminopeptidase regent pelformance

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。

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.