不同厂家试剂检测亮氨酸氨基肽酶的方法比对

Method comparision of the kits from different manufactures in detecting of Leucine aminopeptidase

目的对不同厂家试剂检测亮氨酸氨基肽酶(LAP)结果的可比性及偏倚进行评估。方法依照美国临床实验室标准化协会(CLSI)EP9-A2文件规定,连续5 d收集不同浓度范围分布的40个新鲜血清标本,使用5个不同厂家LAP试剂,每个标本均按正反顺序重复两次,记录测定结果,检查离群点、计算线性方程及相关系数,并对其进行偏倚评估。结果各厂家试剂与Randox试剂方法间的相关性良好(r>0.975),但仅美康和利德曼试剂与Randox试剂检测结果的预期偏倚小于允许误差。结论各厂家的试剂与Randox试剂检测结果相关性良好,但检测结果并不完全一致。

Objective To assess the comparability and bias of the LAP test results detected with leucine aminopeptidase（LAP） reagent from different manufacturers.Methods According to US National Clinical Laboratory Standards Committee（CLSI） EP9-A2,forty fresh serum samples covering different concentrations were continuously collected for 5 days.The collected samples were detected using LAP reagents made by 5 different manufacturers.Each sample was measured twice with the positive and negative order.The results were recorded to check the outliers and to calculate the linear equations and correlation coefficients,and to estimate the bias.Results The correlation between the tested reagents made by different manufacturers and Randox reagent was good（r〉0.975）.Compared with Randox reagent,the expected bias of the results detected with the reagents manufactured by Meikang and Lideman was less than the allowable error region.Conclusion Though the correlation of the tested reagents is good,the detection results are not consistent.