IFCC参考方法对两种常规检测系统ALP结果正确度的验证

摘要

目的：评价常规检测系统测定血清碱性磷酸酶（ALP）的正确度。方法以国际临床化学联合会（IFCC）参考方法和两种常规检测系统（简称A法、B法）同时测定20份新鲜单人份血清样品。按美国临床实验室标准化协会（CLSI）EP9-A2文件评价两种常规检测系统测定结果的正确度，并用改良Bland-Altman图形分析法进行验证，评价常规检测系统与参考方法测定结果的一致性，综合判断常规检测系统的测定结果。按CLSI EP14-A2文件评价A、B两种方法校准品的基质效应。结果 A法、B法与IFCC参考方法测定结果的直线回归方程分别为YA ＝0．9829XIFCC ＋0．0108，YB ＝0．9383XIFCC ＋0．0129，平均偏倚分别为－1．1％、－5．5％。A法和B法检测结果的相关方程为YB ＝0．9552XA ＋0．00136，R2＝0．9976。A法和B法的校准品均存在基质效应，其中A法校准品的基质效应更明显。结论 A法与IFCC参考方法正确度性能一致，B法与IFCC参考方法正确度性能不一致。%Objective To evaluate the accuracy of serum alkaline phosphatase (ALP)determination by routine measurement systems. Methods The fresh serum samples were determined simultaneously by the International Federation and Clinical Chemistry(IFCC)reference method and 2 routine measurement systems (A method and B method).The accuracies were evaluated according to the guideline of EP9-A2,the Clinical and Laboratory Standards Institute(CLSI).Meanwhile,the consistency of results between routine measurement systems and IFCC reference method was evaluated by improved Bland-Altman graphical analysis.The accuracies were evaluated comprehensively. The matrix effects of A and B methods were evaluated according to CLSI EP14-A2.Results The regression equation of A method with IFCC reference method was YA =0.982 9XIFCC +0.010 8,and the average bias was -1.1%.The regression equation of B method with IFCC reference method was YB =0.938 3XIFCC +0.012 9,and the average bias was -5.5%.The correlation equation between A method and B method was YB =0.955 2XA +0.001 36,R2 =0.997 6.The calibrator matrix effects of both A method and B method were found,and the calibrator matrix effect of A method was more significant.Conclusions The accuracy of A method is consistent with that of IFCC reference method, and the accuracy of B method is inconsistent with that of IFCC reference method.