用IFCC参考方法评价11个常规系统测量血清α-淀粉酶结果的正确性  

Accuracy evaluation of results of serum α-amylase measured by 11 routine methods according to IFCC reference method

作　　者：陈宝荣[1] 孙慧颖[1] 邵燕[1] 胡滨[1] 李月玲[1] 李玲[1] 

机构地区：[1]北京航天总医院检验科,北京100076

出　　处：《临床检验杂志》2011年第4期309-313,共5页Chinese Journal of Clinical Laboratory Science

基　　金：国家基础平台建设项目(PT-0719);国家科技支撑计划项目(2007BAI05B09);首都医学发展基金项目(2007-1045)

摘　　要：目的评价常规系统测量血清α-淀粉酶(Amy)结果的正确性。方法优选4种Amy常规分析试剂,建立4个厂家配套常规系统(A1、B1、C1、D1)和7个实验室自建常规系统(A2、B2、C2、D2、B3、C3、D3),以IFCC参考方法和11个Amy常规系统同时测量50份Amy浓度为40～750 U/L的冰冻人血清,根据EP9-A2文件评价测量结果的正确性。同时用改良的Bland-Alt-man图形法评价各常规系统与IFCC参考方法测量结果的一致性,综合判断各常规系统测量结果的正确性。结果 A1至D3的11个Amy常规系统与IFCC参考方法测量结果的回归方程分别为:Y=0.934X+0.886,Y=1.070X-6.249,Y=0.930X+5.388,Y=0.731X-3.574,Y=0.986X+0.996,Y=0.983X-6.195,Y=0.971X+6.957,Y=1.000X-4.649,Y=0.715X-4.648,Y=0.864X+4.821,Y=0.757X-4.253,其中X和Y分别代表IFCC参考方法和常规系统的测量结果。以IFCC参考方法为比较方法,11个常规系统中B1、A2、C2、D2 4个系统测量结果正确。结论血清Amy常规系统测量结果正确性与校准物明显相关;本室研制的准二级标准物做校准物可解决血清Amy常规系统测量结果正确性问题。Objective To evaluate the accuracy of measurement values for α-amylase in serum by routine methods.Methods Four commercial reagents for α-amylase were selected to establish 11 α-amylase routine methods in Hitachi 7170 chemical analyzer including 4 approved test systems（A1,B1,C1 and D1） and 7 conventional methods（A2,B2,C2,D2,B3,C3 and D3）.The levels of α-amylase in frozen human serum samples covering the range from 40 to 750 U/L were measured simultaneously by using IFCC reference method and 11 routine methods.The accuracy of measurement was evaluated according to the guideline of EP9-A2.The consistency of the results between each routine method and IFCC reference method was analyzed by the improved Bland-Altman semi-graphical method.The accuracies of the measurement results of each routine method were evaluated comprehensively.Results The regression equations of the measurement values between each routine method and IFCC reference method were Y=0.934X＋0.886,Y=1.070X-6.249,Y=0.930X＋5.388,Y=0.731X-3.574,Y=0.986X＋0.996,Y=0.983X-6.195,Y=0.971X＋6.957,Y=1.000X-4.649,Y=0.715X-4.648,Y=0.864X＋4.821 and Y =0.757X-4.253,respectively.In the equations,X stood for the measurement values of IFCC reference method and Y stood for the measurement values of each routine methods.Eleven routine methods were evaluated by using IFCC reference method as the comparative method.The measurement results of the 4 methods,i.e.,B1,A2,C2 and D2 were reliable.Conclusions Using frozen human serum samples as calibrators should be an excellent solution for the accuracy of α-amylase values measured by routine methods.

关 键 词：Α-淀粉酶 测量 参考方法 常规方法 标准物质 

分 类 号：O213.2[理学—概率论与数理统计]