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
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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)。


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

    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-Altman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。

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    Abstract: 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.

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陈宝荣,孙慧颖,邵燕,胡滨,李月玲,李玲.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[J].临床检验杂志,2011,29(4):309-313

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  • 收稿日期:2010-09-10
  • 最后修改日期:2011-01-19
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