天门冬氨酸氨基转移酶37℃参考方法的建立及其应用研究  

Study on setting up the reference method of catalytic concentration of aspartate aminotransferase(37℃) and its application

作　　者：齐志宏[1] 邸茜[1] 宋耀虹[1] 张芳[1] 赵芳[1] 苏玉君[1] 嵇巍[1] 谢少伟[1] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院检验科,北京100032

出　　处：《中国实验诊断学》2009年第5期612-617,共6页Chinese Journal of Laboratory Diagnosis

基　　金：863计划诊断试剂标准物质与参考品资助项目(2006AA020909)

摘　　要：目的通过建立37℃天门冬氨酸氨基转移酶(AST)参考方法,对酶校准品定值,探讨血清AST测定结果的准确性与可比性。方法依据国际临床化学与检验医学联合会(IFCC)推荐的参考测量程序建立AST酶催化活性参考方法,并对其精密度、线性范围和干扰因素进行方法学评价,用参考方法测定c.f.a.s多项校准液,并建立本室的参考范围。同时用参考方法对制备的酶校准品进行准确定值,按照NCCLS EP9-A方案比较40份人血清用酶校准品校准的常规方法和参考方法AST结果。结果我室初步建立的37℃AST参考方法相应方法学参数,如下:总CV 0.89%-1.12%、线性范围1.3-300 U/L。AST测定结果在48 U/L左右偏差超过5%的干扰物浓度分别为游离胆红素256.5μmol/L、结合胆红素205.2μmol/L;AST在165 U/L左右测定结果偏差超过5%的干扰物浓度分别为游离胆红素307.8μmol/L、结合胆红素342μmol/L。血红蛋白在1 g/L时对两种浓度的AST干扰均大于5%。而甘油三酯在10 mmol/L以下对两种浓度的AST的干扰仍然小于5%。用参考方法测定c.f.a.s多项校准液AST结果128.5 U/L,比靶值高0.5U/L。本室参考范围AST:男性10-40 U/L;女性7-40 U/L。健康男女AST有显著差别(P<0.05)。用制备的酶校准品校准的常规方法和参考方法进行比较,相关良好(r2=0.9992)。前者结果与后者相对偏倚在±10%之内。结论我室的参考方法基本建立,采用参考方法为酶校准品定值,可以提高血清AST测定结果的准确性和可比性。Objective To investigate the efficacy of using a calibrator with values assigned with the reference method for improving the accuracy and comparability of serum aspartate aminotransferase （AST）. Methods To estabhsh the reference method to measure catalytic concentration of AST at 37℃ according to IFCC primary procedure. The relevant methodological parameters such as the precision, linearity and interference of the reference method were analyzed. To measure c.f.a, s by using the reference method and the reference ranges were known in the healthy peoples. At the same time, A calibrator was prepared and its value for AST was assigned with the reference method, results of 40 samples were compared between the routine method that was calibrated by the prepared calibrator and the reference method by EP9-A of NCCLS. Results The reference method was established elementarily to measure catalytic concentration of AST at 37℃, and to get the relevant methodological parameters： the total coefficients of variation（CV） were 0.89 - 1.12% ;the linear ranges were 1.3 - 300 U/L. When AST was about 48 U/L and the biases of measurement were over 5% ,the concentration of interfering substances were as below：free-bilirubin was 256.5 μmol/L, conjugated-bilimbin was 205.2 μmol/L; When AST was about 165 U/L and the biases of measurement were over 5% ,the concentration of interfering substances were as below：free - bilirubin was 307.8μmol/L, conjngated-bilimbin was 342μmol/L. When hemoglobin was about 1 g/L;both concentrations of AST varied mere than 5%. When Triglyceride was below 10 mmol/L,it did not affect the result of measurement. The result of measuring c. f. a. s was 128.5 U/L and the target value was 128 U/L. Reference range：male： 10- 40 U/L; female： 7- 40 U/. There were various differences between males and females in the groups of healthy subjects（ P 〈 0. 05）. The correlations of the routine methed that was calibrated by the prepared calibrator and the reference method were well（ r^2 = 0.9992）

关 键 词：天门冬氨酸氨基转移酶 参考方法 方法学评价 

分 类 号：R446.1[医药卫生—诊断学]