谷丙转氨酶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 Alanine Aminotransferase(37℃) and Its Application

作　　者：齐志宏[1] 邸茜[1] 赵芳[1] 宋耀虹[1] 张芳[1] 嵇巍[1] 谢少伟[1] 苏玉君[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：《现代检验医学杂志》2008年第5期1-5,共5页Journal of Modern Laboratory Medicine

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℃谷丙转氨酶（ALT）参考方法，对酶校准品定值，探讨血清ALT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ALT酶催化活性参考方法，用参考方法测定ERM-AD 454 ALT参考品，验证参考方法的准确度，并对其精密度、线性范围和干扰因素进行方法学评价，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正的常规方法和参考方法ALT结果。结果用参考方法测定ERM-AD454 ALT参考品结果186．4U／L，在其给定的186±4U／L范围内。初步建立的37℃ALT参考方法总CV0．89％～1．12％，线性范围1．3～300U／L。ALT测定结果在32U／L左右偏差超过5％的干扰物浓度分另4为游离胆红素205．2μmol／L、结合胆红素136．8μmol／L；ALT在123U／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256．5μmol／L、结合胆红素273．6μmol／L。血红蛋白在2g／L和三酰甘油在10mmol／L以下时对两种浓度的ALT干扰分别均大于5％和仍然小于5％。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（r^2=0．9992）。前者结果与后者相对偏倚在±10％之内。结论ALT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ALT测定结果的准确度和可比性。Objective To investigate the efficacy of using a calibrator with values assigned with the reference method for improving the accuracy and comparability of serum alanine aminotransferase （ALT）. Methods To establish the reference method to measure catalytic concentration of ALT at 37℃ according to IFCC primary procedure. In order to verify the accuracy of the reference method ,measured ERM-AD 454 ALT by using the reference method. The relevant methodological parameters such as the precision,linearity and interference of the reference method were analyzed. At the same time,a calibrator was prepared and its value for ALT 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 ALT at 37℃. The result of measuring ERM-AD 454 ALT was 186.4 U/L and the value of ERM-AD 454 ALT was 186±4 U/L. Got 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 ALT was about 32 U/L and the biases of measurement were over 5%. The concentration of interfering substances were as below：free-bilirubin was 205.2 μmol/L and conjugated-bilirubin was 136.8 μmol/L. When ALT was about 123 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 and conjugated-bilirubin was 273. 6 μmol/L. When hemoglobin was about 2 g/L,both concentrations of ALT varied more than 5%. When Triglyceride was below 10 mmol/L,it did not affect the result of measurement. The correlations of the routine method that was calibrated by the prepared calibrator and the reference method were well（r^2= 0. 999 2）. And the relative biases of both results were＋ 10%. Conclusion The reference method of ALT （37 ℃ ）has been already established. Accuracy

关 键 词：谷丙转氨酶 参考方法 方法学评价 

分 类 号：R446.112[医药卫生—诊断学]