37℃α-淀粉酶参考方法的建立及其应用研究  

Study on Setting up the Reference Method of Catalytic Concentration of α-Amylase （37℃）and Its Clinical Application

作　　者：高学慧[1] 齐志宏[1] 秦续珍[1] 赵芳[1] 叶阿里[1] 徐二木[1] 邱玲[1] 宋耀虹[1] 

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730

出　　处：《现代检验医学杂志》2011年第6期8-11,共4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℃α-淀粉酶（α-Amy）参考方法,对酶校准物定值,探讨血清α-Amy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α-Amy酶催化活性参考方法,测定α-Amy有证参考物（CRM）IRMM-456,验证其准确性,并对其精密度进行评价.同时用参考方法对制备的酶校准物进行准确定值,按照NCCLS EP9-A方案留取40份不同α-Amy浓度范围的人血清,采用A^E五种临床常规检测组合在使用自制酶校准物校准前后测定α-Amy,分别与参考方法进行比较,计算这五种常规方法在使用自制酶校准物校准前后测定结果与参考方法的相对偏倚及相关系数.结果 用参考方法测定IRMM-456结果是547.2 U/L,在其给定的546±18 U/L范围内.所建立的37℃α-Amy参考方法总CV〈0.5%.用制备的酶校准物校准前后的五种常规方法和参考方法进行比较,相关性均良好（r2〉0.98）,校准前后的相对偏倚A方法从30%变为10%以下;B方法从30%变为15%以下;C方法从35%变为10%以下;D方法从20%变为8%以下;E方法从35%变为10%以下.结论 所建立的37℃α-Amy参考方法准确可靠,采用参考方法为酶校准物定值后校准常规方法,可以提高血清α-Amy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 α-amylase at 37℃. Methods To establish the reference method to measure catalytic concentration of α-Amy at 37℃according to IFCC primary procedure,ln order to verify the accuracy of the reference method,measured CRM IRMM-456 of a-Amy by using the reference method and evaluated its precision. At the same time,a calibrator was prepared and its value for α-Amy was assigned with the reference method. Before and after the calibration,results of 40 samples which the five routine method from A to E that was calibrated by the prepared calibrator were compared to the reference method and got coefficients of variation（CV） and reIative biases by EP9-A of NCCLS respectively. Results The reference method of α-Amy at 37℃ was established. The result of measuring IRMM-456 α-Amy was 547.2 U/L and the value of IRMM-456 a-Amy was 546 ± 18 U/L. The total CVwas〈0. 5 %. The correlations of the five routine method before and after the calibrating by the prepared calibrator with the reference method were well（r^2〉0. 98）. And the relative biases from A to E had been changed 30% to below 10% ,30% to below 15% ,35% to below 10% ,20% to below 8% and 35% to below 10% ,respectively. Conclusion The reference method of α-Amy （37℃）has been already established. Accuracy and comparability of α-Amy measurements could be improved by using a calibrator that was assigned by the reference method.

关 键 词：Α-淀粉酶 参考方法 酶校准物 

分 类 号：R446.112[医药卫生—诊断学]