摘要
目的通过建立37℃乳酸脱氢酶（LDH）参考方法．对酶校准品定值，探讨血清LDH测定结果的准确度与一致性。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LDH酶催化活性参考方法，用参考方法测定ERM-AD453 LDH参考品．验证参考方法的准确性，并对其精密度进行方法学评价。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方案分别比较40份人血清用酶校准品校正的非配套常规方法、配套常规方法以及理论K值常规方法和参考方法LDH结果，计算前三种常规方法与参考方法的相对偏倚及相关系数。结果用参考方法测定ERM-AD453 LDH参考品结果500．1U／L，在其给定的502±7U／L范围内。初步建立的37℃LDH参考方法CV〈1％。用制备的酶校准品校准的非配套常规方法、配套常规方法、理论K值常规方法和参考方法比较，相关均良好，分别为0.9867，0.9872和0．9878，而与配套常规方法和理论K值常规方法相比较，酶校准品校准的非配套常规方法与参考方法的相对偏倚明显阵低，在10％以下。结论LDH的参考方法基本建立，采用参考方法定值酶校准品，可以提高临床血清LDH测定结果的准确度和一致性。
Objective To investigate the efficacy of using a calibrator with values assigned with the reference method for improving the accuracy and con;parabdity of serum lactate dehydrogenase. Methods To establish the reference method to measure catalytic concentration of LDH at 37℃ according to IFCC primary procedure. In order to verify the accuracy of the reference method,measured ERM-AD 453 LDH by using the teierence nlethod and evaluated its precision. At the same time, a calibrator was prepared arid its value fur LDH was asslgned with the refercnce method. Res ilts of 40 samples which the no-supporting routine method that was calibrated by the prepared calibrator,supporting routine method and the routine method of theoretical K value were compared to the referevce method by EPg-A of NCCLS respectively. Results The reference method was established elementarily to measure eatalytic concentration of LDH at 37℃. The result of measuring ERM-AD 453 LDH was 500. 1 U/L arid the value of ERM-AD 453 LDH was 502±7 U/L. Got the total coefficients of variation （CV） were 〈1%. The correlations of the three routine methods of the no-supporting that was calibrated by the prepared calibrator ,supporting ,and theoretical K value with the reference method were well （r^2 = 0. 9867 ,r^2= 0. 987 2 ,r^2 = 0. 987 8）. And the relative biases of the no-supportlng routine ;nethod that was calibrated by the prepared calibrator and the reference method were below 10%.It was the best among the others routine method Collelusion The reference method of LDH （37℃）has been already established. Accuracy and comparability of LDH measurements can be improved by using a calibrator that was; assigned by the reference method.
出处
《现代检验医学杂志》
CAS
2010年第3期19-21,26,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（2006AA020903）.
关键词
乳酸脱氢酶
参考方法
酶校准品
lactate dehydrogenase （LDH）
reference method
calibrator
