探讨乳酸脱氢酶37℃参考方法在临床中的初步应用

Study on the Reference Method of Catalytic Concentration of Lactate Dehydrogenase at 37℃ and Its Clinical Preliminary Application

目的 建立37℃乳酸脱氢酶（LDH）的参考方法,并对酶校准品定值,探讨血清LDH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LDH酶催化活性参考方法,用参考方法测定LDH（ERM AD453/IFCC）参考品,验证参考方法的准确度,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、理论K值常规方法和参考方法LDH结果,计算常规方法与参考方法的相关系数及相对偏倚.结果 用参考方法测定ERM-AD453LDH参考品结果497.3 U/L,在其给定的502±7 U/L范围内.初步建立的37℃ LDH参考方法总CV〈1%.用酶校准品校正的非配套常规方法、配套常规方法、理论K值常规方法和参考方法比较,相关性均良好,r2分别为0.997,0.995和0.994,与配套常规方法、理论K值常规方法相比较,酶校准品校正的非配套常规方法与参考方法的相对偏倚明显降低,在10%以下.结论 LDH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LDH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 the Reference method for improving the accuracy and comparability of lactate dehydrogenase. Methods To establish the Reference method to measure catalytic concentration of lactate debydrogenase at 37℃ according to IFCC primary procedure. In order to verify the accuracy of the reference method,measured LDH （ERM AD453/IFCC） by the reference method and evaluated its precision. At the same time,enzyme calibrator was prepared and its accurate value was assigned with the reference method. 40 samples which the no-supporting routine method that was calibrated by the prepared enzyme calibrator, supporting routine method and the routine method of theoretical K value were compared to the reference method by EP9-A of NCCLS respectively. Results The result of measuring reference material ERM -AD 453 LDH was 497.3 U/L,and within the Given range 502±7 U/L. The CV which Initially established for LDH at 37 ℃ using the reference method was 〈1 %. The correlations of the routine methods of the no-supporting routine method that was calibrated by the prepared enzyme calibrator, supporting, and theoretical K value with the reference method were well, r^2 were 0. 997,0. 995 and 0. 994, respectively. The relative biases of the nosupporting routine method that was calibrated by the prepared enzyme calibrator and the reference method were below 10 %. It was the best among the others routine method. Conclusion The reference method of LDH has been already established. Accuracy and comparability of LDH measurements can be improved by using a calibrator that was assigned by the reference method.