探讨IFCC原始参考方法与临床常规方法测定血清肌酸激酶结果的相关性

Study the Relativity of Testing Serum Creatine Kinase Results with IFCC Primary Reference Method and Clinical Conventional Methods

目的分析IFCC原始参考方法与临床常规方法测定血清肌酸激酶结果的相关性，并探讨血清CK测定结果的准确度与一致性。方法依据IFCC的参考测量程序建立CK酶活性潮定的参考方法，用参考方法测定ERMRAD455CK参考品，验证方法的准确性，并对其精密度进行方法学评价。按照NCCLSEP9-A方案进行参考方法与临床常规方法CK检测结果的比较。分析两种方法间的相关系数和允许偏差。结果参考方法与临床常规方法CK检测结果相关性良好，回归方程Y=0．967X-2．3397，r^2=0．9987，系统误差（SE）在CLIA’88的误差允许范围内。结论该室CK的参考方法已建立，临床常规方法与参考方法同比对，验证提高了临床血清CK测定结果的准确性和一致性。

Objective To study the relativity of testing serum creatine kinase results with IFCC primary reference methods and clinical conventional methods,analyse accuracy and consistency of the results. Methods To establish the reference method measure catalytic activity concentration of CK at 37℃ according to IFCC primary procedure. Measured ERMR- AD455CK by using the reference method and evaluated the precision,a calibrator was prepared,its value for CK was assigned with the reference method. Compared the results between IFCC primary reference methods and clinical conventional methods by EP-9A of NCCLS. Analyse correlation coefficient and the allowable deviation between IFCC primary reference methods and clinical conventional methods. Results There was good correlation between IFCC primary,reference methods and clinical conventional methods. The regression equation was Y= 0. 967X--2. 339 7,r^2= 0. 998 7. Relative deviation was in the rang of permissible error of CLIA＇88. Conclusion The reference method of CK at 37℃ had been already established. This will improved the accuracy and comparability of the results of serum CK.