天门冬氨酸氨基转移酶参考方法建立及性能评价

Establishment and evaluation of the reference methods of aspartate aminotransferase

目的建立测定血清天门冬氨酸氨基转移酶(AST)的参考方法,并对其主要分析性能进行评价。方法按照国际临床化学与检验医学联合会(IFCC)颁布的AST一级参考测量程序(37℃)的要求建立参考方法,并根据美国临床实验室标准化委员会(NCCLS)系列文件(EP15-A、EP6-A)对建立的参考方法的精密度、线性范围等性能进行评价,通过测定有证参考物质(ERM)和参加国际参考实验室间比对活动(RELA)对准确度性能进行评价。结果所有仪器性能均符合IFCC公布的关于AST的测定参考方法(37℃)的标准操作程序以及CNAS-CL33:《检测和校准实验室能力认可准则在临床酶学参考测量领域的应用说明》中对临床酶学参考实验室的主要设备的计量学性能要求;CV批内<1%,CV总<1%,符合参考方法精密度性能要求;ERM测定均值在其给定的参考值范围内,RELA测定结果在其给定的置信区间内,符合参考方法准确度性能要求;在AST参考方法所涉及的浓度范围内(16.05～361.88U/L)呈线性,本实验室检测线性范围上限为361.88U/L,高于IFCC公布的AST参考方法的最大线性范围(247.65U/L)。结论 AST参考方法已基本建立,精密度、准确度及线性范围等性能指标均符合方法要求。可以提供给参考物质赋值等参考测量服务以及进行相关标准化研究。

Objective To establish the reference methods of aspartate aminotransferase（AST） and evaluate its analytic charac-teristic. Methods The reference method was established according to the primary reference procedure for the measurement of cata- lytic activity concentration of AST（37 ℃ ）, which had been published by IFCC. Furthermore, the EP15-A and EP6-A protocols were used for evaluation of the pricision and linearity range of the methods. ERM and RELA program were used for verification of the trueness. Results All the instruments were confirm to the demand of the primary reference procedure for the measurement of cata-lytic activity concentration of AST（37 ℃） and CNAS-CL33＂Guidance on the Application of Testing and Calibration Laboratories Competence Accreditation Criteria in the Field of Clinical Enzymology Reference Measurement＂. The within-run and total precision were less than 1%. The results of ERM agreed with the certified value. The results of the RELA within the limits of equivalence provided by IFCC. They can verified the precision and accuracy of the reference method. The upper limits of the measurement ranges of AST were 361.88 U/L,which was higher than data published by IFCC（247.65 U/L）. Conclusion The reference method has been established basically, which can be used widely for reference measurement service and correlative standardized research.