不同企业的丙氨酸氨基转移酶试剂盒的质量评价

Quality evaluation of alanine aminotransferase kits from different manufacturers

目的比较不同校准方法校准丙氨酸氨基转移酶试剂盒后测定血清样本的结果,分析不同试剂盒检验结果的可比性。方法以12家企业生产的丙氨酸氨基转移酶试剂盒及配套校准品为待测检测系统,试剂盒及国际标准品为目标检测系统,分别检测40份血清样本,测定结果通过回归方法计算目标检测系统y和待测检测系统x之间的相对偏差,以美国临床医学检验部门修正法规(CLIA’8 8)允许误差的1/2为标准进行比较,并采用SPSS软件进行统计学分析,评价检验结果的可比性。结果部分企业生产的试剂盒待测检测系统与目标检测系统测定结果存在差异,目标检测系统测定结果更为集中,离散度更小。结论统一校准增加了不同检测系统测定结果的可比性,校准品等标准物质统一溯源有利于实现试剂盒检验结果间互认互通。

Objective To compare the serum specimens tested respectively by alanine aminotransferase kits(ALT kits)with different calibration methods,and discuss the comparability of different kits.Methods ALT kits which matched calibrators from 12 manufacturers as the testing system,and the international standard substance as the corresponding system,were used to test 40 serum specimens respectively.The system bias between the testing system and the corresponding system was evaluated by the obtained equation.The comparability of different investigated systems was judged with half of the clinical laboratory improvement amendment 88(CLIA’88)allowed total error as the standard and statistically analyzed by SPSS.Results There were differences between the determination results from the testing system an d the corresponding s ystem in some kits.The corr esponding system was more concentrated and less dispersed.Conclusion Unified calibrator increases the comparability of the determination results in different detection systems.Traceability of calibrator or standard materials may achieve mutua l recognition between the determination results of kits.