摘要
目的对NM—BAPTA法钙检测试剂盒进行性能评价。方法根据美国临床与实验室协会（CLSI）指南文件EP15-A2、EP9-A2、EP6-A、C28-A2，验证日立7180生化分析仪上NM—BAPTA法钙检测试剂盒的精密度、准确度、线性范围、生物参考区间。结果高低2个浓度的血钙质控品批内精密度标准差（SD）分别为0．03mmol／L、0．02mmol／L，批问精密度标准差分别为0．08mmol／L、0．06mmol／L；准确度验证其血钙结果与参比系统cobas8000血钙结果呈良好的相关性，r2=0．9548，相对偏差〈12．5％；线性范围验证斜率为0．971，r2=0．999，线性范围为1．00—4．70mmol／L，线性理想；参考区间验证符合率100％。结论NM—BAPTA法钙检测试剂盒在日立7180生化分析仪上的分析性能符合质量目标要求，可应用于临床检测。
Objective To evaluate the performance of the reagent kit for detecting serum calcium by NM-BAPTA method. Method According to Clinical and Laboratory Standards Institute （ CLSI ） evaluation protocols EPI 5-A2, EP9-A2, EP6-A, and C28-A2, the precision, accuracy, linearity, and reference interval of NM-BAPTA method in detecting serum calcium by Hitachi 7180 biochemistry analyzer were validated. Results The repeatability and within-laboratory precision standard deviation （SD） of both high and low levels of serum calcium quality control were 0.03 mmol/L, 0.02 mmol/L, and 0.08 mmol/L, 0.06 mmol/L, respectively. During the accuracy test, the relative bias was less than 12.5%, r2=0.954 8, which accorded with reference system. The results showed that the linearity slop was 0.971 and r2=0.999. It had a good linearity from 1.00 to 4.70 mmol/L. The biotic reference intervals 100% matched with the current biotic reference intervals. Conclusion The NM-BAPTA method in detecting serum calcium by Hitachi 7180 biochemistry analyzer shows a good performance and can be widely used in clinical laboratory.
作者
刘健平
陈茶
林城通
郑德想
李有强
Chengtong Zheng Dexiang Li Youqiang(Second Hospital, Guangzhou University of Traditional Chinese Medicine, Guangzhou 510000, China, Department of Laboratory Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510000, China)
出处
《国际医药卫生导报》
2017年第13期2088-2090,共3页
International Medicine and Health Guidance News
