NM—BAPTA法钙检测试剂盒的性能评价

Evaluation of performance of NM-BAPTA method in detecting serum calcium

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.