日立7170A生化检测系统检测项目的溯源研究

Study on traceability of Hitachi 7170A Biochemistry Detection System

目的参考美国国家临床实验室标准委员会(NCCLS)的相关文件(EP9-A2、EP6-A)进行自建检测系统与可溯源的目标检测系统之间具有代表性的生化检测项目(Glu、TBIL、AST、LDH、K+)的溯源性研究。方法首先验证检测项目在自建检测系统的可报告范围和检测系统的精密度,再通过系统间的比对进行准确度分析和临床可接受性的验证。结果5个检测项目在自建检测系统与目标检测系统的可报告范围都与说明书相吻合,批内精密度小于CLIA′88(美国临床实验室修正法规)允许误差的1/4,批间不精密度小于CLIA′88允许误差的1/3,系统之间检测项目临床可接受水平小于CLIA′88允许误差的1/2,临床均能接受。结论自建检测系统与目标检测系统的检测项目结果可比,自建检测系统的检测结果能够溯源到目标检测系统。

Objective To investigate traceability of clinical chemistry representative test（Glu, TBIL,AST,LDH ,K^＋ ）between self-established detection system and target detection system according to the NCCLS evaluation protocols （EP 6A and EP-9A）. Methods To validate the linearity of quantitative analytical methods and to evaluate precision performance of clinical chemistry devices, then to analyze accuracy of comparative detection systems and clinical acceptability. Results Linearity of five quantitative analytical methods inosculate the direction of device, precision is less than one-third of CLIA＇88, Bias Estimation and clinical acceptability is less than one-third of CLIA＇88. Conclusion It is comparable of the results of self-established detection system and target detection system, the result of self-established detection system can trace to target detection system.