临床化学非配套检测系统分析性能确认  

Study on the analyze performance of non-matching analytic system in clinical chemistry

作　　者：毕文秀 杨雅琼[1] 杨宏伟[1] 方军[1] 隋立[1] 王毅[1] BI Wen-xiu;YANG Ya-qiong;YANG Hong-wei(Department of Clinical Laboratory,Tianjin Hospital of Tianjin,Tianjin 300211)

机构地区：[1]天津市天津医院检验科,天津300211

出　　处：《医学检验与临床》2019年第7期12-15,4,共5页Medical Laboratory Science and Clinics

摘　　要：目的:探讨临床化学非配套检测系统的分析性能确认方法,以保证检验结果的可信度.方法:依据EP6-A2、WS/T416-2013《干扰试验指南》等文件,以尿素(Urea)为例设计试验方案,对TBA-120FR全自动生化分析仪检验程序的分析测量范围、临床可报告区间及干扰试验等分析性能进行确认.结果:经分析测量范围确认,Urea项目的线性回归系数r2=0.998,斜率a=1.025,确认试验线性良好,确认分析测量范围结果为1.17-208.70 mmol/L,与厂家试剂说明书提供的范围相近.通过可报告范围评价试验,确认Urea项目的可报告区间结果为1.17~906.60mmol/L,能够满足临床的需求.干扰试验结果表明,Urea项目无论是在正常值血清浓度还是病理值血清浓度对胆红素-C、胆红素-F、乳糜、血红蛋白浓度四种干扰物的抗干扰能力均良好.结论:TBA-120FR全自动生化分析仪使用的非配套检测系统检验程序的分析性能良好,能够满足临床需求.Objective: To establish a validation method to evaluate the analyze performance of non-matching analytic system of TBA-120FR automatic biochemical analyzer. Methods: According to CLSI EP5-A2, EP6-A2, WS/T416-2013 interference test guide, the analyze performance of testing procedure on Urea was validated, the accuracy, measurement range, report interval and interference test was evaluated. Results: The measurement range of Urea in validation test were 1.17-208.70 mmol/L with r2=0.998, a=1.025, close to those of manufacturer's statements. The report interval of Urea was 1.17-906.60 mmol/L, which could satisfy the clinic need. The capacity of resisting disturbance of Urea to bilirubin-C, bilirubin-F, chylus and hemoglobin in our study were good, both of them in normal or pathological serum concentration of Urea. Conclusion: The analyze performance of non-matching analytic system of TBA-120FR automatic biochemical analyzer is good, it can be further used in clinical practice.

关 键 词：生化分析仪 非配套检测系统 检验程序 分析性能确认 

分 类 号：R446.1[医药卫生—诊断学]