HITACHI日立7180全自动生化分析仪性能验证  

Performance Verification of Hitachi 7180 Automatic Biochemical Analyzer

作　　者：万倩 陈鲁艺 蔡惠萍 杨轶宗 应龚 谷然然 WAN Qian;CHEN Luyi;CAI Huiping;YANG Yizong;YING Gong;GU Ranran(Department of Clinical Laboratory,Yangpu Hospital affiliated to Tongji University,Shanghai 200090,China)

机构地区：[1]同济大学附属杨浦医院检验科,上海200090

出　　处：《中国医疗设备》2020年第S01期27-31,共5页China Medical Devices

摘　　要：目的对新采购的HITACHI日立7180全自动生化分析仪进行性能验证。方法按照ISO15189的要求,参照美国临床实验室标准化协会(CLSI)和美国临床实验室改进法案CLIA’88的质量要求,本文针对14个常规检测项目:总蛋白(TP)、白蛋白(ALB)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转移酶(GGT)、乳酸脱氢酶(LDH)、尿素(BUN)、肌酐(CRE)、尿酸(UA)、总胆红素(TBIL)、总胆固醇(TC)、甘油三酯(TG)、葡萄糖(GLU)、磷(P)的精密度、正确度、线性范围、参考区间进行性能评价。结果批内精密度小于CLIA’88标准限值要求的四分之一,合格;批间精密度小于CLIA’88标准限值要求的三分之一,合格;正确度不超过CLIA’88标准限值要求的二分之一的要求;各检测项目引用的线性范围、参考区间符合要求。结论HITACHI日立7180全自动生化分析仪检测符合质量要求,可以为临床提供可靠的依据。Objective TIn order to provide accurate and reliable clinical test results,the performance of the newly purchased Hitachi7180 automatic biochemical analyzer was performed.Methods According to the requirements of ISO 15189 and the quality requirements of the American clinical laboratory standard Institute(CLSI)and clinical laboratory improvement act of American CLIA’88,tests for total protein(TP),albumin(ALB),alanine aminotransferase(ALT),aspertate aminotransferase(AST),glutamine transferase(GGT),lactate dehydrogenase(LDH),urea(BUN),creatinine(CRE),uric acid(UA),total bilirubin(TBIL),total cholesterol(TC),triglycerides(TG),glucose(GLU),phosphorus(P)were measured,the precision,accuracy,linear range and reference interval were verified for the tests of 14 conventional biochemical indicators.Results The intra-batch precision was less than one quarter of the standard of CLIA’88,and the inter-batch precision was less than one third of the standard of CLIA’88.The accuracy was not more than one half of CLIA’88 requirements.The linear range and reference interval were all acceptable.Conclusion the various performance indexes of Hitachi7180 automatic biochemical analyzer conform to quality requirements which can provide reliable basis for clinical diagnosis.

关 键 词：性能验证 精密度 准确度 线性范围 参考区间 

分 类 号：R608[医药卫生—外科学]