日立7600检测血清淀粉样蛋白A的实验室性能验证  

The Performance of SAA was Detected with the Hitachi 7600 Automatic Biochemistry Analyzer to Observe Its Verification

作　　者：何一枭 吴前星 熊燏[1] 蔡群芳[1] 李秀文 赫娜 HE Yi-xiao;WU Qian-xing;XIONG Yu;CAI Qun-fang;LI Xiu-wen;HE Na(School of Tropical Medicine,Hainan Medical University,Hainan Haikou 571199;Hainan Cancer Hospital,Hainan Haikou 570312;Kunming Medical University Haiyuan College,Yunnan Kunming 650000)

机构地区：[1]海南医学院热带医学院,海南海口571199 [2]海南省肿瘤医院,海南海口570312 [3]昆明医科大学海源学院,云南昆明650000

出　　处：《中国医疗器械信息》2023年第17期56-58,176,共4页China Medical Device Information

基　　金：2021年度海南省高等学校教育教学改革研究重点项目(项目名称:基于建设海南自由贸易港背景下的医学教育创新发展模式研究与实践,项目编号:Hnjg2021ZD-31)。

摘　　要：目的:日立7600型全自动生化分析仪检测血清淀粉样蛋白A的性能验证。方法:参照CLSI及CNAS有关检测系统性能验证文件方法通过实验对血清淀粉样蛋白A的精密度、正确度、线性范围、临床可报告范围、参考区间进行评价。结果:批间精密度变异系数分别为5.38%,2.29%,小于规定声称值10%;批内精密度变异系数分别为4.87%、1.82%,均小于规定声称值8%。正确度偏倚为-2.1%,<10%;临床可报告范围上限为3072mg/L;厂家说明书的线性范围、参考范围符合要求。结论:日立7600全自动生化分析仪搭载重庆中元生物技术有限公司血清淀粉样蛋白A试剂盒检测血清淀粉样蛋白A符合质量要求,能够为临床提供可靠的依据。Objectives:In order to clarify the accurate and reliable clinical test results,the performance of serum amyloid A(SAA)detection by Hitachi 7600 automatic biochemical analyzer was performed.Methods:The precision,accuracy,linear range,clinical reporting range and reference interval of serum amyloid A(SAA)were evaluated according to the performance verification method of the detection system in CLSI and CNAS specifications.Results:The inter-batch precision coefficients of variation(CV)were:5.38%,2.29%,which were less than the claim value of 10%;The intra-batch precision coefficients of variation(CV)were 4.87%and 1.82%,less than the claimed value of 8%;The accuracy bias were-2.1%,not more than 10%;The upper limit of clinical reportable range was 3072mg/L;The linear range and reference range of manufacturer instructions were acceptable.Conclusion:The detection of serum amyloid A by Hitachi 7600 automatic biochemical analyzer equipped with serum amyloid A kit from Chongqing Zhongyuan Biotechnology Co.,Ltd.conform to quality requirements which can provide reliable basis for clinical diagnosis.

关 键 词：血清淀粉样蛋白A 全自动生化分析仪 检验 

分 类 号：R318[医药卫生—生物医学工程]