Sysmex XN-2000血细胞分析仪的性能验证  

Performance Verification of Sysmex XN-2000 Hematology Analyzer

作　　者：刘丽萍[1] 李婷[1] 曹坤 郑大伟[1] 王松松[1] 高选[1] LIU Li-ping;LI Ting;CAO Kun;ZHENG Da-wei;WANG Song-song;GAO Xuan(Center for Reproductive Medicine,Shandong University/National Research Center for Assisted Reproductive Technology and Reproductive Genetics,China/The Key Laboratory for Reproductive Endocrinology of Ministry of Education,Shandong Jinan 250001)

机构地区：[1]山东大学生殖医学研究中心,国家辅助生殖与优生工程技术研究中心,生殖内分泌教育部重点实验室,山东济南250001

出　　处：《中国医疗器械信息》2021年第3期12-14,148,共4页China Medical Device Information

摘　　要：目的:对本实验室Sysmex XN-2000全自动血细胞分析仪进行性能评价,保证仪器检验结果的准确可靠。方法:按照中华人民共和国卫生行业标准WS/T 406-2012《临床血液学检验常规项目的分析质量要求》及相关文件的要求,对该仪器的本底计数、携带污染率、批内精密度、日间精密度、线性范围、正确度、不同吸样模式可比性、实验室内结果的可比性、准确度、仪器间五分类比对和人机五分类比对进行验证,判断是否符合卫生行业标准的要求。结果:该仪器的本底计数良好,携带污染率、批内精密度、日间精密度、正确度、准确度等均在要求范围内,不同吸样模式比对和实验室内结果比对的偏差均符合要求,仪器间白细胞五分类比对和人机五分类的结果也均合格。结论:本实验室Sysmex XN-2000血细胞分析仪各项指标性能良好,符合质量目标要求。Objective:Performance verification on Sysmex xn-2000 automatic hematology analyzer was performed to ensure test results accurate and reliable.Methods:According to the document named"Analytical Quality Requirements for Clinical Hematology Testing Conventions(WS/T 406-2012)",a People’s Republic of China Health Industry Standard,performance verification including background count,contamination rate of carryover,intra-assay precision,daytime precision,linear range,accuracy,comparability of various sampling mode,comparability of laboratory results,five-category comparison between instruments and man-machine classification of the instrument were conducted to evaluate whether the instrument met the criterion mentioned above.Results:The blank test,contamination rate of carryover,intra-assay precision,daytime precision,accuracy and accuracy of the instrument are all within the allowable range.Different sampling mode and the deviation in the results of the laboratory are in compliance with the requirements.The results of five-category comparison and five-category human-machine classification between instruments were also qualified.Conclusion:Sysmex XN-2000 automatic hematology analyzer has good performance and meets quality requirements.

关 键 词：血细胞分析仪 性能验证 精密度 白细胞五分类比对 人机五分类 

分 类 号：TH776[机械工程—仪器科学与技术]