摘要
目的:对Sysmex XN-9000全自动血液分析仪进行性能评价。方法:按照WS/T 406-2012临床血液学检验常规项目分析质量要求及WS/T 408-2012临床化学设备线性评价指南等制定的有关文件对此仪器的各种性能进行验证,包括仪器的精密度、正确度、线性范围、本底计数和标本携带污染率等各项指标进行验证。结果:Sysmex XN-9000全自动血液分析仪的批内精密度、日间精密度、正确度、线性范围、本底计数和标本携带污染率等方面指标均符合相关质量管理要求。结论:Sysmex XN-9000全自动血液分析仪的各项待验证指标均良好,可以为临床提供准确的检验结果,并可满足疾病诊治的需要。
Objective:To evaluate the performance of Sysmex XN-9000 automatic blood analyzer.Methods:According to WS/T 406-2012 clinical hematology inspection routine item analysis quality requirements and WS/T 408-2012 clinical chemistry equipment linear evaluation guidelines and other related documents,the various performances of this instrument were verified,including the precision of the instrument Various indicators such as accuracy,accuracy,linear range,background count,and sample-carrying contamination rate are verified.Results:The intra-run precision,day-to-day precision,accuracy,linear range,background count,and sample-carrying contamination rate of the Sysmex XN-9000 automatic blood analyzer met the relevant quality management requirements.Conclusion:The Sysmex XN-9000 automatic blood analyzer has good indicators to be verified,which can provide accurate test results for the clinic and meet the needs of disease diagnosis and treatment.
作者
国佳
孙艳艳
GUO Jia;SUN Yan-yan(Department of Laboratory Medicine,Shijingshan Teaching Hospital,Capital Medical University,Beijing Shijingshan Hospital,Beijing 100040)
出处
《中国医疗器械信息》
2021年第9期39-40,52,共3页
China Medical Device Information
