迈瑞CAL-8000血细胞分析流水线的性能验证  

Performance Verification of Mindray CAL-8000 Hematology Analyzer Assembly Line

作　　者：张云霞 宗健敏 Zhang Yunxia;Zong Jianmin(Nanjing Prevention and Treatment Center for Occupational Diseases,Nanjing Jiangsu 210042,China)

机构地区：[1]南京市职业病防治院,江苏南京210042

出　　处：《医疗装备》2022年第5期60-64,共5页Medical Equipment

摘　　要：目的验证实验室新引进的迈瑞CAL-8000血细胞分析流水线(含两台BC-6800Plus全自动血细胞分析仪)的性能。方法依照WS/T 406-2012《临床血液学检验常规项目分析质量要求》对两台BC-6800Plus全自动血细胞分析仪的本底计数、携带污染率、批内精密度、日间精密度、线性范围、正确度、不同吸样模式的结果可比性、实验室内结果的可比性、参考区间9个项目进行评价。结果两台血细胞分析仪的本底计数、携带污染率、批内精密度、日间精密度、线性范围、正确度、不同吸样模式的结果可比性、实验室内结果的可比性、参考区间均在可接受范围内。结论迈瑞CAL-8000血细胞分析流水线各方面的性能均良好,符合相关规定要求,可投入临床进行血细胞分析使用。Objective The performance of the newly introduced Mindray CAL-8000 hematology analyzer assembly line(including two BC-6800 Plus auto hematology analyzers)in the laboratory was verified.Methods The background count,carry-over contamination rate,intra-run precision,inter-day precision,range of linearity,accuracy,comparability of the results of different aspiration modes,comparability of the results in the laboratory,and reference interval evaluation of the two blood cell analyzers were performed in accordance with WS/T406-2012 Analytical quality specifications for routine tests in clinical hematology.Results The results of the background count,carry-over contamination rate,intra-run precision,interday precision,range of linearity,accuracy,comparability of the results of different aspiration modes,comparability of the results in the laboratory,and reference interval of the two blood cell analyzers were all within the acceptable range.Conclusion The hematology analyzer assembly line of Mindray CAL-8000 has good performance in all aspects,which meets the requirements of relevant regulations,and it can be used for clinical hematology analysis.

关 键 词：CAL-8000 全自动血细胞分析仪 性能验证 

分 类 号：R331.14[医药卫生—人体生理学]