Abbott CELL-DYN Sapphire全自动血液分析仪的性能评价  

Performance evaluation of Abbott CELL-DYN Sapphire automatic hematology analyzer

作　　者：张驰 张辉 岳道远 黄铭 王旭[1] ZHANG Chi;ZHANG Hui;YUE Dao-yuan;HUANG Ming;WANG Xu(Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院检验科,武汉430030

出　　处：《医疗卫生装备》2018年第11期49-53,共5页Chinese Medical Equipment Journal

摘　　要：目的:对Abbott CELL-DYN Sapphire全自动血液分析仪的性能进行评估。方法:根据卫生部行业标准制定的验证方法对该仪器检测白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、血细胞比容(HCT)、血小板(PLT)、平均红细胞体积(MCV)、平均红细胞血红蛋白量(MCH)、平均红细胞血红蛋白浓度(MCHC)的本底计数、携带污染率、精密度、准确度、线性范围等方面进行验证,并进行稀释回收试验及手动与自动2种吸样模式对比、与Sysmex XE-5000全自动血液分析仪室内比对、WBC分类的人机对比试验。结果:该仪器检测WBC、RBC、HGB、PLT的本底值符合要求,携带污染率均≤0.36%,稀释回收率高,检测各项目的批内和批间精密度高,室内比对和不同吸样模式比对结果均符合要求;WBC、RBC、HGB、PLT的线性验证范围分别为(0~291)×10~9/L、(0~8.15)×10^(12)/L、(0~252)g/L和(0~1 525)×10~9/L,各项目检测线性良好,线性回归方程的斜率均≤1.00±0.05,相关系数均大于0.975;准确度验证中5份室间质评物的测定偏差均小于5.0%,WBC分类人机比对准确度100%,该仪器检测与手工镜检检测中性粒细胞(NEUT)、淋巴细胞(LYM)、单核细胞(MONO)、嗜酸性粒细胞(EO)、嗜碱性粒细胞(BASO)的相关系数分别为0.935、0.923、0.689、0.741、0.651。结论:Abbott CELL-DYN Sapphire全自动血液分析仪检测性能合格,能满足临床应用和临床实验室的血常规检测要求。Objective To evaluate the performances of Abbott CELL-DYN Sapphire automatic hematology analyzer. Methods The analyzer had its background counts, carryover rates, precision, accuracy and linear ranges verified with the industrial standard of national ministry of health when used to detect WBC, RBC, HGB, HCT, PLT, MCV, MCH and MCHC. Dilution recovery test was executed, and contrast tests were implemented for sampling by manual and automatic modes, internal results by Sysmex XE-5000 automatic hematology analyzer and Abbott CELL-DYN Sapphire automatic hematology analyzer, and leukocyte differential counting by manual mode and the analyzer. Results The analyzer had the background counts for WBC, RBC, HGB and PLT met the desired requirements and the carryover rate not higher than 0.36%, which had high dilution recovery rate and high within-run and within-batch precision; the results for internal contrast and sampling mode accorded with the requirements; the linear range was （0- 291）×10^9/L for WBC, （0 -8.15）×10^12/L for RBC, （0- 252）g/L for HG B and （0-1 525）×10^9/L for PLT, all the items gained high linearity, the linear regression equation had all the slopes not higher than 1.00±0.05, and all the correlation coefficients were higher than 0.975; five pieces of external quality control substance had the accuracy deviation lower than 5.0%, and the accuracy was 100% for leukocyte differential counting; the correlation coefficients between the results by the analyzer and manual mode were 0.935, 0.923, 0.689, 0.741 and 0.651 respectively for neutrophil, lymphocyte, monocyte, eosinophil and basophil. Conclusion Abbott CELL-DYN Sapphire automatic hematology analyzer gains high performances, and thus is worthy promoting for blood routine examination.

关 键 词：全自动血液分析仪 血常规 性能评价 临床检验 

分 类 号：R318.6[医药卫生—生物医学工程] TH776[医药卫生—基础医学]