Xiang D, Yue J, Lan Y, Sha C, Ren S, Li Y, Li M, Wang C
Department of Clinical Laboratory, Chinese People's Liberation Army General Hospital, Beijing, China.
Int J Lab Hematol. 2015 Oct;37(5):597-605. doi: 10.1111/ijlh.12370. Epub 2015 May 5.
The Mindray BC-5000 automated hematology analyzer is a miniature, automated hematology analyzer, and 5-part leukocyte differential counter for in vitro diagnostic use in clinical laboratories.
Precision, linearity, carryover, and method comparison were carried out. The analyzer was evaluated and compared with the Sysmex XE-2100 hematology analyzer and manual microscopic in the hematology laboratory of a tertiary hospital in Chinese.
There were minimal carryover (<0.25%), and excellent linearity for white blood cell, and platelet counts (r > 0.99). Within-run precision was good at all levels for the routine cell blood count parameters (CV < 3.5%). Between-run precision was acceptable at all levels for the analysis parameters (CV < 5%) except for eosinophil and basophil (CV% >10%). BC-5000 displayed very good correlation (r > 0.94) with the XE-2100 for cell blood count and cell differential parameters except for basophil (r = 0.72). The comparison of 258 leukocyte differential count results analyzed in parallel with manual microscopy, BC-5000 analyzer showed perfect specificity (93%) and negative predictive value (90%) on abnormal blood samples.
It is concluded that the overall performance of the BC-5000 is acceptable. The miniature analyzer is suitable for use in small- to medium-size laboratories.
迈瑞BC - 5000全自动血液分析仪是一款微型全自动血液分析仪,也是一款用于临床实验室体外诊断的五分类白细胞分析仪。
进行了精密度、线性、携带污染率及方法学比较研究。在中国一家三级医院的血液学实验室中,对该分析仪与Sysmex XE - 2100血液分析仪及手工显微镜检查进行了评估和比较。
携带污染率极低(<0.25%),白细胞及血小板计数的线性良好(r>0.99)。常规血细胞计数参数在各水平的批内精密度良好(CV<3.5%)。除嗜酸性粒细胞和嗜碱性粒细胞外(CV%>10%),各分析参数在各水平的批间精密度均可接受(CV<5%)。BC - 5000与XE - 2100在血细胞计数及细胞分类参数方面具有很好的相关性(r>0.94),但嗜碱性粒细胞除外(r = 0.72)。与手工显微镜检查平行分析的258例白细胞分类计数结果比较,BC - 5000分析仪在异常血样上显示出极佳的特异性(93%)和阴性预测值(90%)。
得出结论,BC - 5000的整体性能是可接受的。这款微型分析仪适用于中小型实验室。