原文标题:Clinical performance evaluation of the new hematology analyzerMindray BC‐6000

作者:Yimin Shen | Jun Cao | Zhiying Zhou | Yong Wang | Yili Shen | Jun He

Department of Laboratory Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China

原文阐述了迈瑞BC-6000全自动血液细胞分析仪性能情况，由苏州大学附属第一医院临床检测中心进行临床性能验证，并发表于国际实验室血液学杂志。该杂志是国际实验室血液学学会ISLH(International Society for Laboratory Hematology)的官方期刊，影响因子2.073。

With the progression of blood analysis technology, hematology analyzers

become more complex and diverse. How to choose a superb instrument is a challenge for the laboratories. In the essay, we studied whether the newest BC‐6000 hematology analyzer meets the needs of a clinical hematology laboratory.

随着血液分析技术的发展,血液细胞分析仪也变得更加复杂和多样化。如何选择一台性能较好的血液细胞分析仪是当今临床实验室面临的一项挑战。本文通过对迈瑞最新型号BC-6000血液细胞分析仪进行临床性能验证，确认了该仪器性能能否满足临床血液学实验室临床应用需求。

Methods comparison was performed using 350 blood samples from patients between different measurement procedures; the basic analytical performance was also tested, including the throughput, carryover, precision, and linearity in different modes. The flagging performances for blasts, immature granulocytes, and NRBC were compared with manual microscopy.

使用迈瑞BC-6000血液细胞分析仪和对照仪器分别对350例患者新鲜血液标本进行测试，并进行方法学对比;对BC-6000不同检测模式的基本性能包括测试速度、携带污染率、精密度和线性进行评价;将BC-6000测试结果与人工镜检结果进行对比，分析该仪器对原始细胞、未成熟粒细胞及有核红细胞等异常细胞的报警提示能力。

There were minimal carryover (<0.30%)>2≥ 0.997). Repeatability and reproducibility were satisfactory at all testing levels. The functional sensitivity of leukocytes and platelets in the blood and leukocytes and erythrocytes in body fluid was excellent at the 20% CV level. BC‐6000 and XN displayed very high correlations for complete blood count (CBC) parameters and very high consistency for leukocyte

differentials and NRBC compared with manual microscopy. BC‐6000 showed excellent sensitivity and specificity flagging ability on blasts (82.9% and 82.4%) and NRBC (80.0% and 96.9%). For immature granulocytes, BC‐6000 showed excellent sensitivity but common specificity flagging ability (91.7% and 65.6%).

该仪器的CBC参数携带污染率较小(<0.30%)，真实血样的CBC参数以及MCV、IMG、RET、NRBC等参数在其检测范围内均具有非常良好的线性(r2≥0.997)。各检测模式所有检测水平的重复性和长期精密度均满足血液病研究所临床实验室的使用需求。血液中白细胞和血小板，体液中白细胞和红细胞在CV为20%时的功能灵敏度(LLoQ)表现良好。BC-6000和XN在全血细胞计数(CBC)检测中表现出了非常高的相关性，BC-6000与人工镜检在白细胞分类和有核红细胞的检测中也具有良好的一致性。BC-6000对原始细胞报警的灵敏度和特异性分别为82.9%和82.4%，对NRBC报警的灵敏度和特异性分别为80.0%和96.9%。对于未成熟粒细胞，BC-6000表现出良好的灵敏度(91.7%)及其特异性为65.6%。

The clinical performance of BC‐6000 is excellent, and the analyzer can provide timely and accurate reporting for most of the small‐ to large‐scale laboratories.

BC-6000具有极佳的临床性能表现，该仪器能给绝大部分小型至大型试验室提供快速、精准的临床血液细胞筛查价值。

小编点评

迈瑞BC-6000是一台测速110测试/小时的荧光平台血细胞分析仪，提供静脉全血和末梢微量全血模式检测。仅需32ul末梢全血即可输出包括NRBC在内的血常规结果。另外，仪器标配labXpert专家审核系统，且支持单机回退复检功能，实现高效、规范、自动化的检测流程，

文章来源：《中国实验血液学杂志》 网址: http://www.zgsyxyxzz.cn/zonghexinwen/2020/1110/491.html