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迈瑞 Mindray BC-6000 新血液细胞分析仪的临床性能评估。

Clinical performance evaluation of the new hematology analyzer Mindray BC-6000.

机构信息

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

出版信息

Int J Lab Hematol. 2019 Oct;41(5):622-634. doi: 10.1111/ijlh.13075. Epub 2019 Jul 9.

DOI:10.1111/ijlh.13075
PMID:31286670
Abstract

INTRODUCTION

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.

METHODS

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.

RESULTS

There were minimal carryover (<0.30%) and excellent actual blood linearity for all routinely used parameters concerned by the clinicians (R  ≥ 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%).

CONCLUSION

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.

摘要

简介

随着血液分析技术的进步,血液学分析仪变得更加复杂和多样化。如何选择一款优秀的仪器对实验室来说是一个挑战。在本文中,我们研究了最新的 BC-6000 血液学分析仪是否满足临床血液学实验室的需求。

方法

我们对不同测量程序的 350 份患者血液样本进行了方法比较;还测试了基本分析性能,包括不同模式下的吞吐量、携带污染、精密度和线性度。与手动显微镜相比,我们比较了对原始细胞、未成熟粒细胞和有核红细胞的标记性能。

结果

几乎没有携带污染(<0.30%),所有与临床医生相关的常规使用参数的实际血液线性度都很好(R≥0.997)。在所有测试水平上,重复性和再现性都令人满意。在 20%CV 水平下,血液中的白细胞和血小板以及体液中的白细胞和红细胞的功能灵敏度非常出色。与手动显微镜相比,BC-6000 和 XN 对全血细胞计数(CBC)参数具有非常高的相关性,对白细胞分类和 NRBC 具有非常高的一致性。BC-6000 对原始细胞(82.9%和 82.4%)和 NRBC(80.0%和 96.9%)具有出色的敏感性和特异性标记能力。对于未成熟粒细胞,BC-6000 具有出色的敏感性,但特异性标记能力常见(91.7%和 65.6%)。

结论

BC-6000 的临床性能非常出色,该分析仪可以为大多数中小规模实验室提供及时、准确的报告。

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