Clinical Validation of the MC-80 Digital Morphology Analyzer in Leukocyte Classification: A Large-Scale Comparison With Manual Microscopy

IF 2.2 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2026-09-09 Epub Date: 2026-06-17 DOI:10.1111/ijlh.70170

Lianjie Zhang, Yuhong Qin, Hongbin Yu, Lin Wang

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引用次数: 0

Abstract

Introduction

Although AI-powered digital morphology analyzers are widely used for leukocyte classification, their reliability in detecting clinically significant abnormal cells requires rigorous validation. We evaluated the Mindray MC-80 system by comparing its results with those of conventional hematology analyzers and manual microscopy to assess accuracy, sensitivity, and diagnostic limitations.

Methods

We analyzed 1188 routine blood samples (881 normal, 307 abnormal). Preclassification results from the MC-80 were compared with hematology analyzer results for normal samples and with manual microscopy by senior morphologists for abnormal samples. Inter-method agreement was assessed by Passing–Bablok regression, and sensitivity and specificity were calculated using expert-reviewed findings as the reference standard.

Results

The MC-80 preclassification demonstrated excellent correlation with reference assays, with r values greater than 0.9 for the majority of leukocyte subsets. Overall specificity reached over 99% for all cell populations. Excluding blasts and reactive lymphocytes, the sensitivity for all remaining cell types was higher than 90%. For clinically critical abnormal cells, the system attained 75% sensitivity for plasma cells (≥ 1%) and over 90% for the other five abnormal cell groups. Its specificity was above 90% for all abnormal cells except blasts, which had a specificity of 86.73%. Expert review further increased the correlation coefficients by 0.31% to 5.71%.

Conclusion

The MC-80 provides robust performance for routine leukocyte classification, with a screening capability for most abnormal cells comparable to that of manual microscopy. However, its reduced sensitivity for reactive lymphocytes, blasts, and plasma cells indicates that it cannot fully replace manual review. Targeted optimization is therefore warranted before full integration into diagnostic workflows.

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MC-80数字形态学分析仪在白细胞分类中的临床验证：与手工显微镜的大规模比较。

导论：尽管人工智能驱动的数字形态学分析仪被广泛用于白细胞分类，但它们在检测临床显著异常细胞方面的可靠性需要严格的验证。我们将迈瑞MC-80系统的结果与传统血液学分析仪和手工显微镜的结果进行比较，以评估其准确性、灵敏度和诊断局限性。方法：对1188份血常规进行分析，其中正常881份，异常307份。MC-80的预分类结果与正常样本的血液学分析仪结果和异常样本的高级形态学家手工显微镜结果进行了比较。采用Passing-Bablok回归评估方法间一致性，并以专家评审结果作为参考标准计算敏感性和特异性。结果：MC-80预分类与参考测定结果具有良好的相关性，大多数白细胞亚群的r值大于0.9。所有细胞群的总体特异性均达到99%以上。除母细胞和反应性淋巴细胞外，其余细胞类型的敏感性均高于90%。对于临床关键异常细胞，该系统对浆细胞（≥1%）的敏感性达到75%，对其他五种异常细胞组的敏感性超过90%。除原细胞外，其余异常细胞特异性均在90%以上，特异度为86.73%。专家评审进一步将相关系数提高0.31%至5.71%。结论：MC-80提供了常规白细胞分类的强大性能，对大多数异常细胞的筛选能力与人工显微镜相当。然而，它对反应性淋巴细胞、母细胞和浆细胞的敏感性降低，表明它不能完全取代人工复查。因此，在完全集成到诊断工作流程之前，有针对性的优化是必要的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.