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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (02): 89-103. doi: 10.3877/cma.j.issn.2095-5820.2026.02.001

Special Issue:

• Standards, Guidelines and Consensus •     Next Articles

Chinese expert consensus on the establishment of clinical flow cytometry laboratories in medical institutions

Molecular Diagnostics Group of the Chinese Society of Laboratory Medicine, Clinical Immunology Group of the Chinese Society of Laboratory Medicine, Flow Cytometry Clinical Application Promotion Group of the China National Health Association   

  • Received:2026-03-13 Online:2026-05-28 Published:2026-05-28

Abstract:

Flow cytometry, a multi-parameter, high-throughput cell analysis and sorting technology, is now widely used in clinical practice. While many medical institutions and third-party laboratories in China have established testing platforms, the standardization of laboratory construction lags significantly behind the technology's rapid development. The absence of systematic, national-level guidance has resulted inconsistencies and non-standard practices in laboratory layout, equipment and reagent selection, assay configuration, and personnel training, limiting the full potential of this technology. To address the need for systematic standardization in clinical flow cytometry laboratories, the Molecular Diagnostics Group and the Clinical Immunology Group of the Chinese Society of Laboratory Medicine, in collaboration with the Flow Cytometry Clinical Application Promotion Group of the China National Health Association and domestic experts, have developed this consensus based on the integration of ISO 15189, relevant CLSI guidelines, and the practical experience of ISAC, adapted to the specific context of China. This consensus addresses key areas such as general requirements, personnel requirements, laboratory design and construction, configuration of analytical and auxiliary instruments, and management of reagents and consumables. Its aim is to provide comprehensive and practical guidance for medical institutions at all levels and third-party testing laboratories. The widespread adoption of this consensus is expected to enhance the accuracy, comparability, and reliability of flow cytometry testing in China, thereby better serving clinical needs.

Key words: flow cytometry, laboratory construction, clinical laboratory, expert consensus

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