Performance Characteristics for Flow Cytometric Enumeration of Peripheral Blood Lymphocyte Subsets under Harmonized Laboratory Conditions: A Multicenter Study.

Authors

Lin Xiao, Yuan Wang, Yi Li, Feng Wang, Liming Cheng, Chaohui Duan, Min Hu, Mianyang Li, Zhenlong Liang, Sai Qiao, Chenxue Qu, Bisheng Shi, Weimin Wu, Ying Xu, Binwu Ying, Ran You, Jun Zhang, Xu Wu, Gong Cheng, Hui Wang, Min Li, Wei Cui

Published in

Translational research : the journal of laboratory and clinical medicine. Oct 08, 2026. Epub Oct 08, 2026.

Abstract

Flow cytometric enumeration of peripheral blood lymphocyte subsets (EPBLS) is essential for disease management, yet standardized validation criteria are lacking. We defined key performance characteristics under harmonized conditions to support criteria development.
205 whole blood samples and 54 quality control samples at two levels from nine clinical laboratories across five regions in China were used to measure absolute counts (AC) and relative counts (RC) of lymphocyte subsets using flow cytometric single-platform. Performance characteristics were evaluated based on 2,865 measurements and an integrated statistical approach combining the concordance correlation coefficient, Passing-Bablok regression, and Bland-Altman plots.
Performance characteristics for precision, comparability, and sample stability were established to cover the major clinically relevant lymphocyte subset distributions (RC: 1.32-97.53%; AC: 3.37-6,846.98 cells/μL). Intra-assay and inter-assay coefficients of variation were below 8% and 6% for RC, below 10% and 9% for AC, respectively. A rigorous dual-criteria framework (comparability criteria: consistency and correlation; deviation criteria: absolute maximum bias threshold of <20%), supported by a triple-statistical approach, confirmed agreement across reagent batches, laboratories, and storage time points, with comprehensive bias profiles further reported. Whole blood remained stable for 24 hours post-collection (RC bias <14%; AC bias ≤15%), and processed samples for 48 hours post-staining (RC bias <13%; AC bias <19%).
This study establishes a comprehensive performance threshold and dual-criteria evaluation system covering precision, comparability, and stability for EPBLS, based on a harmonized multicenter protocol using stratified routine clinical samples, providing a practical reference for laboratory validation and quality specification development.

PMID:
42849832
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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