Abstract
Objectives
This study aimed to deliver biological variation (BV) estimates for 25 types of lymphocyte subpopulations subjected to deep immunophenotyping (memory T/B cells, regulatory T cells, etc.) and classical, intermediate, and nonclassical monocyte subsets based on the full spectrum flow cytometry (FS-FCM) and a Biological Variation Data Critical Appraisal Checklist (BIVAC) design.
Methods
Samples were collected biweekly from 60 healthy Chinese adults over 10 consecutive two-week periods. Each sample was measured in duplicate within a single run for lymphocyte deep immunophenotyping and monocyte subset determination using FS-FCM, including the percentage (%) and absolute count (cells/μL). After trend adjustment, a Bayesian model was applied to deliver the within-subject BV (CVI) and between-subject BV (CVG) estimates with 95 % credibility intervals.
Results
Enumeration (% and cells/μL) for 25 types of lymphocyte deep immunophenotyping and three types of monocyte subset percentages showed considerable variability in terms of CVI and CVG. CVI ranged from 4.23 to 47.47 %. Additionally, CVG ranged between 10.32 and 101.30 %, except for CD4+ effector memory T cells re-expressing CD45RA. No significant differences were found between males and females for CVI and CVG estimates. Nevertheless, the CVGs of PD-1+ T cells (%) may be higher in females than males. Based on the desired analytical performance specification, the maximum allowable imprecision immune parameter was the CD8+PD-1+ T cell (cells/μL), with 23.7 %.
Conclusions
This is the first study delivering BV estimates for 25 types of lymphocyte subpopulations subjected to deep immunophenotyping, along with classical, intermediate, and nonclassical monocyte subsets, using FS-FCM and adhering to the BIVAC design.
Funding source: National Special Project for Science and Technology Basic Work of Ministry of Science and Technology of China
Award Identifier / Grant number: 2013FY113800
Funding source: Discipline Construction Project of Peking Union Medical College
Award Identifier / Grant number: No. 201920102202
Funding source: National High Level Hospital Clinical Research Funding of China
Award Identifier / Grant number: BJ-2022-139
Acknowledgments
We are grateful to all the volunteers and colleagues participating in the BV study. The authors thank Mrs. Hong Lu, Dr. Zhongli Du, Dr. Gaofeng Hu, and Dr. Chengshan Xu from the National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, China, for all their invaluable efforts and help. We also thank Thomas Røraas and their team for their invaluable contribution to statistical methods and data analysis.
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Research ethics: The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The Ethics Committee of Beijing Hospital gave expedited approval to this study involved human samples. The authors have no other ethical conflicts to disclose.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: This study was supported by the grant from National HighLevel Hospital Clinical Research Funding of China (BJ-2022-139), the Discipline Construction Project of Peking Union Medical College (No. 201920102202), and the National Special Project for Science and Technology Basic Work of Ministry of Science and Technology of China (2013FY113800).
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0371).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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