Guo Kai, Feng Xiaoran, Xu Lei, Li Chenbin, Ma Yating, Peng Mingting
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
12501 National Center for Clinical Laboratories, Chinese Academy of Medical Sciences & Peking Union Medical College , Beijing, P.R. China.
Clin Chem Lab Med. 2024 May 31;62(11):2265-2286. doi: 10.1515/cclm-2024-0371. Print 2024 Oct 28.
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.
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 (CV) and between-subject BV (CV) estimates with 95 % credibility intervals.
Enumeration (% and cells/μL) for 25 types of lymphocyte deep immunophenotyping and three types of monocyte subset percentages showed considerable variability in terms of CV and CV. CV ranged from 4.23 to 47.47 %. Additionally, CV 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 CV and CV estimates. Nevertheless, the CVs 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 CD8PD-1 T cell (cells/μL), with 23.7 %.
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.
本研究旨在基于全谱流式细胞术（FS-FCM）和生物变异数据关键评估清单（BIVAC）设计，给出25种经深度免疫表型分析的淋巴细胞亚群（记忆T/B细胞、调节性T细胞等）以及经典、中间和非经典单核细胞亚群的生物学变异（BV）估计值。
在连续10个两周期间，每两周从60名健康中国成年人中采集样本。每个样本在单次检测中重复测量两次，使用FS-FCM进行淋巴细胞深度免疫表型分析和单核细胞亚群测定，包括百分比（%）和绝对计数（细胞/μL）。经过趋势调整后，应用贝叶斯模型给出受试者内BV（CV）和受试者间BV（CV）估计值以及95%可信区间。
25种淋巴细胞深度免疫表型分析的计数（%和细胞/μL）以及3种单核细胞亚群百分比在CV和CV方面显示出相当大的变异性。CV范围为4.23%至47.47%。此外，CV范围在10.32%至101.30%之间，重新表达CD45RA的CD4效应记忆T细胞除外。在CV和CV估计值方面，男性和女性之间未发现显著差异。然而，女性PD-1 T细胞（%）的CV可能高于男性。基于所需的分析性能规范，最大允许不精密度免疫参数是CD8PD-1 T细胞（细胞/μL），为23.7%。
这是第一项使用FS-FCM并遵循BIVAC设计，给出25种经深度免疫表型分析的淋巴细胞亚群以及经典、中间和非经典单核细胞亚群BV估计值的研究。
