Immunology Department, Immunopathology Group, Marqués de Valdecilla University Hospital-IDIVAL, Santander, Spain.
Centro de Hemoterapia y Hemodonación de Castilla y León, Valladolid, Spain.
Clin Chem Lab Med. 2023 Aug 7;62(2):312-321. doi: 10.1515/cclm-2023-0470. Print 2024 Jan 26.
Flow cytometry analyses of lymphocyte subpopulations (T, B, NK) are crucial for enhancing clinical algorithms and research workflows. Estimating the total error (TE) values for the percentage and absolute number of lymphocyte subpopulations using the state-of-the-art (SOTA) approach with real data from an external proficiency testing (EPT) scheme was performed. A comparison with previously published Biological Variability (BV)-based specifications was carried out.
A total of 44,998 results from 86 laboratories over 10 years were analysed and divided into two five-year periods (2012-2016) and (2017-2021). Data come from the IC-1 Lymphocytes scheme of the Spanish External Quality Assurance System (EQAS) GECLID Program. This quantitative scheme includes percentages and absolute numbers of CD3, CD3CD4, CD3CD8, CD19, and CD3CD56CD16 NK cells. The percentage of TE was calculated as: |reported value - robust mean|*100/robust mean for each laboratory and parameter. The cut-off for TE is set at 80 % best results of the laboratories.
A significant reduction in the SOTA-based TE for all lymphocyte subpopulations in 2017-2021 was observed compared to 2012-2016. The SOTA-based TE fulfils the minimum BV-based TE for percentages of lymphocyte subpopulations. The parameter with the best analytical performance calculated with SOTA (2017-2021 period)-based TE was the percentage of CD3 (TE=3.65 %).
The values of SOTA-based specifications from external quality assurance program data are consistent and can be used to develop technical specifications. The technological improvement, quality commitment, standardization, and training, reduce TE. An update of TE every five years is therefore recommended. TE assessment in lymphocyte subsets is a helpful and reliable tool to improve laboratory performance and data-based decision-making trust.
淋巴细胞亚群（T、B、NK）的流式细胞术分析对于增强临床算法和研究工作流程至关重要。使用最先进的（SOTA）方法，结合外部能力验证（EPT）计划中的真实数据，对淋巴细胞亚群的百分比和绝对数量的总误差（TE）值进行了估计。并与之前发表的基于生物学变异（BV）的规范进行了比较。
分析了来自 86 个实验室的 44998 项结果，这些结果来自 10 年的数据，分为两个五年期（2012-2016 年）和（2017-2021 年）。数据来自西班牙外部质量保证系统（EQAS）GECLID 计划的 IC-1 淋巴细胞计划。该定量计划包括 CD3、CD3CD4、CD3CD8、CD19 和 CD3CD56CD16 NK 细胞的百分比和绝对数量。TE 的百分比计算为：每个实验室和参数的报告值减去稳健均值的绝对值*100/稳健均值。TE 的截止值设定为实验室最佳结果的 80%。
与 2012-2016 年相比，2017-2021 年所有淋巴细胞亚群的 SOTA 基于 TE 显著降低。基于 SOTA 的 TE 满足淋巴细胞亚群百分比的最低 BV 基于 TE。使用 SOTA（2017-2021 年期间）计算的基于 TE 的最佳分析性能的参数是 CD3 的百分比（TE=3.65%）。
来自外部质量保证计划数据的 SOTA 基于规范的值是一致的，可以用于制定技术规范。技术改进、质量承诺、标准化和培训减少了 TE。因此，建议每五年更新一次 TE。淋巴细胞亚群 TE 的评估是提高实验室性能和基于数据的决策信任的有用和可靠工具。
