Evaluation of AQUIOS STEM, a novel method for automated CD34+ stem cell enumeration using flow cytometry

IF 2.2 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2024-02-29 DOI:10.1111/ijlh.14253

Kim Callebaut, Eva Gijbels, Jonathan Vanbesien, Dries Deeren, Jan Van Droogenbroeck, Jan Emmerechts, Elisabeth Moreau

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引用次数: 0

Abstract

Objectives

Hematopoietic stem cell transplantation (HSCT) is a potentially curative treatment for various diseases. The measurement of CD34+ cells is crucial to schedule the peripheral blood stem cell collection and assess the engraftment potential of the apheresis product. The AQUIOS STEM system has been introduced as a novel application on the AQUIOS CL, a fully automated flow cytometer, for the enumeration of CD34+ hematopoietic progenitor cells (HPCs) in accordance with the The International Society for Hematotherapy and Graft Engineering guidelines. This study aimed to assess the potential of the novel AQUIOS STEM system versus currently used systems including the FACSCanto-II and the FACS Lyric flow cytometer in a multicenter study.

Methods

A total of 91 samples were used for the validation of the AQUOIS STEM system, including an analytical performance evaluation by means of assessing precision, sample stability, intersample carryover, and linearity and a method comparison with the present FACS systems in use to assess analytical and clinical decision agreement.

Results

Results showed excellent precision, with coefficient of variations <15% for dedicated quality control material and patient samples. There was no significant carry over. The fresh apheresis samples were stable when stored overnight at room temperature and at 4°C. Analytical comparison with the current systems demonstrated good correlation in peripheral blood, and minimal, clinically neglectable systematic and proportional bias in fresh apheresis products but a low correlation coefficient in cryopreserved products.

Conclusions

The STEM system on AQUIOS CL allows automated enumeration of CD34+ stem cells, demonstrating good analytical performance and promising overall outcomes in peripheral blood and fresh apheresis products.

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评估 AQUIOS STEM，这是一种利用流式细胞仪自动计数 CD34+ 干细胞的新方法。

目的：造血干细胞移植（HSCT）是一种可能治愈多种疾病的治疗方法。CD34+细胞的测量对于安排外周血干细胞采集和评估无细胞采集产品的移植潜力至关重要。AQUIOS STEM 系统是 AQUIOS CL（一种全自动流式细胞仪）上的一种新型应用，用于按照国际血液治疗和移植物工程学会的指南对 CD34+ 造血祖细胞（HPC）进行计数。本研究的目的是在一项多中心研究中评估新型 AQUIOS STEM 系统与目前使用的系统（包括 FACSCanto-II 和 FACS Lyric 流式细胞仪）相比的潜力：共使用了91个样本对AQUOIS STEM系统进行验证，包括通过评估精确度、样本稳定性、样本间携带率和线性度对分析性能进行评估，以及与目前使用的FACS系统进行方法比较，以评估分析和临床决策的一致性：结果：结果显示精确度极高，变异系数为结论：AQUIOS CL 上的 STEM 系统可自动计数 CD34+ 干细胞，在外周血和新鲜采血产品中表现出良好的分析性能和可喜的总体结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.