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

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(degrees)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.