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

Area of Science:

• Hematology
• Flow Cytometry
• Cellular Analysis

Background:

• Hematopoietic stem cell transplantation (HSCT) is a vital curative treatment for numerous diseases.
• Accurate enumeration of CD34+ cells is critical for optimizing stem cell collection and predicting engraftment.
• The AQUIOS STEM system offers a novel, automated solution for CD34+ cell enumeration.

Purpose of the Study:

• To evaluate the performance of the AQUIOS STEM system for CD34+ cell enumeration.
• To compare the AQUIOS STEM system with existing flow cytometry systems (FACSCanto-II, FACS Lyric).
• To assess analytical performance and clinical decision agreement across multiple centers.

Main Methods:

• Validation of the AQUIOS STEM system using 91 samples.
• Assessment of precision, sample stability, carryover, and linearity.
• Method comparison with current FACS systems for analytical and clinical agreement.

Main Results:

• Excellent precision with coefficients of variation <15% for quality control and patient samples.
• No significant carryover detected; fresh apheresis samples showed overnight stability.
• Good correlation in peripheral blood; minimal bias in fresh apheresis products, but lower correlation in cryopreserved products.

Conclusions:

• The AQUIOS CL system with STEM provides automated CD34+ stem cell enumeration.
• The system demonstrates strong analytical performance and positive outcomes for peripheral blood and fresh apheresis samples.
• This automated approach shows potential for reliable CD34+ cell quantification in clinical settings.