Hematopoietic Stem/Progenitor Cell Enumeration in Apheresis Collections Using a New Microfluidic Cartridge-Based Flow Cytometry Platform
Automating flow cytometric analysis enables all levels of technicians to generate accurate and precise cell enumeration and phenotyping results in real time, providing actionable in-process information.
Summary
- A new method for CD34+ cells phenotyping and enumeration in fresh HPC, samples are in advanced stages of evaluation using the ACCELLIX™ automated microfluidic-based flow cytometry platform.
- A new gating strategy, methods of analysis and reportables have been established in line with current clinical standards.
- Method comparison between ACCELLIX™ and predicate flow cytometry platforms demonstrate:
- Comparable measurements of cell viability for both CD45+ and CD34+ cells.
- Nearly identical frequencies of viable CD34+ cells showing strong correlations and concordance.
- No significant difference and strong correlations between the absolute numbers of viable CD34+ cells.
- Acceptable linearity in HPC, serial dilutions and CD34+ cells spiking assays; reproducibility and inter-operator variation had a coefficient of variation of ≤10%.
- Manual and automated analyses of the results obtained on the ACCELLIX™ platform are comparable thus warranting transition to method validation and implementation.
- Preliminary results indicate feasibility and accuracy of the ACCELLIX™ method for dual CD34+/CD3+ phenotyping and enumeration in a single assay.
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