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Multicenter study to evaluate a new enumeration method for hematopoietic stem cell collection management.

Monique Grommé1, Henk Russcher2, Eric Braakman3

  • 1Department of Internal Medicine, Division of Haematology, Erasmus Medical Centre, Rotterdam, the Netherlands.

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|June 28, 2017
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Summary

The Sysmex XN Series analyzer offers a fast, accurate, and cost-effective method for enumerating stem cells, correlating well with CD34 flow cytometry. This new method improves stem cell count accuracy during mobilization and apheresis.

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Area of Science:

  • Hematology
  • Clinical Chemistry
  • Biotechnology

Background:

  • CD34 flow cytometry is the established standard for stem cell enumeration.
  • The Sysmex XN Series analyzer introduces a new stem cell enumeration mode using its WPC channel.
  • This mode analyzes cell size, complexity, and fluorescence intensity to count immature cells.

Purpose of the Study:

  • To evaluate the correlation of the Sysmex XN Series stem cell enumeration method with CD34 flow cytometry.
  • To assess the utility of the XN stem cell count during stem cell mobilization and apheresis.
  • To compare the performance of the XN Series with previous analyzers.

Main Methods:

  • A multicenter study involving 147 peripheral blood samples, 22 during stem cell collection, and 45 from apheresis products.
  • Analysis included samples from 18 healthy allogeneic donors and 84 autologous patients.
  • Correlation analysis with CD34+ cell counts determined by flow cytometry.

Main Results:

  • The XN stem cell enumeration method showed good correlation with viable CD34+ cells.
  • This correlation was observed during stem cell mobilization, apheresis monitoring, and for final product quality control.
  • Improved correlation was noted compared to SE or XE Series analyzers.

Conclusions:

  • The XN stem cell enumeration method is a reliable alternative to CD34 flow cytometry.
  • Advantages include speed, simplicity, reproducibility, and lower cost.
  • CE marking allows its use as a reportable clinical variable.