Multi-site evaluation of the BD Stem Cell Enumeration Kit for CD34(+) cell enumeration on the BD FACSCanto II and BD FACSCalibur flow cytometers.
Abstract
<h4>Background aims</h4>Evaluation of the BD Stem Cell Enumeration Kit was conducted
at four clinical sites with flow cytometry CD34(+) enumeration to assess agreement
between two investigational methods: (i) the BD FACSCanto II and BD FACSCalibur systems
and (ii) the predicate method (Beckman Coulter StemKit and StemTrol, Immunotech SAS,
Beckman Coulter, Marseille Cedex 9, France).<h4>Methods</h4>Leftover and delinked
specimens (n = 1032) from clinical flow cytometry testing were analyzed on the BD
FACSCanto II (n = 918) and BD FACSCalibur (n = 905) in normal and mobilized blood,
frozen and thawed bone marrow and leucopheresis and cord blood anticoagulated with
citrate phosphate dextrose, anticoagulant citrate dextrose-solution A, heparin and
ethylenediaminetetraacetate, alone or in combination. Fresh leucopheresis analysis
addressed site equivalency for sample preparation, testing and analysis.<h4>Results</h4>The
mean relative bias showed agreement within predefined parameters for the BD FACSCanto
II (-2.81 to 4.31 ±7.1) and BD FACSCalibur (-2.69 to 5.2 ±7.9). Results are reported
as absolute and relative differences compared with the predicate for viable CD34(+),
percentage of CD34(+) in CD45(+) and viable CD45(+) populations (or gates). Bias analyses
of the distribution of the predicate low, mid and high bin values were done using
BD FACSCanto II optimal gating and BD FACSCalibur manual gating for viable CD34(+),
percentage of CD34(+) in CD45(+) and viable CD45(+). Bias results from both investigational
methods show agreement. Deming regression analyses showed a linear relationship with
R(2) > 0.92 for both investigational methods.<h4>Discussion</h4>In conclusion, the
results from both investigational methods demonstrated agreement and equivalence with
the predicate method for enumeration of absolute viable CD34(+), percentage of viable
CD34(+) in CD45(+) and absolute viable CD45(+) populations.
Type
Journal articleSubject
Stem CellsFetal Blood
Humans
Antigens, CD34
Stem Cell Transplantation
Flow Cytometry
Cell Count
Cell Lineage
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https://hdl.handle.net/10161/24701Published Version (Please cite this version)
10.1016/j.jcyt.2014.03.006Publication Info
Preti, Robert A; Chan, Wai Shun; Kurtzberg, Joanne; Dornsife, Ronna E; Wallace, Paul
K; Furlage, Rosemary; ... Tonn, Torsten (2014). Multi-site evaluation of the BD Stem Cell Enumeration Kit for CD34(+) cell enumeration
on the BD FACSCanto II and BD FACSCalibur flow cytometers. Cytotherapy, 16(11). pp. 1558-1574. 10.1016/j.jcyt.2014.03.006. Retrieved from https://hdl.handle.net/10161/24701.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Joanne Kurtzberg
Jerome S. Harris Distinguished Professor of Pediatrics
Dr. Kurtzberg is an internationally renowned expert in pediatric hematology/oncology,
pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation,
and novel applications of cord blood and birthing tissues in the emerging fields of
cellular therapies and regenerative medicine. Dr. Kurtzberg serves as the Director
of the Marcus Center for Cellular Cures (MC3), Director of the Pediatric Transplant
and Cellular Therapy Program, Director of the Carolina

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