Multi-site evaluation of the BD Stem Cell Enumeration Kit for CD34+ cell enumeration on the BD FACSCanto II and BD FACSCalibur flow cytometers |
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| Institution: | 1. Progenitor Cell Therapy, NeoStem, Allendale, New Jersey, USA;2. Duke University, Pediatric Blood and Marrow Transplantation Program, Durham, North Carolina, USA;3. Roswell Park Cancer Institute, Buffalo, New York, USA;4. BD Biosciences, San Jose, California, USA;5. German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology, Goethe University, Frankfurt, Germany;1. Aldagen, a wholly owned subsidiary of Cytomedix, Inc, Durham, North Carolina, USA;2. CT2 Program, Duke Translational Medicine Institute, Durham, North Carolina, USA;3. Triangle GxP Solutions, LLC, Morrisville, North Carolina, USA;4. Unicorn Pharma Consulting, Brentwood, Tennessee, USA;1. Department of Animal Medicine and Surgery, Veterinary Faculty, University of Las Palmas de Gran Canaria, 35416 Arucas, Las Palmas, Canary Islands, Spain;2. Animal Health Laboratory, Conselleria of Agriculture, Fishing and Nourishment, Av. Manuel Soto 18, 46024 Valencia, Spain;3. Department of Clinical Sciences, University of Las Palmas de Gran Canaria, P.O. Box 550, 35080 Las Palmas de Gran Canaria, Canary Islands, Spain;1. Department of Pharmacy, The Mount Sinai Medical Center, New York, New York, USA;2. Blood and Marrow Transplantation Program, The Mount Sinai Medical Center, New York, New York, USA;3. Business and Strategic Planning, The Mount Sinai Medical Center, New York, New York, USA;1. Hubei Key Laboratory of Embryonic Stem Cell Research, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, China;2. Zhongnan Hospital of Wuhan University, Wuhan, China;1. Center for Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Stockholm, Sweden;2. Department of Laboratory Medicine, Division of Therapeutic Immunology, Karolinska Institutet, Stockholm, Sweden |
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| Abstract: | Background aimsEvaluation 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).MethodsLeftover 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.ResultsThe 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 R2 > 0.92 for both investigational methods.DiscussionIn 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. |
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| Keywords: | CD34 engraftment flow cytometry progenitor cells stem cells transplantation |
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