PMID- 35211976
OWN - NLM
STAT- MEDLINE
DCOM- 20220407
LR  - 20220513
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Linking)
VI  - 62
IP  - 4
DP  - 2022 Apr
TI  - Validation of automated fluorescent-based technology for measuring total 
      nucleated cell viability of hematopoietic progenitor cell products.
PG  - 848-856
LID - 10.1111/trf.16837 [doi]
AB  - BACKGROUND: A reliable rapid method for measuring total nucleated cell (TNC) 
      viability is essential for cell-based products manufacturing. The trypan blue 
      (TB) exclusion method, commonly used to measure TNC viability of hematopoietic 
      progenitor cell (HPC) products, is a subjective assay, typically uses a 
      microscope, and includes a limited number of cells. The NucleoCounter NC-200 is 
      an automated fluorescent-based cell counter that uses pre-calibrated cartridges 
      with acridine orange and DAPI dyes to measure cell count and viability. This 
      study describes the validation of the NC-200 for testing HPC's viability. 
      METHODS: Samples from 189 fresh and 60 cryopreserved HPC products were included. 
      Fresh products were tested for viability after collection by both TB and NC-200. 
      7-aminoactinomycin D (7AAD) CD45+ cell viability results were obtained from a 
      flow cytometry test. Cryopreserved products thawed specimens were tested for 
      viability by both TB and NC-200. The NC-200 viability results were compared with 
      the other methods. Acceptability criteria were defined as </=10% difference between 
      the NC-200 method and the other methods for at least 95% of the samples. RESULTS: 
      Fresh products' mean viability difference between NC-200 and TB or 7AAD CD45+ 
      method was 4.9% (95%CI 4.6-5.4) and 2.8% (95%CI 2.2-3.4), respectively. Thawed 
      products' mean viability difference between NC-200 and TB was 3.0% (95%CI 
      0.4-5.6). CONCLUSION: The NC-200 automated fluorescent-based method can be used 
      effectively to determine HPC's viability for both fresh and cryopreserved 
      products. It can help eliminate human bias and provide consistent data and 
      operational ease.
CI  - (c) 2022 AABB.
FAU - Patel, Kanan A
AU  - Patel KA
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Patel, Nita
AU  - Patel N
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Kim, Grace H
AU  - Kim GH
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Chape, Laura S
AU  - Chape LS
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Agbon, Kristianne Gail D
AU  - Agbon KGD
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Angulo Fuentes, Minnie P
AU  - Angulo Fuentes MP
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Barbosa, Francis-Marie L
AU  - Barbosa FL
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Castellano, Ryan T
AU  - Castellano RT
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Gonzalez, Gloria N
AU  - Gonzalez GN
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Mathew, Sheeba
AU  - Mathew S
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
FAU - Mantile-Selvaggi, Giuditta
AU  - Mantile-Selvaggi G
AD  - Department of Pathology, Hackensack University Medical Center, Hackensack, New 
      Jersey, USA.
FAU - Reich-Slotky, Ronit
AU  - Reich-Slotky R
AUID- ORCID: 0000-0002-9628-2932
AD  - Department of Stem Cell Transplantation and Cellular Therapy, John Theurer Cancer 
      Center, Hackensack University Medical Center, Hackensack, New Jersey, USA.
LA  - eng
PT  - Journal Article
DEP - 20220225
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
RN  - 0 (Coloring Agents)
SB  - IM
MH  - Cell Survival
MH  - Coloring Agents
MH  - *Cryopreservation/methods
MH  - *Hematopoietic Stem Cells
MH  - Humans
MH  - Technology
OTO - NOTNLM
OT  - automated
OT  - fluorescent
OT  - viability
EDAT- 2022/02/26 06:00
MHDA- 2022/04/08 06:00
CRDT- 2022/02/25 05:41
PHST- 2022/01/24 00:00 [revised]
PHST- 2021/10/18 00:00 [received]
PHST- 2022/02/12 00:00 [accepted]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/04/08 06:00 [medline]
PHST- 2022/02/25 05:41 [entrez]
AID - 10.1111/trf.16837 [doi]
PST - ppublish
SO  - Transfusion. 2022 Apr;62(4):848-856. doi: 10.1111/trf.16837. Epub 2022 Feb 25.