Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units: The BEST Collaborative study

The Biomedical Excellence for Safer Transfusion Collaborative

doi:10.1111/trf.16997

Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units: The BEST Collaborative study

The Biomedical Excellence for Safer Transfusion Collaborative

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

Background: The IL-3-pSTAT5 assay, a new, rapid, and standardized flow-cytometry-based assay may compensate for several limitations of the colony-forming unit (CFU) assay typically used for stem cell potency assessments of cord blood units (CBU). We performed an inter-laboratory evaluation of the performance of this new assay. Study design and methods: This Biomedical Excellence for Safer Transfusion (BEST) Collaborative multicenter, international study included 15 participants from public cord blood banks (CBBs), CBB-supporting research laboratories, and stem cell laboratories. To perform the IL-3-pSTAT5 assay, participating centers received reagents, instructions, and 10 blind CBU samples, including eight normal samples and two samples exposed to a transient warming event. We measured inter-laboratory agreement qualitatively (proportion of correctly classified samples) and quantitatively (coefficient of variation [CV], correlation coefficients, receiver operating characteristics (ROC) curve, and intraclass correlation coefficient [ICC]). Results: The qualitative agreement was 97.3% (i.e., 107/110; Fleiss' kappa = 0.835). The average CV on a per-sample basis was 11.57% among all samples, 8.99% among normal samples, and on a per-center basis was 9.42% among normal samples. In a correlation matrix that compared results across centers, the mean Pearson's correlation coefficient was 0.88 (standard deviation = 0.04). The ICC was 0.83 (95% confidence interval = 0.68–0.95). The area under the curve (AUC) from the ROC curve was 0.9974. Discussion: Excellent qualitative and quantitative agreement was exhibited across laboratories. The IL-3-pSTAT5 assay may therefore be implemented in flow cytometry laboratories to rapidly and reliably provide standardized measures of stem cell potency in CBUs.

Original language	English (US)
Pages (from-to)	1595-1601
Number of pages	7
Journal	Transfusion
Volume	62
Issue number	8
DOIs	https://doi.org/10.1111/trf.16997
State	Published - Aug 2022

Bibliographical note

Funding Information:
The authors would like to thank Sonia Néron, Marie-Eve Rhéaume, Julie Carrier, Liette Vaudry for their direct help with the study, Antoine Lewin for helping with the statistical analyses, and Samuel Rochette for editing the manuscript. We would also like to thank Kelly Murphy at Canadian Blood Services Edmonton Stem Cell Laboratory, Roya Pasha at Canadian Blood Services Ottawa Centre for Innovation, FenFen Hsieh and Ashley at the University of Utah, Takafumi Kimura and Nobuki Matsuyama at Japanese Red Cross Kinki Block Blood Centre, Gemma Aran and Carmen Azqueta at the Banc de Sang I Teixits, and also Matthew N. Klein, Cynthia Thérien and Geneviève Quenneville for their significant contribution to this study.

Publisher Copyright:
© 2022 AABB.

Keywords

cord blood
flow cytometry
multicenter evaluation
potency
stem cells

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10.1111/trf.16997

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@article{e1bd4677bcfc4807baf19a9ccecd1152,

title = "Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units: The BEST Collaborative study",

abstract = "Background: The IL-3-pSTAT5 assay, a new, rapid, and standardized flow-cytometry-based assay may compensate for several limitations of the colony-forming unit (CFU) assay typically used for stem cell potency assessments of cord blood units (CBU). We performed an inter-laboratory evaluation of the performance of this new assay. Study design and methods: This Biomedical Excellence for Safer Transfusion (BEST) Collaborative multicenter, international study included 15 participants from public cord blood banks (CBBs), CBB-supporting research laboratories, and stem cell laboratories. To perform the IL-3-pSTAT5 assay, participating centers received reagents, instructions, and 10 blind CBU samples, including eight normal samples and two samples exposed to a transient warming event. We measured inter-laboratory agreement qualitatively (proportion of correctly classified samples) and quantitatively (coefficient of variation [CV], correlation coefficients, receiver operating characteristics (ROC) curve, and intraclass correlation coefficient [ICC]). Results: The qualitative agreement was 97.3\% (i.e., 107/110; Fleiss' kappa = 0.835). The average CV on a per-sample basis was 11.57\% among all samples, 8.99\% among normal samples, and on a per-center basis was 9.42\% among normal samples. In a correlation matrix that compared results across centers, the mean Pearson's correlation coefficient was 0.88 (standard deviation = 0.04). The ICC was 0.83 (95\% confidence interval = 0.68–0.95). The area under the curve (AUC) from the ROC curve was 0.9974. Discussion: Excellent qualitative and quantitative agreement was exhibited across laboratories. The IL-3-pSTAT5 assay may therefore be implemented in flow cytometry laboratories to rapidly and reliably provide standardized measures of stem cell potency in CBUs.",

keywords = "cord blood, flow cytometry, multicenter evaluation, potency, stem cells",

author = "\{The Biomedical Excellence for Safer Transfusion Collaborative\} and Patrick Tr{\'e}panier and Diane Fournier and Carl Simard and Fontaine, \{Magali J.\} and David Stroncek and Minoko Takanashi and David McKenna and Joseph Schwartz and Tanhehco, \{Yvette C.\} and Reems, \{Jo Anna\} and Silvia Torrents and Gesine Kogler and Stefanie Liedtke and Martin Giroux and Holovati, \{Jelena L.\} and Isabelle Louis and Arun Prasath and Nicolas Pineault and Ren{\'e}e Bazin",

note = "Funding Information: The authors would like to thank Sonia N{\'e}ron, Marie-Eve Rh{\'e}aume, Julie Carrier, Liette Vaudry for their direct help with the study, Antoine Lewin for helping with the statistical analyses, and Samuel Rochette for editing the manuscript. We would also like to thank Kelly Murphy at Canadian Blood Services Edmonton Stem Cell Laboratory, Roya Pasha at Canadian Blood Services Ottawa Centre for Innovation, FenFen Hsieh and Ashley at the University of Utah, Takafumi Kimura and Nobuki Matsuyama at Japanese Red Cross Kinki Block Blood Centre, Gemma Aran and Carmen Azqueta at the Banc de Sang I Teixits, and also Matthew N. Klein, Cynthia Th{\'e}rien and Genevi{\`e}ve Quenneville for their significant contribution to this study. Publisher Copyright: {\textcopyright} 2022 AABB.",

year = "2022",

month = aug,

doi = "10.1111/trf.16997",

language = "English (US)",

volume = "62",

pages = "1595--1601",

journal = "Transfusion",

issn = "0041-1132",

publisher = "John Wiley and Sons Inc.",

number = "8",

}

TY - JOUR

T1 - Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units

T2 - The BEST Collaborative study

AU - The Biomedical Excellence for Safer Transfusion Collaborative

AU - Trépanier, Patrick

AU - Fournier, Diane

AU - Simard, Carl

AU - Fontaine, Magali J.

AU - Stroncek, David

AU - Takanashi, Minoko

AU - McKenna, David

AU - Schwartz, Joseph

AU - Tanhehco, Yvette C.

AU - Reems, Jo Anna

AU - Torrents, Silvia

AU - Kogler, Gesine

AU - Liedtke, Stefanie

AU - Giroux, Martin

AU - Holovati, Jelena L.

AU - Louis, Isabelle

AU - Prasath, Arun

AU - Pineault, Nicolas

AU - Bazin, Renée

N1 - Funding Information: The authors would like to thank Sonia Néron, Marie-Eve Rhéaume, Julie Carrier, Liette Vaudry for their direct help with the study, Antoine Lewin for helping with the statistical analyses, and Samuel Rochette for editing the manuscript. We would also like to thank Kelly Murphy at Canadian Blood Services Edmonton Stem Cell Laboratory, Roya Pasha at Canadian Blood Services Ottawa Centre for Innovation, FenFen Hsieh and Ashley at the University of Utah, Takafumi Kimura and Nobuki Matsuyama at Japanese Red Cross Kinki Block Blood Centre, Gemma Aran and Carmen Azqueta at the Banc de Sang I Teixits, and also Matthew N. Klein, Cynthia Thérien and Geneviève Quenneville for their significant contribution to this study. Publisher Copyright: © 2022 AABB.

PY - 2022/8

Y1 - 2022/8

N2 - Background: The IL-3-pSTAT5 assay, a new, rapid, and standardized flow-cytometry-based assay may compensate for several limitations of the colony-forming unit (CFU) assay typically used for stem cell potency assessments of cord blood units (CBU). We performed an inter-laboratory evaluation of the performance of this new assay. Study design and methods: This Biomedical Excellence for Safer Transfusion (BEST) Collaborative multicenter, international study included 15 participants from public cord blood banks (CBBs), CBB-supporting research laboratories, and stem cell laboratories. To perform the IL-3-pSTAT5 assay, participating centers received reagents, instructions, and 10 blind CBU samples, including eight normal samples and two samples exposed to a transient warming event. We measured inter-laboratory agreement qualitatively (proportion of correctly classified samples) and quantitatively (coefficient of variation [CV], correlation coefficients, receiver operating characteristics (ROC) curve, and intraclass correlation coefficient [ICC]). Results: The qualitative agreement was 97.3% (i.e., 107/110; Fleiss' kappa = 0.835). The average CV on a per-sample basis was 11.57% among all samples, 8.99% among normal samples, and on a per-center basis was 9.42% among normal samples. In a correlation matrix that compared results across centers, the mean Pearson's correlation coefficient was 0.88 (standard deviation = 0.04). The ICC was 0.83 (95% confidence interval = 0.68–0.95). The area under the curve (AUC) from the ROC curve was 0.9974. Discussion: Excellent qualitative and quantitative agreement was exhibited across laboratories. The IL-3-pSTAT5 assay may therefore be implemented in flow cytometry laboratories to rapidly and reliably provide standardized measures of stem cell potency in CBUs.

AB - Background: The IL-3-pSTAT5 assay, a new, rapid, and standardized flow-cytometry-based assay may compensate for several limitations of the colony-forming unit (CFU) assay typically used for stem cell potency assessments of cord blood units (CBU). We performed an inter-laboratory evaluation of the performance of this new assay. Study design and methods: This Biomedical Excellence for Safer Transfusion (BEST) Collaborative multicenter, international study included 15 participants from public cord blood banks (CBBs), CBB-supporting research laboratories, and stem cell laboratories. To perform the IL-3-pSTAT5 assay, participating centers received reagents, instructions, and 10 blind CBU samples, including eight normal samples and two samples exposed to a transient warming event. We measured inter-laboratory agreement qualitatively (proportion of correctly classified samples) and quantitatively (coefficient of variation [CV], correlation coefficients, receiver operating characteristics (ROC) curve, and intraclass correlation coefficient [ICC]). Results: The qualitative agreement was 97.3% (i.e., 107/110; Fleiss' kappa = 0.835). The average CV on a per-sample basis was 11.57% among all samples, 8.99% among normal samples, and on a per-center basis was 9.42% among normal samples. In a correlation matrix that compared results across centers, the mean Pearson's correlation coefficient was 0.88 (standard deviation = 0.04). The ICC was 0.83 (95% confidence interval = 0.68–0.95). The area under the curve (AUC) from the ROC curve was 0.9974. Discussion: Excellent qualitative and quantitative agreement was exhibited across laboratories. The IL-3-pSTAT5 assay may therefore be implemented in flow cytometry laboratories to rapidly and reliably provide standardized measures of stem cell potency in CBUs.

KW - cord blood

KW - flow cytometry

KW - multicenter evaluation

KW - potency

KW - stem cells

UR - https://www.scopus.com/pages/publications/85133809829

UR - https://www.scopus.com/pages/publications/85133809829#tab=citedBy

U2 - 10.1111/trf.16997

DO - 10.1111/trf.16997

M3 - Article

C2 - 35770742

AN - SCOPUS:85133809829

SN - 0041-1132

VL - 62

SP - 1595

EP - 1601

JO - Transfusion

JF - Transfusion

IS - 8

ER -

Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units: The BEST Collaborative study

Abstract

Bibliographical note

Keywords

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