Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2022 Aug;62(8):1595-1601.
doi: 10.1111/trf.16997. Epub 2022 Jun 30.

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

Patrick Trépanier  1 , Diane Fournier  2 , Carl Simard  1 , Magali J Fontaine  3 , David Stroncek  4 , Minoko Takanashi  5 , David McKenna  6 , Joseph Schwartz  7 , Yvette C Tanhehco  8 , Jo-Anna Reems  9 , Silvia Torrents  10 , Gesine Kogler  11 , Stefanie Liedtke  11 , Martin Giroux  12 , Jelena L Holovati  13 , Isabelle Louis  14 , Arun Prasath  15 , Nicolas Pineault  16 , Renée Bazin  1 ; Biomedical Excellence for Safer Transfusion Collaborative
Affiliations
Multicenter Study

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

Patrick Trépanier et al. Transfusion. 2022 Aug.

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.

PubMed Disclaimer

References

REFERENCES

    1. Gluckman E, Broxmeyer HE, Auerbach AD, Friedman HS, Douglas GW, Devergie A, et al. Hematopoietic reconstitution in a patient with Fanconi's anemia by means of umbilical-cord blood from an HLA-identical sibling. N Engl J Med. 1989;321:1174-8.
    1. Gluckman E. History of cord blood transplantation. Bone Marrow Transplant. 2009;44:621-6.
    1. Kurtzberg J, Prasad VK, Carter SL, Wagner JE, Baxter-Lowe LA, Wall D, et al. Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies. Blood. 2008;112:4318-27.
    1. Shoulars K, Noldner P, Troy JD, Cheatham L, Parrish A, Page K, et al. Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay. Blood. 2016;127:2346-54.
    1. Ruggeri A. Optimizing cord blood selection. Hematology. 2019;2019:522-31.

Publication types

LinkOut - more resources