| Autor: |
Patrick, Trépanier, Diane, Fournier, Carl, Simard, Magali J, Fontaine, David, Stroncek, Minoko, Takanashi, David, McKenna, Joseph, Schwartz, Yvette C, Tanhehco, Jo-Anna, Reems, Silvia, Torrents, Gesine, Kogler, Stefanie, Liedtke, Martin, Giroux, Jelena L, Holovati, Isabelle, Louis, Arun, Prasath, Nicolas, Pineault, Renée, Bazin |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
TransfusionREFERENCES. 62(8) |
| ISSN: |
1537-2995 |
| Popis: |
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.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]).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.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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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