Transfusion · 2026
Performance evaluation of a CD34 expression assay by digital PCR in bone marrow harvest from healthy donors.
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Waterhouse Miguel, Kaufmann Anja, David Martina, Enger Sabine, Sieder Melanie, Siegmund Darina, Pantic Milena, Rawluk Justyna, Zeiser Robert, Wehr Claudia, Wäsch Ralph, Duyster Justus, Finke Jürgen, Kiote-Schmidt Chrissoula
Аннотация
BACKGROUND: The aim of this study was to investigate a CD34 expression assay as an additional tool for the total nucleated cell (TNC) count assessment in bone marrow harvest (BMH) obtained from healthy donors.
STUDY DESIGN AND METHODS: Samples obtained from bone marrow donors (n = 71) were analyzed for CD34 expression using a digital PCR assay. The assay was extensively validated and the obtained data was correlated with standard BMH assessment methods such as TNC counts performed using a hematology analyzer and CD34 cell count measured with flow cytometry.
RESULTS: The digital PCR CD34 assay showed a strong correlation with the TNC count (Spearman's rs 0.87, 95% CI: 0.78-0.92, p < .001) and also with the CD34 cell count assessed by flow cytometry (Spearman's rs 0.91, 95% CI: 0.84-0.94, p < .001). To analyze the diagnostic performance of the assay, the true-positive rate (sensitivity) and the false-positive rate (1 - specificity) were plotted in a receiver-operating characteristic (ROC) space. The ROC curve showed an area under the curve (AUC) of 0.96 (95% confidence interval 0.91-1.01, p < .005). The CD34 NCN per kilogram of recipient body weight threshold of 0.54 resulted in a sensitivity of 0.91, a specificity of 0.96, a positive and negative predictive value of 0.97 and 0.91, respectively.
CONCLUSIONS: The CD34 expression assay here described can be used as an additional tool for TNC count estimation after BMH.
STUDY DESIGN AND METHODS: Samples obtained from bone marrow donors (n = 71) were analyzed for CD34 expression using a digital PCR assay. The assay was extensively validated and the obtained data was correlated with standard BMH assessment methods such as TNC counts performed using a hematology analyzer and CD34 cell count measured with flow cytometry.
RESULTS: The digital PCR CD34 assay showed a strong correlation with the TNC count (Spearman's rs 0.87, 95% CI: 0.78-0.92, p < .001) and also with the CD34 cell count assessed by flow cytometry (Spearman's rs 0.91, 95% CI: 0.84-0.94, p < .001). To analyze the diagnostic performance of the assay, the true-positive rate (sensitivity) and the false-positive rate (1 - specificity) were plotted in a receiver-operating characteristic (ROC) space. The ROC curve showed an area under the curve (AUC) of 0.96 (95% confidence interval 0.91-1.01, p < .005). The CD34 NCN per kilogram of recipient body weight threshold of 0.54 resulted in a sensitivity of 0.91, a specificity of 0.96, a positive and negative predictive value of 0.97 and 0.91, respectively.
CONCLUSIONS: The CD34 expression assay here described can be used as an additional tool for TNC count estimation after BMH.