AUTHOR=Loupy Alexandre , Certain Anaïs , Tangprasertchai Narin S. , Racapé Maud , Ursule-Dufait Cindy , Benbadi Kawthar , Raynaud Marc , Vaskova Evgeniya , Marchis Corina , Casas Sílvia , Hague Tim , Bestard Oriol , Kervella Delphine , Lefaucheur Carmen , Viard Thierry , Aubert Olivier TITLE=Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring JOURNAL=Transplant International VOLUME=37 YEAR=2024 URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.13919 DOI=10.3389/ti.2024.13919 ISSN=1432-2277 ABSTRACT=

Donor-derived cell-free DNA (dd-cfDNA) is an emerging non-invasive biomarker for allograft injury detection. This study aimed to evaluate a new, decentralized dd-cfDNA testing kit against a centralized dd-cfDNA testing service broadly utilized in the United States. Kidney transplant recipients with decentralized and centralized dd-cfDNA measurements and concomitant kidney allograft biopsies were included in the study. 580 kidney allograft recipients from 3 referral centers were included for 603 total evaluations. Correlation between assays was evaluated using r-squared (r2) and Spearman’s rank correlation test, and associations with rejection using logistic regression analyses and discrimination using area under the curve. Mean dd-cfDNA levels from decentralized and centralized tests were 0.51% ± 0.81% and 0.43% ± 0.78%, respectively. The assays were highly correlated, with r2 = 0.95 and Spearman’s rank correlation 0.88 (p < 0.0001). Both tests showed significant association with allograft rejection (p < 0.0001) and good and similar discriminations to predict rejection (AUC: 0.758 for the decentralized and AUC: 0.760 for the centralized dd-cfDNA; p = 0.8466). Consistency between the assays was also confirmed across clinical scenarios including post-transplant timepoint, allograft stability, and allograft rejection subcategories. This decentralized dd-cfDNA assessment demonstrates high accuracy and value to non-invasively monitor kidney recipients.