Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring

Altres autors/es

Institut Català de la Salut

[Loupy A] Université Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, France. Department of Kidney Transplantation, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. [Certain A, Racapé M, Ursule-Dufait C, Benbadi K] Université Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, France. [Tangprasertchai NS] CareDx, Brisbane, CA, United States. [Bestard O, Kervella D] Servei de Nefrologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Recerca de Nefrologia i Trasplantament Renal, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain

Vall d'Hebron Barcelona Hospital Campus

Data de publicació

2025-02-03T09:27:33Z

2025-02-03T09:27:33Z

2024-12-17



Resum

Allograft rejection; Liquid biopsy; Non-invasive diagnosis


Rebuig d'al·lograft; Biòpsia líquida; Diagnòstic no invasiu


Rechazo del aloinjerto; Biopsia líquida; Diagnóstico no invasivo


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 (r 2) 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 r 2 = 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.


The author(s) declare financial support was received for the research, authorship, and/or publication of this article. OrganX Foundation.

Tipus de document

Article


Versió publicada

Llengua

Anglès

Matèries i paraules clau

Ronyons - Trasplantació; Rebuig (Biologia); Marcadors bioquímics; Al·loempelts; Biòpsia; CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Cell-Free Nucleic Acids; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Transplantation::Organ Transplantation::Surgical Procedures, Operative::Kidney Transplantation; CHEMICALS AND DRUGS::Biological Factors::Biomarkers; PHENOMENA AND PROCESSES::Immune System Phenomena::Transplantation Immunology::Host vs Graft Reaction::Graft Rejection; NAMED GROUPS::Persons::Transplant Recipients; ANATOMY::Body Regions::Transplants::Allografts; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Biopsy; COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ácidos nucleicos libres de células; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::trasplante::trasplante de órganos::intervenciones quirúrgicas::trasplante de riñón; COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores; FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunología del trasplante::reacción huésped contra injerto::rechazo del injerto; DENOMINACIONES DE GRUPOS::personas::receptores de trasplantes; ANATOMÍA::regiones corporales::trasplantes::aloinjertos; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::biopsia

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Frontiers Media

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