Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring
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...
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Frontiers Media S.A.
2024-12-01
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| Series: | Transplant International |
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| Online Access: | https://www.frontierspartnerships.org/articles/10.3389/ti.2024.13919/full |
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| author | Alexandre Loupy Alexandre Loupy Anaïs Certain Narin S. Tangprasertchai Maud Racapé Cindy Ursule-Dufait Kawthar Benbadi Marc Raynaud Evgeniya Vaskova Corina Marchis Sílvia Casas Tim Hague Oriol Bestard Delphine Kervella Carmen Lefaucheur Carmen Lefaucheur Thierry Viard Olivier Aubert Olivier Aubert |
| author_facet | Alexandre Loupy Alexandre Loupy Anaïs Certain Narin S. Tangprasertchai Maud Racapé Cindy Ursule-Dufait Kawthar Benbadi Marc Raynaud Evgeniya Vaskova Corina Marchis Sílvia Casas Tim Hague Oriol Bestard Delphine Kervella Carmen Lefaucheur Carmen Lefaucheur Thierry Viard Olivier Aubert Olivier Aubert |
| author_sort | Alexandre Loupy |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4b63188cb64c4e4d9b05e9d5b57be308 |
| institution | OA Journals |
| issn | 1432-2277 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Transplant International |
| spelling | doaj-art-4b63188cb64c4e4d9b05e9d5b57be3082025-08-20T01:58:27ZengFrontiers Media S.A.Transplant International1432-22772024-12-013710.3389/ti.2024.1391913919Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection MonitoringAlexandre Loupy0Alexandre Loupy1Anaïs Certain2Narin S. Tangprasertchai3Maud Racapé4Cindy Ursule-Dufait5Kawthar Benbadi6Marc Raynaud7Evgeniya Vaskova8Corina Marchis9Sílvia Casas10Tim Hague11Oriol Bestard12Delphine Kervella13Carmen Lefaucheur14Carmen Lefaucheur15Thierry Viard16Olivier Aubert17Olivier Aubert18Université Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceDepartment of Kidney Transplantation, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, FranceUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceCareDx, Brisbane, CA, United StatesUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceCareDx, Brisbane, CA, United StatesCareDx, Brisbane, CA, United StatesCareDx, Brisbane, CA, United StatesCareDx, Brisbane, CA, United StatesDepartment of Nephrology and Kidney Transplantation, Vall d’Hebron University Hospital, Vall d’ Hebrón Research Institute, Vall d’ Hebrón Barcelona Campus Hospital, Barcelona Autonomous University, Barcelona, SpainDepartment of Nephrology and Kidney Transplantation, Vall d’Hebron University Hospital, Vall d’ Hebrón Research Institute, Vall d’ Hebrón Barcelona Campus Hospital, Barcelona Autonomous University, Barcelona, SpainUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceKidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, FranceCareDx, Brisbane, CA, United StatesUniversité Paris Cité, Institut national de la santé et de la recherche médicale (INSERM) U970, Paris Institute for Transplantation and Organ Regeneration PITOR, Paris, FranceDepartment of Kidney Transplantation, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, FranceDonor-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.https://www.frontierspartnerships.org/articles/10.3389/ti.2024.13919/fullAlloSeqdd-cfDNAliquid biopsyallograft rejectionnon-invasive diagnosis |
| spellingShingle | Alexandre Loupy Alexandre Loupy Anaïs Certain Narin S. Tangprasertchai Maud Racapé Cindy Ursule-Dufait Kawthar Benbadi Marc Raynaud Evgeniya Vaskova Corina Marchis Sílvia Casas Tim Hague Oriol Bestard Delphine Kervella Carmen Lefaucheur Carmen Lefaucheur Thierry Viard Olivier Aubert Olivier Aubert Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring Transplant International AlloSeq dd-cfDNA liquid biopsy allograft rejection non-invasive diagnosis |
| title | Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring |
| title_full | Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring |
| title_fullStr | Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring |
| title_full_unstemmed | Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring |
| title_short | Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring |
| title_sort | evaluation of a decentralized donor derived cell free dna assay for kidney allograft rejection monitoring |
| topic | AlloSeq dd-cfDNA liquid biopsy allograft rejection non-invasive diagnosis |
| url | https://www.frontierspartnerships.org/articles/10.3389/ti.2024.13919/full |
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