Diagnostic performance of kSORT, a blood-based mRNA assay for noninvasive detection of rejection after kidney transplantation: A retrospective multicenter cohort study
| Autor: | Evelyne Lerut, Maud Rabeyrin, Magali Giral, Kris Bogaerts, Dany Anglicheau, Marion Rabant, Valérie Dubois, Maarten Naesens, Silke Roedder, Olivier Thaunat, Sophie Brouard, Elisabet Van Loon, Michael G. Spigarelli |
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| Rok vydání: | 2021 |
| Předmět: |
Graft Rejection
medicine.medical_specialty Biopsy Urology 030230 surgery Kidney Cohort Studies 03 medical and health sciences 0302 clinical medicine Immunology and Allergy Medicine Pharmacology (medical) RNA Messenger Kidney transplantation Retrospective Studies Transplantation medicine.diagnostic_test business.industry Area under the curve Retrospective cohort study medicine.disease Kidney Transplantation ROC Curve Concomitant Renal biopsy business Biomarkers Cohort study |
| Zdroj: | American Journal of Transplantation. 21:740-750 |
| ISSN: | 1600-6135 |
| DOI: | 10.1111/ajt.16179 |
| Popis: | The Kidney Solid Organ Response Test (kSORT) blood gene expression assay was developed to noninvasively detect acute rejection (AR) after kidney transplantation. Its performance in a setting with natural disease prevalence has not been evaluated. A retrospective, multicenter cohort study was conducted across all single kidney transplant recipients, transplanted between 2011 and 2015, with samples within the first year after transplantation available in existing biobanks. The primary objective was to determine the diagnostic performance of the kSORT assay to detect AR (T cell-mediated and/or antibody-mediated rejection) as compared to a concomitant renal biopsy. AR was reported on the concomitant biopsy in 188 of 1763 (10.7%) blood samples and any rejection (including borderline changes) in 614 of 1763 (34.8%) blood samples. In 320 of 1763 samples (18.2%) the kSORT risk category was indeterminate. The kSORT assay had no diagnostic value for AR (area under the curve [AUC] 0.51, 95% confidence interval [CI] 0.50-0.56; P = .46) overall, or when considering indication biopsies (N = 487) and protocol-specified biopsies (N = 1276) separately (AUC of 0.53, 95% CI 0.50-0.59, P = .44 and 0.55, 95% CI 0.50-0.61, P = .09, respectively). This large retrospective study utilizing samples obtained under real-world clinical conditions, was unable to validate the kSORT assay for detection of AR in the first year after transplantation. ispartof: AMERICAN JOURNAL OF TRANSPLANTATION vol:21 issue:2 pages:740-750 ispartof: location:United States status: published |
| Databáze: | OpenAIRE |
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