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Title: | Diagnostic performance of kSORT, a blood-based mRNA assay for noninvasive detection of rejection after kidney transplantation: A retrospective multicenter cohort study | Authors: | Van Loon, Elisabet Giral, Magali Anglicheau, Dany Lerut, Evelyne Dubois, Valérie Rabeyrin, Maud Brouard, Sophie Roedder, Silke Spigarelli, Michael G. Rabant, Marion BOGAERTS, Kris Naesens, Maarten Thaunat, Olivier |
Issue Date: | 2021 | Source: | American journal of transplantation (Print), 21 (2) , p. 740 -750 | Abstract: | 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. | Keywords: | Maarten Naesens and Olivier Thaunat are equally contributed + For the DIVAT consortium Abbreviations: ABMR, antibody-mediated rejection;AR, acute rejection;AUC, area under the curve;BL-TCMR, borderline changes;BX, biopsy;CI, confidence interval;DSA, donor-specific anti-HLA antibodies;eGFR, estimated GFR;HR, high risk for rejection;IND, indeterminate result;IQR, interquartile range;kSORT, Kidney Solid Organ Response Test;LR, low risk for rejection;NPV, negative predictive value;PPV, positive predictive value;ROC, receiver-operating characteristic;sABMR, suspicious for antibody-mediated rejection;TCMR, T cell-mediated rejection | Document URI: | http://hdl.handle.net/1942/34619 | ISSN: | 1600-6135 | e-ISSN: | 1600-6143 | DOI: | 10.1111/ajt.16179 | ISI #: | WOS:000555271700001 | Rights: | 2020 The American Society of Transplantation and the American Society of Transplant Surgeons | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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ajt.16179.pdf Restricted Access | Published version | 791.52 kB | Adobe PDF | View/Open Request a copy |
ajt.16179 (1).pdf | Peer-reviewed author version | 11.83 MB | Adobe PDF | View/Open |
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