{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T20:29:49Z","timestamp":1786480189239,"version":"build-2736575974"},"reference-count":0,"publisher":"Ovid Technologies (Wolters Kluwer Health)","license":[{"start":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T00:00:00Z","timestamp":1778716800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Kidney360"],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Although donor and recipient characteristics are used to estimate graft failure risk, they remain limited in predicting early acute rejection. We developed and validated a next-generation sequencing (NGS) assay targeting the pre-transplant immunologic profile to predict early acute rejection following kidney transplantation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This prospective, international study enrolled 321 kidney transplant participants across 13 sites, forming discovery and validation cohorts. Peripheral blood was collected prior to transplant and at 1, 3, 6, 12, and 24 months post-transplant, with protocol biopsies performed at 3 and 12 months, as well as any indication biopsies. Biopsies were assessed by a blinded central pathologist according to the 2019 Banff criteria. The pre-transplant risk assessment (PTRA\u2122) test to evaluate RNA expression of a 29-gene signature algorithm designed to predict early acute rejection risk was clinically validated utilizing 122 deceased donor kidney transplant recipients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>PTRA classified 31 of 122 participants (25%) as high-risk and 91 (75%) as low-risk. There were 9 early acute rejection events in the first 60 days post-transplant: 6\/31 (19%) in the high-risk group and 3\/91 (3%) in the low-risk group. PTRA discrimination for early acute rejection at 60 days post-transplant yielded an AUC of 0.78 (95% confidence interval [CI]: 64.4 to 91.5), p&lt;0.001. A cut-off of \u226445 was defined as low-risk and &gt;45 as high-risk for early acute rejection within 60 days post-transplant. Sensitivity 0.67 (95% CI: 0.36 to 0.97), specificity 0.78 (95% CI: 0.70 to 0.86), positive predictive value 0.19 (95% CI: 0.05 to 0.33), and negative predictive value 0.97 (95% CI: 0.93 to 1.00). The odds ratio comparing patients identified as high- vs low-risk by PTRA was 7.04 (95% CI: 1.64 to 30.2), p=0.009.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This study validates the ability of PTRA to stratify kidney transplant recipients as high- or low-risk for early acute rejection using a pre-transplant transcriptomic profile, with implications for graft health and personalized treatment management.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.34067\/kid.0000001208","type":"journal-article","created":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T16:03:15Z","timestamp":1778774595000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":1,"title":["A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection"],"prefix":"10.34067","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0576-6756","authenticated-orcid":false,"given":"Beatrice P.","family":"Concepcion","sequence":"first","affiliation":[{"name":"University of Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9468-7920","authenticated-orcid":false,"given":"Oriol","family":"Bestard","sequence":"additional","affiliation":[{"name":"Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7914-1663","authenticated-orcid":false,"given":"Milagros","family":"Samaniego-Picota","sequence":"additional","affiliation":[{"name":"Henry Ford Health System, Detroit, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0102-8684","authenticated-orcid":false,"given":"Rohini","family":"Prashar","sequence":"additional","affiliation":[{"name":"Henry Ford Health System, Detroit, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3933-5869","authenticated-orcid":false,"given":"M. Javeed","family":"Ansari","sequence":"additional","affiliation":[{"name":"Northwestern University, Evanston, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4160-8840","authenticated-orcid":false,"given":"Giorgia","family":"Comai","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Kidney Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-7355-4888","authenticated-orcid":false,"given":"Elisa","family":"Gessaroli","sequence":"additional","affiliation":[{"name":"Nephrology, Dialysis and Kidney Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5130-7286","authenticated-orcid":false,"given":"Lionel","family":"Rostaing","sequence":"additional","affiliation":[{"name":"CHU Grenoble Alpes, Grenoble, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1686-5709","authenticated-orcid":false,"given":"Federico","family":"Alberici","sequence":"additional","affiliation":[{"name":"ASST degli Spedali Civili di Brescia, Brescia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1776-3680","authenticated-orcid":false,"given":"Roslyn B.","family":"Mannon","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center, Omaha, NE, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8625-9288","authenticated-orcid":false,"given":"Joshua","family":"Augustine","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7368-9481","authenticated-orcid":false,"given":"Alvin","family":"Wee","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1492-5103","authenticated-orcid":false,"given":"Emilio","family":"Poggio","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7152-8262","authenticated-orcid":false,"given":"Pierpaolo","family":"DiCocco","sequence":"additional","affiliation":[{"name":"University of Illinois at Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3279-2930","authenticated-orcid":false,"given":"Nicholae","family":"Leca","sequence":"additional","affiliation":[{"name":"University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4602-5700","authenticated-orcid":false,"given":"Saed","family":"Shawar","sequence":"additional","affiliation":[{"name":"Vanderbilt University, Nashville, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4333-5551","authenticated-orcid":false,"given":"Chandra","family":"Bhati","sequence":"additional","affiliation":[{"name":"University of Maryland, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Maluf","sequence":"additional","affiliation":[{"name":"University of Maryland, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9455-7971","authenticated-orcid":false,"given":"David M.","family":"Rothstein","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8649-2901","authenticated-orcid":false,"given":"Aravind","family":"Cherukuri","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6877-5510","authenticated-orcid":false,"given":"Anthony","family":"Chang","sequence":"additional","affiliation":[{"name":"University of Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2603-2778","authenticated-orcid":false,"given":"Fadi","family":"Salem","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Jacksonville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3840-4161","authenticated-orcid":false,"given":"Michael W.","family":"Kattan","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5341-7286","authenticated-orcid":false,"given":"Jesse D.","family":"Schold","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, CO; Department of Epidemiology, School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9582-8630","authenticated-orcid":false,"given":"Patricia","family":"Connolly","sequence":"additional","affiliation":[{"name":"Verici Dx, Franklin, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Rose","sequence":"additional","affiliation":[{"name":"Verici Dx, Franklin, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-2613-3211","authenticated-orcid":false,"given":"Nehal","family":"Doshi","sequence":"additional","affiliation":[{"name":"Verici Dx, Franklin, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6094-1027","authenticated-orcid":false,"given":"Lorenzo","family":"Gallon","sequence":"additional","affiliation":[{"name":"University of Chicago, Chicago, IL, USA"},{"name":"Verici Dx, Franklin, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0772-598X","authenticated-orcid":false,"given":"Michael J.","family":"Donovan","sequence":"additional","affiliation":[{"name":"Verici Dx, Franklin, TN, USA"},{"name":"Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2026,5,14]]},"container-title":["Kidney360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0000001208","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T19:56:25Z","timestamp":1786478185000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0000001208"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,14]]},"references-count":0,"URL":"https:\/\/doi.org\/10.34067\/kid.0000001208","relation":{},"ISSN":["2641-7650"],"issn-type":[{"value":"2641-7650","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,14]]},"assertion":[{"value":"2025-08-25","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-21","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}