Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant.

ABSTRACT: Noninvasive biomarkers are needed to monitor stable patients after kidney transplant (KT), because subclinical acute rejection (subAR), currently detectable only with surveillance biopsies, can lead to chronic rejection and graft loss. We conducted a multicenter study to develop a blood-based molecular biomarker for subAR using peripheral blood paired with surveillance biopsies and strict clinical phenotyping algorithms for discovery and validation. At a predefined threshold, 72% to 75% of KT recipients achieved a negative biomarker test correlating with the absence of subAR (negative predictive value: 78%-88%), while a positive test was obtained in 25% to 28% correlating with the presence of subAR (positive predictive value: 47%-61%). The clinical phenotype and biomarker independently and

SUBMITTER: Friedewald JJ 

PROVIDER: S-EPMC6387870 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature