Real Time Central Assessment of Kidney Transplant Indication Biopsies by Microarrays: The INTERCOMEX Study

摘要: The authors conducted a prospective trial to assess the feasibility of real time central molecular assessment kidney transplant biopsy samples from 10 North American or European centers. Biopsy taken 1 day 34 years posttransplantation were stabilized in RNAlater, sent via courier overnight at ambient temperature laboratory, and processed (29 h workflow) using microarrays T cell- antibody-mediated rejection (TCMR ABMR, respectively). Of 538 submitted, 519 (96%) sufficient for microarray analysis (average length, 3 mm). Automated reports generated without knowledge histology HLA antibody, with diagnoses assigned based on Molecular Microscope Diagnostic System (MMDx) classifier algorithms signed out by one observer. Agreement between MMDx (balanced accuracy) was 77% TCMR, 76% no rejection. A classification tree derived provide automated sign-outs predicted observer >90% accuracy. In 451 where feedback obtained, clinicians indicated that more frequently agreed clinical judgment (87%) than did (80%) (p = 0.0042). 81% forms, reported increased confidence management compared conventional alone. conclude is feasible offers useful new dimension interpretation. ClinicalTrials.gov NCT#01299168.