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Real Time Central Assessment of Kidney Transplant Indication Biopsies by Microarrays: The INTERCOMEX Study
Author(s) -
Halloran P. F.,
Reeve J.,
Akalin E.,
Aubert O.,
Bohmig G. A.,
Brennan D.,
Bromberg J.,
Einecke G.,
Eskandary F.,
Gosset C.,
Duong Van Huyen J.P.,
Gupta G.,
Lefaucheur C.,
Malone A.,
Man R. B.,
Seron D.,
Sellares J.,
Weir M.,
Loupy A.
Publication year - 2017
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.14329
Subject(s) - medicine , biopsy , histology , kidney transplant , medical diagnosis , radiology , kidney , kidney transplantation , pathology
The authors conducted a prospective trial to assess the feasibility of real time central molecular assessment of kidney transplant biopsy samples from 10 North American or European centers. Biopsy samples taken 1 day to 34 years posttransplantation were stabilized in RNA later , sent via courier overnight at ambient temperature to the central laboratory, and processed (29 h workflow) using microarrays to assess T cell– and antibody‐mediated rejection ( TCMR and ABMR, respectively ). Of 538 biopsy samples submitted, 519 (96%) were sufficient for microarray analysis (average length, 3 mm). Automated reports were generated without knowledge of histology and HLA antibody, with diagnoses assigned based on Molecular Microscope Diagnostic System ( MMD x) classifier algorithms and signed out by one observer. Agreement between MMD x and histology (balanced accuracy) was 77% for TCMR, 77% for ABMR , and 76% for no rejection. A classification tree derived to provide automated sign‐outs predicted the observer sign‐outs with >90% accuracy. In 451 biopsy samples where feedback was obtained, clinicians indicated that MMD x more frequently agreed with clinical judgment (87%) than did histology (80%) (p = 0.0042). In 81% of feedback forms, clinicians reported that MMD x increased confidence in management compared with conventional assessment alone. The authors conclude that real time central molecular assessment is feasible and offers a useful new dimension in biopsy interpretation. ClinicalTrials.gov NCT #01299168.