Microarray Diagnosis of Antibody‐Mediated Rejection in Kidney Transplant Biopsies: An International Prospective Study (INTERCOM)

In a reference set of 403 kidney transplant biopsies, we recently developed a microarray‐based test that diagnoses antibody‐mediated rejection (ABMR) by assigning an ABMR score. To validate the ABMR score and assess its potential impact on practice, we performed the present prospective INTERCOM stud...

Full description

Saved in:
Bibliographic Details
Published in:American journal of transplantation 2013-11, Vol.13 (11), p.2865-2874
Main Authors: Halloran, P. F., Pereira, A. B., Chang, J., Matas, A., Picton, M., De Freitas, D., Bromberg, J., Serón, D., Sellarés, J., Einecke, G., Reeve, J.
Format: Article
Language:English
Subjects:
Adolescent
Antibodies
Antibody‐mediated rejection
Biological and medical sciences
Biomarkers - analysis
classifier
Follow-Up Studies
Gene Expression Profiling
Graft Rejection - diagnosis
Graft Rejection - immunology
Graft Survival - immunology
Humans
International Agencies
Isoantibodies - immunology
Kidney Failure, Chronic - immunology
Kidney Failure, Chronic - mortality
Kidney Failure, Chronic - surgery
kidney transplant
Kidney Transplantation - adverse effects
Medical sciences
microarrays
molecular diagnostics
Oligonucleotide Array Sequence Analysis
Postoperative Complications
Prognosis
Prospective Studies
Risk Factors
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Survival Rate
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:In a reference set of 403 kidney transplant biopsies, we recently developed a microarray‐based test that diagnoses antibody‐mediated rejection (ABMR) by assigning an ABMR score. To validate the ABMR score and assess its potential impact on practice, we performed the present prospective INTERCOM study (clinicaltrials.gov NCT01299168) in 300 new biopsies (264 patients) from six centers: Baltimore, Barcelona, Edmonton, Hannover, Manchester and Minneapolis. We assigned ABMR scores using the classifier created in the reference set and compared it to conventional assessment as documented in the pathology reports. INTERCOM documented uncertainty in conventional assessment: In 41% of biopsies where ABMR features were noted, the recorded diagnoses did not mention ABMR. The ABMR score correlated with ABMR histologic lesions and donor‐specific antibodies, but not with T cell–mediated rejection lesions. The agreement between ABMR scores and conventional assessment was identical to that in the reference set (accuracy 85%). The ABMR score was more strongly associated with failure than conventional assessment, and when the ABMR score and conventional assessment disagreed, only the ABMR score was associated with early progression to failure. INTERCOM confirms the need to reduce uncertainty in the diagnosis of ABMR, and demonstrates the potential of the ABMR score to impact practice. The authors report that when the molecular antibody‐mediated rejection score derived in a reference set of kidney transplant biopsies was tested in 300 new biopsies (the INTERCOM study), it validated the value of molecular testing for establishing not only diagnosis but also prognosis, and documented the difficulties centers have in making this diagnosis by conventional means.
ISSN:1600-6135
1600-6143
DOI:10.1111/ajt.12465