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Early clinical experience using donor‐derived cell‐free DNA to detect rejection in kidney transplant recipients
Author(s) -
Huang Edmund,
Sethi Supreet,
Peng Alice,
Najjar Reiad,
Mirocha James,
Haas Mark,
Vo Ashley,
Jordan Stanley C.
Publication year - 2019
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.15289
Subject(s) - medicine , interquartile range , kidney transplantation , cell free fetal dna , biopsy , urology , kidney transplant , area under the curve , transplantation , kidney , gastroenterology , oncology , pregnancy , fetus , prenatal diagnosis , biology , genetics
Donor‐derived cell‐free DNA (dd‐cf DNA ) became Medicare reimbursable in the United States in October 2017 for the detection of rejection in kidney transplant recipients based on results from its pivotal validation trial, but it has not yet been externally validated. We assessed 63 adult kidney transplant recipients with suspicion of rejection with dd‐cf DNA and allograft biopsy. Of these, 27 (43%) patients had donor–specific antibodies and 34 (54%) were found to have rejection by biopsy. The percentage of dd‐cf DNA was higher among patients with antibody–mediated rejection ( ABMR ; median 1.35%; interquartile range [ IQR ]: 1.10%‐1.90%) compared to those with no rejection (median 0.38%, IQR : 0.26%‐1.10%; P < .001) and cell–mediated rejection ( CMR ; median: 0.27%, IQR : 0.19%‐1.30%; P = .01). The dd‐cf DNA test did not discriminate patients with CMR from those without rejection. The area under the ROC curve ( AUC ) for CMR was 0.42 (95% CI : 0.17‐0.66). For ABMR , the AUC was 0.82 (95% CI : 0.71‐0.93) and a dd‐cf DNA ≥0.74% yielded a sensitivity of 100%, specificity 71.8%, PPV 68.6%, and NPV 100%. The dd‐cf DNA test did not discriminate CMR from no rejection among kidney transplant recipients, although performance characteristics were stronger for the discrimination of ABMR .