Abbreviations and Acronyms:ACR (acute cellular rejection), AMR (antibody-mediated rejection), AUC (area under the curve), cfDNA (cell-free DNA), DF (donor fraction), DTRT (DNA-based Transplant Rejection Test), ISHLT (International Society for Heart and Lung Transplantation), NPV (negative predictive value), pAMR (pathologic antibody-mediated rejection), PPV (positive predictive value), QC (quality control), ROC (receiver operating characteristic)
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ClinicalTrials.gov ID NCT02109575.
Funding: National Institutes of Health/National Heart, Lung, and Blood Institute 5R01HL119747, TAI Diagnostics.
Institutional Review Board approval (CW DTRT-2 846823), first approval on February 3, 2016. All participants had signed written informed consent/assent for participation in the study and publication of their data as appropriate.