dd-cfDNA and GEP in heart-transplantation

Description

Our research hypothesis is that matched results from the Prospera™ and AlloSure® donor derived cell-free DNA assays intended to detect acute rejection in single-organ heart transplant patients correlate with each other. Each unique UCSD ID represents an individual single-organ heart transplant patient who received an endomyocardial biopsy at UC San Diego Health between October 2020 and January 2022. A unique "De-identified Sample ID" is assigned to each Prospera™ sample which were collected at the time of biopsy, and matched to an AlloSure® (dd-cfDNA) and AlloMap® (gene expression profiling) sample at most 14 days prior to the biopsy where applicable. The results of the dd-cfDNA assays are provided as a donor fraction percentage and the AlloMap® results are provided as a score from 0-40. We were able to determine that statistically significant correlation existed between the results of the two assays using logistic regression. Using mixed-effects logistic regression, we observed that a subject's demographic characteristics were also important co-predictors of AR when using AlloSure® and Prospera™ results as the primary predictor. Future clinical outcomes data are also provided for each sample, with a positive value indicating that the outcome was noted in UC San Diego Health medical records since the initial sample collection. Future de-novo DSA outcomes were also collected from medical records for each sample but were not included in the "Combined Future Outcomes" column as de-novo DSA is not considered to be a clinical event by itself.

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