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Updated: Sep 28, 2025

Digital Polymerase Chain Reaction Assay for the Genetic Variation in a Sporadic Familial Adenomatous Polyposis Patient Using the Chip-in-a-tube Format

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Published on: August 20, 2018

Donor-Derived Cell Free DNA: Is It All the Same?

Joseph K Melancon¹, Ali Khalil², Mark J Lerman²

¹Department of Surgery, The George Washington University Hospital, Washington, D.C.

|April 4, 2022

Summary

Donor-derived cell-free DNA (dd-cfDNA) assays like AlloSure and Prospera show similar performance in detecting transplant rejection. However, AlloSure offers a faster turnaround time for patient results.

Keywords:

allografts biomarker cell-free nucleic acids dd-cfDNA diagnostic tests donor derived cell free DNA kidney transplantation routine tissue donors transplantation

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Published on: August 24, 2017

Area of Science:

Transplantation immunology
Molecular diagnostics
Biomarker analysis

Background:

Donor-derived cell-free DNA (dd-cfDNA) is a valuable tool for monitoring transplant health and detecting allograft injury.
Clinical implementation of dd-cfDNA requires robust data and understanding of different assay methodologies.
Limited studies have directly compared commercially available dd-cfDNA assays.

Purpose of the Study:

To compare the clinical performance of two commercial dd-cfDNA assays: AlloSure and Prospera.
To evaluate assay concordance with histological findings and manufacturer guidelines.
To assess diagnostic accuracy metrics including sensitivity, specificity, and predictive values.

Main Methods:

Prospective assessment of 76 transplant patients with paired dd-cfDNA sampling.
Comparison of AlloSure and Prospera assay results against biopsy-proven rejection diagnoses.
Analysis of diagnostic performance at manufacturer-recommended cutoffs.

Main Results:

Prospera showed higher dd-cfDNA measurements than AlloSure, though not statistically significant (P=0.12).
No significant differences in sensitivity, specificity, PPV, or NPV were observed between AlloSure and Prospera for rejection detection.
AlloSure demonstrated a significantly shorter turnaround time (P=0.01) compared to Prospera.

Conclusions:

While dd-cfDNA assays are similar, they are not interchangeable due to potential differences in measurement and interpretation.
Consistent use of a single dd-cfDNA platform is crucial for reliable data comparison and clinical decision-making.
Further evidence generation is needed to fully establish the clinical utility and optimize implementation of dd-cfDNA testing.