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Published on: June 17, 2020

Donor-Derived Cell-Free DNA Levels Predict Renal Allograft Biopsy Findings in a UK Single-Centre Study. Results of

Patrick A Flynn1, Martin K Rutter2,3, Natalia Diaz Burlinson1

  • 1Transplantation Laboratory, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.

International Journal of Immunogenetics
|May 28, 2026
PubMed

Insights

Donor-derived cell-free DNA (dd-cfDNA) effectively predicts kidney transplant rejection in UK patients. A 0.7% dd-cfDNA threshold shows high negative predictive value, potentially reducing unnecessary biopsies.

Area of Science:

  • Nephrology
  • Immunology
  • Genetics

Background:

  • Donor-derived cell-free DNA (dd-cfDNA) is a promising biomarker for predicting kidney transplant rejection.
  • Previous studies validating dd-cfDNA were not conducted in UK-based cohorts.

Purpose of the Study:

  • To assess the relationship between dd-cfDNA levels and biopsy-defined rejection in a UK kidney transplant cohort.
  • To evaluate dd-cfDNA performance against donor-specific antibodies (DSA) and creatinine levels.

Main Methods:

  • The KORAD study analyzed 80 samples from 78 UK kidney transplant patients.
  • dd-cfDNA was measured using AlloSeq cfDNA (CareDx).
  • Donor-specific antibodies (DSA) were identified using LABScreen single-antigen beads (Thermo Fisher Scientific).

Main Results:

  • Median dd-cfDNA was significantly lower in DSA-negative versus DSA-positive samples (0.37% vs. 3.15%, p = 0.002).
  • No significant difference in dd-cfDNA was observed between normal and elevated creatinine levels (0.41% vs. 0.36%, p = 0.779).
  • A dd-cfDNA threshold of 0.7% achieved a 93% negative predictive value for biopsy-defined rejection, outperforming DSA and creatinine.
  • The optimal dd-cfDNA threshold (0.7%) in this UK cohort was lower than thresholds identified in non-UK studies.

Conclusions:

  • Donor-derived cell-free DNA (dd-cfDNA) is a valuable non-invasive biomarker for detecting kidney transplant rejection in the UK.
  • The established dd-cfDNA threshold of 0.7% demonstrates potential to reduce the need for invasive renal biopsies.
  • This study provides UK-specific data supporting the clinical utility of dd-cfDNA in kidney transplantation management.

Keywords:
DSAcreatininedd‐cfDNAdonor‐derived cell‐free DNAdonor‐specific antibodieskidney transplantationrenal biopsy

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