Donor-derived cell-free DNA and renal allograft rejection in surveillance biopsies and indication biopsies

Clin Transplant. 2022 Apr;36(4):e14561. doi: 10.1111/ctr.14561. Epub 2022 Jan 24.


To evaluate the role of circulating dd-cfDNA in allograft surveillance in immunologically high-risk patients, a retrospective cross-sectional study of 261 kidney transplant recipients who underwent outpatient allograft biopsy at our center between September 2020 and August 2021 was performed. Of the 236 dd-cfDNA results included, 37 samples were obtained at the time of a surveillance biopsy in sensitized recipients and 199 at the time of a clinically indicated biopsy. The median serum creatinine at the time of the biopsy was 1.3 mg/dl and 2.1 mg/dl for surveillance biopsies and clinically indicated biopsies, respectively (P < .001). Rejection was diagnosed in 27% of surveillance biopsies and 29% of clinically indicated biopsies. Among surveillance biopsies, sensitivity and specificity to detect rejection were 0% and 89%, respectively, and among clinically indicated biopsies they were 28% and 96%, respectively. The sensitivity and specificity to detect antibody-mediated rejection were 0% and 91% among surveillance biopsies and 50% and 94% among clinically indicated biopsies. Nine biopsies without rejection findings had corresponding dd-cfDNA of ≥1%. Our data does not support dd-cfDNA as a biomarker for kidney allograft rejection, even in immunologically high-risk patients in the absence of graft dysfunction.

Keywords: biopsy; immune; monitoring; protocol biopsy; rejection; sensitization; subclinical.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Allografts
  • Biopsy
  • Cell-Free Nucleic Acids*
  • Cross-Sectional Studies
  • Graft Rejection / diagnosis
  • Graft Rejection / etiology
  • Humans
  • Kidney
  • Kidney Transplantation* / adverse effects
  • Retrospective Studies
  • Tissue Donors


  • Cell-Free Nucleic Acids