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Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation.

Publication ,  Journal Article
Deshpande, SR; Zangwill, SD; Richmond, ME; Kindel, SJ; Schroder, JN; Gaglianello, N; Bichell, DP; Wigger, MA; Knecht, KR; Thrush, PT; Mahle, WT ...
Published in: Pediatr Transplant
May 2024

BACKGROUND: The aims of the study were to assess the performance of a clinically available cell-free DNA (cfDNA) assay in a large cohort of pediatric and adult heart transplant recipients and to evaluate performance at specific cut points in detection of rejection. METHODS: Observational, non-interventional, prospective study enrolled pediatric and adult heart transplant recipients from seven centers. Biopsy-associated plasma samples were used for cfDNA measurements. Pre-determined cut points were tested for analytic performance. RESULTS: A total of 487 samples from 160 subjects were used for the analysis. There were significant differences for df-cfDNA values between rejection [0.21% (IQR 0.12-0.69)] and healthy samples [0.05% (IQR 0.01-0.14), p < .0001]. The pediatric rejection group had a median df-cfDNA value of 0.93% (IQR 0.28-2.84) compared to 0.09% (IQR 0.04-0.23) for healthy samples, p = .005. Overall negative predictive value was 0.94 while it was 0.99 for pediatric patients. Cut points of 0.13% and 0.15% were tested for various types of rejection profiles and were appropriate to rule out rejection. CONCLUSION: The study suggests that pediatric patients with rejection show higher levels of circulating df-cfDNA compared to adults and supports the specific cut points for clinical use in pediatric and adult patients with overall acceptable performance.

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Published In

Pediatr Transplant

DOI

EISSN

1399-3046

Publication Date

May 2024

Volume

28

Issue

3

Start / End Page

e14708

Location

Denmark

Related Subject Headings

  • Tissue Donors
  • Surgery
  • Prospective Studies
  • Humans
  • Heart Transplantation
  • Graft Rejection
  • Child
  • Cell-Free Nucleic Acids
  • Biomarkers
  • Adult
 

Citation

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Deshpande, S. R., Zangwill, S. D., Richmond, M. E., Kindel, S. J., Schroder, J. N., Gaglianello, N., … Mitchell, M. E. (2024). Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation. Pediatr Transplant, 28(3), e14708. https://doi.org/10.1111/petr.14708
Deshpande, Shriprasad R., Steven D. Zangwill, Marc E. Richmond, Steven J. Kindel, Jacob N. Schroder, Nunzio Gaglianello, David P. Bichell, et al. “Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation.Pediatr Transplant 28, no. 3 (May 2024): e14708. https://doi.org/10.1111/petr.14708.
Deshpande SR, Zangwill SD, Richmond ME, Kindel SJ, Schroder JN, Gaglianello N, et al. Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation. Pediatr Transplant. 2024 May;28(3):e14708.
Deshpande, Shriprasad R., et al. “Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation.Pediatr Transplant, vol. 28, no. 3, May 2024, p. e14708. Pubmed, doi:10.1111/petr.14708.
Deshpande SR, Zangwill SD, Richmond ME, Kindel SJ, Schroder JN, Gaglianello N, Bichell DP, Wigger MA, Knecht KR, Thrush PT, Mahle WT, North PE, Simpson PM, Zhang L, Dasgupta M, Tomita-Mitchell A, Mitchell ME. Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation. Pediatr Transplant. 2024 May;28(3):e14708.
Journal cover image

Published In

Pediatr Transplant

DOI

EISSN

1399-3046

Publication Date

May 2024

Volume

28

Issue

3

Start / End Page

e14708

Location

Denmark

Related Subject Headings

  • Tissue Donors
  • Surgery
  • Prospective Studies
  • Humans
  • Heart Transplantation
  • Graft Rejection
  • Child
  • Cell-Free Nucleic Acids
  • Biomarkers
  • Adult