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, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38553812
ABSTRACT
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Heart Transplantation
/
Cell-Free Nucleic Acids
Limits:
Adult
/
Child
/
Humans
Language:
En
Journal:
Pediatr Transplant
/
Pediatr. transplant
/
Pediatric transplantation
Journal subject:
PEDIATRIA
/
TRANSPLANTE
Year:
2024
Type:
Article
Affiliation country:
United States