ArticleTransplant international : official journal of the European Society for Organ Transplantation2026
Prospective evaluation of donor-derived cell-free DNA for noninvasive detection of acute rejection in an Asian heart transplant population.
Article in Transplant international : official journal of the European Society for Organ Transplantation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Endomyocardial biopsy (EMB) is the gold standard for diagnosing post-heart transplant acute rejection (AR) but is invasive. Donor-derived cell-free DNA (dd-cfDNA) is a promising noninvasive biomarker, yet thresholds for Asian recipients remain undefined. This prospective study enrolled 80 patients, with 299 dd-cfDNA specimens analyzed via a novel Chinese-developed next-generation sequencing assay targeting 48 Indel sites. A reference cohort (n = 42) established post-transplant dd-cfDNA kinetics, while a biopsy cohort (n = 41, 18 acute cellular rejection [ACR], 9 antibody-mediated rejection [AMR], 14 no rejection [NR]) paired with EMB evaluated diagnostic performance. dd-cfDNA peaked at week 1, with a stable trend emerging from week 4 and stable levels reached by week 8. AR patients had significantly higher dd-cfDNA levels than NR patients (0.87% vs. 0.23%, P < 0.001). The optimal composite AR threshold was 0.33% (AUC = 0.874, sensitivity 81.0%, specificity 85.7%). dd-cfDNA decreased post-therapy (P = 0.011) and showed an inverse association with left ventricular ejection fraction (LVEF) (P = 0.004). This study provides initial evidence for an assay- and cohort-specific dd-cfDNA threshold (0.33%) for AR detection in Chinese recipients. Given the modest NPV (75.0%), this threshold is better suited for a "rule-in" strategy, and low values should not be used in isolation to defer biopsy. External validation in multicenter cohorts is required before routine clinical implementation.
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