UC San Diego Health, San Diego, California, USA.
Department of Family Medicine and Public Health, University of California San Diego, La Jolla, USA.
Clin Transplant. 2023 Jun;37(6):e14984. doi: 10.1111/ctr.14984. Epub 2023 Apr 10.
Donor-derived cell-free DNA (dd-cfDNA) testing is an emerging screening modality for noninvasive detection of acute rejection (AR). This study compared the testing accuracy for AR of two commercially available dd-cfDNA and gene-expression profiling (GEP) testing in heart transplant (HTx) recipients.
This is a retrospective, observational study of HTx only patients who underwent standard and expanded single nucleotide polymorphism (SNP) dd-cfDNA between October 2020 to January 2022. Comparison with GEP was also performed. Assays were compared for correlation, accurate classification, and prediction for AR.
A total of 428 samples from 112 unique HTx patients were used for the study. A positive standard SNP correlated with the expanded SNP assay (p < .001). Both standard and expanded SNP tests showed low sensitivity (39%, p = 1.0) but high specificity (82% and 84%, p = 1.0) for AR. GEP did not improve sensitivity and showed worse specificity (p < .001) compared to standard dd-cfDNA.
We found no significant difference between standard and expanded SNP assays in detecting AR. We show improved specificity without change in sensitivity using dd-cfDNA in place of GEP testing. Prospective controlled studies to address how to best implement dd-cfDNA testing into clinical practice are needed.
供体游离 DNA（dd-cfDNA）检测是一种新兴的非侵入性筛选方法，用于检测急性排斥反应（AR）。本研究比较了两种商业上可用的 dd-cfDNA 和基因表达谱（GEP）检测在心脏移植（HTx）受者中检测 AR 的检测准确性。
这是一项回顾性观察性研究，仅纳入 2020 年 10 月至 2022 年 1 月期间接受标准和扩展单核苷酸多态性（SNP）dd-cfDNA 的 HTx 患者。还与 GEP 进行了比较。比较了检测方法的相关性、准确分类和对 AR 的预测。
共纳入 112 例 HTx 患者的 428 个样本进行研究。标准 SNP 阳性与扩展 SNP 检测呈正相关（p<0.001）。标准和扩展 SNP 检测的敏感性均较低（39%，p=1.0），但特异性较高（82%和 84%，p=1.0）。与标准 dd-cfDNA 相比，GEP 并未提高敏感性，特异性较差（p<0.001）。
我们发现标准和扩展 SNP 检测在检测 AR 方面没有显著差异。与 GEP 检测相比，dd-cfDNA 检测的敏感性无变化，特异性提高。需要前瞻性对照研究来解决如何将 dd-cfDNA 检测最佳应用于临床实践的问题。
