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供者游离 DNA:抗体介导排斥反应的肾移植患者的独立生物标志物。

Donor-derived cell-free DNA: An independent biomarker in kidney transplant patients with antibody-mediated rejection.

机构信息

National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, 210002, China.

AlloDx Biotech Co, Ltd, Shanghai, 201100, China.

出版信息

Transpl Immunol. 2021 Dec;69:101404. doi: 10.1016/j.trim.2021.101404. Epub 2021 May 8.

Abstract

INTRODUCTION

Antibody-mediated rejection (ABMR) is a major cause of kidney transplant failure which requires donor-specific antibodies (DSA) for a definitive diagnosis. Donor-derived cell-free DNA (ddcfDNA) is an emerging biomarker used to assess kidney allograft injury. However, current data is limited to predict the accuracy of ddcfDNA in ABMR diagnosis. This study was conducted to compare the performance of DSA with plasma ddcfDNA for the diagnosis of ABMR.

METHODS

In this retrospective single-center observational study, we enrolled 50 kidney transplant recipients who were diagnosed with the suspicion of rejection between June 2018 and May 2019 at the Jinling Hospital. Plasma ddcfDNA was measured by using a novel target region capture sequencing methodology. A total of 37 patients who were tested with DSA and biopsy were divided into four subgroups (ABMR+/DSA+, ABMR+/DSA-, ABMR-/DSA+, ABMR-/DSA-) for the distribution of ddcfDNA (%) by ABMR and DSA.

RESULTS

The median level of ddcfDNA in biopsy showed that the ABMR group (1.66%, IQR 1.34-3.76%) was significantly higher than the median level (0.63%, IQR 0.43-0.74%) in non-ABMR (p < 0.001). With a ddcfDNA cutoff of 0.96%, the AUC was 0.90 (95%CI, 0.86-0.95), which was associated with a sensitivity of 90.5% (95%CI, 69.6-98.8%) and specificity of 96.6% (95%CI, 82.2-100%), a PPV of 95% (95%CI, 73.4-99.2%) and NPV of 93.3% (95%CI, 78.9-98.1%) were also observed. Among the four subgroups, ddcfDNA had no significant difference in both DSA+ group and DSA-group (p > 0.05). In the diagnosis of ABMR, the specificity, sensitivity, PPV and NPV of DSA were 50%, 74.1%, 41.7%, 80%, respectively.

CONCLUSIONS

ddcfDNA levels in the blood could highly distinguish (biopsy-supported) ABMR occurrence, irrespective of whether this method is accompanied by DSA or not.

摘要

介绍

抗体介导的排斥反应(ABMR)是导致肾移植失败的主要原因,其明确诊断需要供体特异性抗体(DSA)。供体来源的无细胞游离 DNA(ddcfDNA)是一种新兴的生物标志物,用于评估肾移植损伤。然而,目前的数据仅限于预测 ddcfDNA 在 ABMR 诊断中的准确性。本研究旨在比较 DSA 和血浆 ddcfDNA 对 ABMR 诊断的性能。

方法

本回顾性单中心观察性研究纳入了 2018 年 6 月至 2019 年 5 月在南京金陵医院接受疑似排斥反应诊断的 50 例肾移植受者。通过使用新型靶向区域捕获测序方法测量血浆 ddcfDNA。共有 37 例接受 DSA 和活检检测的患者被分为四组(ABMR+/DSA+、ABMR+/DSA-、ABMR-/DSA+、ABMR-/DSA-),按 ABMR 和 DSA 分布 ddcfDNA(%)。

结果

活检中 ddcfDNA 的中位数水平显示,ABMR 组(1.66%,IQR 1.34-3.76%)显著高于非 ABMR 组的中位数水平(0.63%,IQR 0.43-0.74%)(p<0.001)。ddcfDNA 截断值为 0.96%时,AUC 为 0.90(95%CI,0.86-0.95),与 90.5%(95%CI,69.6-98.8%)的敏感性和 96.6%(95%CI,82.2-100%)的特异性、95%(95%CI,73.4-99.2%)的阳性预测值和 93.3%(95%CI,78.9-98.1%)的阴性预测值相关。在四个亚组中,DSA+组和 DSA-组之间 ddcfDNA 无显著差异(p>0.05)。在 ABMR 的诊断中,DSA 的特异性、敏感性、阳性预测值和阴性预测值分别为 50%、74.1%、41.7%、80%。

结论

血液中 ddcfDNA 水平可高度区分(活检支持)ABMR 的发生,无论是否伴有 DSA。

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