Accurate and noninvasive monitoring of renal allograft posttransplant is essential for early detection of acute rejection (AR) and to affect the long-term survival of the transplant. We present the development and validation of a noninvasive, spot urine-based diagnostic assay based on measurements of six urinary DNA, protein, and metabolic biomarkers. The performance of this assay for detecting kidney injury in both native kidneys and renal allografts is presented on a cohort of 601 distinct urine samples. The urinary composite score enables diagnosis of AR, with a receiver-operator characteristic curve area under the curve of 0.99 and an accuracy of 96%. In addition, we demonstrate the clinical utility of this assay for predicting AR before a rise in the serum creatinine, enabling earlier detection of rejection than currently possible by standard of care tests. This noninvasive, sensitive, and quantitative approach is a robust and informative method for the rapid and routine monitoring of renal allografts.

中文翻译：

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用于无创准确诊断和预测肾移植排斥反应的尿液评分。

移植后准确、无创地监测同种异体肾对于早期发现急性排斥反应（AR）并影响移植物的长期存活至关重要。我们基于六种尿液 DNA、蛋白质和代谢生物标志物的测量，开发并验证了一种无创、基于尿液的诊断测定。该检测方法检测天然肾脏和肾同种异体移植肾损伤的性能在 601 个不同尿液样本的队列中得到展示。尿液综合评分能够诊断 AR，受试者-操作者特征曲线曲线下面积为 0.99，准确度为 96%。此外，我们还证明了该测定在血清肌酐升高之前预测 AR 的临床实用性，从而能够比目前标准护理测试更早地检测到排斥反应。这种无创、灵敏和定量的方法是一种用于快速、常规监测同种异体肾移植物的可靠且信息丰富的方法。