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Article

Clinical and Analytical Validation of a Novel Urine-Based Test for the Detection of Allograft Rejection in Renal Transplant Patients

1
NephroSant Inc., 150 North Hill Drive, Brisbane, CA 94005, USA
2
Department of Surgery, University of California San Francisco, San Francisco, CA 94143, USA
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(8), 2325; https://doi.org/10.3390/jcm9082325
Received: 22 June 2020 / Revised: 16 July 2020 / Accepted: 17 July 2020 / Published: 22 July 2020
(This article belongs to the Special Issue Clinical Complications after Kidney Transplantation)
In this clinical validation study, we developed and validated a urinary Q-Score generated from the quantitative test QSant, formerly known as QiSant, for the detection of biopsy-confirmed acute rejection in kidney transplants. Using a cohort of 223 distinct urine samples collected from three independent sites and from both adult and pediatric renal transplant patients, we examined the diagnostic utility of the urinary Q-Score for detection of acute rejection in renal allografts. Statistical models based upon the measurements of the six QSant biomarkers (cell-free DNA, methylated-cell-free DNA, clusterin, CXCL10, creatinine, and total protein) generated a renal transplant Q-Score that reliably differentiated stable allografts from acute rejections in both adult and pediatric renal transplant patients. The composite Q-Score was able to detect both T cell-mediated rejection and antibody-mediated rejection patients and differentiate them from stable non-rejecting patients with a receiver–operator characteristic curve area under the curve of 99.8% and an accuracy of 98.2%. Q-Scores < 32 indicated the absence of active rejection and Q-Scores ≥ 32 indicated an increased risk of active rejection. At the Q-Score cutoff of 32, the overall sensitivity was 95.8% and specificity was 99.3%. At a prevalence of 25%, positive and negative predictive values for active rejection were 98.0% and 98.6%, respectively. The Q-Score also detected subclinical rejection in patients without an elevated serum creatinine level but identified by a protocol biopsy. This study confirms that QSant is an accurate and quantitative measurement suitable for routine monitoring of renal allograft status. View Full-Text
Keywords: acute rejection; subclinical rejection; T cell-mediated rejection; antibody-mediated rejection; cell-free DNA; CXCL10; allograft; kidney transplant; methylated cell-free DNA; QiSant; QSant acute rejection; subclinical rejection; T cell-mediated rejection; antibody-mediated rejection; cell-free DNA; CXCL10; allograft; kidney transplant; methylated cell-free DNA; QiSant; QSant
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MDPI and ACS Style

Nolan, N.; Valdivieso, K.; Mani, R.; Yang, J.Y.C.; Sarwal, R.D.; Katzenbach, P.; Chalasani, K.; Hongo, D.; Lugtu, G.; Mark, C.; Chen, E.; Nijor, R.; Savoca, D.; Wexler, D.S.; Whitson, T.; Huang, S.-J.; Lu, L.H.; Zawada, R.J.X.; Hytopoulos, E.; Sarwal, M.M. Clinical and Analytical Validation of a Novel Urine-Based Test for the Detection of Allograft Rejection in Renal Transplant Patients. J. Clin. Med. 2020, 9, 2325. https://doi.org/10.3390/jcm9082325

AMA Style

Nolan N, Valdivieso K, Mani R, Yang JYC, Sarwal RD, Katzenbach P, Chalasani K, Hongo D, Lugtu G, Mark C, Chen E, Nijor R, Savoca D, Wexler DS, Whitson T, Huang S-J, Lu LH, Zawada RJX, Hytopoulos E, Sarwal MM. Clinical and Analytical Validation of a Novel Urine-Based Test for the Detection of Allograft Rejection in Renal Transplant Patients. Journal of Clinical Medicine. 2020; 9(8):2325. https://doi.org/10.3390/jcm9082325

Chicago/Turabian Style

Nolan, Niamh, Katherine Valdivieso, Rekha Mani, Joshua Y.C. Yang, Reuben D. Sarwal, Phoebe Katzenbach, Kavita Chalasani, Donna Hongo, Gladys Lugtu, Corinne Mark, Edna Chen, Reggie Nijor, David Savoca, David S. Wexler, Todd Whitson, Shih-Jwo Huang, Lucy H. Lu, Robert J.X. Zawada, Evangelos Hytopoulos, and Minnie M. Sarwal 2020. "Clinical and Analytical Validation of a Novel Urine-Based Test for the Detection of Allograft Rejection in Renal Transplant Patients" Journal of Clinical Medicine 9, no. 8: 2325. https://doi.org/10.3390/jcm9082325

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