Revista de Métodos de Diagnóstico Médico
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Analytical Performance Validation of a Multi-Biomarker Test for Assessment of Allograft Rejection in Renal Transplant Recipients

Zawada RJX, Valdivieso K, Katzenbach P, Chalasani K, Mark C, Hongo D, Lugtu G, Chen E, Huang SJ, Wexler DS, Yang JYC, Sarwal R, Sarwal MM, Nolan N*

A novel algorithm has been developed for a multi-biomarker urine test, as a clinical tool to provide a quantitative measurement for the noninvasive detection of renal transplant rejection. The analytical performance of the six urinary biomarkers (Cell-Free DNA (cfDNA), Methylated cfDNA (m-cfDNA), Clusterin, CXCL10, Creatinine, and Total Protein) was assessed for sensitivity, specificity, and reproducibility as per Clinical Laboratory Improvement Amendments (CLIA) recommended guidelines. The characterization analysis indicated robust analytical performance across all six biomarkers contributing to the composite renal transplant rejection Q-score. This test was designed be used as a surveillance tool to accurately and reliably assess the rejection status of kidney transplant patients. The potential clinical utility of the test includes early detection, proactive management of graft rejection, and ultimately controlling subclinical intragraft inflammation thereby prolonging graft survival.