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Research Article
Analytical and Clinical Validation of a Molecular Diagnostic Signature in Kidney Transplant Recipients
Author(s): Martin Roy First, Deirdre Pierry, Michael McNulty, Sunil M Kurian, Stan Rose, Thomas Whisenant, Terri Gelbart, April Venzon, Nadia Bayat, Peter Lewis, John J Friedewald, Michael M Abecassis and Darren LeeMartin Roy First, Deirdre Pierry, Michael McNulty, Sunil M Kurian, Stan Rose, Thomas Whisenant, Terri Gelbart, April Venzon, Nadia Bayat, Peter Lewis, John J Friedewald, Michael M Abecassis and Darren Lee
Context: The TruGraf test is a blood-based assay that provides non-invasive, accurate assessment of adequacy of immunosuppression in kidney transplant recipients. TruGraf relies on gene-expression “signatures” that differentiate a state of Transplant eXcellence (TX, indicating adequately immunosuppressed) from not-TX. Objective: To evaluate the performance of the TruGraf test. Design: Analytical performance studies to characterize stability of RNA in blood during collection and shipment, analytical sensitivity (input RNA concentration), analytical specificity (interfering substances) and assay performance (clinical validity, and intra-assay, inter-assay, inter-laboratory reproducibility). Results: Total RNA extracted from whole blood specimens collected in PAXgene Blood RNA tubes was stab.. Read More»
DOI:
10.4172/2161-0991.1000176
Transplantation Technologies & Research received 223 citations as per Google Scholar report