Transplant Genomics Inc, Mansfield, MA 02048, USA; Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA; Scripps Research Institute, La Jolla, CA 92037, USA
Research Article
Analytical and Clinical Validation of a Novel Blood-Based Biomarker of Liver Transplant Rejection
Author(s): Juston C Weems*, Deirdre Pierry, John Holman, Manoj Kandpal, Sunil M Kurian, Peter Meintjes, Neal Beswick and Josh Levitsky
Background: We have discovered and validated a microarray-based test that analyzes blood gene expression profiles (GEP) as an indicator of immune status in liver transplant recipients with stable liver function.
Methods: 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 stable up to 3 days at room temperature (stable RNA yield). Under routine ambient shipping conditions, storage and shipping temperatures did not affect results. However, specimen shipments exposed to t.. Read More»
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