Evaluation of novel urinary renal biomarkers: biological variation and reference change values.

Pinches MD, Betts CJ, Bickerton SJ, Beattie L, Burdett LD, Thomas HT, Derbyshire NA, Moores M, Price SA.
Journal   Toxicol Pathol.
Species  
Analytes Measured   Albumin , GSTYb1 , HAVCR1 KIM-1 , Osteopontin , RPA-1
Matrix Tested   Urine
Year   2012
Volume   40
Page Numbers   541-549
Application   Toxicology
Abstract
A number of novel urinary biomarkers have been identified and partially qualified for use as markers for renal injury in rats. We used two multiplex assays for these novel biomarkers to quantify biomarker concentration in serial urine collections from rats of both sexes administered varying concentrations of cisplatin. From these data, we calculate inter-individual variation and reference ranges from predose animals and intra-individual variation and reference change values from undosed control animals. The biomarkers evaluated are albumin, α glutathione s-transferase, glutathione S-transferase-yb1, lipocalin-2, kidney injury molecule-1, osteopontin, and renal papillary antigen 1. For any creatinine-corrected novel biomarkers, we found intra-individual variation to be no greater than 44% and inter-individual variation to be no greater than 46%. Reference change values for most corrected analytes (except osteopontin) were 50-100%, indicating that a >100% increase in analyte concentration between serial samples would be unlikely to be associated with inherent analytical or biological variation.;

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