title: Assay validation for KIM-1: human urinary renal dysfunction biomarker.
abstract: Urinary kidney injury molecule (KIM-1) is a sensitive quantitative biomarker for early detection of kidney tubular injury. The objective of the present work was to analytically validate this urinary renal injury biomarker. Duo-set reagents from R&D were used to develop the ELISA and validate the assay's linearity, intra-run precision, inter-run precision, lower limit of quantification, recovery, dilutional verification, reference range, stability, and length of run. The reference range data suggests that the healthy population falls within the assay range (59 - 2146 pg/mL) and upper limit of quantitation for this assay is 17168 pg/mL for the patient population. This is a robust assay to detect urinary levels of KIM-1, which serves as a non-invasive sensitive, reproducible, and potentially high-throughput method to detect early kidney injury in drug development studies.
authors.affiliation: Department of Biomarker Services, Covance Central Laboratory Services Inc., 8211 SciCor Drive, Indianapolis, Indiana 46214-2985, USA.
authors.forename: Shalini
authors.initials: S
authors.lastname: Chaturvedi
authors.forename: Takeisha
authors.initials: T
authors.lastname: Farmer
authors.forename: Gordon F
authors.initials: GF
authors.lastname: Kapke
mesh_terms: D001681:Biological Assay; D015415:Biomarkers / Q000652:urine*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005919:Glomerular Filtration Rate; D000072596:Hepatitis A Virus Cellular Receptor 1; D006801:Humans; D007674:Kidney Diseases / Q000652:urine*; D008562:Membrane Glycoproteins / Q000652:urine*; D011991:Receptors, Virus; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers; C491143:HAVCR1 protein, human; D000072596:Hepatitis A Virus Cellular Receptor 1; D008562:Membrane Glycoproteins; D011991:Receptors, Virus