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Int J Biol Sci 2009; 5(2):128-134. doi:10.7150/ijbs.5.128

Research Paper

Assay Validation for KIM-1: human urinary renal dysfunction biomarker

Shalini Chaturvedi, Takeisha Farmer, Gordon F. Kapke

Department of Biomarker Services, Covance Central Laboratory Services Inc., 8211 SciCor Drive, Indianapolis, Indiana 46214-2985, USA

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.

Keywords: KIM-1, ELISA, urinary biomarker, validation.

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) License. See http://ivyspring.com/terms for full terms and conditions.
How to cite this article:
Chaturvedi S, Farmer T, Kapke GF. Assay Validation for KIM-1: human urinary renal dysfunction biomarker. Int J Biol Sci 2009; 5(2):128-134. doi:10.7150/ijbs.5.128. Available from http://www.ijbs.com/v05p0128.htm