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Related Experiment Video

Updated: Jun 26, 2026

Assessment of Kidney Function in Mouse Models of Glomerular Disease

Assessment of Kidney Function in Mouse Models of Glomerular Disease

Published on: June 30, 2018

Assay validation for KIM-1: human urinary renal dysfunction biomarker.

Shalini Chaturvedi¹, Takeisha Farmer, Gordon F Kapke

¹Department of Biomarker Services, Covance Central Laboratory Services Inc., 8211 SciCor Drive, Indianapolis, Indiana 46214-2985, USA.

International Journal of Biological Sciences

|January 29, 2009

Summary

This study validates a robust assay for urinary Kidney Injury Molecule-1 (KIM-1), a sensitive biomarker for early kidney tubular injury detection. The assay provides a reliable, non-invasive method for monitoring kidney health in drug development.

Keywords:

ELISA KIM-1 urinary biomarker validation.

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Assessment of Kidney Function in Mouse Models of Glomerular Disease

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Published on: June 30, 2018

CRISPR-Cas-mediated Multianalyte Synthetic Urine Biomarker Test for Portable Diagnostics

CRISPR-Cas-mediated Multianalyte Synthetic Urine Biomarker Test for Portable Diagnostics

Published on: December 8, 2023

Area of Science:

Biomarker Discovery and Validation
Renal Physiology and Pathology
Drug Development and Toxicology

Background:

Urinary Kidney Injury Molecule-1 (KIM-1) is a key biomarker for detecting kidney tubular injury.
Early and accurate detection of kidney injury is crucial in clinical settings and drug development.
Non-invasive biomarkers are highly desirable for routine monitoring and high-throughput screening.

Purpose of the Study:

To analytically validate a quantitative assay for urinary KIM-1.
To establish the reliability and performance characteristics of the KIM-1 assay.
To confirm the utility of urinary KIM-1 as a biomarker for early kidney injury.

Main Methods:

Development of an Enzyme-Linked Immunosorbent Assay (ELISA) using Duo-set reagents.
Validation of assay parameters including linearity, precision, limit of quantification, recovery, and stability.
Determination of reference ranges and upper limit of quantitation for healthy and patient populations.

Main Results:

The assay demonstrated robustness across all validated parameters.
Established reference range for healthy individuals: 59 - 2146 pg/mL.
Determined upper limit of quantitation for patient samples: 17168 pg/mL.

Conclusions:

The validated assay is a robust, sensitive, and reproducible method for quantifying urinary KIM-1.
This non-invasive assay facilitates early detection of kidney injury in drug development.
Urinary KIM-1 measurement offers a potentially high-throughput approach for renal safety assessment.