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

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...

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Bibliographic Details
Published in:International journal of biological sciences 2009-01, Vol.5 (2), p.128-134
Main Authors: Chaturvedi, Shalini, Farmer, Takeisha, Kapke, Gordon F
Format: Article
Language:English
Subjects:
Biological Assay
Biomarkers - urine
Enzyme-Linked Immunosorbent Assay - methods
Glomerular Filtration Rate
Hepatitis A Virus Cellular Receptor 1
Humans
Kidney Diseases - urine
Membrane Glycoproteins - urine
Receptors, Virus
Reproducibility of Results
Research Paper
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Summary: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.
ISSN:1449-2288
1449-2288
DOI:10.7150/ijbs.5.128