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Kidney injury molecule 1 (KIM-1) is markedly upregulated in the proximal tubule after injury and is maladaptive when chronically expressed. A practical sensitive chemiluminescence immunoassay combined with magnetic bead separation for the determination of KIM-1 in human urine has been developed. Based on a sandwich-type immunoassay, the analyte is captured by the monoclonal antibodies (mAb) coated in magnetic beads and those labeled with the alkaline phosphatase. The changes of KIM-1 concentration levels were monitored by the CLIA for the early diagnosis of kidney disease. The established immunoassay exhibited a wide linear range from 0.5 to 81 ng/mL with a detection limit of 0.17 ng/mL. The recoveries, specificity, and interference results of the developed method were satisfactory. The whole analysis time was 30 min. The developed method was for the detection of kidney disease in patients. This work is a novel chemiluminescence immunoassay with excellent performance for the early diagnosis of kidney diseases.

Novel Chemiluminescence Immunoassay (CLIA) for the Sensitive Determination of Kidney Injury Molecule-1 in Human Urine