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

Abstract

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.

Keywords:

• Biomarkers
• chemiluminescence immunoassay (CLIA)
• kidney disease
• kidney injury molecule-1
• urine

Acknowledgments

The study was approved by the Ethics Committee of the Shuyang Hospital of Traditional Chinese Medicine (Ethics number: 20210202-001) and written informed consent was obtained from all the patients.

Additional information

Funding

This work was supported by grants from National Natural Science Foundation of China (81860399), the Provincial Youth Science Fund of Jiangxi Province (20142BAB215072), and the Science and Technology Key R & D Program of Jiangxi Province (20202BBG72001).