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Published on: October 10, 2013
Evaluation of a multiplexed assay for six urinary proteins based on liquid microarray analysis technology
Peng Zhang1, Yi Liu1, Xinyun Zhou2
1Department of Clinical Laboratory, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Faculty of Medical Laboratory Science, College of Health Science and Technology, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Institute of Artificial Intelligence Medicine, Shanghai Academy of Experimental Medicine, Shanghai, China.
A new flow fluorescence luminescence method accurately quantifies six urine proteins, aiding chronic kidney disease diagnosis and treatment monitoring. This sensitive assay shows strong correlation with established methods, meeting clinical application standards.
Area of Science:
- Clinical Chemistry
- Nephrology
- Biomedical Engineering
Background:
- Proteinuria is a key marker for chronic kidney disease (CKD) progression.
- Accurate urinary protein quantification is vital for CKD diagnosis and therapy monitoring.
- Current methods like nephelometry and turbidimetric immunoassay are standard for protein detection.
Purpose of the Study:
- To develop and evaluate a novel flow fluorescence luminescence method for quantifying six urinary proteins.
- To assess the clinical performance and accuracy of this new method using the Luminex®200™ platform.
Main Methods:
- Developed a quantitative flow fluorescence luminescence assay for six urine proteins.
- Evaluated method performance using sensitivity, precision, recovery, linearity, and interference tests.
- Compared results against nephelometry immunoassay on a SIEMENS BNII platform using Bland-Altman and Passing-Bablok analyses.
Main Results:
- The flow fluorescence luminescence method demonstrated high sensitivity, precision, recovery, linearity, and minimal interference, meeting clinical needs.
- Strong linear correlations (r = 0.9375–0.9847) were observed between the new method and nephelometry.
- Bland-Altman and Passing-Bablok analyses confirmed minimal systematic bias and consistency between the methods.
Conclusions:
- The developed urine six protein quantification method exhibits satisfactory clinical performance and accuracy.
- This flow fluorescence luminescence assay is suitable for medical diagnosis and clinical applications in monitoring kidney disease.
