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Development and validation of point-of-care testing of albuminuria for early screening of chronic kidney disease
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Document Title
Development and validation of point-of-care testing of albuminuria for early screening of chronic kidney disease
Author
Vutthikraivit N.,Kiatamornrak P.,Boonkrai C.,Pisitkun T.,Komolpis K.,Puthong S.,Lumlertgul N.,Peerapornratana S.,Thanawattano C.,Tungsanga S.,Praditpornsilpa K.,Tungsanga K.,Eiam-Ong S.,Srisawat N.
Name from Authors Collection
Affiliations
Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Excellence Center for Critical Care Nephrology, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand; Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence in Systems Biology, Chulalongkorn University, CUSB, Bangkok, Thailand; Epithelial Systems Biology Laboratory, Systems Biology Center, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, United States; Institute of Biotechnology and Genetic Engineering, Chulalongkorn University, Bangkok, Thailand; Food Risk Hub, Research Unit of Chulalongkorn University, Bangkok, Thailand; Critical Care Nephrology Research Unit, Chulalongkorn University, Bangkok, Thailand; Department of Laboratory Medicine, Chulalongkorn University, Bangkok, Thailand; Biomedical Signal Processing (BSP) Research Team, National Science and Technology Development Agency (NSTDA), Pathumthani, Thailand; Department of Critical Care Medicine, The Center for Critical Care Nephrology, CRISMA, University of Pittsburg School of Medicine, Pittsburg, PA, United States; Academy of Science, Royal Society of Thailand, Bangkok, Thailand; Tropical Medicine Cluster, Chulalongkorn University, Bangkok, Thailand; Excellence Center for Critical Care Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Type
Article
Source Title
Journal of Clinical Laboratory Analysis
ISSN
08878013
Year
2021
Volume
35
Issue
4
Open Access
All Open Access, Gold, Green
Publisher
John Wiley and Sons Inc
DOI
10.1002/jcla.23729
Abstract
Introduction: Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests for CKD are non-specific and expensive. We aimed to develop and validate antibody-based-albumin point-of-care testing (POCT) to detect patients with impaired kidney function at early stage. Methods: The prototype strip test was developed under the concept of competitive lateral flow immunochromatography assay, or strip test. Monoclonal antibodies (MAbs) to human serum albumin (HSA) were harvested from the hybridomas of spleen cells from immunized mice and mouse myeloma cells. Presence of MAbs was detected by enzyme-linked immunosorbent assay (ELISA). Spot urine was obtained from patients with kidney disease, type I, or type II Diabetes Mellitus upon their visit at King Chulalongkorn Memorial Hospital during 2018–2019. All samples were analyzed for urine albumin with our POCT (CU microalbumin) and the other two commercial POCTs (Microalbu PHAN and MICRAL). The results were validated against standard method for urine microalbumin measurement. A urine microalbumin concentration of less than 20 ug/ml was defined as normal. The sensitivity, specificity, and predictive values were calculated in comparison with the standard laboratory method. Result: A total of 100 adult patients were included. CU microalbumin had a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96%. Our POCT showed good correlation with the laboratory results. Conclusion: CU microalbumin correlated well with the standard method for quantitative measurement of urine albumin. Therefore, it has the potential for early screening of CKD, especially in primary health care facilities in resource limited settings. © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC
Industrial Classification
Knowledge Taxonomy Level 1
Knowledge Taxonomy Level 2
Knowledge Taxonomy Level 3
License
CC BY-NC-ND
Rights
Author
Publication Source
Scopus