Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease

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 analyzedThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Lab on a Chip Device for Diagnostic Evaluation and Management in Chronic Renal Disease: A Change Promoting Approach in the Patients’ Follow Up

“…This LOC system was tested by using urine samples from CKD and type I and II diabetes patients and the results were compared to both the available POCTs and gold standard methods for albumin detection. The LFA-based biosensor developed by Vutthikraivit showed a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96% [ 89 ]. Another valuable POCT device designed for urine albumin detection is an electrochemical biosensor.…”

“…In the proposed device, amaranth (an electroactive substance) is adsorbed on the surface of the electrode under the effects of an external potential and subsequently reacts with the albumin content in the urine sample. The reaction process results in the formation of an inert layer on the electrode surface, which leads to a reduction in the response current, from which the albumin concentration can then be inversely derived [ 89 ].…”