Background: Chronic kidney disease (CKD) is a progressive condition affecting over 10% of the global population. Monitoring the urine albumin-to-creatinine ratio (uACR) is the gold standard for early detection and ongoing management of nephropathy. However, access to laboratory testing is limited in many community healthcare settings.
Objective: This study aimed to develop and evaluate the
performance of MyACR, a simple, accurate, sensitive, and rapid point-of-care
test (PoCT) device for measuring uACR, with the goal of facilitating CKD screening
and monitoring in community settings.
Methods: MyACR uses spectrophotometric dye-binding
(tetrabromophenol blue) and colourimetric Jaffe methods to quantify urinary
albumin and creatinine, respectively. Urine samples were diluted 1:80 with
distilled water and reacted with respective reagent mixtures. The creatinine
reaction was incubated at 25°C for 30 minutes before analysis. Optical
densities were measured at 625 nm (albumin) and 515 nm (creatinine).
Calibration curves were established for albumin (0–60 mg/L) and creatinine (0–2
mg/dL), and analytical performance was evaluated in terms of linearity,
accuracy, precision, and sensitivity. Clinical validation was conducted on
urine samples from 20 CKD patients.
Results: Calibration curves demonstrated strong linearity,
with correlation coefficients (R²) exceeding 0.997. The method demonstrated
good intra- and inter-day accuracy (per cent deviation of mean value ≤ 5.42%)
and precision (coefficient of variation ≤ 12.69%). The method was specific,
without interference from blood components. The limits of quantification were 5
mg/L for albumin and 0.25 mg/dL for creatinine, based on spiked samples (n =
5). Comparison with hospital-based immunoassays showed a high correlation (R²
> 0.98) and acceptable agreement (median %DMV = 3.48%, range: -17.05% to
21.64%).
Conclusion: MyACR demonstrated satisfactory analytical
performance for the point-of-care measurement of uACR, offering a promising
tool for early detection and monitoring of CKD in resource-limited settings.
Further studies are warranted to assess its cost-effectiveness and clinical
utility in large-scale, multisite community and home-based applications.
Author(s)
Details
Nadda Muhamad
Department of Biomedicine and Health Informatics, Faculty of Pharmacy,
Silpakorn University, Nakhon Pathom 73000, Thailand
Napaporn Youngvises
Bangkok High Lab Co., Ltd., Bang Khen District, Bangkok 10220, Thailand.
Tullayakorn
Plengsuriyakarn
Graduate Program in Bioclinical Sciences, Chulabhorn International College
of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Wanchai Meesiri
Bangkok High Lab Co., Ltd., Bang Khen District, Bangkok 10220, Thailand.
Wanna Chaijaroenkul
Graduate Program in Bioclinical Sciences, Chulabhorn International College
of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Kesara Na-Bangchang
Graduate Program in Bioclinical Sciences, Chulabhorn International College
of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Please
see the book here:- https://doi.org/10.9734/bpi/msraa/v7/5796
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