ECONOMICAL STRIP VALIDATION FOR CKD SCREENING: A CROSS-SECTIONAL TRIAL

 

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https://storage.unitedwebnetwork.com/files/1099/59a52671df789db1bfde6bc5d80e140e.pdf
ECONOMICAL STRIP VALIDATION FOR CKD SCREENING: A CROSS-SECTIONAL TRIAL

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Sirirat
Anutrakulchai
Issaree Bunyawannukul doctorpoundpoundz.fbi@gmail.com Khon Kaen university Faculty of medicine Khon kaen Thailand *
Sirirat Anutrakulchai siriratrj@gmail.com Khon Kaen university Faculty of medicine Khon kaen Thailand -
Ubon Cha’on ubocha@kku.ac.th Khon Kaen university Faculty of medicine Khon kaen Thailand -
Vuddhidej Ophascharoensuk vuddhidej@yahoo.com Chiang Mai University Faculty of medicine Chiang Mai Thailand -
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Chronic kidney disease (CKD) represents a significant global public health concern, particularly in low- and middle-income countries, where more than 80% of stage 3 CKD cases remain undiagnosed due to the limited availability of effective screening tools. The urine albumin-to-creatinine ratio (UACR) is the reference standard for detecting albuminuria; however, point-of-care dipstick tests offer a feasible and cost-effective alternative in resource-constrained settings.

This cross-sectional diagnostic study was conducted at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Random midstream spot urine samples were evaluated using seven testing methods: 1) MicroalbuPHAN® (manual visual strip), 2) MicroalbuPHAN® with LAURA automated reader, 3) CYBOW 2AC (manual visual strip), 4) CYBOW 2AC with automated reader, 5) Thai-developed AL strip using competitive immunochromatography, 6) standard macro-protein dipstick, and 7) UACR measured by the Roche® analyzer (reference standard). Precision and linearity were assessed using albumin (10–150 mg/L) and creatinine (10–300 mg/dL) standards in triplicate. Manual readings were performed by trained personnel blinded to UACR results, while automated readings followed the manufacturers' protocols.

A total of 1,042 participants were enrolled, with a mean age of 62.53 ± 12.66 years and 52.78% being male. The prevalence of comorbidities included diabetes mellitus (59.79%), hypertension (52.88%), and CKD (26.01%). The mean estimated glomerular filtration rate (eGFR) was 67.96 ± 23.56mL/min/1.73 m², and the median UACR was 15.08 (IQR 4.62–83.39) mg/gCr. The lowest cost per test was observed with the macro-albumin strip, while the AL strip had the highest cost. Diagnostic performance for detecting UACR ≥ 30 mg/gCr varied across methods, with the highest receiver operating characteristic (ROC) area observed in strips coupled with automated readers. The strongest correlation with UACR was noted in the MicroalbuPHAN® with LAURA automated reader (r = 0.75), which also offered favorable economic value.

Semi-quantitative urine dipstick tests, especially when used with automated readers, demonstrate diagnostic performance comparable to laboratory-based UACR assessments at a reduced cost. These findings support the utility of such methods in CKD screening programs within resource-limited settings. Further studies incorporating clinical outcomes are recommended to validate their long-term efficacy.

Kewords