Evaluation of SCINTIGLO™ as a Point-of-care Device for Urinary Protein Estimation

Background and aim: Early detection and serial monitoring of proteinuria are of utmost importance in the management of diseases such as diabetes, hypertension, and pre-eclampsia.Most current screening tools for proteinuria are qualitative or semiquantitative.SCINTIGLO is a low-cost, semiautomated point-of-care (POC) device for urinary microprotein quantification, measuring not only albumin but all residual urinary proteins, thereby providing a more reliable and sensitive assessment of microproteinuria.This study aimed to evaluate the diagnostic accuracy of SCINTIGLO as compared to automated analyzers. Materials and methods:The study was conducted on 46 patient samples, 44 samples spiked with albumin, and 636 blind samples.The blind samples were artificially prepared with known albumin concentrations, but the operators were unaware of these values to ensure unbiased assessment.The results obtained from SCINTIGLO for these samples were compared with those from two commercially available dipsticks and a fully automated chemistry analyzer, which is also considered the gold-standard method.Results: SCINTIGLO demonstrated an overall agreement of 84.79% with gold-standard results in patient samples and 81.82% in spiked samples, compared to 67.4 and 47.83% for dipsticks A and B, respectively.In the masked study, SCINTIGLO matched 93.19% of prepared sample results with expected values, while dipsticks A and B had match rates of 70.08 and 52.28%, respectively.Across all samples, SCINTIGLO demonstrated superior diagnostic performance compared to commercially available dipsticks, demonstrating a sensitivity of 94.2%, specificity of 94.5%, precision of 94.4%, and overall accuracy of 94.3%.Conclusion: SCINTIGLO provides a cost-effective, accurate, and accessible method for early detection of proteinuria, making it a promising alternative to existing diagnostic tools.Clinical significance: The ability to rapidly and accurately detect urinary proteins is crucial for early diagnosis of renal and cardiovascular complications of hypertension and diabetes, as well as pre-eclampsia.SCINTIGLO presents a cost-effective POC solution for early diagnosis and monitoring of proteinuria, particularly beneficial in resource-limited settings, where laboratory-based testing is often inaccessible.