Evaluation of Proflo-U® Platform: A Novel Fluorescence-Based Point of Care Device for Quantitative Estimation of Urine Albumin.

Urine albumin estimation has a very high diagnostic significance. The scope of this assay widens if the method has potential for point of care deployment, while remaining truly quantitative. This study compares Proflo-U® a novel PoC device that estimates urine albumin, with standard immunoturbidity based assays. Proflo-U® is a novel PoC device which works with an android based mobile application by Bluetooth connectivity. This unique fluorescence-based urine albumin assay has been compared with the well-established gold standard Immunoturbidity based method on Beckman Coulter AU platform and also using Biosystem kit. The Proflo-U® generated data from standard recombinant human serum albumin (rHSA) and human urine spiked with rHSA has shown high correlation R (2) ~ 0.99 and p > 0.05. This novel platform has scored 115 out of 150 among 30 parameters to determine its suitability for point of care deployment. The fluorescence-based urine albumin assay of the novel Proflo-U® platform comparable with the gold standards in the field, is easy to use, and found to be deployable as a point of care device. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12291-024-01185-0.