Early detection of Chronic Kidney Disease (CKD) is critical to preventing progression to end-stage renal disease, especially in resource-limited and high-burden settings. Laboratory-based urine albumin testing, while accurate, is often inaccessible for large-scale screening due to infrastructure, cost, and turnaround time constraints. This study provides strong clinical evidence that Proflo-U®, a fluorescence-based point-of-care platform, can bridge this diagnostic gap by delivering laboratory-comparable accuracy at the point of care—enabling timely intervention and scalable CKD screening programs.

Publication Details

This research was published in the Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (eJIFCC),
Volume 36, Issue 3, 2025, pages 328–342.

Title:
Evaluation of Proflo-U® Platform for Urine Albumin Measurement in Chronic Kidney Disease Diagnosis: A Comparative Study

What Was Done in the Study

The study conducted a blinded, head-to-head clinical evaluation of the Proflo-U® point-of-care platform against the Beckman Coulter immunoturbidimetric system, a widely accepted laboratory reference method for urine albumin estimation.

• Sample size: 255 real patient urine samples
• Study site: NABL-accredited Biochemistry Laboratory, AIIMS Bhubaneswar
• Study period: November 23, 2021 to March 8, 2022
• Methodology: Parallel testing using Proflo-U® cartridges and Beckman Coulter AU5800 analyzer
• Analysis: Passing–Bablok regression, Bland–Altman analysis, and Receiver Operating Characteristic (ROC) curves
  

The study specifically assessed Proflo-U®’s ability to accurately classify albuminuria across A1 (<30 mg/L), A2 (30–300 mg/L), and A3 (>300 mg/L) categories relevant to CKD diagnosis and risk stratification.

Key Outcomes

• Strong correlation with laboratory reference method: Pearson correlation coefficient R² > 0.9, indicating excellent agreement with Beckman Coulter measurements.
• High diagnostic performance across all albuminuria categories. Sensitivity ranged from 94.2% to 97.37%. Specificity ranged from 94.41% to 100%
• Robust clinical accuracy: ROC analysis demonstrated AUC values of 0.977 (A1 vs A2) and 0.998 (A2 vs A3), confirming excellent discrimination capability.
• Validated in real-world clinical conditions: Performance confirmed using real patient samples rather than spiked or synthetic specimens.
  

Why This Study Matters

This study clinically validates Proflo-U® as a reliable, quantitative, and scalable point-of-care solution for urine albumin measurement, addressing key limitations of conventional dipsticks and centralized laboratory testing. Its fluorescence-based technology, broad analytical range, portability, and ease of use make it particularly well-suited for:

• Mass CKD screening programs
• Primary care and community health settings
• Resource-constrained and remote environments
  

By enabling early CKD detection and monitoring at the point of care, Proflo-U® has the potential to significantly improve patient outcomes and reduce long-term healthcare burden.

Authors and Contributors

The study was authored by:

• Midde Hari Satyanarayana – Department of Biochemistry, AIIMS Bhubaneswar
• Shivam Mishra – Prantae Solutions Private Limited
• Dr. Debapriya Bandyopadhyay (Corresponding Author) – Additional Professor, Department of Biochemistry, AIIMS Bhubaneswar
  The study was collaboratively designed, executed, analyzed, and reviewed by the authors, with ethical approval from AIIMS Bhubaneswar.

At Prantae Solutions, we take immense pride in this publication and what it represents for both our team and the Proflo-U® platform. This milestone is the culmination of months of focused research, rigorous clinical validation, cross-institutional collaboration, and sustained perseverance. Seeing our work published in a reputed international journal such as eJIFCC is a strong affirmation of the scientific robustness, clinical relevance, and real-world value of Proflo-U® as a point-of-care diagnostic solution.

This recognition reinforces our belief that Proflo-U® can play a meaningful role in transforming early CKD detection, particularly in settings where accessibility, affordability, and speed of diagnosis are critical. It also strengthens the foundation for broader clinical adoption, partnerships, and impact-driven deployment of the platform.

This achievement motivates us to continue pushing boundaries in point-of-care diagnostics and advancing solutions that enable better healthcare outcomes—closer to patients, when they need it most.