Abstract: SA-PO565
Evaluation of Clinical Performance of an In Vitro Diagnostic Medical Device for Detecting Microalbuminuria Using a Smartphone Application
Session Information
- Bioengineering
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bioengineering
- 400 Bioengineering
Authors
- Ryu, Jiwon, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of)
- Oh, Yun Jung, H Plus Yangji Hospital, Seoul, Korea (the Republic of)
- Lee, Dong-Hoon, QSTAG Incorporation, Seoul, Korea (the Republic of)
- Park, Eung-Kyu, QSTAG Incorporation, Seoul, Korea (the Republic of)
Background
Microalbuminuria indicates kidney damage and can serve as a marker for treatment and prognosis in patients with kidney disease or diabetes mellitus. Urine albumin tests are typically conducted in hospitals, which is impractical for daily patient monitoring. We assessed the feasibility of using a commercially available in-vitro diagnostic medical device to measure urine microalbumin in daily life.
Methods
In our study, we enrolled 303 patients from three tertiary care hospitals who tested positive for urine protein using dipstick tests. We utilized a self-checking semi-quantitative urine test strip with QR code technology to evaluate urinary microalbumin and creatinine levels. Integrating QR code technology and correction color pads significantly enhanced QR code recognition and color reaction extraction accuracy. The device utilizes pH indicators and benzoic acid for precise microalbumin and creatinine measurement. A mobile application scans the QR code to provide semi-quantitative values of microalbumin and creatinine. These results were compared to those obtained from a hospital’s benchtop machine, with a predefined class agreement for semi-quantitative data set at 95%.
Results
Variations in application environments, laboratory conditions, and hospital settings impacted QR code recognition and the detection of urine microalbumin and creatinine, necessitating adjustments to the colorimetric extraction formula. Comparing results between patients and experts, the agreement rates for urine microalbumin were 92.9%, 92.5%, 97.4%, and 97.3% for normal range, 1 positive, 2 positive, and 3 positive, respectively. After accounting for urine creatinine, the agreement rates for the urine microalbumin/creatinine ratio were 97.1%, 100%, and 98.0% for “Good”, “Moderate”, and “High”, respectively. Expert data on urine microalbumin correlated well with semi-quantitative results from the benchtop machine, with agreement rates of 66.7%, 94.1%, 100.0%, and 87.0% for normal range, 1 positive, 2 positive, and 3 positive in the dipstick test, respectively.
Conclusion
Using this in-vitro diagnostic medical and software enable semi-quantitative urine microalbumin assessment outside hospitals, supporting disease management and patient prognosis in real-life settings.
Funding
- Commercial Support – QSTAG Incorporation