A Low-Cost Paper-Based Device for the Colorimetric Quantification of Bilirubin in Serum Using Smartphone Technology

Area of Science:

• Biomedical Engineering
• Medical Diagnostics
• Analytical Chemistry

Background:

• Total bilirubin levels are crucial biomarkers for diagnosing liver diseases like jaundice and bile obstruction.
• Conventional bilirubin testing methods can be costly and inaccessible in certain healthcare settings.

Purpose of the Study:

• To develop and validate the KromaHealth Kit, a novel device for quantifying total bilirubin in human serum.
• To assess the KromaHealth Kit's performance against clinical and laboratory standards.

Main Methods:

• The KromaHealth Kit utilizes paper-based biochemical assays and an acrylic backbone.
• Image processing and machine learning algorithms analyze colorimetric changes in response to serum.
• A smartphone application captures images and converts them into quantitative bilirubin values (0.5–7.0 mg/dL).

Main Results:

• The KromaHealth Kit demonstrated acceptable precision, limit of detection, linearity, and stability.
• Interference analysis confirmed the device's specificity.
• Comparison with a predicate method showed comparable performance.

Conclusions:

• The KromaHealth Kit provides an inexpensive, precise, and user-friendly method for total bilirubin quantification.
• Its ease-of-use, long shelf-life, and rapid results make it suitable for limited-resource settings.
• The device represents a valuable alternative to conventional bilirubin testing in clinical practice.