ABSTRACT
Total bilirubin values have been used as a potential marker to pre-screen and diagnose various liver-based diseases such as jaundice, bile obstruction, liver cancer, etc. A device known as KromaHealth Kit, composed of paper and an acrylic backbone, is developed to quantify total bilirubin in human serum using image processing and machine learning technology. The biochemical assays are deposited on absorbent paper pads that act as reaction zones when serum is added. A dedicated smartphone app captures images of the colorimetric changes on the pad and converts them into quantitative values of bilirubin. The range of bilirubin concentration that can be quantified using the device ranges from 0.5 mg/dl to 7.0 mg/dl. The precision, limit of detection, interference analysis, linearity, stability, and comparison with a predicate are studied in this paper in accordance with clinical and laboratory standards institute. The results indicate that the KromaHealth Kit can be used as an inexpensive alternative to conventional bilirubin testing in clinical settings. With its level of precision, ease-of-use, long shelf-life, and short turnaround time, it will prove to be invaluable in limited-resource settings.
