Dispositivo "Point of Care" baseado em IA para quantificação de bilirrubina total

Abstract

This work presents the development of a point-of-care medical device aimed at quantifying total bilirubin in human samples, with the objective of providing a practical, accessible, and rapid solution for clinical diagnostics, especially in settings with limited laboratory infrastructure. The justification for creating this system is based on the high demand for decentralized diagnostic methods that allow early identification of alterations in bilirubin levels, an essential biomarker for assessing liver function and diagnosing conditions such as neonatal jaundice and liver diseases in adults. The device was developed using the chromatography principle for sample flow, a technology that enables the separation and detection of bilirubin directly in human serum samples. The system was designed to serve both adult and neonatal populations, broadening its clinical applicability. A significant innovation was the integration of artificial intelligence into the reading and interpretation process of the results, performed through a dedicated reading instrument, which ensures greater standardization in analysis, reducing human errors and the need for highly trained operators. The analytical performance of the device was evaluated according to the CLSI EP15-A3 guideline, using controls and clinical samples to determine the precision and accuracy of the results. Performance studies demonstrated that the device has a linearity range from 0.7 mg/dL to 20 mg/dL for total bilirubin, with intra-assay variation of 7.6% and intralaboratory variation of 6.9%, meeting the expected precision criteria for this type of analysis. Comparison with the biochemical reference method indicated excellent correlation, with a Pearson coefficient of 0.996, and t-test results showed no statistically significant difference between the methods (p > 0.05), demonstrating clinical equivalence between the approaches. Product stability studies indicated a validity of up to 12 months after manufacturing, maintaining the established performance throughout the period. Another highlight of the system was the ability to obtain results in less than 10 minutes, characterizing the device as a rapid and efficient solution for emergency contexts and primary healthcare. The combination of analytical technologies and artificial intelligence algorithms resulted in a product that is easy to use, requiring minimal infrastructure and training. In conclusion, the developed device represents a significant advancement in the field of portable laboratory diagnostics, with clinical performance comparable to conventional methods, but with greater accessibility, mobility, and speed, contributing to strengthening screening and early diagnosis strategies in different healthcare settings.