Analytical Accuracy and Clinical Agreement of a Novel Internet of Things and AI-based Point-of-Care Testing Laboratory

ABSTRACT Point-of-care testing (POCT) offers several advantages over conventional laboratory testing. Nonetheless, a faster turnaround time, with less invasive procedures, is not enough if not associated with an acceptable level of accuracy. Here, we show the analytical validation behind the Hilab Flow (HiF), a multi-analyte POCT analyzer. HiF quantitative and qualitative tests for 6,175 clinical samples were compared to gold-standard methods from College of American Pathologists accredited laboratories. The compatibility between methods was evaluated in terms of association and clinical agreement. The established approval criteria was a kappa agreement > 0.8. A strong concordance was observed for the 27 analytes tested. Accuracy was greater than 90% for all HiF exams, indicating a good clinical agreement to gold standard laboratory testing. Results indicate that all quantitative and qualitative tests are suitable for POCT and present a reliable performance. HiF stands as a useful tool to aid decision-making in the clinical setting, with potential to contribute to healthcare solutions in diagnostic medicine worldwide.