CLINICAL PERFORMANCE ANALYSIS OF AFIAS IMMUNOANALYZERS IN POINT-OF-CARE TESTING: A COMPREHENSIVE MULTICENTER REVIEW

The rapid evolution of Point-of-Care Testing (POCT) has fundamentally transformed clinical decision-making, particularly in emergency departments, intensive care units (ICUs), and specialized outpatient clinics. The demand for automated, highly sensitive, and fast diagnostic platforms is critical for the early diagnosis of acute myocardial infarction (AMI), sepsis, and severe metabolic deficiencies. The AFIAS (Automated Fluorescence Immunoassay System) family, developed by Boditech Med Inc. (Republic of Korea), represents a significant advancement in POCT. Utilizing fluorescence-based lateral flow immunoassay technology integrated into an all-in-one cartridge system, AFIAS analyzers — including the AFIAS-1, AFIAS-6, and the high-throughput AFIAS-10 — offer laboratory-quality results within minutes. This comprehensive research article evaluates the analytical and clinical performance of the AFIAS platform across critical biomarkers: Troponin I (cardiac emergencies), Procalcitonin (PCT) and Interleukin-6 (IL-6) (sepsis management), and 25-OH Vitamin D (endocrinology). Results are compared against established gold-standard methods including Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and central laboratory automated analyzers (Abbott ALINITY, BRAHMS Kryptor Compact Plus, Roche Cobas e411). A Python-based computational framework is presented to automate POCT data visualization and facilitate integration into Hospital Information Systems (HIS).