Impact of FilmArray Gastrointestinal Panel Compared to Standard of Care Diagnostic Tests in Clinical Practice of Acute Gastroenteritis in a Resource Limited Region

Background/Objectives: Gastroenteritis remains a major global health concern, particularly in resource-limited regions, where rapid and accurate diagnosis is crucial for effective patient management. Syndromic multiplex PCR panels, such as the FilmArray gastrointestinal (FAGI) panel, offer the potential to significantly improve diagnostic yield and turnaround time, enabling more targeted treatments and reducing unnecessary antibiotic use. However, real-world data on their performance in low-resource settings remains scarce. This study evaluates the performance, clinical impact, and cost-effectiveness of the FAGI panel compared to standard of care (SOC) diagnostic methods in gastroenteritis cases at São José Hospital for Infectious Diseases in Fortaleza, Brazil, a resource-limited region of a middle-income country. Methods: A retrospective observational study was conducted between patients tested with FAGI (n=161) and a historical control group tested only with SOC methods (n=166). Results: The FAGI panel was associated with a significant reduction in the turnaround time, antimicrobial use, and total treatment costs while increasing the pathogen detection rate. Specifically, the median diagnostic time was reduced by 18%, with a 77% increase in pathogen detection compared to SOC methods. Moreover, the FAGI group experienced a 30% reduction in antibiotic use, with a corresponding 83% reduction in antimicrobial costs. Conclusions: These results suggest that the FilmArray panel may offer substantial benefits in terms of efficiency and cost savings, highlighting its potential for broader implementation in clinical practice, especially in resource-limited settings, to improve patient outcomes in infectious disease management.