Evaluation of the BioFire Gastrointestinal Panel to Detect Diarrheal Pathogens in Pediatric Patients

Area of Science:

• Clinical microbiology
• Molecular diagnostics
• Pediatric infectious diseases

Background:

• Infectious diarrhea is a significant global health issue in children.
• Accurate and rapid detection of enteropathogens is crucial for effective management.
• Existing diagnostic methods can be time-consuming and may not cover a broad range of pathogens.

Purpose of the Study:

• To evaluate the performance of the BioFire FilmArray Gastrointestinal (GI) Panel for detecting enteropathogens in pediatric patients.
• To compare the BioFire GI Panel against established laboratory tests for bacterial and viral pathogens.
• To assess the utility of the BioFire GI Panel for rapid identification of infectious diarrhea causes.

Main Methods:

• Prospective collection and testing of stool samples from pediatric patients with diarrhea.
• Comparison of the BioFire GI Panel with culture, conventional PCR, and other multiplex molecular assays (Allplex, BD MAX panels).
• Definition of "true positive" based on culture results and/or multiple molecular test positives for discrepancy analysis.

Main Results:

• The BioFire GI Panel detected 123 pathogens in 90 out of 184 samples (50.5% true positive rate).
• High sensitivity (100% for 12 targets) and specificity (>95% for 16 targets) were observed for the BioFire GI Panel.
• The panel identified multiple pathogens in 16.9% of samples, with higher rates in children without underlying diseases.

Conclusions:

• The BioFire GI Panel offers comprehensive and rapid (within 2 hours) detection of enteropathogens.
• The test demonstrates high accuracy, making it a valuable tool for diagnosing infectious diarrhea in pediatric populations.
• Its speed and breadth of coverage can significantly improve patient management and public health surveillance.