Retrospective analysis and clinical performance of BD MAX enteric pathogen testing with a focus on reliable identification of vibrio species in stool samples

Abstract

Infectious diarrhea is a significant health concern, particularly for immunocompromised and pediatric patients. Traditional stool culture methods are labor-intensive and often lack sensitivity, prompting clinical laboratories to adopt PCR-based gastrointestinal pathogen panels (GIPPs). This study evaluated the BD MAX™ GIPP compared to traditional methods, focusing on the accuracy of the platform's automatic interpretations. Positivity rates increased from 4.0 % to 6.4 % after implementing BD MAX. The system detected significantly more Vibrio spp. and Yersinia enterocolitica than traditional culture, with most of these positives unrecoverable by culture. Irregular PCR amplification curves were frequently observed in cases where viable organisms were not recovered in culture, yet these still produced positive automatic interpretations. These findings emphasize the need for cautious interpretation of results and highlight the importance of incorporating amplification curve reviews into laboratory workflows to improve accuracy and ensure reliable diagnoses.