Evaluation of the Hologic Panther Fusion investigational use only assays for gastrointestinal bacterial pathogens.

Historic detection methods for diarrheal pathogens are time-consuming, laborious, and may lack specificity and sensitivity. Multiplexed molecular panels for enteric pathogens are widely used for rapid and accurate results. We evaluated the performance of the investigational use only (IUO) Hologic Panther Fusion GI Bacterial and Expanded Bacterial assays (Fusion GI Bac), the Verigene Enteric Pathogens (EP), and BioFire FilmArray Gastrointestinal (BioFire GI) panels for the detection of primary bacterial causes of gastrointestinal infection. We conducted a multi-platform evaluation for the detection of IMPORTANCE: Bacterial causes of diarrhea lead to significant morbidity and mortality around the world. Historic testing methods, for example, antigens and culture. For these reasons, molecular testing for enteric bacterial pathogens has become widely used, but there are limited numbers of commercially available tests on the market, especially those suitable for higher-throughput testing. We show that the high-throughput, random- access investigational use only Hologic Panther Fusion Gastrointestinal (GI) Bacterial assay and Panther Fusion GI Expanded Bacterial assay perform comparably to existing assays.