Evaluation of the Hologic Panther Fusion investigational use only assays for gastrointestinal bacterial pathogens
Year: 2025
Type: article
Abstract: ABSTRACT 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 Salmonella , Shigella /Enteroinvasive Escherichia coli , Campylobacter , Shiga toxin-producing E. coli , Vibrio , and Yersinia enterocolitica . Limited analysis of Plesiomonas shigelloides and E. coli O157 was also performed. A total of 591 stool specimens underwent complete analysis: 263 frozen positive specimens and 328 freshly collected samples. We used a 2-out-of-3 consensus as the reference for assay performance. Positive and negative percent agreement (PPA and NPA) were high for most pathogen/assay pairs. Individual false-positive (FP) or false-negative (FN) results were seen for all pathogens and assays. PPAs below 95% in the retrospective samples were seen for Shiga toxin (Verigene EP, 89.3%) and Y. enterocolitica (Verigene EP, 88.9% and Fusion GI Bac, 72.2%). There were 12 FP results for Vibrio affecting all assays. Factors contributing to erroneous results, including freeze/thaw effects, are discussed. Overall, the IUO Panther Fusion GI Bacterial and Expanded Bacterial assays were comparable to two commercially available GI panels with a straightforward workflow using a high-throughput instrument. 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.
Source: Journal of Clinical Microbiology
DOI: 10.1128/jcm.00730-25
Institutions: Yale University, Yale New Haven Hospital
Language: English
Subfield: Clinical Biochemistry
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4416227299