Diagnostic microbiology and infectious disease · 2026
Comparative evaluation of BD MAX™ Enteric Panels and Luminex NxTAG® GPP for the detection of gastrointestinal pathogens in clinical stool samples.
СтатьяСравнительное исследованиеОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Guillem Javier, Albert Eliseo, Giménez Estela, Corrales Isabel, Navarro David, Torres Ignacio
Аннотация
PURPOSE: To compare the diagnostic performance of BD MAX™ Enteric Panels and the Luminex NxTAG® Gastrointestinal Pathogen Panel (GPP) for the detection of enteric pathogens under routine clinical conditions.
METHODS: A prospective single-center study analyzed 165 stool samples (one per patient) from individuals with suspected gastrointestinal infection attending the Clínico-Malvarrosa Health Department (Valencia, Spain) between October and November 2023. Samples tested using all BD MAX™ enteric panels (bacterial, viral, and Clostridioides difficile panels) were also processed by Luminex NxTAG® GPP assay. Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), Cohen's κ index were calculated. Discrepant results were investigated using the VIASURE real-time PCR and targeted Next-Generation Sequencing, as appropriate.
RESULTS: Among the 165 samples analyzed, 107 (64.8%) were positive for at least one pathogen by either method, with norovirus (n = 40) and Clostridioides difficile (n = 18) being the most frequently detected targets. Overall, both assays exhibited moderate initial agreement (PPA 69.3%, NPA 90.6%, κ = 0.56), with an average PPA of 78.6%. PPA exceeded 85% for most targets, except for sapovirus. Salmonella spp., and Shiga toxin-producing E. coli (stx1, stx2) (STEC) accounted for most discordant results, often associated with low pathogen loads or analytical variability. After discrepancy resolution, both assays demonstrated comparable diagnostic performance, with a substantial concordance of (κ = 0.79 and 0.77, respectively).
CONCLUSION: BD MAX™ and Luminex NxTAG® GPP demonstrated comparable accuracy in detecting enteric pathogens, supporting their use in cost-effective, culture-independent molecular diagnosis and their integration within microbiological diagnostic stewardship programs.
METHODS: A prospective single-center study analyzed 165 stool samples (one per patient) from individuals with suspected gastrointestinal infection attending the Clínico-Malvarrosa Health Department (Valencia, Spain) between October and November 2023. Samples tested using all BD MAX™ enteric panels (bacterial, viral, and Clostridioides difficile panels) were also processed by Luminex NxTAG® GPP assay. Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), Cohen's κ index were calculated. Discrepant results were investigated using the VIASURE real-time PCR and targeted Next-Generation Sequencing, as appropriate.
RESULTS: Among the 165 samples analyzed, 107 (64.8%) were positive for at least one pathogen by either method, with norovirus (n = 40) and Clostridioides difficile (n = 18) being the most frequently detected targets. Overall, both assays exhibited moderate initial agreement (PPA 69.3%, NPA 90.6%, κ = 0.56), with an average PPA of 78.6%. PPA exceeded 85% for most targets, except for sapovirus. Salmonella spp., and Shiga toxin-producing E. coli (stx1, stx2) (STEC) accounted for most discordant results, often associated with low pathogen loads or analytical variability. After discrepancy resolution, both assays demonstrated comparable diagnostic performance, with a substantial concordance of (κ = 0.79 and 0.77, respectively).
CONCLUSION: BD MAX™ and Luminex NxTAG® GPP demonstrated comparable accuracy in detecting enteric pathogens, supporting their use in cost-effective, culture-independent molecular diagnosis and their integration within microbiological diagnostic stewardship programs.