A novel comparative evaluation of multiplex PCR panels for gastrointestinal pathogen detection: Seegene Allplex™ vs. Luminex NxTAG® in clinical stool samples.

Purpose: Accurate and rapid diagnosis of gastrointestinal infections is essential for effective patient management. This study compared the diagnostic performance of two multiplex PCR panels- the Seegene Allplex™ Gastrointestinal Panels (Seegene, Seoul, Korea) and the Luminex NxTAG^® Gastrointestinal Pathogen Panel (Luminex Corporation, Austin, Texas, a Diasorin Company)-in detecting gastrointestinal pathogens from clinical stool samples.

Methods: A total of 196 stool samples, collected from patients at a Spanish hospital during 2023, were analyzed using both assays through prospective and retrospective approaches. The performance of each test was assessed based on Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), and overall agreement. Discrepancies between methods were resolved with a third confirmatory technique when available.

Results: Both assays demonstrated high overall concordance, with NPA values consistently above 95% and overall Kappa values exceeding 0.8 for most pathogens. The average PPA was greater than 89% for nearly all targets; however, lower agreement was observed for Cryptosporidium spp. (86.6%). Notably, discrepancies were primarily observed for certain pathogens, such as Salmonella spp. and Cryptosporidium spp., highlighting the diagnostic challenges associated with these targets.

Conclusion: To our knowledge, this is the first study to compare the novel Luminex NxTAG^® panels from Diasorin with the Seegene Allplex™. Both multiplex assays provide rapid and reliable detection of gastrointestinal pathogens, making them valuable tools in clinical diagnostics. Future research should focus on improving detection accuracy for challenging pathogens and expanding target panels to further enhance patient management and reduce disease burden.