Workflow optimization for syndromic diarrhea diagnosis using the molecular Seegene Allplex™ GI-Bacteria(I) assay

Area of Science:

• Clinical Microbiology
• Molecular Diagnostics
• Infectious Diseases

Background:

• Syndromic panel-based molecular testing offers potential for improved and accelerated microbiological diagnosis.
• Bacterial diarrhea diagnosis traditionally relies on culture methods, which can be time-consuming.

Purpose of the Study:

• To evaluate the workflow improvements and diagnostic performance of the Seegene Allplex™ GI-Bacteria(I) assay as a first-line test for bacterial diarrhea.
• To compare the assay's performance against traditional culture methods in a routine clinical setting.

Main Methods:

• Technical evaluation using spiked and patient stool samples.
• Implementation of the multiplex assay in the routine workflow.
• Comparative analysis of 5032 clinical samples tested with the Seegene assay versus 4173 control samples tested by culture.

Main Results:

• High sensitivity for key gastrointestinal pathogens: Campylobacter (100%), Salmonella (92%), Aeromonas (89%), Shigella (83%), and C. difficile toxin B (93.9%).
• Increased detection rates for Aeromonas, Campylobacter, and Shigella compared to culture.
• Significant reduction in median time-to-result from 52.7 to 26.4 hours.

Conclusions:

• The Seegene Allplex™ GI-Bacteria(I) assay provides accelerated and reliable detection of major gastrointestinal bacteria within approximately one day.
• The assay reduces laboratory workload, particularly beneficial in low-prevalence settings.
• Molecular panel testing enhances diagnostic efficiency for bacterial diarrhea.