www.apjph.comwww.apjph.com
...
Original research
Ref Number: APCP-RP-036

A Closed-Tube PCR-Invader Assay for Rapid, Low-Cost Detection of Six Major Pediatric Enteric Pathogens

Yan Lu¹, Zhifeng Liu¹, Nan Yang¹
1- Children's Hospital of Nanjing Medical University, China
Corresponding Author: Yan Lu (luyan_cpu@163.com)
Abstract Body
Introduction: Infectious diarrhea remains a leading cause of childhood morbidity . Current diagnostic approaches—including stool culture and immunoassays—are time-consuming, lack sensitivity , or require separate tests for different pathogens. Although qPCR offers speed and sensitivity , dye-based methods lack specificity , while probe-based assays are costly for multiplex detection. Objectives: To develop a novel, closed-tube assay that integrates PCR amplification with Invader-based sequence-specific detection for rapid, low-cost identification of six major pediatric diarrheal pathogens. Methods: We designed a two-stage, high-annealing-temperature PCR protocol that seamlessly couples amplification with Invader reaction in a single closed tube, eliminating the need for probe modifications. The assay targets Shigella spp., Vibrio cholerae, non-typhoidal Salmonella, Campylobacter jejuni, rotavirus, and enteric adenovirus (types 40/41). Analytical performance was evaluated using plasmid DNA and reference strains; clinical validation was performed on simulated and actual stool samples. Results: The assay achieved a detection limit of 2 copies per reaction for each target, with no cross-reactivity . The entire process—from amplification to detection—was completed within 45 minutes in a closed-tube format on a standard qPCR instrument. By employing universal Invader probes, the per-test cost was reduced to approximately 2 RMB. Validation confirmed concordance with reference methods. Conclusions: This PCR-Invader assay provides a rapid, low-cost, and contamination-free platform for the parallel detection of six major diarrheal pathogens. It offers a practical alternative to current disparate testing strategies, with strong potential for deployment in primary healthcare settings and large-scale screening to guide targeted therapy and reduce antibiotic misuse in childhood infectious diarrhea.
Keywords: Low-cost detection; Enteric pathogens; Diarrheal pathogens
Presentation Type: Original research
Disclaimer: The Views and opinions expressed in the articles are of the authors and not of the journal.
Editor-In-Chief
Journal Office
Mid City Hospital, 3-A Shadman II
Jail Road, Lahore ,Pakistan
Managing Editor
Dr. Intan Juliana Abd Hamid
Support & Help
Assistant Editor
Dr. Sadia Shabbir Hussain
Support & Help
Digital Content Editor
Dr. Khalid Masud
Administrator