Rapid and accurate detection of respiratory pathogens using a field-deployable POCT system based on multiplex...

Area of Science:

• Molecular Diagnostics
• Infectious Disease Detection
• Point-of-Care Testing (POCT)

Background:

• Urgent need for rapid and accurate diagnostics for respiratory infections.
• Current methods may lack speed or comprehensiveness for simultaneous pathogen detection.
• Timely diagnosis is critical for effective treatment and infection control.

Purpose of the Study:

• Develop a novel multiplex real-time PCR panel for simultaneous detection of 14 common respiratory pathogens.
• Evaluate the performance of a field-deployable POCT system for rapid respiratory pathogen identification.
• Assess the clinical utility of the developed diagnostic system.

Main Methods:

• Design and validation of a multiplex real-time PCR panel targeting 14 respiratory pathogens.
• Integration of the panel with a field-deployable POCT system.
• Clinical evaluation of the system's diagnostic accuracy, including PPV, NPV, PPA, NPA, and Kappa value.

Main Results:

• Simultaneous detection of 14 respiratory pathogens (including SARS-CoV-2, influenza viruses, S. pneumoniae, etc.) within 30 minutes.
• High specificity, reproducibility, and anti-interference ability demonstrated.
• Lower limit of detection (LOD) of 10^3 copies/ml for most pathogens.
• Clinical evaluation showed high reliability with 97.09% total accuracy and a Kappa value of 0.94.

Conclusions:

• The developed multiplex PCR panel on a POCT system offers rapid and reliable diagnosis of multiple respiratory pathogens.
• This system provides a valuable platform for clinical decision-making and public health surveillance.
• Potential to significantly improve the management of respiratory infections.