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High-throughput Detection of Respiratory Pathogens in Animal Specimens by Nanoscale PCR
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An open source, PCR based, point-of-care testing platform.

Yaping Xie1, Zhou Sha1, Shuaiwu Huang1

  • 1Research and Development Department, Sansure Biotech Co., Ltd, Changsha, 410125, China.

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Summary

A novel open point-of-care testing (POCT) platform with a rotating cartridge enables rapid, low-cost nucleic acid detection for infectious diseases like HPV and COVID-19.

Keywords:
CartridgeDetachableInfectious diseaseNucleic acidPoint-of-care

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Area of Science:

  • Biomedical Engineering
  • Molecular Diagnostics
  • Point-of-Care Testing

Background:

  • Current point-of-care testing (POCT) platforms are closed systems, limiting reagent validation and causing resource waste.
  • Incompatibility between different POCT devices hinders widespread adoption and efficient diagnostics.

Purpose of the Study:

  • To develop an open, programmable POCT platform for rapid nucleic acid testing.
  • To address limitations of closed POCT systems, enabling customized reagent validation and reducing resource waste.

Main Methods:

  • Development of a rotating cartridge with a detachable reagent rack for an open POCT instrument.
  • Simultaneous detection of six targets with high sensitivity and specificity for various viruses.

Main Results:

  • The system detected HPV at 1000 copies/mL and novel coronavirus at 200 copies/mL within 1 hour.
  • Achieved high accuracy with sensitivity at 100% and specificity above 98% for multiple viruses.
  • Demonstrated excellent stability and reliability with coefficient of variation (CV) under 3% and AUC values > 0.98.

Conclusions:

  • The developed open POCT platform offers a stable, reliable, and cost-effective solution for infectious disease diagnosis.
  • This innovative system provides a competitive alternative for low-cost, open point-of-care nucleic acid testing, improving diagnostic accessibility.