Ultrafast PCR Detection of COVID-19 by Using a Microfluidic Chip-Based System

Area of Science:

• Molecular Biology
• Biotechnology
• Medical Diagnostics

Background:

• Traditional reverse transcriptase-polymerase chain reactions (RT-PCR) are the gold standard for COVID-19 diagnosis but are time-consuming and lab-dependent.
• Limitations of conventional PCR hinder rapid field application and timely disease control.

Purpose of the Study:

• To introduce and evaluate SWM-02, a novel microchip-based ultrafast PCR system for rapid, portable, and low-cost COVID-19 testing.
• To assess the performance, limit-of-detection, and clinical applicability of the SWM-02 system.

Main Methods:

• Development of a microchip-based ultrafast PCR system (SWM-02) capable of 6-sample detection with multiple fluorescent channels.
• Performance evaluation using gradient-diluted COVID-19 reference samples and a commercial PCR kit.
• Validation with clinical samples to assess consistency with conventional PCR protocols.

Main Results:

• The SWM-02 system completed ultrafast COVID-19 RT-PCR tests within 40 minutes.
• Determined limit-of-detection (LoD) of 500 copies/mL for N and ORF1ab genes with low variation coefficients (1.427% and 0.7872%).
• Demonstrated excellent linear correlation (R2 > 0.99) between Ct values and dilution factors, and high consistency with conventional PCR in clinical samples.

Conclusions:

• The SWM-02 system provides a compact, user-friendly, and rapid solution for on-site molecular diagnosis.
• This technology has the potential to significantly enhance timely and sensitive detection for pathogen transmission control.
• The microchip-based PCR system overcomes the limitations of traditional methods for field applications.