Rapid detection of SARS-CoV-2 with a mobile device based on pulse controlled amplification

Area of Science:

• Biomedical Engineering
• Molecular Diagnostics
• Biosensor Technology

Background:

• Extensive research exists in biosensors and point-of-care (PoC) diagnostics.
• Despite advances, a low-cost molecular biosensor with antigen test user-friendliness and PCR sensitivity/specificity remains undeveloped.
• The SARS-CoV-2 pandemic highlighted the need for rapid, accurate diagnostic tools.

Purpose of the Study:

• To develop a novel, low-cost, handheld PoC device for molecular diagnostics.
• To achieve PCR-level sensitivity and specificity in viral detection within 40 minutes.
• To enable decentralized or home-based testing using microfluidics and pulse-controlled amplification (PCA).

Main Methods:

• Developed a microfluidics-based handheld PoC device incorporating pulse-controlled amplification (PCA).
• Utilized finite element analysis (FEA) simulations to understand PCA principles and parameter dependencies.
• Integrated a streamlined sample preparation workflow and evaluated analytical performance.

Main Results:

• The PCA device demonstrated PCR sensitivity and specificity for viral detection in under 40 minutes, including sample preparation.
• Achieved a limit of detection (LoD) for SARS-CoV-2 viral RNA of 0.88 copies/μL, comparable to RT-qPCR.
• Validated the target specificity of the developed biosensor.

Conclusions:

• The developed PCA device offers a cost-effective, rapid, and mobile solution for molecular diagnostics.
• This technology holds promise for decentralized and home-use settings, improving diagnostic accessibility.
• The combination of microfluidics and PCA enables sensitive and specific molecular detection outside traditional laboratory environments.