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Smartphone-assisted tuberculosis detection by a smart amplification process and lateral flow immunoassay with a
Chung-An Chen1,2, Natalie Yi-Ju Ho2, Chang-Chi Yang2
1School of Medicine, Chang Gung University, Taoyuan, Taiwan. tsai1129@gap.cgu.edu.tw.
Summary
A novel 3D-printed device with smart amplification and lateral flow immunoassay allows for rapid, on-site tuberculosis diagnosis using smartphone imaging or the naked eye. This portable platform was validated with real patient samples.
Area of Science:
- Biomedical Engineering
- Point-of-Care Diagnostics
- Molecular Biology
Background:
- Tuberculosis (TB) diagnosis remains a challenge, especially in resource-limited settings.
- Existing diagnostic methods often require specialized equipment and trained personnel, hindering rapid on-site detection.
- There is a need for portable, sensitive, and user-friendly diagnostic tools for TB screening.
Purpose of the Study:
- To develop and validate a portable, 3D-printed sensing platform for on-site tuberculosis diagnosis.
- To integrate a novel smart amplification process with a lateral flow immunoassay for enhanced sensitivity.
- To enable both smartphone-assisted and naked-eye detection for broad accessibility.
Main Methods:
- Development of a 3D-printed sensing platform incorporating stacking pad lateral flow immunoassay (sLFIA).
- Utilized a sunrise-biotin-labeled smart amplification process (sb-SmartAmp) for signal amplification.
- Validated the platform using clinical TB samples, comparing results with established diagnostic methods.
Main Results:
- The integrated sb-SmartAmp and sLFIA system demonstrated high sensitivity and specificity for TB detection.
- The portable 3D-printed platform facilitated rapid, on-site diagnosis.
- Smartphone-assisted image analysis and naked-eye detection provided reliable results, validated with clinical samples.
Conclusions:
- The developed 3D-printed sensing platform offers a promising solution for accessible, on-site TB diagnosis.
- The combination of sb-SmartAmp and sLFIA significantly enhances detection capabilities.
- This technology has the potential to improve TB management and control globally, especially in resource-limited areas.

