Development of a Microfluidic Point-of-Care Platform for HPV Detection Based on Helicase-Dependent Amplification.

Area of Science:

• Molecular Diagnostics
• Biotechnology
• Public Health

Background:

• Human papillomavirus (HPV) is a major cause of cervical cancer, with high-risk types HPV-16 and HPV-18 responsible for most deaths.
• Conventional PCR methods for HPV detection are costly and require specialized labs, limiting use in low-resource areas.

Purpose of the Study:

• Develop a cost-effective, portable point-of-care (POC) diagnostic platform for HPV-16/18 detection.
• Enable rapid and specific HPV diagnosis in decentralized or resource-limited settings.

Main Methods:

• Integrated helicase-dependent amplification (HDA) into a microfluidic device for isothermal amplification.
• Utilized a portable warming mat and compact electrophoresis chamber for fluorescence-based detection.
• Validated the platform on 33 samples with a low reaction volume (20 µL) and rapid turnaround time (<60 min).

Main Results:

• Achieved a limit of detection (LOD) of 15 copies (cp) per reaction.
• Demonstrated high diagnostic accuracy with 95.52% sensitivity and 100% specificity.
• The complete POC platform has an estimated cost of $320 USD.

Conclusions:

• The developed POC platform is a reliable, scalable, and cost-effective tool for HPV detection.
• This technology supports global efforts to eliminate cervical cancer by enabling accessible screening.
• The platform's portability makes it suitable for implementation in diverse healthcare settings worldwide.