Fingerpick Blood-Based Nucleic Acid Testing on A USB Interfaced Device towards HIV self-testing.

Area of Science:

• Biotechnology
• Medical Diagnostics
• Virology

Background:

• Existing HIV self-tests using antibody detection may miss early infections during the window period.
• Nucleic acid testing (NAT) offers higher sensitivity for detecting HIV RNA.
• Streamlined, user-friendly NAT devices are needed for accessible HIV self-testing.

Purpose of the Study:

• To develop and evaluate a fully integrated, user-friendly nucleic acid testing (NAT) device for HIV self-testing.
• To enable early detection of HIV infection using a small volume of finger-prick blood.
• To provide a sensitive and rapid self-testing solution for high-risk populations.

Main Methods:

• Development of a microfluidic reagent cartridge and an ultra-compact NAT-on-USB analyzer.
• Integration of sample preparation, purification, and real-time reverse-transcription loop-mediated isothermal amplification (RT-LAMP).
• Utilized 100 μL of finger-prick whole blood for testing with a custom graphical user interface (GUI) for result readout.

Main Results:

• Achieved a limit of detection (LoD) of 214 viral RNA copies/mL of whole blood at a 95% confidence level.
• Demonstrated a rapid turnaround time of approximately 60 minutes.
• The device successfully integrated complex NAT procedures into a simple self-testing format.

Conclusions:

• The developed HIV NAT-on-USB device offers a highly sensitive and rapid method for HIV self-testing.
• Its ease of use and sensitivity make it suitable for early detection in high-risk individuals.
• This technology has the potential to significantly improve early HIV diagnosis and management through self-testing.