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Phase Transition of Wax Enabling CRISPR Diagnostics for Automatic At-Home Testing of Multiple Sexually Transmitted
Hu Zhou1,2,3, Yixuan Cai1,2, Liang He1,2
1Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Small (Weinheim an Der Bergstrasse, Germany)
|November 5, 2024
Summary
A new automated diagnostic system, Wax-CRISPR, enables rapid, at-home detection of multiple sexually transmitted infections (STIs). This user-friendly platform offers accurate results in 30 minutes, improving accessibility for women's reproductive health.
Area of Science:
- Biomedical Engineering
- Molecular Diagnostics
- Point-of-Care Testing
Background:
- Sexually transmitted infections (STIs) pose significant risks to women's reproductive health.
- Accessible, rapid, and sensitive diagnostic methods are crucial for early detection and management, especially for home-based testing.
- Existing methods may lack the speed, affordability, or multiplexing capability required for widespread at-home STI screening.
Purpose of the Study:
- To develop and evaluate an automated, user-friendly diagnostic system for multiplexed at-home detection of common STIs.
- To demonstrate the feasibility of a wax-transition-based microfluidic platform for simultaneous pathogen identification.
- To assess the clinical performance and usability of the system by untrained operators.
Main Methods:
- Development of the Wax-CRISPR system utilizing wax phase transitions for sequential reagent mixing in a microfluidic chip.
- Integration of recombinase polymerase amplification (RPA) and CRISPR assays for multiplexed detection of six gynecological pathogens (CT, MG, UU, NG, HPV 16, HPV 18).
- Clinical evaluation with 100 samples and a double-blinded usability test involving untrained operators.
Main Results:
- The Wax-CRISPR system achieved simultaneous detection of six critical gynecological pathogens within 30 minutes.
- A low detection limit of 10-18 M was achieved.
- Clinical evaluation showed high sensitivity (96.8%) and specificity (97.3%).
- Untrained operators successfully identified STI targets in clinical samples, demonstrating user-friendliness.
Conclusions:
- The Wax-CRISPR system provides a low-cost, stable, and user-friendly platform for multiplexed STI detection.
- This technology is well-suited for at-home or field-based testing, enhancing accessibility to women's reproductive health diagnostics.
- The wax-transition-based approach offers a novel strategy for automated, one-pot molecular assays.
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