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Integrated 3D-Printed Hollow Microneedle Array and Lateral Flow Immunoassay for Point-of-Care Wound Healing
Amadeo Sena-Torralba1, Marc Parrilla2,3, Ana Hernanz-Grimalt1
1Instituto Interuniversitario de Investigación de Reconocimiento Molecular y Desarrollo Tecnológico (IDM), Universitat Politècnica de València, Universitat de València, Camino de Vera s/n, 46022 Valencia, Spain.
Analytical Chemistry
|December 17, 2024
Summary
A novel microneedle patch with a lateral flow immunoassay enables convenient, home-based monitoring of chronic wounds. It accurately detects matrix metalloproteinase 8 (MMP-8), a key healing biomarker, for improved patient care.
Area of Science:
- Biomedical Engineering
- Point-of-Care Diagnostics
- Wound Healing Research
Background:
- Chronic wound management necessitates frequent monitoring for effective healing assessment.
- Current diagnostic methods like swabs are often inconvenient and provide limited information.
- There is a need for user-friendly, minimally invasive tools for at-home chronic wound monitoring.
Purpose of the Study:
- To develop and validate a novel hollow microneedle array patch integrated with a lateral flow immunoassay (LFIA) for chronic wound diagnostics.
- To assess the patch's ability to extract wound exudate and detect key biomarkers for wound healing phases.
- To evaluate the device's performance in a clinical setting for ease of use, accuracy, and cost-effectiveness.
Main Methods:
- Development of a 3D-printed hollow microneedle array patch for painless exudate extraction.
- Integration of the patch with a lateral flow immunoassay strip for rapid biomarker detection.
- Clinical study with 90 patients to identify and validate matrix metalloproteinase 8 (MMP-8) as a proliferative phase biomarker.
- Mechanical and cytotoxicity assays to confirm patch durability and biocompatibility.
- Ex vivo skin model validation for exudate extraction efficiency and biomarker recovery.
Main Results:
- The microneedle patch successfully extracted wound exudate (61 ± 6 μL) with high biomarker recovery (122% for MMP-8).
- Matrix metalloproteinase 8 (MMP-8) was identified as a reliable biomarker for the proliferative healing phase, with 80.3% sensitivity.
- The developed LFIA for MMP-8 demonstrated a low detection limit (0.7 ng/mL), suitable for clinical application.
- The 3D-printed patch was cost-efficient (<€0.10/patch), biocompatible, durable, and painless.
- The device provided clear, visible results within 10 minutes, facilitating rapid clinical interpretation.
Conclusions:
- The hollow microneedle array patch integrated with LFIA offers a convenient, minimally invasive, and cost-effective solution for at-home chronic wound monitoring.
- This technology enables rapid, accurate detection of MMP-8, aiding in the assessment of the wound healing phase.
- The device has the potential to improve early intervention, reduce healthcare costs, and enhance patient outcomes in chronic wound management.
