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Microneedle-based skin patch for blood-free rapid diagnostic testing.

Xue Jiang1, Peter B Lillehoj1,2

  • 1Department of Mechanical Engineering, Rice University, Houston, TX 77005 USA.

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A new microneedle skin patch offers rapid, minimally invasive detection of infectious disease biomarkers in dermal fluid. This simple, equipment-free test enhances point-of-care diagnostics, overcoming limitations of traditional blood sampling methods.

Keywords:
EngineeringNanoscience and technology

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Area of Science:

  • Biomedical Engineering
  • Point-of-Care Diagnostics
  • Biosensor Technology

Background:

  • Rapid diagnostic tests are crucial for infectious disease screening, especially in developing nations.
  • Current methods often rely on finger-prick blood sampling, posing challenges like infection risk and difficulties with specific populations.
  • There is a need for simpler, less invasive, and equally effective diagnostic tools.

Purpose of the Study:

  • To develop and validate a novel microneedle-based skin patch for rapid detection of protein biomarkers.
  • To demonstrate the feasibility of using dermal interstitial fluid for diagnostic testing.
  • To enhance the sensitivity of lateral flow assays for point-of-care applications.

Main Methods:

  • Utilized a microneedle array to extract dermal interstitial fluid.
  • Integrated fluid extraction with an antibody-based lateral flow test strip for colorimetric antigen detection.
  • Applied a gold enhancement technique to improve assay sensitivity.
  • Validated the device for detecting *Plasmodium falciparum* histidine-rich protein 2.

Main Results:

  • Successfully detected *Plasmodium falciparum* histidine-rich protein 2 at concentrations as low as 8 ng/mL.
  • Demonstrated a complete test in under 20 minutes without requiring external equipment.
  • Confirmed the mechanism of gold enhancement for improved sensitivity.
  • Established proof-of-concept for microneedle-based lateral flow assay in dermal interstitial fluid.

Conclusions:

  • The microneedle skin patch provides a simple, minimally invasive, and cost-effective method for rapid protein biomarker detection.
  • This technology overcomes the limitations associated with traditional blood-sampling diagnostic tests.
  • The platform is adaptable for detecting various protein biomarkers, showing significant potential for point-of-care diagnostics.