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Area of Science:

  • Materials Science
  • Analytical Chemistry
  • Biomedical Engineering

Background:

  • Counterfeit diagnostic devices, including point-of-care diagnostics (POCDs) and rapid diagnostic tests (RDTs), are a recurring global health concern.
  • The illicit trade in counterfeit medical devices is driven by profitability and ease of replication, leading to severe public health risks.
  • Existing authentication methods are insufficient to prevent widespread counterfeiting of POCDs and RDTs.

Purpose of the Study:

  • To develop and demonstrate a novel method for authenticating diagnostic devices using optical security codes.
  • To implement these codes on both silicon and nitrocellulose-based microfluidic platforms.
  • To enable smartphone-based verification for combating counterfeit diagnostic devices.

Main Methods:

  • Optical security codes were fabricated using inkjet spotting of inks onto nitrocellulose or silicon micropillars.
  • High-density codes (up to 32 elements/mm²) with multiple colors (up to 8) were created to maximize information encoding capacity.
  • Methods for code erasure (liquid wicking, continuous flow) and dynamic code generation (PEG/glycerol additives, programmable routing nodes) were explored.

Main Results:

  • The developed optical codes can encode up to 10^45 combinations, offering robust security.
  • Codes are easily fabricated, viewable with a smartphone, and can be dynamically altered or erased.
  • Static, labile, and sequentially activated codes were successfully implemented on both material platforms.

Conclusions:

  • Optical security codes integrated into microfluidic flow paths provide a simple, efficient, and scalable solution for authenticating diagnostic devices.
  • This technology offers a powerful tool to combat the proliferation of counterfeit point-of-care diagnostics and rapid diagnostic tests.
  • Combining these codes with package-level information can significantly enhance the security and integrity of diagnostic devices.