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Integrated, biological diagnostics on a molecular level

• Objective

  The major challenges of point-of-care clinical diagnostics is sample preparation and detection accuracy. The field of clinical diagnostics is moving toward molecular testing, such as polymerase chain reaction (PCR), which is the most sensitive and specific methodology currently available. On the other hand, PCR suffers from labor intensive sample preparation to isolate nucleic acids and physical separation requirements in a laboratory to minimize sample contamination. Existing point-of-care diagnostics use antibody-based immuno-detection, which enables simple test protocols but lacks the sensitivity and specificity of molecular techniques.

  To address this challenge, we are collaborating with Professor Catherine Klapperich of Boston University to design an integrated lab-on-a-chip consumable, prototype instrument. Approximately the size of a credit card, the plastic, microfluidic chip automates preparation of bacteria and viruses from clinical samples, amplifies the nucleic acid, and optically detects target presence or absence.

• Methodology

  The chip cost is minimized by keeping all active components in the instrumentation (valves, heating units, optics, etc.) and by having a simple, planar layout. The individual channel technology was derived from precision machining techniques and polymer-solvent activated thermal bonding for single plane, low-cost, consumable construction. Our prototype automates fluidic handling, thermal control, and optical detection. Bacterial and viral detections in a point-of-care setting were equivalent in sensitivity and specificity to a hospital's clinical laboratory. The prototype used for bacterial detection implemented a unique, valveless switching fluidic control system.

• Results

  • Integrated chip design includes bacterial and mammalian cell lysis, mixing reagents, isolation and concentration of nucleic acids, PCR, and fluorescence detection
  • Automation of fluidics, thermal cycling, and optical detection
  • Low-cost manufacturing design

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