4-Color qPCR Measurement Module for POC Molecular Diagnostics

Another case of Volpi succeeding where others had failed, our client came to us after two failed attempts and 2 years of delays with another optics supplier. Volpi succeeded in putting the project back on track and the product to market in a timely fashion.

Discipline:
Molecular Diagnostics Molecular Diagnostics

Customer Requirements

  • Fast time-to-market
  • A reliable optoelectronics expert for design and development of a miniaturized 4-wavelength measurement module for qPCR at the POC
  • Expertise in design to cost
  • 0.5 nM measurement sensitivity and high dynamic range
  • High measurement reliability
  • Read-out from a customer-specific consumable for 4 samples each
  • An established change management system with critical components tracking
  • Proven expertise in fast manufacturing ramp-up to thousands of units per year
  • Expertise in tester development and build
  • ISO 13485 certification
  • Manufacturing in the USA

Volpi’s Solutions

Rapid development and industrialization

  • Knowledge based, straight forward development, verification and validation

Miniaturized, low-cost design suitable for a reliable POC MDx instrument

  • Comprehensive expertise in optoelectronics measurement solutions for fluorescence

Favorable module cost at target level for anticipated quantities

0.5nM sensitivity and 5 log dynamic range

Regulatory compliance

  • QA proven through dedicated, specially developed testers
  • Design, development and manufacturing in compliance to ISO 13485

Technical Features

  • Measurement principle:
    Fluorescence
  • Consumable type:
    Integrated, microfluidic plastic consumable with 4 measurement chambers
  • Number of optical channels for multiplexing:
    4
  • Illumination technology:
    LED
  • Detection technology:
    Photodiodes
  • Number of different component types/module:
    33
  • Number of components/module:
    66

Technical Features

  • Measurement principle:
    Fluorescence
  • Consumable type:
    Integrated, microfluidic plastic consumable with 4 measurement chambers
  • Number of optical channels for multiplexing:
    4
  • Illumination technology:
    LED
  • Detection technology:
    Photodiodes
  • Number of different component types/module:
    33
  • Number of components/module:
    66
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