Diagnostics
The MiniFAB Team has extensive Diagnostic Product Development experience requiring intimate knowledge of microfludic environments:
- Biosensors (electrochemical, conductimetric, fluorescence, acoustic wave, QCM, nanoparticles, quantum dots)
- Sample handling (filtering, extraction, concentrating, trapping)
- Sample control (mixing, storing, transport, flow control, valves)
- Reaction zones (chambers, wells, flow cells, PCR chambers)
- Surface bio-functionalization (SAMs, Ab-Ag, assays)
- Human diagnostics
- Veterinary diagnostics
- Cell culture
- Environmental monitoring
- Food quality control
Our microfabrication capabilities are described in detail in the Technical Capabilities section. Many of these technologies and methods are typical for micro-technology and microfluidic service providers. What give us a distinct advantage and significantly enhances our ability to design, optimize and test microfabricated products is internally developed microfluidic platform consisting of Microfluidic Toolbox and MiniChemLab Instrument. In addition, we have acquired extensive expertise in materials, particularly polymer processing which enable us to focus on cost-effective strategies in developing predominantly disposable diagnostic products.
Our specialty is integration:
- Injection moulding
- Electrochemical sensors
- Microfluidic channels
- Reaction chambers
- Fluidic mixers
- Passive valves
A typical example is development of a disposable cartridge for ELISA-based immune-assay.
Case Study Nanofluidics
Osmolarity Test Card
MiniFAB’s technical capabilities and product delivery is demonstrated in the Award winning TearLabTM Osmolarity Test Card. The TearLabTM system is a product of TearLabTM Corporation. It consists of an instrument and a disposable nanofluidic sensor the Osmolarity Test Card.
MiniFAB managed the development of the Osmolarity Test Card and delivered technical expertise in micro- and nano- fluidics and technology. From the initial concept to full manufacturing MiniFAB delivered a result in less than two years and is now the sole global manufacturer of the Osmolarity Test Card. As a start-up company, TearLabTM appreciated MiniFAB’s careful management of the deliverables, milestones and time lines while keeping within a tight budget.
The design brief was to create a cheap, disposable device capable of collecting 50nl of tear fluid, preferably without the use of active components such as pumps and valves. Internal gold electrodes were to be integrated to perform an electrical measurement on the tear sample, providing an osmolarity reading with a CV < 1.5%. Previous experiences with other vendors of microfluidic solutions had been unsuccessful, however after an initial concept was agreed, MiniFAB delivered a working proof-of-principle within 3 months.
MiniFAB formed an internal multidisciplinary team which included engineers from the client’s company. Following the successful proof-of-principle the Staged Development Plan delivered Concept Demonstrator Prototypes to evaluate the design strategy: Alpha Production units for design evaluation, a Manufacturing strategy and implementation and Beta Production units for pre-clinical trials. Today MiniFAB is the sole manufacturer of the TearLabTM Osmilarity Test Card and is now working with TearLabTM on future generations of the product. The complete development and manufacturing process was executed under MiniFAB’s ISO13485:2003 certified quality system.
For its design, TearLabTM has been awarded the prestigious Medical Design Excellence Award® 2009. We believe this is the first of many awards to come. A press release from TearLabTM can be read here:
TearLab Press Release
