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Advancing Molecular Diagnostics for SARS-CoV-2: Scalable Sensor Chip Production
The ongoing need for efficient and reliable diagnostics for SARS-CoV-2 and other pathogens has spurred the development of innovative solutions in the field of molecular diagnostics. The Microfluidics Innovation Hub (MIH) is leading a project to produce scalable, high-volume sensor chips for detecting SARS-CoV-2, encompassing both antibody and viral genetic material testing. This initiative leverages advanced roll-to-roll (R2R) manufacturing processes to enhance the availability and efficiency of in-vitro diagnostics (IVD).
The core of this project is a versatile platform that uses a polymer foil-based microfluidic chip equipped with a reaction chamber and capillary pump. This technology facilitates rapid and accurate detection of SARS-CoV-2 and can be adapted for broader medical diagnostics applications.
Key Components and Features:
Polymer Foil Microfluidic Chip: A disposable chip featuring a reaction chamber and integrated capillary pump for fluid movement.
Roll-to-Roll (R2R) Manufacturing: Enables high-volume production with processes like UV nanoimprint lithography, biomolecule printing, and lamination.
Multiplexed Detection: Capable of simultaneously detecting multiple biomarkers, including both viral RNA and antibodies.
Compliance with IVD Regulations: Designed to meet ISO 13485 and European Medical Device Regulations (MDR).
This project aims to revolutionize molecular diagnostics by providing a scalable solution for the rapid detection of SARS-CoV-2 and other pathogens. The development and implementation of foil-based microfluidic chips offer several significant benefits:
High-Volume Production: Transition from traditional injection molding to scalable R2R manufacturing processes for cost-effective production.
Regulatory Compliance: Ensure the manufacturing process and final products comply with stringent IVD standards and regulations.
Multiplexed Detection: Develop assays capable of detecting multiple biomarkers from a single sample, enhancing diagnostic capabilities.
Expected Impact:
Rapid Diagnostics: Enable quick and reliable testing for SARS-CoV-2 and other pathogens, critical for controlling pandemics.
Cost-Effective Solutions: Reduce the cost of diagnostics through scalable manufacturing, making advanced testing more accessible.
Enhanced Readiness: Provide a robust platform that can be quickly adapted to new diagnostic needs as they arise.
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Goal
Develop a Scalable Microfluidic Chip: Create a high-volume production process for polymer foil-based microfluidic chips using R2R techniques.
Multiplex Assay Integration: Implement assays that detect both viral RNA and antibodies for comprehensive SARS-CoV-2 testing.
Regulatory Compliance: Ensure all processes and products meet ISO 13485 and MDR requirements.
Solution
R2R Manufacturing: Employ UV nanoimprint lithography and extrusion coating to produce microfluidic chips at scale.
Assay Development: Use multiplexed local immobilization of biomarkers and chemiluminescent detection to achieve high sensitivity and specificity.
Full Value Chain Implementation: Integrate all manufacturing steps, including biomolecule printing and lamination, into a streamlined, regulatory-compliant process.
Requirements
High Sensitivity and Specificity: The platform must reliably detect low concentrations of viral RNA and antibodies.
Rapid Turnaround: Provide diagnostic results within 15 minutes to facilitate timely clinical decisions.
Scalable Production: Utilize R2R manufacturing to produce large quantities of microfluidic chips efficiently.
Regulatory Adherence: Comply with ISO 13485 and MDR to ensure safety and efficacy.
Collaboration and Expertise
The project harnesses the expertise of multiple MIH partners to achieve scalable production and high-performance diagnostics:
GENSPEED Biotech GmbH: Specializes in developing multiplex assays for integrating into the microfluidic chip for point-of-care testing.
JOANNEUM RESEARCH Forschungsgesellschaft mbH: Provides expertise in R2R UV nanoimprint lithography for creating high-fidelity microfluidic structures.
Inmold A/S: Focuses on R2R extrusion coating and structuring, ensuring cost-effective and scalable production of microfluidic chips.
Scienion AG: Implements precision microspotting technology to functionalize the sensor surfaces with specific biomolecules.
Partners Involved
Services and Technologies
