Microfluidic diagnostic assembly
Inventors
LEE, Eon Soo • Nunna, Bharath Babu • Suh, K. Stephen
Assignees
New Jersey Institute of Technology
Publication Number
US-10898894-B2
Publication Date
2021-01-26
Expiration Date
2037-06-21
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Abstract
Improved diagnostic assemblies are provided. More particularly, the present disclosure provides improved and highly advantageous chip based diagnostic assemblies configured to detect human diseases (e.g., cancer) and/or pathogens, and related methods of use. In exemplary embodiments, the present disclosure provides for consumable micro- or nano-fluidic chip based diagnostic assemblies having visual biosensors, with the diagnostic assemblies using continuous flow-based micro- or nano-fluidic channels and antibody-based immuno-complex designs. In certain embodiments, the diagnostic assembly includes a self-sustainable and operable chip (e.g., thumb-sized chip) that is configured to be deployed as a single use consumable with a direct all-or-none readout as an output to satisfy a point of screening method to screen a population.
Core Innovation
The invention provides chip-based diagnostic assemblies utilizing micro- or nano-fluidic technology to detect human diseases such as cancer and pathogens. These assemblies incorporate visual biosensors, continuous flow-based channels, and antibody-based immuno-complex designs. A key aspect is the creation of self-sustainable, operable chips that function as single-use, consumable devices, providing a direct all-or-none readout suitable for population screening and point-of-care applications.
A significant advancement over conventional ELISA platforms, the assemblies feature microfluidic channels—typically fabricated from polydimethylsiloxane (PDMS)—that are hydrophilic and designed for capillary-driven blood flow without external force. The inner surfaces of these channels are coated with disease-specific antibodies or antigens, enabling detection through antigen-antibody binding. This process is electronically monitored via a capacitor method using nano-electronics, which translates binding events into digital signals that can be directly or visually read out, such as through illuminated lights.
The problem addressed by the invention is the lack of sensitivity in traditional immunoassay formats for low abundance biomarkers, high sample and reagent consumption, elevated costs, inefficiency for mass population screening, and lack of user-friendly, point-of-care diagnostic solutions. The disclosed microfluidic chips are designed to overcome these limitations by enabling minimally invasive sampling (such as from a finger-prick), reduced reagent use, disposable low-cost use, and high-throughput quantitative and qualitative diagnosis, particularly for early detection of diseases like ovarian cancer.
Claims Coverage
The patent claims three primary independent inventive features focused on unique diagnostic assemblies utilizing microfluidic channels, layered structures, biosensor coatings, electronic signal detection, and tailored readout systems.
Microfluidic diagnostic assembly with electronic signal generation
A diagnostic assembly comprising: - A channel layer with a microfluidic channel extending between its surfaces and ending at a point within the layer. - An insulation layer positioned below the channel layer, the top surface of which has a coated area (antibody or antigen) aligned under the channel and sealing it. - A circuit layer positioned beneath the insulation layer and under the coated area. - Upon introduction of fluid flow into the channel, the circuit layer is configured to generate signals based on the interaction of the fluid with the coated area.
Microfluidic diagnostic assembly with integrated control panel layer for signal processing and display
A diagnostic assembly including: - A microfluidic channel layer and insulation layer as above, with a coated area for antigen-antibody interaction. - A circuit layer positioned below the insulation layer. - A control panel layer mounted below the circuit layer, comprising a signal receiver, signal amplifier, and signal processor. - The circuit layer produces signals upon fluid interaction which are processed by the control panel to visually display results (for example, by illuminating lights).
Dual circuit layer diagnostic assembly with dielectric separation for enhanced signal detection
A diagnostic assembly featuring: - A microfluidic channel layer and insulation layer with a coated area. - A first circuit layer and a second circuit layer, separated by a dielectric material, arranged beneath the insulation layer. - A control panel layer mounted beneath a base member, which receives and processes signals from the dual circuit layers as generated by fluid-coating interactions. - The control panel includes a signal receiver, amplifier, and signal processor to support visual display of diagnostic results.
The independent claims cover diagnostic assemblies with microfluidic channels, disease-specific biosensor coatings, multi-layered structures including circuit and insulation layers, electronic signal generation based on antigen-antibody interactions, and integrated panels for processing and visually displaying diagnostic signals.
Stated Advantages
The diagnostic assembly requires only a minimal blood volume, enabling diagnosis with micro-liter samples compared to conventional methods needing larger volumes.
Diagnosis can be performed instantly and efficiently on the microfluidic chip, eliminating many processing steps present in traditional methods and reducing disturbance of blood properties.
The device's compact and user-friendly design enables personal self-evaluation with minimal training or expertise, in contrast to conventional ELISA that requires skilled technicians.
The microfluidic chip is low-cost to manufacture, making diagnostic testing affordable and accessible compared to investments in sophisticated laboratory setups.
Simplified operation and quick diagnosis increase the likelihood of regular testing and early disease detection, which can save lives by enabling treatment in earlier stages.
High specificity and sensitivity due to the use of robust, disease-specific antibodies and ability to multiplex for multivariate assays, especially for cancer biomarker detection.
High throughput and suitability for mass screening as a point-of-care or consumable device, reducing healthcare costs and improving efficiency in routine clinical environments.
Documented Applications
Detection and early diagnosis of human diseases such as cancer, including but not limited to ovarian cancer, using blood samples.
Screening of populations for disease biomarkers at the point-of-care in clinical and public health settings.
Quantitative and qualitative analysis of antigen-antibody interactions for diagnosis, prognosis, and treatment monitoring of diseases.
Self-administered personal diagnostic testing for diseases, enabling user-friendly healthcare monitoring similar to diabetic tests.
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