Unitary biochip providing sample-in to results-out processing and methods of manufacture
Inventors
Selden, Richard F. • Tan, Eugene
Assignees
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Publication Number
US-12722157-B2
Publication Date
2026-09-01
Expiration Date
Abstract
A biochip for the integration of all steps in a complex process from the insertion of a sample to the generation of a result, performed without operator intervention includes microfluidic and macrofluidic features that are acted on by instrument subsystems in a series of scripted processing steps. Methods for fabricating these complex biochips of high feature density by injection molding are also provided.
Core Innovation
The described invention is a unitary, stationary biochip that connects with an electrophoresis instrument having pneumatic, thermal, high-voltage, and optical subsystems and a process controller to generate a nucleic acid sequencing or sizing profile from at least one sample. The biochip integrates macrofluidic processing, fluidic, pneumatic, valve, and separation and detection subassemblies connected to one another and to corresponding instrument subsystems.
The biochip utilizes patterned thermoplastic sheets bonded to plates to form fluid transport channels and drive lines, using air driven through valves to route fluids across the subassemblies. Embodiments provide automated nucleic-acid processing, including purification, amplification, separation, and detection within plastic subassemblies. Electrophoresis output illustrates DNA fragment sizing profiles, single-base-pair resolution, and reduced fluorescence noise.
Claims Coverage
The claims identify one independent claim comprising six primary inventive features directed to integrated biochip subassemblies, along with five dependent claim refinements.
Unitary, stationary biochip for profile generation
A unitary, stationary biochip that, upon insertion into an electrophoresis instrument having pneumatic, thermal, high-voltage, and optical subsystems and a process controller, generates a nucleic acid sequencing or sizing profile from at least one sample.
Macrofluidic processing subassembly
A macrofluidic processing subassembly connected with a fluidic subassembly and a pneumatic subassembly, comprising at least one chamber adapted to receive a sample.
Fluidic subassembly
A fluidic subassembly comprising a fluidic plate with patterned thermoplastic sheets bonded on its top and bottom to form at least one fluid transport channel on each side, and an amplification chamber adapted to connect to the thermal subsystem.
Pneumatic subassembly
A pneumatic subassembly adapted to connect to the instrument pneumatic subsystem and the biochip subassemblies, comprising a pneumatic plate with a patterned thermoplastic sheet bonded on top and one or a plurality of drive lines to pneumatically drive only air on instructions from the process controller.
Valve subassembly
A valve subassembly positioned between and connected to the fluidic and pneumatic subassemblies that receives only air from the drive lines and opens or closes at least one valve in response, thereby driving air or fluids on or within the fluidic subassembly.
Separation and detection subassembly
A separation and detection subassembly adapted to connect to the instrument high-voltage and optical subsystems and process controller, comprising at least one separation channel and a detection region positioned to send signals from each separation channel to the optical subsystem.
Plastic subassembly construction
A dependent claim specifies that the macrofluidic, pneumatic, fluidic, and separation and detection subsystems are plastic.
Elastomeric valve
A dependent claim specifies that the valve subassembly comprises at least one elastomeric valve.
Electrophoresis orientation
A dependent claim specifies that the separation and detection subassembly is oriented so sample electrophoresis proceeds opposite to the general sample flow through the fluidic plate.
Reagents contained in the biochip
A dependent claim specifies that the biochip contains all reagents needed to process at least one sample.
Closed fluid transport pathways
A dependent claim specifies that each fluid transport channel on each side of the fluidic plate is a closed pathway.
The claim elements cover the biochip's integrated sample processing, fluid transport, pneumatic actuation, valve control, and separation and detection subassemblies for profile generation, while dependent claims refine plastic materials, valve structure, orientation, reagent containment, and closed fluid pathways.
Stated Advantages
Reduced fluorescence noise using a notch filter, with yellow-channel peak-to-peak noise decreasing from 67 to 39 rfu and signal-to-noise ratio increasing from 23 to 32.
Single-base-pair resolution and STR profiles generated in approximately 90–94 minutes.
Reduced operator intervention.
Reduced fabrication cost.
Closed sample pathways limit cross-contamination.
Documented Applications
Generating a nucleic acid sequencing or sizing profile from at least one sample using the biochip inserted into an electrophoresis instrument.
Automated nucleic-acid processing, including nucleic-acid purification, PCR amplification, and STR analysis.
Sample splitting and dilution, reagent storage and release, and pathogen detection.
Nucleic-acid sizing and detection, as illustrated by electrophoresis output and DNA fragment sizing profiles.
Automated STR profiling from buccal swabs and electrophoretic separation and detection of genetic markers.
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