Devices and methods for rapid PCR
Inventors
Ririe, Kirk Max • Jones, David E. • Pasko, Christopher Paul • Chamberlain, Anson Cole • David, Derek • Wernerehl, Aaron • Bruns, Jonathan Allen
Assignees
Publication Number
US-11969731-B2
Publication Date
2024-04-30
Expiration Date
2037-02-21
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Abstract
Instruments, methods, and kits are disclosed for performing fast thermocycling.
Core Innovation
Devices and methods are disclosed for performing rapid amplification of nucleic acids using a flexible sample container. Specifically, the innovation provides a flexible sample container that includes a reaction chamber having an array of reaction wells, each fluidly connected to a selectively openable and selectively sealable fill channel. The structure involves multiple layers—film layers, adhesive layers, and a card layer in which the wells are formed—enabling efficient filling and sealing of the wells for PCR processes.
The background describes challenges in PCR, such as the need for rapid diagnosis of infectious agents, the inefficiency of traditional microbiology, and the limitations of existing PCR protocols when rapid cycling is desired. Limitations include lengthy cycle times due to temperature transition delays, poor efficiency and yield during extremely fast cycles, and increased risk of contamination. The necessity for improved PCR systems that allow faster cycling with robust performance and minimized contamination risk is highlighted.
The invention solves these problems by offering flexible containers with innovative flow paths formed via selective cutouts and adhesive layers, allowing precise control of sample distribution and minimization of cross-well contamination. The construction allows for efficient heat transfer and sealing, enabling rapid thermocycling compatible with fast PCR protocols. This architectural approach supports closed-system operations for increased safety, reliability, and speed in nucleic acid amplification.
Claims Coverage
The patent contains one independent claim focusing on the structure and features of a flexible sample container for rapid PCR applications.
Flexible sample container with multi-layer construction and array of reaction wells
A flexible sample container comprising: - A reaction chamber having an array of reaction wells. - Each well is fluidly connected to a selectively openable and selectively sealable fill channel. - The container is fabricated from a first film layer, a second film layer at least partially bonded to the first film layer, an adhesive layer bonded to the second film layer and one surface of a card layer (in which the reaction wells are formed), and a second adhesive layer bonded to a third, exterior film layer and an opposite surface of the card layer. - The fill channel comprises an open space between the first and second film layers. These features collectively provide a structural configuration optimized for precise fluid distribution and manipulation required for rapid PCR processes.
The inventive features of the patent center on a uniquely structured flexible sample container designed for efficient and rapid nucleic acid amplification workflows. This construction ensures secure, controlled, and rapid fluid handling specifically suited to fast PCR and related molecular diagnostic applications.
Stated Advantages
The sample container enables rapid temperature changes for nucleic acid amplification, allowing fast thermocycling.
By using multiple layers and selectively openable/sealable fill channels, the design allows precise control over filling and sealing, which minimizes cross-contamination and supports high-throughput applications.
Flexible sample containers with this structure can operate in closed systems, reducing contamination risks and improving safety.
Efficient heat transfer due to container architecture supports cycle times as short as 8, 6, or even 4 seconds per PCR cycle.
Documented Applications
Amplification of nucleic acids for rapid diagnosis of infectious agents in clinical and research settings, especially where fast and high-throughput testing is needed.
Integrated sample preparation, initial multiplex PCR, dilution, and second-stage PCR within a single flexible pouch, providing closed-system molecular diagnostics.
Assaying for multiple pathogens, including panels of respiratory viruses and bacteria, in a single flexible sample container using high-density arrays.
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