Devices and methods for rapid sample processing and analysis
Inventors
McFall, Sally Maureen • Kelso, David M. • Reed, Jennifer Lynn • Westberg, Tom
Assignees
Publication Number
US-12269040-B2
Publication Date
2025-04-08
Expiration Date
2038-05-24
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Abstract
Provided herein are devices and methods for the rapid processing and analysis of samples. In particular, a small-volume sample (e.g., nucleic acid sample) is exposed to (e.g., contacted with) different temperature zones within a device to process (e.g., amplify) and/or analyze (e.g., quantitate) the sample in an assay.
Core Innovation
The invention provides devices and methods for rapid processing and analysis of samples, particularly small-volume samples such as nucleic acid samples. The device exposes a sample to different temperature zones within the apparatus to enable processing (such as amplification) and analysis (such as quantification) in an assay. This is accomplished by physically shuttling the sample or regions of the device so that the sample is sequentially brought into contact with temperature-regulated zones and, where relevant, a detection zone.
A major problem addressed by this invention is the inefficiency and slow processing time of traditional thermal cyclers, which rely on plastic tubes and thermoelectric coolers to heat and cool PCR solutions. Traditional systems require over an hour to conduct multiple temperature cycles, with additional delays and inefficiencies caused by bulk thermal masses and slow heat exchange. Quantitative PCR further increases this processing time because of the need for fluorescence readings and cycle-by-cycle measurements. These limitations prevent the deployment of nucleic acid testing in scenarios requiring rapid and accurate diagnosis.
The core innovation replaces traditional thermal cycling with a system where the sample container is shuttled between fixed temperature zones using a shuttling mechanism, such as a servo or motor, or where the zones themselves are moved relative to a stationary sample container. Temperature zones are regulated by heaters, and detection can occur through a dedicated detection zone comprising devices like fluorimeters or image sensors. The sample is contained in a cassette constructed from thin layers with a central sample cutout, promoting rapid heat transfer and efficient sample handling. The system is programmable and capable of executing predefined thermal and detection cycles, supporting rapid and flexible nucleic acid processing and analysis.
Claims Coverage
There are two independent claims in the patent, each defining key inventive features regarding device architecture and method of sample processing.
Layer-based sample cassette with transparent window and temperature zone alignment
The device comprises a sample cassette made from three layers (front, central, rear), each less than 1 mm thick. The central layer has a sample containment cutout, and the front and/or rear layers include a transparent window aligned with the cutout. The sample container is structurally defined by these layers. The device features two sets of opposing heaters—each set comprising a front and rear heater—to create first and second temperature zones. A shuttle motor and sample holder physically align the sample container within either temperature zone. A heater motor adjusts the gap between heater sets to clamp or release the cassette as required during the cycling process.
Sample processing method via programmable shuttling between temperature zones
The method includes providing the above device, placing a sample into the sample container, and shuttling the sample cassette between positions where the sample container resides in the first and second temperature zones, following a programmed cycle. The method ensures that the sample container is held in each temperature zone for sufficient time to equilibrate to the respective temperature.
The inventive features cover both the specific, layered cassette device with programmable shuttling and temperature zone clamping, and the method for rapid sample processing and analysis via temperature cycling within this architecture.
Stated Advantages
Provides faster heat transfer and significantly reduces processing time for sample amplification and analysis.
Lowers power consumption compared to traditional thermal cyclers.
Enables the use of self-filling containers and efficient sample containment, minimizing risk of contamination and sample loss.
Compatible with standard PCR reagents and protocols, including dry reagent storage within the same container used for reactions.
Reduces the mass of container materials, enabling rapid thermal cycling and efficient heat exchange.
Simplifies multiplex and parallel testing by allowing multiple sample containers or wells.
Allows for rapid sample cycling and analysis in point-of-care and other resource-limited settings due to low energy and material requirements.
Documented Applications
Amplification, detection, and quantification of target nucleic acids by PCR, qPCR, RT-PCR, and RT-qPCR.
Point-of-care infectious disease testing and diagnostic applications.
High throughput nucleic acid testing systems.
Environmental testing applications.
Food testing applications.
Veterinary testing applications.
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