Systems and methods of sample depositing and testing
Inventors
Assignees
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Publication Number
US-12472492-B2
Publication Date
2025-11-18
Expiration Date
Abstract
The present application is generally directed to systems, methods, and devices for diagnostics for sensing and/or identifying pathogens, genomic materials, proteins, and/or other small molecules or biomarkers, for example, using loop-mediated isothermal amplification (LAMP). Some implementations include additional improvements, such as improvements to sample and reagent mixing, sample deposition, and compensation of inhibitors in the sample. Also disclosed herein are nucleic acid primers for use in the sensitive and specific detection of pathogens in biological samples by LAMP, which may be performed in the devices disclosed herein. The biological samples may be derived from patients including humans, plants, food, soil, contaminated surfaces, or animals such as livestock.
Core Innovation
The disclosure describes an assay cartridge and a sample cartridge for containing a sample comprising a target agent for detection by a reader device. The sample introduction area is configured to receive a sample carrier or swab having a shaft and a flange, and includes a retention feature with a closure having a first end proximate an exterior of the cartridge and a second end extending into an interior of the sample introduction area.
The closure includes one or more recesses that define a first interior diameter at the first end and a second interior diameter at the second end, with the second interior diameter smaller than the first interior diameter and, in an undilated conformation, smaller than the outer diameter of the flange. The closure allows passage of the sample carrier by dilating through widening of the recesses as the flange travels from the first end to the second end, and then returns to the undilated conformation to prevent or inhibit exiting from the sample introduction area once the carrier is positioned.
The cartridge further includes a mixing region configured to mix the sample with a reagent to generate a sample mixture, with at least one mixing object disposed in the mixing region and configured to move within the mixing region to enhance mixing in response to a force applied to the mixing region. A test well is provided with an excitation electrode and a sensing electrode, and the test well is configured to contain at least a portion of the sample mixture undergoing an amplification process. A fluid path fluidically couples the sample introduction area to the mixing region and the test well.
The document also describes amplification-based detection of pathogens or biomarkers using (reverse transcription) loop-mediated isothermal amplification ((RT-)LAMP), contactless electrical sensing in the test well, and a wellness-scoring concept that stores test results in profiles and compares results to threshold values using remote computing and biometric identification.
Claims Coverage
The provided set includes two independent claims. Across the independent claims, the coverage centers on a closure-based retention feature that dilates to admit a shaft-and-flange carrier and then returns to inhibit exiting, together with an electrode-based test well coupled by a fluid path, and in one claim a mixing region with movable mixing objects.
Closure configured to dilate and return to inhibit flange exiting
A closure comprising a first end proximate an exterior and a second end extending into an interior, with one or more recesses forming a first interior diameter at the first end and a second interior diameter at the second end, where the second interior diameter is smaller than the first interior diameter and, in an undilated conformation, smaller than an outer diameter of the flange; the closure allows passage of the sample carrier by dilating through widening of the one or more recesses as the flange travels from the first end to the second end; and the closure returns to an undilated conformation after passage past the second end, thereby preventing or inhibiting the carrier from exiting when positioned in the sample introduction position.
Sample introduction area retention feature for a shaft-and-flange sample carrier
A sample introduction area configured to receive a sample carrier comprising a shaft and a flange positioned on the shaft, wherein the sample introduction area includes a retention feature configured to accept and retain the sample carrier, with the retention feature comprising the closure configured to allow passage of the flange into a sample introduction position and to prevent or inhibit exiting once positioned.
Electrode-based test well for amplification
A test well comprising an excitation electrode and a sensing electrode, configured to contain at least a portion of the sample mixture undergoing an amplification process.
Fluid path coupling between sample introduction area and test well
A fluid path fluidically coupling the sample introduction area to the test well, and in the assay cartridge claim also fluidically coupling the sample introduction area to the mixing region and the mixing region to the test well.
Mixing region with movable mixing object(s) responsive to applied force
A mixing region configured to mix the sample with a reagent to generate a sample mixture, including at least one mixing object disposed in the mixing region and configured to move within the mixing region to enhance mixing of the sample with the reagent in response to a force applied to the mixing region.
Swab-based carrier for the sample cartridge
A sample introduction area configured to receive a swab containing a sample, where the swab comprises a shaft and a flange, and the swab retention feature allows passage to a sample introduction position and prevents or inhibits exiting when positioned in that position.
Overall, the independent claims primarily cover a closure and retention feature that dilates to allow a flange-bearing sample carrier to enter and then returns to prevent exiting, together with a test well having excitation and sensing electrodes and a fluid path coupling the sample introduction area to the test well. In the assay cartridge claim, the cartridge additionally includes a mixing region with movable mixing objects to enhance mixing in response to an applied force.
Stated Advantages
Prevents or inhibits the sample carrier or swab from exiting the sample introduction area once positioned.
Enhances mixing of the sample with a reagent in response to a force applied to the mixing region.
Enables contactless electrical sensing in the test well while the sample mixture undergoes an amplification process.
Documented Applications
Detection by a reader device of a sample comprising a target agent, including pathogens or biomarkers, using amplification processes such as (reverse transcription) loop-mediated isothermal amplification ((RT-)LAMP).
A wellness-scoring concept using test results stored in profiles and compared to threshold values via remote computing and biometric identification.
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