Device for analyzing a fluid sample
Inventors
Revilla, Ryan Alan • Heltsley, Roy James • Lee, Steve Hoe • Izadi Kharazi, Farzad • Patel, Tej Rushikesh
Assignees
Publication Number
US-12359249-B2
Publication Date
2025-07-15
Expiration Date
2036-06-17
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Abstract
Apparatuses and methods related to a point-of-care portable assay device are described herein. In an embodiment, a device for analyzing a fluid sample includes a fluid actuation source configured to engage a port on a test card. The fluid actuation source is configured to apply pressure to the port to cause the fluid sample to move along a microchannel of the test card to enable one or more assays to be performed. The device also includes a controller configured to receive an indication as to which one or more assays are to be performed, cause the fluid actuation source to move the fluid sample into one or more regions on the test card, cause a plurality of electrical contacts to provide power to the test card for performing the one or more assays, and determine at least one test result based on the performed assays.
Core Innovation
The invention relates to a portable device for analyzing fluid samples using disposable test cards, particularly suited for performing a plurality of polymerase chain reactions (PCR) and other assays such as flow cytometry and enzyme-linked immunosorbent assays (ELISA). The device includes a slot to receive a test card, a fluid actuation source configured to engage a port on the test card to apply pressure and move the fluid sample along a microchannel, electrical contacts to power the test card, and a controller to coordinate assay selection, sample movement, power delivery, and analysis of test results.
The problem addressed by the invention arises from limitations of current point-of-care (POC) diagnostic testing methods. POC immunoassays, while simple, suffer from lower sensitivity and specificity compared to nucleic acid amplification tests (NAATs), particularly at early stages of infection when antibody or antigen levels are low. Although NAATs offer high sensitivity and specificity and early detection capability, they require complicated equipment and complex sample preparation, limiting their deployment in low-resource settings.
The invention solves this problem by providing a low complexity, portable diagnostic system capable of performing rapid, high sensitivity, and high specificity nucleic acid amplification and other assays using a low-cost microfluidic platform with disposable test cards. The device uses a vacuum or pump to pull fluid through a microchannel in the test card, electrodes to heat the fluid sample for PCR, and optical components, including a camera and light source, to monitor and analyze reactions such as PCR through fluorescence imaging. The controller integrates assay selection, fluid actuation, sample heating, image capture, and analysis to deliver assay results with minimal user input.
Additionally, the device allows for multiple assays on a single or multiple fluid samples using different test cards, each identified by a code read by the device. The system supports a range of assays, including nucleic acid amplification, immunoassays, ion selective assays, and image cytometry, thereby broadening diagnostic capabilities at the point of care.
Claims Coverage
The claims disclose two independent analyzer apparatuses focused on performing multiple assay types on fluid samples using test cards, involving fluid actuation, electrical contacts, imaging, and assay-specific control.
Integrated fluid actuation and assay control via test card interface
An apparatus with a slot to receive a test card, a fluid actuation source engaging a port on the test card to move fluid through microchannels, and an electrical contact device powering the test card to perform assays, controlled by a controller detecting test card insertion, assay selection, fluid movement, power application, and result determination.
Use of a pneumatic tube and vacuum or pump for fluid movement
Inclusion of a pneumatic tube fluidly connecting the fluid actuation source to the test card outlet, where the fluid actuation source includes a pump or vacuum source to move fluid.
Memory storing multiple assay modalities with controller coordination
Memory storing a plurality of assays including nucleic acid amplification, immunoassay, ion selective assay, and image cytometry, with the controller managing assay performance, sample heating, fluorescence measurement, capacitance or voltage measurement, and temperature sensing based on assay type.
Optical system for fluorescence excitation and imaging
A light source emitting specific wavelengths (fluorescence excitation light), a camera aligned with the test card to record images of target zones, and optical filters enabling fluorescence-based measurements and imaging during assays.
Assay-specific multiplexed electrical contact pairs
Multiple pairs of electrical contacts on the apparatus aligned with test card contacts, providing current for heating the fluid sample, performing capacitance or voltage measurements, and facilitating multiplexed assay functionalities.
Controller configured for selectable and parallel assay execution
The controller is configured to perform various assays individually or simultaneously in parallel or series, based on user selection or test card code, including nucleic acid amplification assays (such as PCR), immunoassays (such as ELISA), ion selective assays, and image cytometry.
User interface and code reader enabling assay identification and control
A user interface for assay selection or code input, and a code reader aligned with the test card to read assay-identifying codes, allowing the controller to select and run appropriate assays without further user instruction.
Temperature sensing at target zone during assays
A sensor measuring fluid sample temperature at the target zone on the test card, with the controller utilizing this sensor to control heating during nucleic acid amplification assays.
The independent claims collectively cover a portable analyzer apparatus that integrates fluid actuation, electrical contact-based control, optical imaging, temperature sensing, code-based assay identification, and multiplexed assay execution including nucleic acid amplification, immunoassay, ion selective, and image cytometry assays on disposable test cards.
Stated Advantages
Provides rapid, high sensitivity and high specificity nucleic acid amplification assays suitable for low resource settings.
Supports multiple assay types including PCR, flow cytometry, and ELISA with a single portable device.
Uses inexpensive, disposable test cards enabling low-cost and convenient testing.
Enables early detection of infections by directly detecting pathogen nucleic acid, overcoming delays inherent in immunoassay-based testing.
Requires minimal user intervention with automatic assay selection based on test card codes or user input.
Capable of performing multiple assays individually or in parallel, increasing diagnostic flexibility and throughput.
Combines microfluidic fluid movement, electrical heating, and optical imaging to perform and analyze assays efficiently.
Documented Applications
Point-of-care in vitro diagnostics for infectious agents, including early stage detection of bacteria and viruses via polymerase chain reaction.
Flow cytometry for analyzing cell size, count, morphology, cycle phase, DNA content, and cell surface proteins.
Enzyme-linked immunosorbent assay (ELISA) for analyte concentration measurement via colorimetric analysis.
Ion selective assays measuring analytes such as sodium levels using electrical properties detected in microchannels.
Droplet-based reactions monitored via fluorescence for image cytometry.
Diagnostic testing in low resource or point-of-care settings requiring portable, rapid, and reliable analysis.
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