Apparatus and method for image analysis of a fluid sample on a test card to determine whether the fluid sample tests positive or negative for a bacterium or virus
Inventors
Patel, Tej Rushikesh • Revilla, Ryan Alan • Heltsley, Roy James
Assignees
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Publication Number
US-12406356-B2
Publication Date
2025-09-02
Expiration Date
Abstract
An apparatus and method for image analysis of a fluid sample on a test card are disclosed. An example apparatus for analyzing a fluid sample includes a camera imaging device configured to record a plurality of images of the fluid sample while located within a target zone of a fluid microchannel of a test card. The example apparatus also includes a controller configured to perform a cytometry analysis on the fluid sample to determine whether the fluid sample tests positive or negative for a bacteria or virus.
Core Innovation
The invention relates to a point-of-care diagnostic system that analyzes a fluid sample on a disposable test card using an assay device with a camera imaging device and a light source. The system positions a camera within a housing to record an image of a target zone on the test card and illuminates at least the target zone. After the test card is inserted through a slot, a controller activates the light source, controls image acquisition, and performs image analysis of the target zone to support a positive or negative determination for a bacterium or a virus.
The system analyzes recorded images to distinguish wanted objects from unwanted objects within the target zone. The wanted objects include at least one of nucleic acid molecules or cells, while unwanted objects include objects that do not have at least one of an average size or an average shape of the nucleic acid molecules or cells. The analysis is further described as using fluorescence and image-based bin-based fluorescence analysis with brightness thresholds and bin exclusion or weighting to identify wanted object signals while suppressing contributions from unwanted objects such as air bubbles.
The disclosed approach supports fluorescence-based detection and decision-making that is linked to diagnostic outputs. The documented analysis includes distinguishing signal patterns associated with amplification and fluorescence measurement, including amplification curve and melt curve crossover analysis, and determining positive or negative results from the distinguished wanted-object information. The system is also described as capable of further supported analyses such as cytometry analysis and other assay types, with outputs including determination of positivity/negativity and additional reporting such as titer-based colony counting.
Claims Coverage
The partial content identifies one independent claim (clm-00001). It contains a single overall inventive framework: image-based analysis of a target zone on a test card using a camera and light source, followed by controller-driven distinction of wanted versus unwanted objects and a positive/negative determination for a bacterium or a virus; the claims center on distinguishing nucleic acid molecules or cells from objects lacking matching average size or average shape characteristics.
Imaging a target zone on a test card after insertion
A device having a housing defining a slot sized to receive a test card, with a camera imaging device positioned within the housing configured to record an image of a target zone on the test card.
Illumination of the target zone with a light source
A device with a light source positioned within the housing configured to illuminate at least the target zone on the test card.
Controller activation, image capture, and wanted-unwanted object distinction
A controller positioned within the housing communicatively coupled to the camera imaging device and the light source, where the processor executes instructions to activate the light source after detecting the test card was inserted through the slot, control the camera imaging device to record at least one image of the target zone, and analyze the at least one image to distinguish wanted objects from unwanted objects within the at least one image.
Positive/negative determination for bacterium or virus based on wanted objects
The controller determines whether the fluid sample tests positive or negative for a bacterium or a virus based on the wanted objects, where the wanted objects include at least one of nucleic acid molecules or cells and the unwanted objects include objects that do not have at least one of an average size or an average shape of the at least one of nucleic acid molecules or cells.
Across the single independent claim, the inventive coverage focuses on an apparatus that images an illuminated target zone on a test card, then uses controller-executed image analysis to separate wanted objects (nucleic acid molecules or cells) from unwanted objects (objects lacking matching average size and/or average shape) and uses that separation to determine whether the fluid sample is positive or negative for a bacterium or a virus.
Stated Advantages
Provides a positive or negative determination for a bacterium or a virus based on distinguishing wanted objects (nucleic acid molecules or cells) from unwanted objects.
Documented Applications
Point-of-care diagnostic analysis of a fluid sample for detecting bacteria or viruses using imaging of a target zone on a test card.
Support for nucleic-acid and cell detection within the target zone as part of diagnostic determinations for bacterium or virus.
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