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Publication Number
US-12493027-B2
Publication Date
2025-12-09
Expiration Date
Abstract
Among other things, two or more different antibodies are caused to bind to one or more units of a chemical component in a sample. Each of the antibodies is attached to one or more beads (e.g., microbeads). The sample is situated on a surface of an image sensor. At the image sensor, light is received originating at a light source that is other than the beads. The received light includes light reflected by, refracted by, or transmitted through the beads. At least one image of the sample is processed to separately enumerate individual beads and complexes of two or more of the beads attached to the two or more antibodies that are bound to a unit of the chemical component. The results of the processing are used to identify a presence or a level of the chemical component in the sample.
Core Innovation
The invention provides a computer-implemented method for identifying a presence or a level of a chemical component in a sample by obtaining one or more images of the sample and using those images to count bead-based binding events. The sample includes multi-bead complexes, where a unit of the chemical component is bound to two or more beads, and singleton beads that are not in multi-bead bound complexes with units of the chemical component. The method uses the images to support identification based on both multi-bead complex counts and singleton bead counts.
The method determines a count of separate multi-bead complexes in the one or more images by associating the two or more beads of each multi-bead complex with one another based on a proximity of the two or more beads. It also determines a count of singleton beads in the one or more images. A stored relationship is accessed between the count of separate multi-bead complexes, the count of singleton beads, and a concentration of the chemical component.
Using the stored relationship, the method identifies, based on the count of separate multi-bead complexes and the count of singleton beads, the presence or the level of the chemical component in the sample. The disclosed approach further includes counting multi-bead complexes, including bead complexes such as doublets and triplets, and mapping a complex index to a stored relationship or standard curve to determine presence and/or concentration.
Claims Coverage
The independent claim covers a computer-implemented image-based identification of the presence or level of a chemical component by counting multi-bead complexes and singleton beads in images, associating beads within complexes based on proximity, and mapping both counts to a concentration via a stored relationship. Overall, the claim is structured around four inventive elements: image acquisition, image-based counting and association, stored relationship access, and presence or level identification from the mapped counts.
Image-based multi-bead and singleton bead counting
Obtaining one or more images of the sample, wherein the sample comprises multi-bead complexes, each multi-bead complex comprising a unit of the chemical component bound to two or more beads, and singleton beads that are not in multi-bead bound complexes with units of the chemical component.
Proximity-based association of beads into complexes
Determining a count of separate multi-bead complexes in the one or more images by associating the two or more beads of each multi-bead complex with one another based on proximity.
Stored relationship between counts and concentration
Accessing a stored relationship between the count of separate multi-bead complexes, the count of singleton beads, and a concentration of the chemical component.
Presence or level identification from mapped bead counts
Identifying, based on the stored relationship, the count of separate multi-bead complexes, and the count of singleton beads, the presence or the level of the chemical component in the sample.
Across the independent claim, identification of analyte presence or level is enabled by image-based counting of both multi-bead complexes and singleton beads, proximity-based association of beads into multi-bead complexes, and mapping those counts through an accessed stored relationship to determine presence or concentration.
Stated Advantages
Enables identifying a presence or a level of a chemical component in a sample based on image-derived counts of multi-bead complexes and singleton beads.
Uses a stored relationship between bead counts and concentration to determine presence or level of the chemical component.
Supports determining multi-bead complex counts by associating beads based on proximity, rather than relying only on singleton bead counts.
Documented Applications
Bead-based, non-fluorescence chemical analysis at point-of-care on a contact image sensor, including mapping complex index to determine presence and/or concentration.
Multiplexing based on differing bead optical characteristics for multiple targets in the same imaging context.
Optional integration with complete blood count (CBC) imaging using the same sensor/illumination setup.
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