Indicator-based analysis of a sample

Inventors

Fine, Alan Marc

Assignees

Alentic Microscience Inc

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Publication Number

US-12517117-B2

Patent

Publication Date

2026-01-06

Expiration Date


Abstract

An indicator of a first type and an indicator of a second type are attached to a unit of a chemical component in a sample to form a first multi-indicator complex. The first multi-indicator complex includes the unit of the chemical component, the indicator of the first type, and the indicator of the second type. The indicator of the first type and the indicator of the second type have different discernible characteristics. An image of the sample, including the first multi-indicator complex corresponding to the unit of the chemical component, is captured by an image sensor. Based on a first image of the sample, a count is generated of multi-indicator complexes that include an indicator of the first type and an indicator of the second type, including the first multi-indicator complex. Based on the count, a presence or a level of the chemical component in the sample is identified.

Core Innovation

The invention relates to indicator-based chemical analysis in which a unit of a chemical component in a sample is attached to a location on a first surface. The unit of the chemical component is attached to a first indicator, or attachment of the unit to the location causes displacement of a second indicator that was previously attached to the location. An image of the location on the first surface is captured by an image sensor comprising an array of light sensitive elements.

The capturing of the image is performed while the sample is in a gap between the first surface and a second surface, in contact with the first surface and the second surface. The second surface is in-between the first surface and the array of light-sensitive elements, and the first surface faces the array of light sensitive elements. Based on the image, it is identified that the first indicator is attached to the unit of the chemical component attached to the location, or that the second indicator has been displaced from the location.

Using the image-based identification of indicator attachment or indicator displacement, the method determines a presence or a level of the chemical component in the sample. The document further discusses multi-indicator complexes formed from two indicator types with different discernible characteristics attached to a unit of a chemical component, and imaging and processing to count relevant complexes or indicators for presence or quantitative level determination.

Additional variants described include competitive assays in which decreased complex formation or displacement of indicators is used to provide an image-based signal, including displacement to singleton or empty locations. The document also describes optional location-based attachment units on sensor or lid surfaces, and multiplexing based on indicator characteristics such as color, spectra, shape, and size.

Claims Coverage

The document contains one independent claim describing an imaging-based indicator attachment/displacement method with a specific sensor gap geometry. The independent claim’s core inventive features are combined into a single method for determining the presence or level of a chemical component in a sample.

Indicator attachment or displacement detected by imaging

Attaching a unit of a chemical component in a sample to a location on a first surface, wherein the unit of the chemical component is attached to a first indicator, or attachment of the unit causes displacement of a second indicator previously attached to the location, and identifying based on the image that the first indicator is attached to the unit or that the second indicator has been displaced from the location.

Image capture geometry with a gap and intervening second surface

Capturing, by an image sensor comprising an array of light sensitive elements, an image of the location on the first surface while the sample is in a gap between the first surface and a second surface and in contact with the first surface and the second surface, wherein the second surface is in-between the first surface and the array and the first surface faces the array of light sensitive elements.

Determining presence or level from indicator attachment/displacement

Determining, based on the first indicator being attached to the unit of the chemical component attached to the location or the second indicator having been displaced from the location, a presence or a level of the chemical component in the sample.

Across the independent claim, the inventive coverage combines indicator attachment or displacement at defined surface locations, imaging captured with a gap geometry where an intervening second surface lies between the first surface and the sensor array, and determining the presence or level of the chemical component from the image-based identification of indicator attachment or displacement.

Stated Advantages

Determines a presence or a level of the chemical component in the sample based on image-based identification of indicator attachment or indicator displacement.

Allows identification of whether the first indicator is attached to the unit of the chemical component or whether the second indicator has been displaced from the location based on the captured image.

Supports quantitative approaches using a complex index and a standard curve, as discussed in the document.

Supports competitive assay signaling via decreased complex formation or displacement to singleton or empty locations, as discussed in the document.

Enables multiplexing based on indicator characteristics such as color, spectra, shape, and size, as discussed in the document.

Enables point-of-care use with whole blood, including combined CBC and chemical analysis, as discussed in the document.

Documented Applications

Point-of-care chemical analysis with whole blood, including combined CBC and chemical analysis.

Multiplexed chemical analysis using indicator characteristics to distinguish multiple targets or indicators, as discussed in the document.

Competitive assays using decreased complex formation or displacement to singleton or empty locations, as discussed in the document.

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