IP Library Granted Patent US 12,165,373
Granted Patent B2
US 12,165,373 · App. 18/456,451 · Granted Dec 10, 2024

Software and algorithms for use in remote assessment of disease diagnostics

Inventors: Houman Yaghoubi (San Diego, CA); Curtis Marsh (San Diego, CA); Scott Rongey (San Diego, CA); Ziad Salem (San Diego, CA); Adonis Stassinopoulos (Del Mar, CA)
Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.
G06V10/17G06T7/0014G06T7/12G06T7/168G06T7/80G06V10/25G06T2207/20081G06T2207/20084G06T2207/30168G06V10/247
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Quick Facts
Patent No.
US 12,165,373
App. No.
18/456,451
Granted
Dec 10, 2024
Kind
B2
Abstract

A method to assess a subject diagnosis is provided. The method includes receiving an image from an image-capturing device, the image comprising an area of interest in a test cartridge, and finding a border of the area of interest of the test cartridge and applying a geometrical transformation on an area delimited by the border of the test cartridge to bring the image of the area of interest in the test cartridge to a selected size and a selected shape. The method also includes identifying a target region within the area of interest of the test cartridge, evaluating a quality of the image based on a characteristic feature of the target region, and providing commands to adjust an optical coupling in the image-capturing device when the quality of the image is lower than a selected threshold.

Claims (48)

1. A computer-implemented method, comprising:

receiving, from an image-capturing device, one or more images of an area of interest of a substrate;

finding a border of the area of interest and applying a geometrical transformation on an area delimited by a border of the substrate to bring an image of the area of interest to a selected size and a selected shape;

identifying a target region within the area of interest;

evaluating a quality of the one or more images based on a characteristic feature of the target region;

providing commands to adjust an optical coupling and a frequency rate for collecting the one or more images in the image-capturing device when the quality of the one or more images is lower than a selected threshold; and

when the quality of the one or more images meets the selected threshold, assessing a subject diagnostic based on digital analysis of the one or more images.

2. The computer-implemented method of claim 1 , wherein evaluating the quality of the one or more images further comprises evaluating an image of a background sample or a blank sample.

3. The computer-implemented method of claim 1 , further comprising normalizing an intensity value for a pixel in an image of the area of interest relative to a selected intensity value from multiple pixels in the image of the area of interest.

4. The computer-implemented method of claim 1 , wherein the target region comprises a process control area including at least one of a positive control area or a negative control area, and evaluating a quality of the one or more images comprises evaluating a signal intensity in the process control area.

5. The computer-implemented method of claim 1 , wherein identifying a target region within the area of interest comprises identifying at least a test line and a control line in the area of interest within a field of view of the one or more images.

6. The computer-implemented method of claim 1 , further comprising displaying the one or more images in a computer display, and including a viewing guide in the computer display, the viewing guide overlapping at least a portion of the digital analysis of the one or more images.

7. The computer-implemented method of claim 1 , further comprising displaying a test result in a computer display, and not displaying the one or more images.

8. The computer-implemented method of claim 1 , wherein evaluating a quality of the one or more images comprises comparing a selected feature of the one or more images with a value associated with selected features of multiple images having known quality values.

9. A computer-implemented method, comprising:

receiving, from an image-capturing device, a first image of an area of interest of a substrate at a first time;

receiving, from the image-capturing device, a second image of the area of interest at a second time;

forming a volume of interest, having a time dimension between the first image and the second image;

associating a dynamic value for an assay based on the time dimension;

identifying a target region within the area of interest;

providing a first identifier code identifying the image-capturing device;

evaluating a quality of the first image based on a characteristic feature of the target region, the dynamic value for the assay, and on the first identifier code; and

when a quality of the first image meets a selected threshold, assessing a subject diagnostics based on a digital analysis of the first image.

10. The computer-implemented method of claim 9 , further comprising retrieving a calibration table from software using the first identifier code, the calibration table associated with the image-capturing device, and indicative of a signal value that is a threshold for evaluating the quality of the first image.

11. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises selecting a threshold for a signal intensity in a process control area within the target region based on the first identifier code.

12. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises verifying that a signal intensity at an end of a test channel in the substrate is higher than a selected threshold indicative that a sample flowed to the end.

13. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises verifying that a reference line appears at a selected location.

14. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises verifying that a signal intensity of a negative control is less than a selected threshold indicative of an assay interference.

15. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises verifying an exposure and a focus.

16. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises verifying that a valid crop in the first image contains features from a substrate.

17. The computer-implemented method of claim 9 , wherein evaluating a quality of the first image comprises monitoring a physical attribute of the image-capturing device.

18. The computer-implemented method of claim 17 , wherein the physical attribute is internal temperature of the image-capturing device.

19. A computer-implemented method, comprising:

retrieving a first image associated with an assay in a substrate carrying a biological sample from a user for a disease diagnostic;

receiving a second image comprising a same area of interest in the substrate, at a second time;

forming a volume of interest, having a time dimension between the first image and the second image;

selecting a digital portion including the volume of interest;

modifying, with a model, the digital portion of the first image to obtain a weighted value of the digital portion associating a dynamic value for an assay in the substrate based on the time dimension;

determining, based on the weighted value of the digital portion and the model, a diagnostic value; and

determining a certainty level for the diagnostic value based on a second weighted value from a second digital portion of the second image and the dynamic value for the assay in the substrate.

20. The computer-implemented method of claim 19 , wherein retrieving the first image comprises receiving an image from a client device via a remote network communication channel.

21. The computer-implemented method of claim 19 , wherein retrieving the first image comprises accessing a database including multiple images of multiple assays including different biological samples from multiple users.

22. The computer-implemented method of claim 19 , further comprising updating the model when the certainty level for the diagnostic value is less than a predetermined value.

23. The computer-implemented method of claim 19 , wherein modifying the digital portion of the first image comprises convoluting a value of the digital portion of the first image with multiple values of adjacent digital portions of the first image according to a weighting coefficient in the model.

24. The computer-implemented method of claim 19 , wherein the assay is an immunoassay.

25. The computer-implemented method of claim 19 , wherein the assay is a lateral flow immunoassay.

26. The computer-implemented method of claim 19 , wherein the assay is a molecular diagnostic assay.

27. The computer-implemented method of claim 26 , wherein the molecular diagnostic assay comprises amplification of a molecular target and binding of the molecular target to a surface for visualization.

Assignments (3)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: QUIDEL CORPORATION
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 068657/0827 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2023
From: YAGHOUBI, HOUMAN; MARSH, CURTIS; RONGEY, SCOTT; SALEM, ZIAD; STASSINOPOULOS, ADONIS
To: QUIDEL CORPORATION
Reel/Frame 064780/0421 →