IP Library Granted Patent US 12,298,251
Granted Patent B2
US 12,298,251 · App. 17/423,053 · Granted May 13, 2025

System and methods for remote assessment of a sample assay for disease diagnostics

Inventors: Andrew Attila Pal (San Diego, CA); Werner Kroll (Wayland, MA); Adonis Stassinopoulos (Dublin, CA)
Assignee: Ortho-Clinical Diagnostics, Inc.
G01N21/8483G01N21/6456G01N2021/6417G01N2021/6463G01N2021/7759
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Quick Facts
Patent No.
US 12,298,251
App. No.
17/423,053
Granted
May 13, 2025
Kind
B2
Abstract

A method for performing a lateral flow assay is provided. The method includes inserting a sample cartridge ( 201 ) in a dark chamber ( 220 ) and activating a light emitter ( 251 ) in the dark chamber ( 220 ). The method includes focusing an optical coupling mechanism ( 115 a, 115 b ) in an image-capturing device ( 100 a, 100 b ) to optimize an image of a sensitive area ( 202 ) in the sample cartridge ( 201 ) and capturing, with an image capturing device ( 100 a, 100 b ), an image of a sensitive area ( 202 ) in the sample cartridge ( 201 ) after a selected period of time. The method also includes providing the image of the sensitive area ( 202 ) to a processor, wherein the processor comprises an image-capturing application ( 122 ). A system and a computer-implemented method to perform at least partially the above method are also provided.

Claims (32)

1. A method, comprising:

inserting a sample cartridge in a dark chamber;

activating a light emitter, configured to excite a fluorescence light from the sample cartridge, in the dark chamber;

positioning an optical coupling mechanism in an image-capturing device with respect to the sample cartridge to obtain a sharp image of a sensitive area in the sample cartridge;

capturing, with the image capturing device, fluorescence light scattered from the sensitive area of the sample cartridge after a selected period of time;

providing the image of the sensitive area to a processor, wherein the processor comprises an image-capturing application;

integrating along a selected direction of the image, with the image-capturing application, multiple pixel counts separately for different color pixels in a sensor array of the image-capturing device;

digitally filtering the image of the sensitive area by determining a first spatial derivative of a pixel count in a horizontal and/or vertical direction of the sample cartridge;

determining a presence of a target analyte based on an aggregate of the filtered pixel count; and

capturing a second image of the sensitive area after a second period of time, and determining the selected period of time and the second period of time based on a diffusion time for a reagent fluid in a membrane contained in the sensitive area in the sample cartridge.

2. The method of claim 1 , further comprising interacting a user sample containing a biological residual from a user with a reagent, in the sample cartridge.

3. The method of claim 1 , wherein activating the light emitter in the dark chamber comprises activating a fluorescence excitation source.

4. The method of claim 1 , wherein providing the image of the sensitive area to the processor comprises storing the image of the sensitive area in a memory of the image capturing device, and transmitting the image of the sensitive area over a network to a remote server or to a database.

5. The method of claim 1 , wherein capturing the image of the sensitive area comprises capturing a digital image including discrete values associated with an array of pixels in the image-capturing device, the method further comprising applying a spatial filter and a color filter to the digital image to determine a presence of a target agent in the sensitive area of the sample cartridge.

6. The method of claim 1 , further comprising determining the selected period of time according to a threshold of an intensity of a light captured by the image-capturing device from a control portion of the sensitive area.

7. The method of claim 1 , wherein capturing the image of the sensitive area in the image-capturing device comprises storing the image as a fluorescence background image.

8. The method of claim 1 , wherein using an image-capturing device to capture an image of a sensitive area in the sample cartridge comprises capturing an image of a fluorescent fiducial mark excited by the light emitter, and identifying the sensitive area in the sample cartridge based on a shape and location of the fluorescent fiducial mark.

9. The method of claim 1 , wherein capturing the image of the sensitive area after a selected period of time comprises one of: (i) capturing multiple images of the sensitive area at a selected periodicity, or (ii) capturing a video recording of a sample assay as it is diffusively transported along the sensitive area in the sample cartridge.

10. A computer-implemented method, comprising:

identifying, upon receipt of a user input, a fiduciary figure in a bottom side of an enclosure with an image-capturing device;

adjusting, in the image-capturing device, an optical coupling to obtain a sharp image of the fiduciary figure;

identifying a sensitive area of a sample cartridge within a field of view of the optical coupling;

finding a border of the sensitive area of the sample cartridge and applying geometrical transformations on an area delimited by the border of the sample cartridge;

identifying a target region within the sensitive area of the sample cartridge;

integrating, with the image-capturing application, multiple pixel counts separately for different color pixels in a sensor array of the image-capturing device;

extracting a value of a selected color for multiple pixels in the target region;

determining a presence of a target analyte when the value of the selected color is greater than a pre-selected threshold; and

capturing a second image of the sensitive area after a second period of time, and determining the selected period of time and the second period of time based on a diffusion time for a reagent fluid in a membrane contained in the sensitive area in the sample cartridge.

11. The computer-implemented method of claim 10 , further comprising removing a horizontal skew and a vertical skew to adjust an image of the sensitive area of the sample cartridge.

12. The computer-implemented method of claim 10 , wherein adjusting an optical coupling comprises filtering an image of the sensitive area of the sample cartridge to remove a color and a spatial artifact from the sensitive area of the sample cartridge.

13. The computer-implemented method of claim 10 , wherein adjusting an optical coupling comprises finding a scale factor between an image of the sensitive area of the sample cartridge and the sample cartridge.

14. The computer-implemented method of claim 10 , wherein extracting a value comprises spatially filtering an image and spectrally filtering the image to obtain a selected group of pixel values to form the value of the selected color.

Assignments (5)
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 →
RELEASE (REEL 060220 / FRAME 0711) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
Reel/Frame 072577/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: QUIDEL CORPORATION
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 068657/0827 →
SECURITY AGREEMENT Recorded May 31, 2022
From: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 060220/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 18, 2022
From: PAL, ANDREW ATTILA; KROLL, WERNER; STASSINOPOULOS, ADONIS
To: QUIDEL CORPORATION
Reel/Frame 059053/0640 →
Continuity (3)
Provisional Application 62843846 · May 6, 2019
Provisional Application 62792813 · Jan 15, 2019
Related Publication 20220065795A1 · Mar 3, 2022
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