IP Library Granted Patent US 12,055,542
Granted Patent B2
US 12,055,542 · App. 17/333,944 · Granted Aug 6, 2024

System and methods for remote assessment of a sample assay for 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 (Dublin, CA)
Assignee: Quidel Corporation
G01N33/54373G01N21/6428G01N21/6456H04N7/183H04N23/56H04N23/62
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Quick Facts
Patent No.
US 12,055,542
App. No.
17/333,944
Granted
Aug 6, 2024
Kind
B2
Abstract

A circuit in an image-capturing device is provided. The circuit includes a light source controller configured to provide a signal to a light source when a cartridge mount has received, inside a dark chamber, a test cartridge. The circuit also includes a sensor array controller configured to activate at least one pixel in a sensor array when the light source is activated, and to receive a signal from the at least one pixel, the signal indicative of an optical intensity of a light emitted from the test cartridge. The circuit also includes a processor, configured to form a transmittable file with the signal from the at least one pixel, and a radio-frequency antenna configured to transmit the transmittable file to an external processor.

Claims (43)

1. A method for determining presence or absence of an analyte of interest, comprising:

receiving, in a client device, a radio signal from an image-capturing device when a test cartridge has been inserted in an enclosure of the image-capturing device, the test cartridge loaded with a sample;

identifying the image-capturing device through a unique ID provided through the radio signal;

pairing the image-capturing device and the client device;

triggering multiple functions in the image-capturing device according to a schedule, the multiple functions comprising turning ‘on’ a light source in the image-capturing device;

receiving a data stream from the image-capturing device, the data stream comprising a first image of the test cartridge;

adjusting the first image of the test cartridge to improve an image quality and to reduce a size of the data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge;

determining the presence of a target analyte in the sample based on the first image of the test cartridge; and

receiving, from the image-capturing device, a temperature value for a temperature inside an enclosure holding the test cartridge in the image-capturing device, and adjusting a performance characteristic of the sensor array in the image-capturing device.

2. A method for determining presence or absence of an analyte of interest, comprising:

receiving, in a client device, a radio signal from an image-capturing device when a test cartridge has been inserted in an enclosure of the image-capturing device, the test cartridge loaded with a sample;

identifying the image-capturing device through a unique ID provided through the radio signal;

pairing the image-capturing device and the client device;

triggering multiple functions in the image-capturing device according to a schedule, the multiple functions comprising turning ‘on’ a light source in the image-capturing device;

receiving a data stream from the image-capturing device, the data stream comprising a first image of the test cartridge; wherein receiving the data stream comprises receiving a testing metadata from the image-capturing device, the testing metadata comprising information in a fiduciary label of the test cartridge;

adjusting the first image of the test cartridge to improve an image quality and to reduce a size of the data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge; and

determining the presence of a target analyte in the sample based on the first image of the test cartridge.

3. The method of claim 1 , further comprising providing a power to the image-capturing device via a universal serial bus coupled to the client device.

4. A method for determining presence or absence of an analyte of interest, comprising:

receiving, in a client device, a radio signal from an image-capturing device when a test cartridge has been inserted in an enclosure of the image-capturing device, the test cartridge loaded with a sample;

identifying the image-capturing device through a unique ID provided through the radio signal;

pairing the image-capturing device and the client device;

triggering multiple functions in the image-capturing device according to a schedule, the multiple functions comprising turning ‘on’ a light source in the image-capturing device;

receiving a data stream from the image-capturing device, the data stream comprising a first image of the test cartridge, wherein the first image is collected at a first working distance;

adjusting the first image of the test cartridge to improve an image quality and to reduce a size of the data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge;

determining the presence of a target analyte in the sample based on the first image of the test cartridge;

receiving a second image in the data stream at a second working distance;

evaluating a quality of a measurement based on a comparison of the first image and the second image to determine which of the first and second images exhibits less lens aberration.

5. A method for capturing an image of a lateral flow assay from a sample in a test cartridge, comprising:

receiving, from a presence sensor, a signal indicative of a presence of the test cartridge within an enclosure;

providing, to a client device, a radio signal requesting a start of a measurement to identify the presence of a target analyte in the sample, the radio signal comprising a unique ID;

actuating a light shield to enclose a distal end of the test cartridge in response to insertion of the test cartridge into the enclosure and triggering the start of the measurement;

collecting a first image of the test cartridge from a sensor array; determining a quality of the measurement based on the first image;

adjusting the first image of the test cartridge to improve an image quality and to reduce a size of a data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge; and

providing, to the client device, the data stream comprising a subject diagnostic based on a digital analysis of the image when the quality of the measurement is higher than a selected threshold.

6. The method of claim 5 , further comprising turning ‘on’ a light source to illuminate the test cartridge for a selected time period, upon receipt of a trigger signal from the client device, and transmitting a light image to the client device, the light image collected from the sensor array when the light source is on.

7. The method of claim 5 , wherein collecting the first image comprises collecting the image of the test cartridge while a light source is turned ‘off’.

8. The method of claim 5 , further comprising cropping the first image to capture a selected area of interest from the lateral flow assay.

9. The method of claim 1 , wherein triggering multiple functions in the image-capturing device further comprises adjusting a performance setting in a sensor array in the image-capturing device, the performance setting comprising one of an exposure time, or a data transfer format.

10. The method of claim 2 , wherein triggering multiple functions in the image-capturing device further comprises adjusting a performance setting in a sensor array in the image-capturing device, the performance setting comprising one of an exposure time, or a data transfer format.

11. The method of claim 2 , further comprising providing a power to the image-capturing device via a universal serial bus coupled to the client device.

12. The method of claim 4 , wherein triggering multiple functions in the image-capturing device further comprises adjusting a performance setting in a sensor array in the image-capturing device, the performance setting comprising one of an exposure time, or a data transfer format.

13. The method of claim 4 , further comprising providing a power to the image-capturing device via a universal serial bus coupled to the client device.

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 Jul 20, 2021
From: YAGHOUBI, HOUMAN; MARSH, CURTIS; RONGEY, SCOTT; SALEM, ZIAD; STASSINOPOULOS, ADONIS
To: QUIDEL CORPORATION
Reel/Frame 056911/0661 →