IP Library › Granted Patent US 12,656,310
Granted Patent B2
US 12,656,310 · App. 18/457,201 · Granted Jun 16, 2026

Diagnostics systems and methods

Inventors: Peter Galen (Portland, OR); Umut Atakan Gurkan (Shaker Heights, OH); Muhammad Noman Hasan (Cleveland, OH); James Daren Bledsoe (Portland, OR); Tyler Witte (Portland, OR)
Assignee: Hemex Health, Inc.
G01N27/44721G01N21/6428G01N33/68G01N2021/6439
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Quick Facts
Patent No.
US 12,656,310
App. No.
18/457,201
Granted
Jun 16, 2026
Kind
B2
Abstract

A diagnostic system that includes a cartridge and a reader is discussed herein. The cartridge can contain a patient sample, such as a blood sample. The cartridge is inserted into the reader and the patient sample is analyzed. The reader contains various analysis systems, such as an electrophoresis detection system that uses electrophoresis testing to identify and quantify various components of the blood sample. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disorder, condition, disease, or infection of the patient.

Claims (62)

1 . An electrophoresis detection system, comprising:

an illumination source structured to:

during an assay run on an electrophoresis strip, emit a first stimulus,

during the assay run on the electrophoresis strip, emit a second stimulus, and

a processing circuitry programmed to:

generate an instruction to cause the illumination source to emit the first stimulus and the second stimulus;

receive multiple optical images of the electrophoresis strip, each of the multiple optical images captured during the assay run, including a first image captured at a first time point during the assay run when the first stimulus is emitted and a second image captured at a second time point during the assay run when the second stimulus is emitted;

during the assay run, detect band detection data based on the multiple optical images of the electrophoresis strip, the band detection data having:

a detection characteristic generated from the first image, the detection characteristic of the first image detected in response to emission of the first stimulus including band thickness and band speed of one or both of a first band and a second band, respectively, in the first image, and

a detection characteristic generated from the second image, the detection characteristic of the second image detected in response to emission of the second stimulus including band thickness and band speed of one or both of the first band and the second band, respectively, in the second image;

during the assay run, identify a component associated with the band detection data based on the detection characteristic generated from the first image and the detection characteristic generated from the second image; and

during the assay run, transmit an identifier of the component to an output.

2 . The electrophoresis detection system of claim 1 , wherein the first stimulus includes a first wavelength and the second stimulus includes a second wavelength.

3 . The electrophoresis detection system of claim 2 , wherein the first wavelength and the second wavelength have the same value or are within a range of values.

4 . The electrophoresis detection system of claim 2 , wherein the first wavelength and the second wavelength have different values.

5 . The electrophoresis detection system of claim 2 , wherein the component has a peak absorption in an ultraviolet (UV) spectrum.

6 . The electrophoresis detection system of claim 2 , wherein the first wavelength is in an ultraviolet (UV) spectrum and the second wavelength is in a visible spectrum.

7 . The electrophoresis detection system of claim 2 , wherein the first wavelength or the second wavelength is within a range of 375-440 nm.

8 . The electrophoresis detection system of claim 1 , wherein the component conjugated with multiple stains, a first stain of the multiple stains having a peak absorption at a first wavelength of the first stimulus or within a range that includes the first wavelength, and a second stain of the multiple stains having a peak absorption at a second wavelength of the second stimulus or within a range that includes the second wavelength.

9 . The electrophoresis detection system of claim 8 , wherein the first wavelength and the second wavelength are the same.

10 . The electrophoresis detection system of claim 8 , wherein the first wavelength and the second wavelength are different.

11 . The electrophoresis detection system of claim 8 , wherein the component is a first component conjugated to the first stain, and the processing circuitry is further programmed to:

identify the first component based on the detection characteristic generated from the first image and the detection characteristic generated from the second image of the first band of the band detection data, and

identify a second component based on the detection characteristic generated from the first image and the detection characteristic generated from the second image of the second band of the band detection data.

12 . The electrophoresis detection system of claim 8 , wherein at least one of the first stain and the second stain are fluorescent, and the detection characteristic in the first image and the detection characteristic in the second image includes one or both of:

an emission by the first stain when excited by the first stimulus, and

an emission by the second stain when excited by the second stimulus.

13 . The electrophoresis detection system of claim 1 , wherein the detection characteristic generated by the first image includes a detected emission value of the component in response to the first stimulus emitted, and the detection characteristic generated by the second image includes a detected emission value of the component in response to the second stimulus emitted.

14 . The electrophoresis detection system of claim 1 , wherein one or both of the detection characteristic generated by the first image and the detection characteristic generated by the second image include one or more of location, emission intensity, absorption intensity, relative comparison of a parameter of a band in the multiple optical images, or a relative comparison of a parameter of the first band of the band detection data to the parameter of one or more other bands of the band detection data in the multiple optical images of the electrophoresis strip.

15 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to detect the band detection data from the first band and the second band on the electrophoresis strip in more than one of the multiple optical images, and determine a position with respect to time of each of the first band and the second band between the more than one of the multiple optical images.

16 . The electrophoresis detection system of claim 15 , further comprising:

a detection module configured to, during the assay run:

generate a first band signal representing a combination of the detection characteristic generated by the first image and the detection characteristic generated by the second image of the first band of the band detection data,

generate a second band signal representing a combination of the detection characteristic generated by the first image and the detection characteristic generated by the second image of the second band of the band detection data,

combine the first band signal and the second band signal into a combined band detection signal, and

the processing circuitry is further programmed to, during the assay run, identify the component associated with the band detection data based on a characteristic of the combined band detection signal.

17 . The electrophoresis detection system of claim 1 , further comprising an optical detector configured to:

during the assay run, capture the first image of the electrophoresis strip at the first time point and the second image of the electrophoresis strip at the second time point, and

generate the band detection data based on the first image and the second image.

18 . The electrophoresis detection system of claim 1 , wherein the multiple optical images received by the processing circuitry includes a video of the electrophoresis strip over a time period, wherein the video is acquired during the assay run.

19 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further configured to output diagnostic results based on one or more of the band detection data, the component, or the identifier.

20 . The electrophoresis detection system of claim 19 , wherein one or both of the identifier and the band detection data is transmitted to a remote computing device, network, or server.

21 . The electrophoresis detection system of claim 1 , wherein the component includes a type or variant of hemoglobin.

22 . The electrophoresis detection system of claim 1 , wherein the component includes a protein.

23 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to determine a quantification parameter of the band detection data, the quantification parameter including a quantity or relative quantity of the component.

24 . The electrophoresis detection system of claim 23 , wherein the quantification parameter of the band detection data further includes one or more of position or intensity of a band over time during a time period that occurs during the assay run.

25 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to determine a qualification parameter of the band detection data.

26 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to, during the assay run, continuously transmit the multiple optical images to the output.

27 . The electrophoresis detection system of claim 1 , wherein:

the detection characteristic of the first image includes a light intensity value of the first band and a light intensity value of the second band in the first image, and

the detection characteristic of the second image includes a light intensity value of the first band and a second light intensity value of the second band in the second image, and

wherein the processing circuitry is further programmed to, during the assay run, detect the band detection data based on a difference or a relative change of the detection characteristic of the first image to the detection characteristic of the second image.

28 . The electrophoresis detection system of claim 27 , wherein the processing circuitry is further configured to, during the assay run, detect the band detection data based on the difference or the relative change of the detection characteristic increasing or decreasing during the assay run from the first image to the second image.

29 . The electrophoresis detection system of claim 1 , wherein:

the detection characteristic of the first image includes a characteristic of a first signal representing light intensity values across a band width of the first band in the first image and a characteristic of a second signal representing light intensity values across a band width of the second band in the first image, and

the detection characteristic of the second image includes a characteristic of a first signal representing light intensity values across a band width of the first band in the second image and a characteristic of a second signal representing light intensity values across a band width of the second band in the second image.

30 . The electrophoresis detection system of claim 29 , wherein the characteristics of the first signal and the second signal in the detection characteristic in the first image and the detection characteristic in the second image, respectively, include a waveform shape of the first signal and the second signal in the first and second images, respectively.

31 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to compare the detection characteristic generated by the first image and the detection characteristic generated by the second image and, during the assay run, to identify the component based on the comparison of the detection characteristic generated by the first image and the detection characteristic of the second image.

32 . The electrophoresis detection system of claim 1 , wherein the second image includes a band of interest and the first image does not include the band of interest.

33 . The electrophoresis detection system of claim 1 , wherein the processing circuitry is further programmed to:

determine an effectiveness of the assay run based on the detection characteristic of the first image and the detection characteristic of the second image, and

based on the determined effectiveness of the assay run, generate an instruction to stop, continue, or re-run the assay or to output an error message or suggested solution.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 5, 2023
From: GALEN, PETER; GURKAN, UMUT ATAKAN; HASAN, MUHAMMAD NOMAN; BLEDSOE, JAMES DAREN; WITTE, TYLER
To: HEMEX HEALTH, INC.
Reel/Frame 065134/0968 →
Continuity (4)
Continuation 16912346 · Jun 25, 2020
Provisional Application 62987237 · Mar 9, 2020
Provisional Application 62866554 · Jun 25, 2019
Related Publication 20230400431A1 · Dec 14, 2023
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