# US 11,112,406 B2 · System and method for digital remote primary, secondary, and tertiary color calibration via smart device in analysis of medical test results

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- Number: US 11,112,406 B2
- Document ID: US11112406B2
- Status: Granted
- Kind: B2
- Application number: 16/010,046
- Filed: 2018-06-15
- Published: 2019-12-19
- Granted: 2021-09-07
- Earliest claimed: 2018-06-15
- Assignees: Reliant Immune Diagnostics, Inc.
- Applicants: Reliant Immune Diagnostics, Inc.
- Inventors: Jovan Hutton Pulitzer; Henry Joseph Legere, III; Nicholas Solter; Dogu Baran Aydogan
- Web page: https://patentgrep.com/patent/US11112406B2

## CPC

- G01N 33/54388: {based on lateral flow}
- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- G01N 33/54389: {with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones}
- G01N 33/54391: {based on vertical flow}
- G01N 33/56983: {Viruses}
- G01N 33/76: Human chorionic gonadotropin {including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors}
- G06T 7/0012: {Biomedical image inspection}
- G06T 7/90: Determination of colour characteristics
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 30/20: for handling medical images, e.g. DICOM, HL7 or PACS
- G16H 30/40: for processing medical images, e.g. editing
- G16H 40/63: for local operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G01N 2333/185: Flaviviruses or Group B arboviruses, e.g. yellow fever virus, japanese encephalitis, tick-borne encephalitis, dengue
- G01N 2333/59: Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- G06T 2207/30204: Marker
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method for providing immunoassay test results includes collecting at least one biologic with a testing device, conjugating the biologic with particles on a conjugate pad of a test strip to create an immune complex, binding antigens or antibodies of the immune complex to antigens or antibodies of a test line, providing a software application to be stored on a mobile device having a camera; capturing an image of the testing device, including a color mosaic having at least one color value corresponding to a positive test result, comparing the color values of the test line image to the color values of the image of the color mosaic, determining if the color values of the image of the test line are within a predetermined range of the at least one color value of the image of the color mosaic corresponding to a positive test result; and presenting test results on the viewing screen.

## Claims

### Claim 1

A method for providing immunoassay test results for medical conditions, the method comprising:
collecting at least one biologic with a testing device including at least one immunoassay test strip;
conjugating the at least one biologic with particles on a conjugate pad on the at least one immunoassay test strip to create an immune complex;
receiving the immune complex at a test line on a membrane strip on the at least one immunoassay test strip, wherein the test line includes particular antigens or antibodies;
binding, if the immune complex contains antigens or antibodies capable of binding with the particular antigens or antibodies included on the test line, the antigens or antibodies of the immune complex to the particular antigens or antibodies of the test line;
producing a qualitative response on the test line if the antigens or antibodies of the immune complex are bound to the particular antigens or antibodies on the test line;
providing a software application to be stored on a mobile device, the mobile device having a camera and a viewing screen;
presenting an outlined area on the viewing screen to be aligned with borders of the testing device;
presenting on the viewing screen an alignment graphic to be aligned with an alignment target of the testing device, wherein the alignment graphic is offset from a center of the outlined area;
capturing an image of the testing device, wherein the testing device includes a color mosaic, wherein the image of the testing device includes the color mosaic, wherein the color mosaic includes at least two groups of adjacent differently-colored tiles, wherein each group of the at least two groups of differently-colored tiles is associated with a primary color, and wherein each group of the at least two groups of differently-colored tiles includes different shades of the associated primary color;
processing the image to assign mosaic color values to each of the differently-colored tiles;
retrieving known color values for the differently-colored tiles;
comparing the known color values with the mosaic color values;
performing a color shift on the mosaic color values based on the comparison of the known color values with the mosaic color values;
processing the image to determine test line color values of the pixels on the test line of the at least one immunoassay test strip;
comparing the test line color values;
determining if the test line color values are within a predetermined range of at least one color value of the mosaic color values corresponding to a positive test result; and
presenting test results on the viewing screen.

### Claim 2 (depends on 1)

The method of claim 1 further comprising:
detecting when an alignment of the outlined area and borders of the testing device has taken place, and when an alignment of the alignment graphic and the alignment target has taken place; and
capturing the image of the testing device in response to the detecting of the alignment.

### Claim 3 (depends on 1)

The method of claim 1 wherein the test line color values of the pixels of the image of the test line are averaged and an average color value of the image of the test line is compared to the mosaic color values of the differently-colored tiles.

### Claim 4 (depends on 3)

The method of claim 3 wherein a test line of one of a plurality of immunoassay test strips includes Zika virus antigens and the test line of another one of the plurality of immunoassay test strips includes antibodies suitable for binding with hCG, the method further comprising:
collecting at least one biologic with the testing device having thereon the alignment target and contacting the test line of the one of the plurality of immunoassay test strips that includes the Zika virus antigens with a biologic; and
contacting with a biologic the test line of the one of the plurality of immunoassay test strips that includes the antibodies suitable for binding with hCG.

### Claim 5 (depends on 1)

The method of claim 1, wherein the differently-colored tiles of each of the at least two groups of differently-colored tiles are immediately adjacent.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least two groups of differently-colored tiles are each disposed within the testing device and visible through one of a plurality of windows of the testing device.

### Claim 7 (depends on 1)

The method of claim 1, wherein each of the at least two groups of differently-colored tiles is arranged in an identical manner.