Quantifying color changes of chemical test pads induced concentrations of biological analytes under different lighting conditions

• US 9,285,323 B2
• Filed: 02/27/2015
• Issued: 03/15/2016
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: Healthy.io, Ltd.
• Original Assignee: Scanadu Incorporated
• Inventors: Burg, Bernard, Zizi, Martin, Rowe, Aaron Alexander, Smart, Anthony, De Brouwer, Walter
• Primary Examiner(s): Chowdhury, Tarifur
• Assistant Examiner(s): RAHMAN, MD M
• Application Number:
  US14/633,513
• Publication Number:
  US 20150308961A1
• Time in Patent Office: 382 Days
• Field of Search: 356/402
• US Class Current: 1/1
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/79 Photometric titration
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 2201/12 Circuits of general importance; Signal processing
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02

Abstract

Color quantification of chemical test pads and titration of analytes can be performed under different lighting conditions. In one embodiment, the lighting condition is estimated under which a digital image is captured and utilized to select a set of reference colors from which the quantified color is compared to determine the titration. In another embodiment, a plurality of comparisons are made with different lighting conditions with the result having the highest confidence level being selected to determine the titration.

Claims

1. A method for quantifying color change of at least one test medium on a diagnostic instrument, the method comprising:

with a digital camera, capturing a digital image of at least a portion of the diagnostic instrument that has been exposed to a biological sample, the diagnostic instrument comprising at least one color reference including a plurality of reference samples of different colors and a plurality of test medium respectively having a plurality of reagents, each reagent changing color in response to concentration of a particular analyte in the biological sample;

identifying at least one reference sample of the plurality of reference samples for at least one of the plurality of test medium in the diagnostic instrument;

determining a dominant camera-captured color of the at least one reference sample and a dominant camera-captured color of the at least one test medium;

correcting the dominant camera-captured color of the at least one test medium, based on a color correction factor derived at least in part from the dominant camera-captured color of the at least one reference sample, to determine a corrected test medium color;

performing a plurality of comparisons of the corrected test medium color to a plurality of different sets of possible test medium colors corresponding to predetermined analyte concentrations to determine a plurality of potential test results, wherein each of the different sets of possible test medium colors is responsive to a different lighting condition; and

selecting a test result including an analyte concentration of the biological sample out of the plurality of potential test results in response to a measurement having a highest level of confidence.

2. The method of claim 1, wherein a level of confidence is determined by a tube of confidence around each color trajectory for each different lighting condition, and wherein a measurement within the tube of confidence is a valid measurement and a measurement outside the tube of confidence is an invalid measurement.

3. The method of claim 2, wherein if one or more tubes of confidence overlap and there are a plurality of valid measurements, then a result decision making algorithm is used to select the measurement with the highest level of confidence.

4. The method of claim 1, wherein the diagnostic instrument comprises a plurality of test media arranged in a plurality of test specific sequences.

5. The method of claim 1, wherein the diagnostic instrument further comprises an identification label including or associated with identification information about the diagnostic instrument, and wherein the captured digital image of the diagnostic instrument includes at least a portion of the identification label.

6. A system for performing diagnostic tests of a biological sample, the system comprising:

a diagnostic instrument comprising a paddle, a color reference mounted to the paddle having a plurality of color reference samples of different colors, and a plurality of test media mounted to the paddle, the plurality of test media respectively containing reagents which change color in the presence of particular analytes in the biological sample; and

a portable electronic device comprising a digital camera sensor for capturing a digital image of at least a portion of the diagnostic instrument, and a processor configured to;

identify at least one of the plurality of color reference samples and at least one of the plurality of test media in the digital image of the diagnostic instrument;

determine a dominant camera-captured color of a reference sample and a dominant camera-captured color of at least one test medium;

correct the dominant camera-captured color of the at least one test medium based on a color correction factor derived at least in part from the dominant camera-captured color of the reference sample to determine a corrected test medium color;

compare the corrected test medium color to a plurality of different sets of possible test medium colors corresponding to predetermined analyte concentrations to determine a plurality of potential test results, wherein each of the different sets of possible test medium colors is responsive to a different lighting condition; and

select a test result including an analyte concentration of the biological sample out of the plurality of potential test results in response to a measurement having a highest level of confidence.

7. The system of claim 6, wherein a level of confidence is determined by a tube of confidence around each color trajectory for each different lighting condition, and wherein a measurement within the tube of confidence is a valid measurement and a measurement outside the tube of confidence is an invalid measurement.

8. The system of claim 6, wherein if one or more tubes of confidence overlap and there are a plurality of valid measurements, then a result decision making algorithm is used to select the measurement with the highest level of confidence.

9. The system of claim 6, wherein the plurality of test media are arranged in a plurality of test specific sequences.

10. The system of claim 6, further comprising an identification label associated with the diagnostic instrument, wherein the digital image includes at least a portion of the identification label.

11. The system of claim 6, wherein the portable electronic device further comprises a visual display device for displaying instructions for using the system or for displaying the test result.

12. A portable electronic device for analyzing a digital image of a diagnostic instrument, the portable electronic device comprising:

at least one processor to execute program instructions;

at least one display device coupled in communication with the at least one processor;

at least one digital camera sensor coupled in communication with the at least one processor; and

at least one computer-readable medium coupled in communication with the at least one processor, the at least one computer-readable medium comprising program instructions that, when executed by the at least one processor, cause the portable electronic device to;

capture a digital image of at least a portion of the diagnostic instrument, which has been exposed to a biological sample, with the camera sensor, the diagnostic instrument comprising at least one color reference comprising a plurality of reference samples of different colors and at least one test medium containing a reagent, which changes color in the presence of particular analytes in the biological sample;

identify, in the digital image, at least one of the reference samples for the at least one test medium of the diagnostic instrument;

determine, in the digital image, a dominant camera-captured color of the at least one reference sample and a dominant camera-captured color of the at least one test medium;

correct the dominant camera-captured color of the at least one test medium based on a color correction factor derived at least in part from the dominant camera-captured color of the at least one reference sample to determine a corrected test medium color; and

perform a plurality of comparisons of the corrected test medium color to a plurality of different sets of possible test medium colors corresponding to predetermined analyte concentrations to determine a plurality of potential test results, wherein each of the different sets of possible test medium colors is responsive to a different lighting condition; and

select a test result including an analyte concentration of the biological sample out of the plurality of potential test results in response to a measurement having a highest level of confidence.

13. The portable electronic device of claim 12, wherein a level of confidence is determined by a tube of confidence around each color trajectory for each different lighting condition, and wherein a measurement within the tube of confidence is a valid measurement and a measurement outside the tube of confidence is an invalid measurement.

14. The portable electronic device of claim 12, wherein if one or more tubes of confidence overlap and there are a plurality of valid measurements, then a result decision making algorithm is used by the at least one processor to select the measurement with the highest level of confidence.

15. The portable electronic device of claim 12, wherein the program instructions further cause the portable electronic device to display use instructions on the at least one display device, and wherein the use instructions explain to a user at least how to expose the diagnostic instrument to the biological sample or how to capture the digital image of the diagnostic instrument.

16. The portable electronic device of claim 15, wherein the use instructions are displayed in conjunction with a video image of the diagnostic instrument.

17. The portable electronic device of claim 12, further comprising:

a timer; and

wherein the program instructions further cause the portable electronic device to;

instruct a user to expose the diagnostic instrument to the biological sample;

measure a predetermined exposure time with the timer; and

instruct the user to capture the digital image with the camera sensor after the predetermined exposure time has been measured.

18. The portable electronic device of claim 17, wherein the program instructions further cause the portable electronic device to:

measure an actual exposure time with the timer, the actual exposure time being the time between instructing a user to expose the diagnostic instrument to the biological sample and capturing the digital image of the diagnostic instrument; and

record a corrected exposure time, wherein the corrected exposure time is based on a difference between the predetermined exposure time and the actual exposure time.

19. The portable electronic device of claim 18, wherein the program instructions further cause the portable electronic device to color correct the dominant camera-captured color of the at least one test medium based on the corrected exposure time.

20. The portable electronic device of claim 12, further comprising a data entry device and wherein the program instructions further cause the portable electronic device to:

receive patient information from the data entry device; and

compare the test results with the patient information to determine a possible patient condition.