Method and apparatus for determining analyte concentration by quantifying and interpreting color information captured in a continuous or periodic manner

• US 9,528,941 B2
• Filed: 03/05/2015
• Issued: 12/27/2016
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: Healthy.io, Ltd.
• Original Assignee: Scanadu Incorporated
• Inventors: Burg, Bernard, Zizi, Martin, De Brouwer, Walter, Smart, Anthony
• Primary Examiner(s): Geisel, Kara E
• Assistant Examiner(s): SMITH, MAURICE C
• Application Number:
  US14/639,509
• Publication Number:
  US 20150241358A1
• Time in Patent Office: 663 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 2021/7793 Sensor comprising plural indicators
• CPC Class Codes: G01N 2021/7796 Special mountings, packaging of indicators
• CPC Class Codes: G01N 21/272 for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/80 Indicating pH value
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: H04N 23/50 Constructional details

Abstract

In one embodiment, an apparatus for automatic test diagnosis of a test paddle is disclosed. The apparatus comprises a personal computing device including: a camera to capture images over time of test pads of a test paddle, a processor coupled to the camera, and a display device coupled to the processor. The processor analyzes the color changes over time of each test pad to determine a color trajectory over time for each test pad. The processor compares the color evolution trajectory for each test pad with color calibration curves for each test pad to determine an analyte concentration of a test biological sample, such as urine. During the analysis by the processor, the display device displays a user interface with results of the analyte concentration in response to the analysis over time.

Claims

1. A method comprising:

applying a biological sample to a plurality of test pads of a test paddle;

capturing images over periods of time of the plurality of test pads of the test paddle as different reagents of the test pads react to the biological sample;

quantifying each color of the plurality of test pads in each of the captured images over time;

determining a color trajectory over time for each test pad of the plurality of test pads;

comparing the color trajectory with calibration curves to determine analyte concentration for one or more of the plurality of test pads; and

displaying results of the analyte concentration to a user in response to the comparison.

2. The method of claim 1, further comprising:

determining temperature and acidity (pH) of a chemical reaction between the biological sample and a test pad.

3. The method of claim 2, further comprising:

before determining the color trajectory, correcting the calibration curves to account for effects of one or more of a reaction time, the temperature, and the acidity (pH).

4. The method of claim 1, wherein

the biological sample is urine or blood.

5. An apparatus for automatic test diagnosis of a biological sample with a test paddle, the apparatus comprising:

a personal computing device including;

a camera to capture images over time of test pads of a test paddle;

a processor coupled to the camera, the processor to

analyze color over time of each test pad;

determine a color trajectory over time for each test pad;

compare the color trajectory for each test pad with associated color calibration curves for each test pad to determine analyte concentrations in a biological sample;

and

a display device coupled to the processor, the display device to display results of the analyte concentrations to a user in response the comparison.

6. The apparatus of claim 5, wherein

the personal computing device is a head mounted device.

7. The apparatus of claim 6, wherein

the head mounted device includes one of a heads-up-display, contact lenses, corrective lenses, and monocles.

8. The apparatus of claim 5, wherein the personal computing device includes

an eyeglass frame;

and

wherein the display device is a small video display device coupled to the eyeglass frame;

wherein the camera is a small camera coupled to the eyeglass frame.

9. The apparatus of claim 5, wherein the personal computing device includes

an eyeglass frame with a left eyeglass and a right eyeglass;

and

wherein the display device is a small video projector coupled to the eyeglass frame to project a display on either the left eyeglass or the right eyeglass to display the results of the analyte concentration to the user;

wherein the camera is a small camera coupled to the eyeglass frame.

10. A method comprising:

(a) applying a known concentration of an analyte in a biological sample of a predetermined acidity to a test pad at a predetermined temperature;

(b) capturing color images over a plurality time points of the test pad as it reacts to the biological sample;

(c) quantifying a color of the test pad in each of the captured color images at each of the plurality of time points;

repeating steps (a) through (c) for a plurality of differing concentrations of the analyte in a plurality of biological samples for one or more test pads; and

plotting along a curve in three dimensions of color space coordinates of a color graph, the quantified color for each respective time point for the plurality of concentrations of analyte to form a plurality of color calibration curves respectively associated with the plurality of time points.

11. The method of claim 10, further comprising:

(d) applying a known concentration of the analyte in a biological sample of a known acidity to a test pad at a known temperature;

(e) capturing color images over known periods of time of the test pad as it reacts to the known concentration of analyte in the biological sample;

(f) quantifying a color of the test pad in each of the captured color images at each known period of time; and

(g) plotting a plurality of the quantified colors of the test pad in the color graph over time.

12. The method of claim 11, further comprising:

interpolating between each quantified color of the test pad in the color graph to form a color evolution trajectory associated with the known concentration of analyte to intersect with the plurality of color calibration curves.

13. The method of claim 12, further comprising:

applying a second biological sample with an unknown concentration of analyte to a second test pad;

capturing color images of the test pad at measured time points as it reacts to the unknown concentration of analyte in the second biological sample;

quantifying each color of the test pad in each of the captured color images at each measured time point from a first measured time point to a last measured time point; and

determining a concentration of an analyte in the second biological sample in response to one or more quantified colors of the test pad at one or more measured time points.

14. The method of claim 10, wherein

the color space coordinates are red, green, and blue colors of a red-green-blue color space.

15. A method comprising:

applying a biological sample with an unknown concentration of analyte to a test pad;

capturing color images of the test pad at measured time points as it reacts to the unknown concentration of analyte in the biological sample;

quantifying each color of the test pad in each of the captured color images at each measured time point from a first measured time point to a last measured time point; and

determining a concentration of an analyte in the measured biological sample in response to one or more quantified colors of the test pad at one or more measured time points.

16. The method of claim 15, wherein

the determining of the concentration of the analyte in the biological sample includes determining an intersection point between a color evolution trajectory and a final color calibration curve.

17. The method of claim 15, wherein

the determining of the concentration of the analyte in the biological sample includes

plotting a plurality of quantified colors of the test pad in a color graph over a plurality of measured time points.

18. The method of claim 15, further comprising:

determining a measured acidity and a measured temperature associated with the biological sample;

correcting for differences in acidity and temperature between the measured acidity of the biological sample and the measured temperature associated with the biological sample and a calibration acidity of one or more calibration samples and a calibration temperature associated with the one or more calibration samples.

19. The method of claim 18, wherein

the differences are corrected by forming an adjusted final color calibration curve.

20. The method of claim 15, wherein

the concentration of analyte in the measured biological sample is determined by finding one or more intersections of a color evolution trajectory associated with the concentration of the analyte in the measured biological sample with a plurality of color calibration curves.

21. The method of claim 15, wherein

the biological sample is urine or blood.