Methods and apparatus for quantifying color changes induced by specific concentrations of biological analytes

• US 9,607,380 B2
• Filed: 03/26/2016
• Issued: 03/28/2017
• 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): Nur, Abdullahi
• Application Number:
  US15/081,884
• Publication Number:
  US 20160260215A1
• Time in Patent Office: 367 Days
• Field of Search: 356402-425
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: G01J 3/02 Details
• CPC Class Codes: G01J 3/46 Measurement of colour; Colour measuring devices, e.g. colorimeters measuring colour temperature G01J5/60
• CPC Class Codes: G01N 2021/1765 Method using an image detector and processing of image signal
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 21/27 using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/78 producing a change of colour
• 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 2201/12 Circuits of general importance; Signal processing
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G06T 2207/10024 Color image
• CPC Class Codes: G06T 2207/30004 Biomedical image processing
• CPC Class Codes: G06T 7/0014 using an image reference approach
• CPC Class Codes: G06T 7/60 Analysis of geometric attributes
• CPC Class Codes: G06T 7/70 Determining position or orientation of objects or cameras camera calibration G06T7/80
• CPC Class Codes: G06T 7/90 Determination of colour characteristics
• CPC Class Codes: G06V 40/1324 by using geometrical optics, e.g. using prisms G06V40/1312 takes precedence

Abstract

Methods and electronic devices for performing color-based reaction testing of biological materials. The method includes capturing and interpreting digital images of an unexposed and later exposed paddle at various delay times within an automatically calibrated environment. The test paddle includes a unique identification mechanism (UID), a Reference Color Bar (RCB) providing samples of standardized colors for image color calibration, compensation and corrections, and several test-specific sequences of Chemical Test Pads (CTP). The method further includes locating the paddle in the image, extracting the UID and validating the paddle, extracting the RCB and locating the plurality of CTP in each image. The method further reduces image noise in the CTP and calibrates the image automatically according to lighting measurements performed on the RCB. To determine test results, the method further determines several distances between the CTP and its possible trajectory in the color space described by the Manufacturer Interpretation Color Chart.

Claims

1. A computer-implemented method for determining a relative position on a diagnostic instrument, the method comprising:

capturing a digital image of at least a portion of the diagnostic instrument, which has been exposed to a biological sample, the diagnostic instrument comprising at least one test medium containing a reagent, which changes color in the presence of particular analytes in the biological sample;

scanning the digital image to identify the position of a predetermined region on the diagnostic instrument;

identifying the at least one test medium on the digital image based at least in part on the position of the predetermined region; and

determining a test result by comparing the color of the at least one test medium to a set of possible test medium colors corresponding to predetermined analyte concentrations to determine an analyte concentration of the biological sample being tested.

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

3. The method of claim 1, wherein the identifying step further comprises:

determining geometric corrections for the digital image based at least in part on the position of the predetermined region, the geometric corrections comprising an angle of rotation of the diagnostic instrument about at least one of the following;

the x-axis, the y-axis, the z-axis, or any combination thereof, and,

calculating the position of the at least one test medium based at least partially on the position of the identification label and the geometric corrections.

4. The method of claim 1, wherein the predetermined region comprises an identification label including or associated with identification information about the diagnostic instrument.

5. The method of claim 4, wherein the identification information includes at least one of the following:

the manufacture date of the diagnostic instrument;

the expiration date of the diagnostic instrument;

the analytes tested for by the instrument;

identifying information about the test subject;

patient condition information;

or any combination thereof.

6. The method of claim 4, wherein the identification label comprises at least one of the following:

a bar code, a QR code, a near-field communication tag, or any combination thereof.

7. A method for validating a diagnostic instrument comprising:

capturing a pre-use digital image of at least a portion of the diagnostic instrument, prior to exposing the diagnostic instrument to a biological sample, 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;

identifying the at least one test medium in the pre-use digital image of the diagnostic instrument;

comparing a color of the at least one test medium to a set of possible test medium colors for reagents, which have not been exposed to an analyte; and

determining whether the diagnostic instrument is in condition for use based at least in part on the color of the at least one test medium.

8. The method of claim 7, 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.

9. The method of claim 8, wherein the identification label is at least one of the following:

a bar code;

a QR code, a near-field communication tag, or any combination thereof.

10. The method of claim 8, wherein the identification information includes at least one of the following:

the manufacture date of the diagnostic instrument;

the expiration date of the diagnostic instrument;

the analytes tested for by the instrument;

identifying information about the test subject;

patient condition information;

or any combination thereof.

11. The method of claim 8, wherein the determining step further comprises analyzing the portion of the pre-use digital image including the identification label to determine the identification information and determining whether the diagnostic instrument is in condition for use based, at least in part, on the identification information.

12. A diagnostic instrument for identifying a plurality of test results by testing a single patient fluid, the instrument comprising:

an instrument housing;

a color reference comprising a plurality of reference samples of different colors affixed to or associated with the housing for determining the test results from a digital image of the diagnostic instrument; and

a plurality of test media affixed to the housing containing color-changing reagents, which change color in the presence of particular analytes in a biological sample.

13. The diagnostic instrument of claim 12, wherein the plurality of test media are arranged in a plurality of test specific sequences.

14. The diagnostic instrument of claim 13, wherein the instrument housing comprises a paddle having a handle and a plurality of indentations disposed on the paddle for receiving the plurality of test media.

15. The diagnostic instrument of claim 13, further comprising an identification label disposed on the instrument housing including or associated with identification information about the diagnostic instrument including at least one of the following:

the manufacture date of the instrument, the expiration date of the instrument, the analytes for which the instrument tests, identifying information about the test subject, the patient conditions, or any combination thereof.

16. The diagnostic instrument of claim 15, wherein the identification label comprises at least one of the following:

a bar code, a QR code, a near-field communication tag, or any combination thereof.

17. The diagnostic instrument of claim 12, wherein the plurality of test media comprise a super-hydrophobic coating for preventing fluid from dripping from the test media.