Vendor exclusivity security feature for paper-based diagnostic solution

Patent metadata

Field	Value
Publication number	US-9933359-B2
Application number	US-201514806412-A
Country	US
Kind code	B2
Filing date	Jul 22, 2015
Priority date	Jun 23, 2014
Publication date	Apr 3, 2018
Grant date	Apr 3, 2018

Abstract

Disclosed herein is a paper based diagnostic device including a portable biomedical diagnostic device comprising, paper, wax, and reagents. The biomedical diagnostic device can analyze biochemical assays in test fluids such as blood, urine, and saliva. Diagnostic devices can include one or more of tracking information, personal identification information, security information, color calibration information, and environmental indicators. The security information can further include keys or codes identifying one or more unique characteristics. One aspect of the security information ensures that only predeterminable vendors are able to determine the results of a test from the diagnostic devices.

First claim

What is claimed is:

1. A paper-based sensor method comprising:
providing a paper sensor device including a test zone with multiple assay regions, each assay has a different concentration of a same reagent to measure different levels of a single test sample, the paper sensor device further including a calibration color area including a reference color;
after the single test sample has been applied to the paper-based sensor and reacted to the reagents, capturing an image of the paper-based sensor including one or more color indicators each associated with an assay region;
using a computer, performing colorimetric image processing of the captured image of the paper-based sensor to determine a concentration of analyte contained in the single test sample, the processing including comparing a color change of the assay regions to the reference color to determine the concentration of at least one analyte contained in the single test sample;
wherein the paper-based sensor includes one or more of tracking information, personal identification information, security information, color calibration information, and environmental indicators; and,
wherein said security information includes a key to decode at least one unique characteristic.

2. The paper-based sensor method according to claim 1 , comprising:
communicating the concentration of the at least one analyte contained in the test sample to one or more of a patient and a caregiver.

3. The paper-based sensor method according to claim 1 , comprising:
performing predictive analytics.

4. The paper-based sensor method according to claim 1 , wherein the unique characteristic includes one or more of a unique identifier, color calibration field, orientation of the reagents, doping of reagents, and concentration of reagent.

5. The paper-based sensor method according to claim 1 , wherein the paper-based sensor includes tracking information, environmental indicators and security information, and the method validates the captured image of the paper-based sensor based on one or more of the tracking information, environmental indicators and security information.

6. The paper-based sensor method according to claim 1 , wherein capturing the image of the paper-based sensor comprises a camera phone.

7. A paper-based sensor processing system comprising:
a paper sensor device including a test zone with multiple assay regions, each assay has a different concentration of a same reagent to measure different levels of a single test sample, the paper sensor device further including a calibration color area including a reference color;
a processor and associated memory configured to receive a captured image of a the paper-based sensor after the single test sample has reacted to the reagents, the processor and associated memory configured to execute instructions to perform a method comprising:
performing colorimetric image processing of the captured image of the paper-based sensor to determine a concentration of analyte contained in the single test sample, the processing including comparing a color change of the assay regions to the reference color to determine the concentration of at least one analyte contained in the single test sample;
wherein the paper-based sensor includes one or more of tracking information, personal identification information, security information, color calibration information, and environmental indicators; and,
wherein said security information includes a key to decode at least one unique characteristic.

8. The paper-based sensor processing system according to claim 7 , comprising:
communicating the one or more attributes associated with the test sample to one or more of a patient and a caregiver.

9. The paper-based sensor processing system according to claim 7 , comprising:
performing predictive analytics.

10. The paper-based sensor method according to claim 7 , wherein the unique characteristic includes one or more of a unique identifier, color calibration field, orientation of the reagents, doping of reagents, and concentration of reagent.

11. A computer program product comprising:
a non-transitory computer-usable data carrier storing instructions that, when executed by a computer, cause the computer to perform a method comprising:
after a single test sample has reacted to a reagent, receiving a captured image of a paper sensor device including a test zone with multiple assay regions, each assay has a different concentration of the reagent to measure different levels of the single test sample, the paper sensor device further including a calibration color area including a reference color;
performing colorimetric image processing on the captured image including comparing a color of the assay regions to the reference color to determine a concentration of at least one analyte contained in the single test sample, wherein the color of an assay region corresponds to the concentration of reagent in the assay region;
wherein the paper-based sensor includes one or more of tracking information, personal identification information, security information, color calibration information, and environmental indicators; and,
wherein said security information includes a key to decode at least one unique characteristic.

12. The computer program product according to claim 11 , the method further comprising:
communicating the concentration contained in the test sample to one or more of a patient and a caregiver.

13. The computer program product according to claim 12 , the method further comprising:
performing predictive analytics.

14. The computer program product, according to claim 13 , wherein the paper-based sensor includes tracking information, environmental indicators and security information, and the method validates the captured image of the paper-based sensor based on one or more of the tracking information, environmental indicators and security information.

15. The paper-based sensor method according to claim 14 , wherein the unique characteristic includes one or more of a unique identifier, color calibration field, orientation of the reagents, doping of reagents, and concentration of reagent.

Assignees

• Xerox Corp

Inventors

• Zehler Peter J
• Zhou Jing
• Jia Nancy Y

Classifications

• G01N21/253 Primary

  for batch operation, i.e. multisample apparatus (analytical automats G01N35/00) · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title

• G01N21/78

  producing a change of colour · CPC title

• G01N21/8483

  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 title

• G16H10/60

  for patient-specific data, e.g. for electronic patient records · CPC title