Method, apparatus and system for detecting and determining compromised reagent pads by quantifying color changes induced by exposure to a hostile environment

Patent metadata

Field	Value
Publication number	US-11754564-B2
Application number	US-202117206399-A
Country	US
Kind code	B2
Filing date	Mar 19, 2021
Priority date	Aug 8, 2012
Publication date	Sep 12, 2023
Grant date	Sep 12, 2023

Abstract

A reagent test paddle includes a contamination detection medium, a reference color bar, at least one chemical test medium, and a unique identifier. The contamination detection medium includes a reagent that changes color in the presence or when exposed to a hostile or inhospitable environment. Each chemical test medium includes a regent that is responsive to a respective analyte in a biological sample. The reference color bar includes reference color samples of different colors. The unique identifier, like a serial number, identifies the particular paddle and its chemical test medium so it can be uniquely and anonymously associated with a user. A method includes capturing and interpreting digital images of a biologically unexposed and subsequently exposed reagent test paddle at various delay times within an automatically calibrated environment; locating the paddle in a plurality of digital images, extracting the reference color bar and locating the contamination detection medium and chemical test medium in each digital image. Color changes of the chemical test medium and contamination medium are detected at various delay times after sample exposure. To determine validity of test results, the method further compares the detected colors of the contamination detection medium with predetermined colors expected for no contamination and contamination.

First claim

What is claimed is:

1. A method to determine exposure of a diagnostic instrument to a hostile environment, the method comprising:
capturing a first digital image of at least a portion of a diagnostic instrument, the portion of the diagnostic instrument comprising at least one color reference including a plurality of reference samples of different colors, at least one test medium having a reagent that changes color in a presence of particular analytes in a biological sample, and at least one contamination detection medium having a reagent that changes color in the presence of being exposed to a hostile environment;
identifying at least one reference sample of the plurality of reference samples 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 contamination detection medium;
color correcting the dominant camera-captured color of the at least one contamination detection medium to determine a first corrected contamination detection medium color in response to a correction factor derived at least in part from the dominant camera-captured color of the at least one reference sample; and
comparing the first corrected contamination detection medium color to a predetermined exposure detection color range to determine an exposure detecting result.

2. The method of claim 1 , further comprises
in response to the exposure detecting result, generating an alert that the diagnostic instrument has been exposed to a hostile environment and is compromised.

3. The method of claim 1 , wherein the first digital image is captured before the diagnostic instrument has been exposed to a biological sample.

4. The method of claim 1 , wherein the first digital image is captured after the diagnostic instrument has been exposed to a biological sample.

5. The method of claim 4 , wherein the first digital image is captured at a beginning stage of a chemical reaction between reagents and analytes of the biological sample.

6. The method of claim 4 , wherein the first digital image is captured after five seconds of exposure of the diagnostic instrument to the biological sample.

7. The method of claim 4 , wherein the first digital image is captured after ten seconds of exposure of the diagnostic instrument to the biological sample.

8. The method of claim 1 , wherein the hostile environment is humidity or moisture.

9. The method of claim 1 , wherein
the reagent in the at least one contamination detection medium changes color in response to a chemical hazard or a biological hazard that compromises the reagent in the at least one test medium.

10. The method of claim 9 , wherein
the chemical hazard or the biological hazard that compromises the reagent in the at least one test medium is one or more of oil, dirt, dust, and grime.

Assignees

• Healthy Io Ltd

Inventors

• Burg Bernard
• Zizi Martin
• De Brouwer Walter
• Tenedorio Jaime
• Aghazadeh Babak
• Cui Jie
• Menezes Sheena

Classifications

• G01N33/54388 Primary

  based on lateral flow · CPC title

• G01N33/528

  Atypical element structures, e.g. gloves, rods, tampons, toilet paper · CPC title

• G01N21/78

  producing a change of colour · CPC title

• G01N21/80

  Indicating pH value · 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