Method, apparatus and system for detecting and determining comprised reagent pads by quantifying color changes induced by exposure to a hostile environment
Inventors
Burg, Bernard • Zizi, Martin • De Brouwer, Walter • Tenedorio, Jaime • Aghazadeh, Babak • Cui, Jie • Menezes, Sheena
Assignees
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Publication Number
US-12146878-B2
Publication Date
2024-11-19
Expiration Date
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.
Core Innovation
An at-home diagnostic instrument includes at least one color reference with 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 response to being exposed to a hostile environment. A portable electronic device captures a digital image of at least a portion of the at-home diagnostic instrument using at least one camera sensor.
The device identifies at least one reference sample associated with the at least one contamination detection medium, determines 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, and determines a 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. This provides automatically calibrated, lighting-independent color correction based on the color reference.
The corrected contamination detection medium color is compared to a predetermined contamination detection medium color to determine if the at-home diagnostic instrument has been exposed to a hostile environment and compromised. The process can use comparisons across critical time points and reaction stages, including before biological sample exposure, after specific time durations, or after chemical reactions of at least one test medium and the at least one contamination detection medium have ceased.
Claims Coverage
The patent includes two independent claims (portable electronic device and a method). Across these independent claims, the inventive content centers on dominant-color determination using a color reference for contamination detection medium color correction, and then comparing the corrected contamination color to a predetermined contamination detection medium color to determine hostile-environment exposure and compromise, with analyte-responsive test medium context included.
Dominant color analysis with color reference
Capture a digital image of at least a portion of an at-home diagnostic instrument and identify at least one reference sample of a plurality of reference samples, including determining a dominant camera-captured color of the at least one reference sample associated with the contamination detection medium.
Corrected contamination detection medium color using correction factor
Determine a dominant camera-captured color of the at least one contamination detection medium and color correct the dominant camera-captured color of the at least one contamination detection medium to determine a 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.
Hostile environment and compromise determination by comparing to predetermined contamination color
Compare the corrected contamination detection medium color to a predetermined contamination detection medium color to determine if the at-home diagnostic instrument has been exposed to a hostile environment and compromised.
At-home diagnostic instrument includes analyte-responsive and hostile-environment-responsive media
Use an at-home diagnostic instrument that includes 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 response to being exposed to a hostile environment, together with the at least one color reference with a plurality of reference samples of different colors.
Both independent claims require capturing an image of an at-home diagnostic instrument, using a color reference to determine dominant camera-captured colors and apply a correction factor to obtain a corrected contamination detection medium color, and then comparing that corrected contamination color to a predetermined contamination detection medium color to determine hostile-environment exposure and compromised results.
Stated Advantages
Allows determination of whether the at-home diagnostic instrument has been exposed to a hostile environment and compromised.
Provides correction of camera-captured contamination detection medium color using reference samples to determine a corrected contamination detection medium color.
Supports use with automatically calibrated, lighting-independent color correction based on the color reference.
Enables determining exposure severity using comparisons across critical time points and reaction stages, including rate-of-change comparison in dependent claims.
Documented Applications
At-home diagnostics using a portable electronic device (e.g., capturing a digital image) to analyze an at-home diagnostic instrument for contamination/compromise due to exposure to a hostile environment.
Analyzing digital images of an at-home diagnostic instrument to detect and invalidate compromised results by comparing corrected contamination detection medium color to predetermined contamination detection medium color.
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