Method, apparatus and system for detecting and determining compromised 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-11754564-B2
Publication Date
2023-09-12
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
The invention determines exposure of a diagnostic instrument to a hostile environment using a diagnostic instrument portion that includes at least one color reference and a plurality of reference samples of different colors, at least one test medium having a reagent that changes color in the 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. A mobile or portable imaging system captures digital images of the diagnostic instrument at one or more time points before and/or after exposure to the biological sample, and locates the contamination detection medium and the test pads for analysis.
Dominant camera-captured colors of the reference samples and the contamination detection medium are determined from the captured images. A correction factor derived at least in part from the dominant camera-captured color of the reference samples is used to color-correct the dominant camera-captured color of the contamination detection medium to determine a first corrected contamination detection medium color, removing lighting and camera variation effects.
The first corrected contamination detection medium color is compared to a predetermined exposure detection color range to determine an exposure detecting result, indicating contamination detected versus not. In response to contamination detection, the test results are invalidated and the paddle is replaced, and the expected color evolution trajectories during various reaction stages are used to assess contamination based on the color changes.
Claims Coverage
The independent claim includes at least three core inventive aspects: imaging a color-referenced diagnostic instrument, color-correcting contamination-detection colors using reference samples, and comparing the corrected contamination color to a predetermined exposure detection color range to produce an exposure-detecting result. The dependent claims further refine the hostile environment and timing/context of image capture and relate the contamination detection reagent color change to specific hazards compromising test-medium reagents.
Capturing a color-referenced diagnostic instrument image
Capturing a first digital image of at least a portion of a diagnostic instrument, the portion 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 the 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.
Dominant color identification for reference and contamination media
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.
Reference-based color correction using a correction factor
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.
Predetermined exposure detection color-range comparison
Comparing the first corrected contamination detection medium color to a predetermined exposure detection color range to determine an exposure detecting result.
Overall, claim coverage centers on capturing images of a color-referenced diagnostic instrument, using dominant colors of reference samples to correct the contamination-detection medium color, and comparing the corrected color to predetermined exposure-detection color ranges to determine an exposure detecting result, with dependent refinements specifying hostile-environment type and timing/context of image capture and hazard-compromised reagent contexts.
Stated Advantages
Determines exposure of a diagnostic instrument to a hostile environment by using color reference samples to correct camera-captured colors before comparison to predetermined exposure detection color ranges.
Enables detection of contamination and supports invalidating/compromising test results when exposure is detected.
Documented Applications
Point-of-care or in-home testing using a diagnostic instrument reagent paddle that includes contamination detection and a reference color bar, where a portable imaging device captures digital images to determine hostile-environment exposure.
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