Secure Assay Device with Optical Coating for Confidential Testing
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Solution Overview
Problem
Current diagnostic testing assays lack confidentiality and security, as test results can be easily interpreted by users, leading to potential misinterpretation and fraud, especially in sensitive conditions like infectious diseases and healthcare, with existing solutions being costly, inefficient, and not applicable to most assay technologies.
Innovation Solution
A secure assay device with a multi-layer coating that blocks user visualization of optical changes, combined with a reader system featuring control electronics, a digital camera, and encryption processing to securely transmit results to authorized entities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the test results are made visible to the user for immediate interpretation, then the convenience and speed of self-testing is improved, but the confidentiality and security of the results deteriorates
Solution Approach 1:
The patent introduces a multi-layer optical coating system as an intermediary between the test result and the user. This coating allows light to pass through in a controlled manner, enabling the reader device to detect the test result while preventing the user from visually observing it. The coating acts as a selective mediator that permits optical detection by the authorized device while blocking visual access by unauthorized users.
Solution Approach 2:
The patent applies different optical properties to different regions or layers of the assay device. The multi-layer coating has specific optical characteristics (transparency to certain wavelengths, opacity to others) that are localized to the result display area. This allows the test result to be optically accessible to the reader device while remaining visually hidden from users, creating local quality differentiation between user-accessible and machine-accessible regions.
2Loss of information
If a multi-layer optical coating is applied to block user visualization, then the confidentiality of test results is improved, but the device complexity increases
Solution Approach 1:
The multi-layer optical coating serves multiple functions simultaneously: it blocks user visualization of the test result, allows optical detection by the reader device, and maintains the structural integrity of the assay device. By integrating these multiple functions into a single coating layer, the patent avoids the need for separate components for each function, thereby reducing overall device complexity despite the advanced functionality provided.
Solution Approach 2:
The patent employs a multi-layer composite coating structure with different material properties. Each layer is composed of materials with specific optical characteristics that, when combined, achieve the desired effect of selective transparency. This composite approach allows the coating to provide multiple optical functions (blocking user view while allowing machine detection) without requiring a complex assembly of separate parts.
3Measurement precision
If the test results are hidden from users and require a reader device for interpretation, then the accuracy of result interpretation is improved, but the time required to obtain results increases
Solution Approach 1:
The patent replaces the manual visual interpretation mechanism with an automated optical detection system. Instead of users visually examining and interpreting test results (a mechanical human-cognition process), the system uses an optical reader device with sensors and algorithms to automatically detect and interpret the test result. This substitution eliminates the time delay associated with manual interpretation while maintaining or improving accuracy.
Solution Approach 2:
The reader device is designed to automatically detect and interpret test results without requiring user intervention or manual operation. The device autonomously reads the optical signal from the assay, processes the data through embedded algorithms, and provides the interpretation. This self-service capability eliminates the time loss associated with human reading and interpretation while ensuring consistent accuracy.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Ensures secure, accurate, and confidential transmission of test results, applicable to various existing assay technologies with minimal adaptation, reducing costs and maintaining assay performance.
Implementation Method 1
at least one multi-layer coating that at least partially covers the assay membrane, the assay device or a combination thereof, wherein the multi-layer coating blocks or impairs the user visualization of the optical change
Data Source
AI summary
A secure assay device is disclosed herein that provides: an assay or a test device that provides at least one result, wherein the assay or test device comprises at least one surface which exhibits optical change in response to at least one target particle, at least one marker or a combination thereof; and at least one multi-layer coating that at least partially covers the assay membrane, the assay device or a combination thereof, wherein the multi-layer coating blocks or impairs the user visualization of the optical change, the at least one result or a combination thereof. A secure reader and method of utilizing the secure assay device and secure reader are disclosed herein.