Diagnostic testing assays and related devices with security and methods of use thereof
Inventors
Karlovac, Neven • Mudanyali, Onur
Assignees
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Publication Number
US-11255845-B2
Publication Date
2022-02-22
Expiration Date
Abstract
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.
Core Innovation
The invention provides a secure assay device including an assay membrane or a test device that provides at least one result. The assay membrane or test device comprises at least one surface which exhibits a change in response to at least one target particle and/or at least one marker, or a combination thereof, and the change is illuminated or digitally visible and is recordable by a camera system.
A key part of the invention is at least one multi-layer coating that at least partially covers the assay membrane, the secure assay device, or a combination thereof. The multi-layer coating actively blocks or impairs a user visualization of the change, the at least one result, or a combination thereof, while the change/result remains recordable by the camera system.
The disclosure also includes secure reader architectures and a confidential in-vitro diagnostic test workflow. The secure reader includes control electronics, a digital camera component, an illumination component, and a housing component to obtain results based on the hidden optical change, and a method provides for obtaining test results invisible to the user and providing results securely and confidentially to others.
Claims Coverage
The document includes three independent claim directions: a secure assay device, a secure reader, and a method for confidential in-vitro diagnostic testing. Across these, the claims center on a camera-recordable, illuminated or digitally visible assay change that is actively blocked or impaired to prevent user visualization, combined with a secure reader instrument for obtaining and securing results.
Secure assay device with blocked visualization coating
An assay membrane or a test device that provides at least one result, wherein the assay membrane or test device comprises at least one surface which exhibits a change in response to at least one target particle and at least one marker or a combination thereof, wherein the change is illuminated or digitally visible and is recordable by a camera system; and at least one multi-layer coating that at least partially covers the assay membrane, the secure assay device or a combination thereof, wherein the multi-layer coating actively blocks or impairs a user visualization of the change, the at least one result or a combination thereof.
Secure reader instrument for obtaining hidden camera-recordable results
A secure reader comprising control electronics, a digital camera component, an illumination component, and a housing component, with an assay membrane or a test device that provides at least one result, wherein the change is illuminated or digitally visible and is recordable by a camera system, and at least one multi-layer coating that at least partially covers the assay membrane, the secure assay device or a combination thereof, wherein the multi-layer coating actively blocks or impairs a user visualization of the change, the at least one result or a combination thereof.
Method for confidential in-vitro diagnostic testing
Providing an assay membrane or a test device that provides at least one result, wherein the change is illuminated or digitally visible and is recordable by a camera system; providing at least one multi-layer coating that at least partially covers an assay membrane, the assay device or a combination thereof, wherein the multi-layer coating actively blocks or impairs a user visualization of the change, the at least one result or a combination thereof; and utilizing a reader instrument to obtain test results invisible to the user and to provide results securely and confidentially to others.
Overall, the claims tie together an assay surface that produces an illuminated or digitally visible change recordable by a camera system, a multi-layer coating that actively blocks or impairs user visualization of the change or result, and a secure reader instrument and method to obtain invisible results and provide them securely and confidentially to others.
Stated Advantages
Provides test results invisible to the user
Provides results securely and confidentially to others
Actively blocks or impairs a user visualization of the change and the at least one result
Documented Applications
Confidential in-vitro diagnostic test
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