Methods and rapid test kits facilitating epidemiological surveillance
Inventors
Zaharik, Michelle L • Heyde, Ron P
Assignees
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Publication Number
US-11011278-B1
Publication Date
2021-05-18
Expiration Date
Abstract
A method for facilitating epidemiologic surveillance for a target disease such as Covid-19 includes a step of using an optical identifier such as a barcode or a numerical code to rapidly report de-identified test results to a central database. A rapid test device may be based on a direct flow point-of-care device comprising a porous membrane with at least one recombinant antigen applied thereto and procedural control. The recombinant antigen may comprise an epitope for detecting the target disease marker. The first optical identifier may be applied to the device and facilitate remote communication of the test results without the use of any specialized equipment.
Core Innovation
The invention relates to an epidemiological surveillance method for a target disease using a rapid test kit for direct-flow point-of-care testing. The rapid test kit includes at least one rapid test device having a porous membrane with a procedural control applied to generate a first visual indicator configured to confirm validity of the test procedure.
The test device also includes at least one recombinant antigen comprising at least one epitope for a disease marker corresponding to the target disease, with the recombinant antigen applied to the porous membrane to capture antibodies specific to the disease marker from a single collected specimen. The recombinant antigen forms a second visual indicator configured to confirm if the disease marker is present in the collected specimen, enabling a positive test result or a negative test result to be visually detected.
Validity is visually confirmed using the first visual indicator, and the test result is obtained without using the first optical identifier. After performing the rapid test, the first optical identifier is used to remotely and anonymously communicate the visually detected test result to a central database configured for epidemiological surveillance of the target disease. The remote communication permits identifying a time of the rapid test and a geographical location of the rapid test, and may use an optical identifier such as a barcode, numeric/alphanumeric code, a two-dimensional QR code, or an NFC tag.
Claims Coverage
The independent claim covers an epidemiological surveillance method that combines a porous membrane rapid test with a procedural control first visual indicator, recombinant antigen visual disease-marker detection, and a two-phase reporting workflow using a first optical identifier only after visual reading. The remote reporting associates de-identified results with test time and geographical location in a central database. The claim set includes dependent refinements that further specify offline transmission, acceptance criteria for validity verification, additional identifier formats, and an exemplary target disease.
Porous membrane validity indicator with procedural control
A rapid test kit comprising at least one rapid test device comprising a porous membrane and a procedural control applied to said porous membrane, configured to generate a first visual indicator to confirm a validity of test procedure.
Recombinant antigen visual disease-marker indicator on porous membrane
At least one recombinant antigen comprising at least one epitope for a disease marker corresponding to said target disease, applied to said porous membrane to capture antibodies specific to said disease marker from a single collected specimen, and forming a second visual indicator configured to confirm if said disease marker is present in said collected specimen.
First optical identifier used after visual reading for remote anonymous communication
A first optical identifier provided therewith and applied to either said rapid test kit or said rapid test device, fully visible on said rapid test kit, wherein the test result is obtained without using said first optical identifier and, after performing said rapid test, said first optical identifier is used to remotely and anonymously communicate said visually detected test result to a central database configured for epidemiological surveillance of said target disease.
Time and geographical location associated with remote result communication
Remote communicating permits identifying a time of said rapid test and a geographical location of said rapid test.
Offline and later transmission when remote communication is unavailable
Storing a test result together with its geographical location and time when remote communication to a central database is unavailable, and later communicating it to the central database once communication is reestablished.
Acceptance-criterion validity verification
Verifying the validity of test results against an acceptance criterion.
Acceptance criterion based on geographical distribution, deployment history, rapid test time, or absence of prior results
Selecting an acceptance criterion from geographical distribution of rapid tests, deployment history over rapid test time, or absence of prior test results for the same first optical identifier.
Two-dimensional QR code as first optical identifier
Specifying the first optical identifier as a two-dimensional QR code.
Covid-19 as exemplary target disease
Configuring the rapid test kit such that the target disease is Covid-19.
Overall, the claim coverage centers on a rapid, direct-flow point-of-care epidemiological surveillance method where a porous membrane test uses a procedural control for a first visual validity indicator and recombinant antigen epitopes for a second visual disease-marker indicator from a single specimen. A first optical identifier is applied to the kit and is used only after visual reading to remotely and anonymously communicate results to a central database that records test time and geographical location. Dependent claims further refine the workflow by adding offline transmission, acceptance-criterion-based validity verification, example optical identifier formats, and an exemplary target disease.
Stated Advantages
Rapid, direct-flow point-of-care epidemiological surveillance.
Visual confirmation of validity of the test procedure using a first visual indicator.
Visual detection of a test result using a second visual indicator with presence or absence of a disease marker.
Remote and anonymously communicating visually detected test results to a central database without using the optical identifier during visual reading.
Associating communicated results with test time and geographical location.
De-identified reporting.
Supports offline/queued transmission via a mobile device and a smartphone application when remote communication is unavailable.
Documented Applications
Epidemiological surveillance of a target disease using rapid test kits and central-database reporting.
Central-database processing for geographical maps and heat maps and outbreak tracking for downstream resource/vaccine planning [procedural detail omitted for safety].
Mass reporting while preserving privacy through de-identified remote communication.
Vaccine deployment planning based on central-database data [procedural detail omitted for safety].
Example surveillance target disease: Covid-19.
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