Method and devices for rapid diagnosis of foot-and-mouth disease
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Publication Number
US-11598775-B2
Publication Date
2023-03-07
Expiration Date
Abstract
A rapid immunoassay method and apparatus for detecting foot and mouth disease virus are disclosed. The method and test device permit pen-side testing of animals and provide test results within a relatively short time period. In a preferred embodiment, the method and apparatus provide a means for differentiating between FMDV-infected and FMDV-vaccinated animals.
Core Innovation
The invention provides a rapid pen-side immunochromatographic test device and method for detecting foot-and-mouth disease virus (FMDV) antibodies in animal body fluids. The method uses a recombinant FMDV antigen system that differentiates antibodies to FMDV structural proteins and antibodies to FMDV non-structural proteins. Antibodies of interest bind to a labeled binding partner and form a specific binding complex that is transported by capillary action along a membrane strip to immobilized capture reagent zones.
The membrane strip includes multiple zones that provide differentiated signals for structural and non-structural targets. Immobilized capture reagents specific for an FMDV structural protein comprising at least one of VP1, VP2, VP3, or VP4 form a structural test band signal, while an adjacent zone with immobilized capture reagents specific for an FMDV non-structural protein comprising at least one of Lb, 2B, 2C, 3A, 3AB, or 3ABC forms a non-structural test band signal. The method also includes a third band of immobilized control capture reagent for an internal control signal.
Detection and differentiation are based on detecting an amount of antibodies of interest and an amount of internal control signal, as indicated by an intensity of a signal producing system. The structural and non-structural band results are used to differentiate between antibodies of interest, including differentiation of infected versus vaccinated animals via signals to structural proteins and non-structural proteins.
Claims Coverage
The independent claim defines one rapid capillary membrane strip method that simultaneously detects and differentiates antibodies of interest to FMDV structural proteins and FMDV non-structural proteins, with an internal control and differentiation based on signal intensity. Dependent claims refine the labeled binding partner and the application point arrangement. In total, the coverage includes one independent method claim and multiple dependent refinements.
Simultaneous detection and differentiation of structural and non-structural antibodies
A method for simultaneously detecting and differentiating between antibodies of interest comprising antibodies to FMDV structural proteins and antibodies to FMDV non-structural proteins in a sample.
Rapid membrane strip device with labeled binding partner, labeled control reagent, and immobilized capture zones
A membrane strip with a proximal end containing a labeled binding partner and a labeled control reagent, a structural zone with at least one immobilized capture reagent specific for an FMDV structural protein comprising at least one of VP1, VP2, VP3 or VP4, a second zone with at least one immobilized capture reagent specific for an FMDV non-structural protein comprising at least one of Lb, 2B, 2C, 3A, 3AB, or 3ABC, and a third band of immobilized control capture reagent, with fluid moving by capillary action.
Capillary transport to structural and non-structural capture reagents with internal control
Antibodies of interest bind to the labeled binding partner to form a specific binding complex, and the fluid transports the complex and labeled control reagent by capillary action through the membrane strip to the immobilized structural, non-structural, and control capture reagents.
Signal detection and differentiation based on internal control signal intensity
Detecting an amount of the antibodies of interest and an amount of internal control signal, as indicated by an intensity of a signal producing system, and differentiating between the antibodies of interest.
Labeled binding partner comprising specified FMDV proteins
The labeled binding partner comprises at least one of VP1, 3D, 2C, or 3ABC and at least one of VP1, VP2, VP3, and VP4.
Labeled binding partner as protein G and/or protein A
The labeled binding partner is protein G and/or protein A.
Application point with a filter pad holding labeled reagents
The membrane strip includes an application point containing a filter pad loaded with at least one of the labeled binding partner or the labeled control reagent.
Labeled binding partner limited to protein A
The labeled binding partner is protein A.
Application point filter pad containing both labeled binding partner and labeled control reagent
The membrane strip includes an application point made of a filter pad containing the labeled binding partner and the labeled control reagent.
The claim set covers a rapid immunochromatographic strip method with immobilized capture reagents for FMDV structural proteins and FMDV non-structural proteins, plus an immobilized control capture reagent. Dependent claims narrow the labeled binding partner, including protein G and/or protein A and protein A, and specify a filter pad application point for the labeled reagents.
Stated Advantages
Provides simultaneous detection and differentiation between antibodies to FMDV structural proteins and antibodies to FMDV non-structural proteins.
Uses a rapid measurement device with capillary action to transport binding complexes to immobilized capture zones.
Includes an internal control capture reagent for internal control signal detection.
Differentiation is supported by signal intensity from a signal producing system.
Documented Applications
Differentiating infected versus vaccinated animals based on signals to structural proteins and non-structural proteins [procedural detail omitted for safety].
Performance evaluation of the test against ELISA using sensitivity, specificity, and accuracy [procedural detail omitted for safety].
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