Method of selecting analyte to samples using a lateral flow device
Inventors
Wong, JR., Winston • Kao, Stephen Chang-Chi
Assignees
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Publication Number
US-10598656-B2
Publication Date
2020-03-24
Expiration Date
Abstract
Lateral flow devices and methods of use for a molecular diagnostic assay are provided. The method is suitable for detection or monitoring of targets, including biological, chemical, and material targets that exist in very low concentrations in biological samples. The methods and devices of the present application are amenable to power source-free point of care testing.
Core Innovation
The invention relates to a lateral flow assay device for detecting the presence of an analyte within a test sample using a power-source-free lateral flow molecular diagnostic concept. The device uses a chromatographic medium with a sample loading zone upstream of a detection zone, and a reporting carrier zone located between the sample loading zone and the detection zone. The reporting carrier zone includes a reporting carrier capable of forming a complex with the analyte, where the reporting carrier comprises a carrier and at least one proficient enzyme.
In the detection zone, the device provides a capture component for the analyte together with an indicator for indicating the presence or absence of a product. The indicator responds to a reaction of the proficient enzyme and a substrate, such that formation or absence of the enzyme/substrate reaction product indicates the presence or absence of the analyte. This detection architecture is described to enable analyte detection without target amplification by relying on enzyme/substrate reaction product readouts.
The device further includes a control zone configured to capture uncomplexed reporting carrier from the detection zone. The control zone comprises a further capture component for the uncomplexed reporting carrier and a further indicator for indicating the presence or absence of a product from a reaction of the proficient enzyme and the substrate. Documented embodiments describe proficient enzyme examples and indicator/detection modalities that generate observable outputs from enzyme/substrate reaction products within the lateral flow format.
Claims Coverage
The independent claim defines a lateral flow assay device architecture with two detection readouts, analyte and control, and a proficient-enzyme/substrate product indicator centered on a reporting carrier that complexes the analyte. The independent claim contains four principal inventive structural elements.
Reporting carrier complexing the analyte and including a proficient enzyme
A reporting carrier zone includes a reporting carrier capable of forming a complex with the analyte, wherein the reporting carrier comprises a carrier and at least one proficient enzyme.
Detection zone with analyte capture and enzyme/substrate product indicator
A detection zone comprises a capture component for the analyte, and an indicator for indicating presence or absence of a product from a reaction of the proficient enzyme and a substrate to indicate presence or absence of the analyte.
Control zone capturing uncomplexed reporting carrier with an enzyme/substrate indicator
A control zone comprises a further capture component for the uncomplexed reporting carrier from the detection zone, and a further indicator for indicating presence or absence of a product from a reaction of the proficient enzyme and the substrate to indicate presence or absence of uncomplexed reporting carrier.
Sample loading zone upstream of the detection zone
The chromatographic medium includes a sample loading zone located upstream of a detection zone.
Across the independent claim, analyte detection is achieved by coupling a reporting carrier that complexes the analyte and carries at least one proficient enzyme to a detection zone that uses an analyte capture component and an indicator responsive to a proficient-enzyme/substrate reaction product, together with a control zone that separately captures and reports uncomplexed reporting carrier via a further proficient-enzyme/substrate product indicator.
Stated Advantages
Enables detection of an analyte or target at very low concentrations without target amplification, using a power-source-free lateral flow format.
Documented Applications
Power-source-free point of care (POC) molecular diagnostic applications for detecting broad analytes or targets, including proteins, nucleic acids, cells or pathogens, and small molecules.
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