Systems, devices, and methods for amplifying signals of a lateral flow assay
AssigneeBecton, Dickinson and Company
InventorHuimiao Ren
Life of this patent
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Abstract
Lateral flow assay devices, systems, and methods described herein detect analyte present in a sample in low quantity or at low concentration by amplifying a signal generated at a detection zone. The generated signal can exceed a detection threshold of a measurement system and increase the sensitivity of the lateral flow assay devices, systems, and methods. In one aspect, the lateral flow device includes a signal-amplification conjugate that binds to a complex bound to immobilized capture agent in the detection zone, causing a chain reaction of binding events in the detection zone that result in an amplification of the signal generated in the detection zone.
Claims25
A lateral flow assay device for detecting an analyte of interest in a sample comprising:
- a first conjugate comprising a first label, an agent configured to specifically bind to the analyte of interest, and a first binding partner;
- a second conjugate upstream of the first conjugate along a fluid flow path of the lateral flow assay device, wherein the second conjugate comprises a second label and a second binding partner configured to specifically bind to the first binding partner, wherein the second binding partner is an antibody against the first binding partner, and wherein the first label and the second label are the same;
- and
- a detection zone downstream of the first conjugate and the second conjugate along the fluid flow path of the lateral flow assay device, the detection zone comprising an immobilized capture agent that specifically binds the analyte of interest.
A method of detecting an analyte of interest in a sample, comprising:
- applying a sample to a lateral flow assay device comprising
- a first conjugate comprising a first label, an agent configured to specifically bind to the analyte of interest, and a first binding partner;
- a second conjugate upstream of the first conjugate along a fluid flow path of the lateral flow assay device, wherein the second conjugate comprises a second label and a second binding partner configured to specifically bind to the first binding partner, wherein the second binding partner is an antibody against the first binding partner, and wherein the first label and the second label are the same;
- and
- a detection zone downstream of the first conjugate and the second conjugate along the fluid flow path of the lateral flow assay device, the detection zone comprising an immobilized capture agent that specifically binds the analyte of interest;
- binding a complex to the immobilized capture agent in the detection zone, wherein the complex comprises analyte of interest bound to the first conjugate;
- after binding the complex, releasing the second conjugate to flow along the fluid flow path of the lateral flow assay device;
- binding the second conjugate to the complex bound in the detection zone;
- and
- detecting a signal generated by the complex and the second conjugate bound in the detection zone, thereby detecting analyte of interest in the sample.
Dependencies are inferred from the claim text.