Immunogenicity Assay
Inventors
Yin, Ray • Pan, Jing • Vallejo, Yli Remo • Small, Thomas • Qin, Dujie • Chen, De
Assignees
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Publication Number
US-9329187-B2
Publication Date
2016-05-03
Expiration Date
Abstract
Assays for detecting antibodies to pharmaceutical preparations, food allergens and environmental allergens are described.
Core Innovation
The patent describes an immunoassay method for detecting the presence of an antibody that binds a drug of interest, a food antigen, or an environmental antigen. The method uses at least one immunochromatographic solid phase having a proximal region and a distal region in fluid communication, where fluid flows from the proximal region to the distal region. A liquid sample suspected of containing an antibody that binds the drug of interest, food antigen, or environmental antigen is contacted with the proximal region at a pad made of paper or a membrane.
As the sample flows to the distal region, the distal region comprises an immobilized capture agent that immobilizes a complex comprising a first drug of interest, food antigen, or environmental antigen moiety bound to a first antigen binding site of the antibody and a second drug of interest, food antigen, or environmental antigen moiety bound to a second antigen binding site of the antibody. The first moiety includes a first member of a first binding pair, and the second moiety includes a reporter moiety. The reporter moiety can be detected visually with an unaided eye and is associated with a branched polymer.
Detection is performed by detecting the reporter moiety bound to the immobilized capture agent, where detecting the reporter moiety correlates with the presence of the antibody that binds the drug of interest, food antigen, or environmental antigen in the sample. The assay design emphasizes immunochromatographic, lateral-flow antibody detection, together with branched polymer architectures and visually detectable reporter moieties within the claimed framework.
Claims Coverage
The document provides one independent claim covering an immunochromatographic immunoassay method for detecting antibodies binding a drug of interest, a food antigen, or an environmental antigen. The dependent claims refine the method with seven additional inventive features related to binding pairs, reporter moieties, branched polymer types, solid-phase materials, membrane compositions, and pre-mixing steps.
Immunochromatographic solid phase with proximal-to-distal fluid flow
Contacting at least one immunochromatographic solid phase comprising a proximal region in fluid communication with a distal region such that fluid flows from the proximal region to the distal region, wherein the proximal region comprises a pad to receive the sample, the pad consisting of a paper or a membrane.
Immobilized distal capture agent that immobilizes antibody complexes
Allowing the sample to flow from the proximal region to the distal region, wherein the distal region comprises an immobilized capture agent which immobilizes a complex comprising a first drug of interest, food antigen, or environmental antigen moiety bound to a first antigen binding site of the antibody, and a second moiety bound to a second antigen binding site of the antibody, the second moiety comprising a reporter moiety that can be detected visually with an unaided eye and a branched polymer.
Visually detectable reporter correlated with antibody presence
Detecting reporter moiety bound to said immobilized capture agent, wherein detecting reporter moiety bound to said capture agent correlates with presence of said antibody that binds said drug of interest, food antigen, or environmental antigen in said sample.
Selected branched polymer architecture used with the reporter moiety
The branched polymer includes one of several specified branched polymer types including a star-shaped polymer, a comb-shaped polymer, a dendrimer, a starburst dendrimer, a combburst dendrigraft, or a hypercombbranched polymer.
Visually detectable reporter moiety selected from specified label types
The reporter moiety is selected from a specified group of labeling agents including enzymes, protein and particle-based reporters, metal or quantum materials, and luminescent electrochemical reporters.
Immunochromatographic solid phase material includes membrane and/or micro/nanochannels and wick formats
The solid phase includes one or more of a membrane, glass micro/nanochannel, plastic micro/nanochannel, natural wick, synthetic wick, microbead particles, nanobead particles, or a combination thereof.
Membrane material selected from specific membrane compositions
The membrane comprises nitrocellulose, glass fiber, cotton, or polyamide.
Pre-mixing sample with moieties prior to contacting the solid phase
The method further includes mixing a sample with a first drug of interest, food antigen, or environmental antigen moiety and a second moiety, or both, before contacting a solid phase.
Overall, claim coverage centers on an immunochromatographic, proximal-to-distal flow assay that uses a distal immobilized capture agent to form antibody-linked moiety complexes and detects a visually detectable reporter moiety associated with a branched polymer. Dependent features refine the assay by selecting branched polymer architectures, reporter moiety label types, and specific immunochromatographic solid-phase materials and structures, including optional pre-mixing of sample with moieties.
Stated Advantages
Detecting presence of antibodies that bind a drug of interest, a food antigen, or an environmental antigen by correlating visual detection of a reporter moiety with antibody presence.
Report the ability to detect reporter moiety visually with an unaided eye.
Documented Applications
Immunogenicity assays for detecting anti-drug antibodies using immunochromatographic formats.
Detection of food allergen antibodies using immunochromatographic formats.
Detection of environmental allergen antibodies using immunochromatographic formats.
Detection of specific immunoglobulin isotypes including IgG, IgM, IgA, IgD, and IgE using immunochromatographic formats.
Lateral-flow detection examples reported for PEG/PEO, glucagon, and GLP-1.
Human serum screening/confirmation outcomes for antibody detection using the described lateral-flow immunoassays.
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