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Publication Number
US-9360477-B2
Publication Date
2016-06-07
Expiration Date
Abstract
Modified branched polymers are combined with bioactive agents which are one member of a binding pair for use in an assay.
Core Innovation
The invention relates to an assay kit for detecting a target in a sample, where detection is based on binding-pair interactions using a branched polymer conjugate. A detecting antibody or antigen-binding portion thereof specifically binds the target and is tagged with a plurality of a first member of a binding pair, while a conjugate comprising a branched polymer is tagged with a second member of the binding pair, and the kit further includes a capture molecule that specifically binds the target or the antibody or antigen-binding portion thereof and a reporter.
The core concept uses modified branched polymer structures, including symmetrically branched polymers and asymmetrically branched polymers such as random/regular ABP and dendritic polymers such as dendrimers and dendrigrafts, as labeling conjugate carriers. The branched polymer functions as a spacer, carrier, and anchor that self-orients bioactives on solid surfaces, enabling improved assay performance and reduced denaturation.
This self-orientation is described in connection with immunoassays and microarrays, including indirect immunoassays and sandwich and sequential assay formats. The branched polymer conjugate is further described across solid phases and detection formats, including lateral flow/dipstick immunoassay tickets and multiplex protein microarrays, with asserted reduction of background and false positives and enhanced sensitivity relative to non-polymer controls.
Claims Coverage
The independent claim defines an assay kit with four inventive features: a detecting antibody or antigen-binding portion tagged with a first binding-pair member, a branched-polymer conjugate tagged with a second binding-pair member, a capture molecule, and a reporter.
Assay kit with detecting antibody tagged with first binding-pair member
An assay kit for detecting a target in a sample comprising a detecting antibody or antigen-binding portion thereof that specifically binds the target, wherein the detecting antibody or antigen-binding portion thereof is tagged with a plurality of a first member of a binding pair.
Branched polymer conjugate tagged with second binding-pair member
A conjugate comprising a branched polymer and a second member of the binding pair.
Capture molecule that specifically binds the target or detecting antibody
A capture molecule that specifically binds the target or the detecting antibody or antigen-binding portion thereof.
Reporter
A reporter.
The claim coverage centers on the assay kit framework that combines binding-pair-tagged detecting and branched-polymer conjugate components with a capture molecule and reporter for target detection.
Stated Advantages
Enhanced assay performance, including enhanced sensitivity.
Reduced denaturation of bioactives on solid surfaces.
Reduced background and reduced false positives.
Simpler assay development, as stated in the document summary.
Documented Applications
Immunoassays, including indirect immunoassays.
Microarrays, including multiplex protein microarrays.
Lateral flow/dipstick immunoassay tickets.
Sandwich and sequential assay formats.
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