Method for detection of analytes via polymer complexes
Inventors
Wong, Wesley Philip • Hansen, Clinton H.
Assignees
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Publication Number
US-12331349-B2
Publication Date
2025-06-17
Expiration Date
Abstract
Provided herein are products and methods for detecting analytes using polymers that bind to such analytes and thereby undergo a conformational change or contribute to a newly formed complex.
Core Innovation
The invention describes detecting an analyte in a sample by combining the sample with a plurality of polymers, where each polymer is conjugated to an analyte-specific binding partner. The analyte-specific binding partners are able to bind to a single analyte simultaneously, so that binding enables formation of a distinguishable complex.
The polymers of the plurality are not bound to each other directly or indirectly in the absence of the analyte, so the complex formation depends on analyte binding. The formed complex is indicative of the presence of the analyte in the sample, including complex conformational change described as an X-shaped complex upon simultaneous binding to a single analyte.
The document further describes approaches using polymer pairs versus single-polymer loop and cleavage approaches, and detection of the complex by gel electrophoresis or single-molecule/optical methods such as fluorescence-based approaches. Quantitation is described using band intensity and downstream extraction/sequencing/qPCR, with applications to analyte and panel analysis in complex samples.
Claims Coverage
The independent claim is clm-00001. It covers detecting an analyte by simultaneous binding of multiple polymer-conjugated analyte-specific binding partners to a single analyte to form a complex while the polymers are not bound to each other in the absence of the analyte; dependent claims refine polymer formats, complex-detection modalities, and analyte/context constraints.
Simultaneous binding to a single analyte by multiple polymer-conjugated binding partners
Combining a sample with a plurality of polymers, each polymer conjugated to an analyte-specific binding partner, under conditions that allow binding of each analyte-specific binding partner to an analyte, wherein the analyte-specific binding partners are able to bind to a single analyte simultaneously.
Analyte-dependent complex formation with polymers unbound without analyte
The polymers of the plurality are not bound to each other directly or indirectly in the absence of the analyte, detecting a complex formed by the binding of the plurality of polymers or a subset of the plurality of polymers to an analyte, wherein presence of the complex is indicative of presence of the analyte.
Across the dependent claims identified in the provided material, coverage extends to specifying binding partner classes (antibodies/antigen-binding antibody fragments), constraining binding specificity via different epitopes or repeated identical epitopes, specifying at least one polymer as a single-stranded nucleic acid, adding low-copy analyte detection thresholds, and detecting the complex using listed detection modalities.
Stated Advantages
Sensitive detection of an analyte via analyte-indicative complex formation.
Enables multiplexed analysis through use of polymer-conjugated analyte-specific binding partners.
Allows detection in complex samples and supports panel analysis.
Documented Applications
Detecting analytes in complex samples, including analyte/panel use in complex samples [procedural detail omitted for safety].
Urine sample detection, including detection of Early Pregnancy Factor (EPF) [procedural detail omitted for safety].
Applications involving low-copy analytes using explicit detection thresholds for analyte copies [procedural detail omitted for safety].
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