USPTO Patent Application: Ultrasensitive Immunoassay Method and Reagents

ChangeBridge: Patent Apps - Peptides (C07K)

Detected March 23rd, 2026

Summary

The USPTO has published a patent application detailing a new method and reagents for ultrasensitive detection of target molecules using reconstituted functional proteins. The invention aims to improve specificity and signal-to-noise ratios in various assay formats, including those for detecting viruses, bacteria, and proteins.

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What changed

This USPTO patent application, US20260079158A1, describes a novel method and reagents for ultrasensitive immunoassays. The core innovation involves fusion proteins with binding moieties that, upon encountering a target molecule, reconstitute a functional protein to generate a detectable signal. The application highlights enhanced sensitivity, specificity, and reduced background noise, applicable to detecting viruses (e.g., SARS-CoV-2), bacteria, and peptides.

While this is a patent application and not a regulatory rule, it signals potential future developments in diagnostic technologies. Companies involved in developing diagnostic kits, assays, or reagents for infectious diseases, protein detection, or general molecular diagnostics should be aware of this patented technology. No immediate compliance actions are required, but it may influence R&D strategies and intellectual property considerations in the diagnostics sector.

Source document (simplified)

← USPTO Patent Applications

METHOD AND REAGENTS FOR ULTRASENSITIVE IMMUNOASSAY

Application US20260079158A1 Kind: A1 Mar 19, 2026

Inventors

Ai-Ping Wei

Abstract

Disclosed are assays, reagents, and methods for ultrasensitive detection of target molecules. The assay comprises fusion proteins including binding moieties, such as antibodies, nanobodies (VHH/VNAR), or aptamers, linked to nonfunctional fragments of a protein. In the presence of a target molecule, the binding moieties recognize distinct target regions and bring the protein fragments into close proximity, reconstituting a functional protein that generates a detectable signal. Linkers connecting the fusion components may be flexible peptides or polypeptides that spontaneously form dimers, trimers, or tetramers, thereby providing multivalent fusion proteins with enhanced sensitivity. The reconstituted protein may produce luminescent, fluorescent, colorimetric, or spectroscopic signals detectable by microplate readers, handheld luminometers, or lateral flow devices. The invention encompasses solid-phase, homogeneous, and lateral flow assay formats for detecting viruses, bacteria, proteins, peptides, or small molecules, including GLRaV-3, SARS-CoV-2, PSA, and E. coli. The disclosed assays exhibit improved specificity, reduced background, and enhanced signal-to-noise ratios.

CPC Classifications

G01N 33/54388 C07K 14/195 C07K 16/104 C07K 16/1232 C07K 16/3069 C12Q 1/28 G01N 21/76 G01N 33/56916 G01N 33/56983 G01N 33/57555 C07K 2317/569 C07K 2319/61 G01N 2333/165 G01N 2333/245 G01N 2333/908