Method for Producing a Standard for Detecting Protein Aggregates of a Protein Misfolding Disease, as Well as a Standard and the Use Thereof

Simple SummaryContent extracted from patent full text and abstract with AI.

This invention describes a method for creating standardized particles (standards) used in detecting protein aggregates associated with protein misfolding diseases, such as Alzheimer's and Parkinson's. The process involves attaching segments of disease-relevant proteins or their recognition sites to the surfaces of inorganic nanoparticles (like silica, gold, or quantum dots) that are sized to mimic disease aggregates. These standards provide a stable, reproducible reference to improve medical diagnostic tests by enabling accurate and consistent detection and quantification of misfolded protein aggregates in biological samples.

Use CasesContent extracted from patent full text and abstract with AI.

• Calibration and quality control in laboratory tests for neurodegenerative diseases like Alzheimer's, Parkinson's, prion diseases, and amyloidosis.
• Development of highly sensitive diagnostic assays (such as immunoassays or biosensors) for early detection of misfolded protein aggregates in patient samples (e.g., blood, cerebrospinal fluid).
• Standardization of quantitative protein aggregate measurement in clinical and research settings.
• Benchmarking and validating new medical diagnostic devices or platforms targeting protein misfolding diseases.
• Research into mechanisms of protein aggregation by providing well-defined models of pathogenic aggregates.

BenefitsContent extracted from patent full text and abstract with AI.

• Highly reproducible and homogeneous standards, eliminating batch-to-batch variation found in traditional aggregate preparations.
• Customizable to mimic different types and sizes of pathogenic protein aggregates for multiple diseases.
• Stable over time, with no risk of further aggregation or degradation during storage, ensuring long shelf life.
• Reduces reagent cost and complexity compared to using pure or recombinant proteins for standard preparation.
• Compatible with a wide range of diagnostic platforms and detection methods, including fluorescence labeling for robust signal readout.
• Improves assay sensitivity, accuracy, and comparability between tests and laboratories.
• Enables precise determination of test performance characteristics and quantitative analysis of unknown samples.
• Facilitates development and approval of new diagnostics by ensuring quality and regulatory compliance.

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Patent Abstract

The invention relates to a method for producing a standard for detecting protein aggregates of a protein misfolding disease, comprising the following steps: A) providing an inorganic nanoparticle with the size of the aggregate of the protein misfolding disease; B) forming free amino groups or free carboxyl groups on the surface of the nanoparticle (for functionalising the nanoparticle surface to form an amine- or carboxyl-functionalised nanoparticle); C) i) bonding maleinimide-spacer-carboxylic acid to the free amino groups in step B), or ii) converting the free carboxyl groups in step B) into NHS-esters; D) bonding monomers of the protein aggregate i) to the maleinimide-spacer-carboxylic acid via a sulfhydryl group at the free end of the monomers, or ii) to the NHS-esters via the amino group at the free end of the monomer. The invention also relates to a standard as well as the use thereof in the detection of protein aggregates occurring in the case of protein misfolding diseases.