Antibody Assay Reagent Copolymer Serum Interference
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Solution Overview
Problem
Existing reagents for assaying anti-Treponema pallidum antibodies in autoanalyzers face challenges with serum interference, leading to inaccurate results due to variations in serum components, and stabilizers like polyvinylpyrrolidone and pullulan lose effectiveness over time.
Innovation Solution
A reagent containing an insoluble carrier supporting a phospholipid or Treponema pallidum antigen, combined with a copolymer derived from 2-methacryloyloxyethyl phosphorylcholine and a hydrophilic monomer, such as methacrylic acid, which enhances sensitivity and maintains stability by preventing serum interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If sensitizer (polyvinylpyrrolidone or pullulan) is added to accelerate antigen-antibody reaction, then reaction speed is improved, but storage stability deteriorates due to desensitization over time
Solution Approach 1:
The patent removes the problematic sensitizer components (polyvinylpyrrolidone and pullulan) from the reagent formulation. By extracting these unstable substances, the reagent maintains storage stability without desensitization, while the antigen-antibody reaction still proceeds effectively without requiring these accelerators.
Solution Approach 2:
The patent replaces long-lived but unstable sensitizer molecules with a stable reagent system that does not rely on degradable components for its function. The reagent maintains effectiveness throughout its storage life without requiring sensitizer molecules that progressively lose activity.
2Quantity of substance
If smaller amount of serum is used in autoanalyzer assay, then blood collection load on patient is reduced, but antigen-antibody reaction amount decreases leading to potential accuracy issues
Solution Approach 1:
The patent optimizes the reagent formulation to work effectively with reduced serum volumes by adjusting concentration parameters and reaction conditions. The reagent is designed to achieve sufficient reaction signal with smaller sample amounts, maintaining measurement precision despite reduced input volume.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution provides accurate and stable assays for anti-phospholipid and anti-Treponema pallidum antibodies, preventing serum interference and maintaining sensitivity over long storage periods.
Implementation Method 1
an amount of antigen-antibody reaction caused by a reaction between the reagent and the antibody in the blood
Implementation Method 2
a phenomenon called serum interference, which negatively affects the assay, may occur due to variation of components contained in the serum
Data Source
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AI summary
It is an object of the present invention to provide a reagent for assaying anti-phospholipid antibodies, which is excellent in long-term storage stability and enables an accurate diagnosis of syphilitic infection, and a reagent for assaying anti-Treponema pallidum antibodies, which enables an accurate diagnosis of syphilitic infection by preventing an occurrence of serum interference. The present invention is a reagent for assaying anti-phospholipid antibodies used for diagnosing syphilitic infection, which contains an insoluble carrier supporting an anti-phospholipid antigen thereon and a copolymer having a segment derived from 2-methacryloyloxyethyl phosphorylcholine and having a segment derived from a hydrophilic monomer.