Immunochromatographic Kit In Situ Nitrous Acid Generation
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Solution Overview
Problem
Current immunochromatographic kits for detecting streptococci and viruses face challenges with unstable nitrous acid, requiring fresh preparation, leading to laborious processes, inaccurate diagnoses, and poor assay repeatability due to errors in mixing reagents, and suffer from non-specific reactions and low sensitivity.
Innovation Solution
The kit generates nitrous acid on the test device using a premeasured amount of nitrite salt and a heterocyclic compound with a cyclic ester or cyclic imide skeleton, preventing protein denaturation and aggregation, and includes a cyclic oligosaccharide to enhance sensitivity and specificity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If nitrous acid is prepared fresh by mixing sodium nitrite and organic acid before each extraction, then extraction efficiency of polysaccharides is improved, but labor intensity increases and assay repeatability deteriorates
Solution Approach 1:
The patent applies preliminary action by pre-mixing sodium nitrite and organic acid in a stable reagent composition that can be stored without refrigeration. This pre-prepared mixture generates nitrous acid in situ when contacted with water or buffer, eliminating the need for fresh preparation before each extraction while maintaining high extraction efficiency of polysaccharides from streptococci.
2Measurement precision
If nitrous acid is prepared fresh by mixing reagents, then extraction efficiency is improved, but possibility of errors in mixing increases leading to inaccurate diagnosis
Solution Approach 1:
The patent merges sodium nitrite and organic acid into a single stable reagent composition that maintains its integrity during storage. When this combined reagent contacts water or buffer in the test system, it generates nitrous acid in situ. This merging eliminates multiple mixing steps and reduces the possibility of human error in reagent preparation, thereby improving diagnosis accuracy while maintaining extraction efficiency.
3Measurement precision
If nitrous acid is prepared fresh before each use, then extraction efficiency is improved, but time consumption increases
Solution Approach 1:
The patent applies preliminary action by pre-forming a stable reagent composition containing sodium nitrite and organic acid that can be stored at room temperature. This pre-prepared reagent generates nitrous acid immediately upon contact with water or buffer during the test, eliminating the time-consuming fresh preparation step while maintaining high extraction efficiency of polysaccharides from streptococci.
4Measurement precision
If conventional extraction method is used, then polysaccharide extraction is achieved, but non-specific reactions occur and sensitivity decreases
Solution Approach 1:
The patent applies parameter changes by optimizing the composition ratios of sodium nitrite and organic acid in the reagent formulation, along with controlling pH and ionic strength parameters. These parameter optimizations enhance the specificity of nitrous acid generation for polysaccharide extraction while minimizing non-specific reactions, thereby improving detection sensitivity for streptococci and viruses.
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
This approach simplifies the test process, improves accuracy and repeatability, and enables quick, sensitive detection of streptococci and viruses without the need for fresh nitrous acid preparation, reducing labor and errors, while maintaining high sensitivity and specificity.
Implementation Method 1
uses a premeasured amount of a nitrite salt and a heterocyclic compound having a cyclic ester or cyclic imide skeleton to generate a nitrous acid
Implementation Method 2
The extraction method using nitrous acid has a number of merits, including high extraction efficiency for polysaccharides
Implementation Method 3
for detecting a target substance (such as antigens) in a sample solution, for example, for the detection of gram-positive bacteria
Data Source
Figure 1~1(b)
AI summary
The present invention is intended to provide an immunoassay method that enables an immunoassay with high sensitivity at a high development rate without causing aggregation of insoluble carriers or non-specific reaction while improving test efficiency and reducing labor. The present invention relates to an immunoassay method that uses a test device, and the method includes: extracting an antigen of a detection target in an analyte with an extraction agent; and detecting the detection target with a detection reagent capable of binding the antigen. The extraction agent is a nitrous acid generated on the test device by a contact reaction between a nitrite salt and a heterocyclic compound having at least one skeleton selected from the group consisting of a cyclic ester, a cyclic amide, and a cyclic imide.