Latex Immunoturbidimetric sST2 Kit for Sensitive Clinical Detection
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Solution Overview
Problem
Existing methods for detecting soluble growth stimulation expressed gene 2 protein (sST2) in human blood lack sensitivity and specificity, particularly in the context of immune diseases such as asthma and rheumatoid arthritis, where ST2L neutralizing antibodies are needed to block ST2L-ligand binding and down-regulate Th2 cytokines.
Innovation Solution
A latex-enhanced turbidimetric immunoassay kit is developed, comprising specific reagents and calibrators, using latex microspheres functionalized with anti-sST2 antibodies, optimized for pH, temperature, and cross-linking conditions, to enhance detection accuracy and sensitivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional immunoassay methods are used for detecting sST2, then the detection can be performed, but the sensitivity and specificity are insufficient
Solution Approach 1:
The patent optimizes multiple parameters including pH (using boric acid buffer at pH 9.0), temperature (incubation at 37°C), and cross-linking conditions (using EDC cross-linking agent) to enhance the detection sensitivity and specificity of sST2. These parameter changes transform the conventional immunoassay into a more precise detection system suitable for clinical immune disease diagnosis
Solution Approach 2:
The patent employs composite reagent composition including boric acid buffer, EDC cross-linking agent, latex microspheres, and anti-sST2 antibodies. This composite material system enhances the stability, sensitivity, and specificity of the detection assay, resolving the contradiction between measurement precision and reliability
2Measurement precision
If latex-enhanced turbidimetric immunoassay is implemented with optimized reagents, then detection sensitivity improves, but reagent composition complexity increases
Solution Approach 1:
The patent develops a multi-functional reagent system where the boric acid buffer serves multiple purposes: maintaining optimal pH for antibody-antigen binding, facilitating EDC cross-linking reaction, and ensuring reagent stability. This multi-functionality reduces the need for separate optimization steps while maintaining high detection sensitivity
Solution Approach 2:
The patent performs preliminary cross-linking of anti-sST2 antibodies to latex microspheres using EDC before the actual detection assay. This preliminary action prepares the reagents in advance with optimized binding characteristics, simplifying the detection process while maintaining high sensitivity
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 kit provides improved detection sensitivity and specificity for sST2, enabling accurate measurement in clinical samples, with a clinical reference range established for disease diagnosis.
Implementation Method 1
a latex-enhanced turbidimetric immunoassay kit for detecting the concentration or content of the sST2
Implementation Method 2
transmission immunoturbidimetry and scattering immunoturbidimetry
Data Source
AI summary
The present disclosure relates to a kit for detecting a soluble growth stimulation expressed gene 2 protein. In particular, the present disclosure relates to a latex-enhanced turbidimetric immunoassay kit for detecting the concentration and/or content of the sST2 in human samples. The kit can be used in transmission immunoturbidimetry and scattering immunoturbidimetry. The kit comprises a buffer system, an anti-interference component, latex microspheres, an anti-sST2 antibody, etc. The latex-enhanced immunoturbidimetric agent of the present disclosure can detect sST2 proteins within a range of <400 ng/ml in a sample, with a sensitivity of up to 0.1 ng/ml and a high specificity, accuracy and precision. The kit is suitable for a fully automatic biochemical analyzer and a scattering analyzer, and has the advantages of convenient and fast use and low cost, and can be used clinically to detect the sST2 protein.