Multiple Analyte Fecal Antigen Testing Stabilization
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Solution Overview
Problem
Current Fecal Immunochemical Tests (FIT) for colorectal cancer screening are limited to detecting hemoglobin and do not effectively analyze other protein biomarkers associated with colorectal adenoma and cancer, due to poor protein stability and low analyte concentration in small stool samples collected using FIT sample collection devices.
Innovation Solution
A method and composition for stabilizing and analyzing multiple protein biomarkers, including hemoglobin, calprotectin, haptoglobin, and complement component 3, in small fecal samples using a FIT sample collection device, by dispersing the samples in a stabilizing solution and employing immunochemical assays, which allows for the detection of these markers in both FIT device samples and whole stool supernatants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If FIT sample collection devices are used to collect small stool samples, then the convenience and affordability of CRC screening is improved, but the ability to detect multiple protein biomarkers is limited due to poor protein stability and low analyte concentration
Solution Approach 1:
The patent applies preliminary action by incorporating a stabilizing solution into the FIT sample collection device before sample collection. This stabilizing solution is prepared in advance to maintain protein stability and preserve analyte concentration throughout the testing process, enabling subsequent multi-biomarker detection without degrading sample quality
Solution Approach 2:
The patent implements multi-functionality by designing the FIT sample collection device and stabilizing solution system to support detection of multiple protein biomarkers (hemoglobin, calprotectin, haptoglobin, complement component 3) simultaneously, rather than being limited to hemoglobin detection only. This universal approach allows a single device to perform multiple diagnostic functions
2Ease of operation
If small fecal samples are collected using FIT devices, then sample collection convenience is improved, but protein stability and analyte concentration deteriorate
Solution Approach 1:
The patent uses a stabilizing solution as an intermediary substance between the collected fecal sample and the detection process. This stabilizing solution mediates the interaction by creating a protective environment that maintains protein stability and prevents degradation, allowing small samples to retain their analytical integrity throughout the testing workflow
3Ease of operation
If small fecal samples are collected using FIT devices, then sample collection convenience is improved, but analyte concentration decreases
Solution Approach 1:
The patent applies parameter changes by modifying the chemical and physical parameters of the sample environment through the stabilizing solution. The stabilizing solution adjusts pH, ionic strength, and other parameters to optimize analyte preservation, thereby maintaining detectable concentrations of multiple protein biomarkers even in small sample volumes
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 enhances the sensitivity and specificity of colorectal cancer detection by combining the analysis of multiple protein biomarkers, particularly hemoglobin, haptoglobin, and complement component 3, improving the diagnostic performance of FIT tests beyond hemoglobin alone.
Implementation Method 1
dispersed sample comprising a small human fecal sample dispersed in a volume of a stabilizing solution
Implementation Method 2
Fecal immunochemical tests (FIT tests) are antibody-based assays that detect hemoglobin in a stool specimen
Data Source
AI summary
Methods, compositions, and systems for testing fecal samples, including small human fecal samples, for a plurality of different marker analytes, e.g., a plurality of different human protein, nucleic acid, and other molecular marker analytes.