Stool Sample Kit for IBS Diagnosis via Elastase and Calprotectin Testing
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Solution Overview
Problem
Current methods for diagnosing Irritable Bowel Syndrome (IBS) are often delayed and inaccurate, leading to unnecessary procedures and misattribution of symptoms, as they do not effectively differentiate IBS from other gastrointestinal conditions and do not provide timely or accurate assessments of digestion, inflammation, and gut flora imbalances.
Innovation Solution
A comprehensive approach involving non-invasive tests for stool samples to assess pancreatic sufficiency, inflammation, and gut flora, including measurements for pancreatic elastase, calprotectin, and microbial analysis, along with the use of specific kits for sample collection and preservation, to evaluate digestion, inflammation, and gut health.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional diagnostic methods are used for IBS, then the diagnosis process is simple, but the accuracy and timeliness are poor leading to delayed diagnosis
Solution Approach 1:
The diagnostic approach is segmented into three distinct testing modules: maldigestion testing (pancreatic elastase), inflammation testing (calprotectin), and gut flora testing (microbiome analysis). Each module independently assesses a specific aspect of GI health, allowing comprehensive evaluation without requiring complex invasive procedures and enabling timely results for each component.
Solution Approach 2:
The patent performs preliminary non-invasive testing using stool samples to assess pancreatic function, inflammation markers, and gut flora composition before proceeding to more invasive diagnostic procedures. This preliminary action identifies IBS patients early and distinguishes them from other GI conditions, reducing diagnostic delays and avoiding unnecessary invasive tests.
2Measurement precision
If comprehensive testing for digestion, inflammation, and gut flora is performed, then diagnostic accuracy improves, but device complexity and test complexity increase
Solution Approach 1:
The stool sample serves as a universal medium that simultaneously enables assessment of multiple GI functions: pancreatic enzyme activity (maldigestion), inflammatory markers (calprotectin), and microbial composition (gut flora). This multi-functional approach allows comprehensive diagnostic evaluation through a single non-invasive sample, reducing overall system complexity compared to multiple separate invasive tests.
Solution Approach 2:
The stool sample acts as an intermediary medium that indirectly reflects the state of the gastrointestinal tract without requiring direct tissue biopsy or invasive procedures. By analyzing markers in the stool, the system obtains comprehensive diagnostic information about digestion, inflammation, and gut flora through a simple non-invasive collection method.
3Ease of operation
If non-invasive stool testing is used, then ease of operation and patient comfort improve, but measurement precision may be compromised
Solution Approach 1:
The patent utilizes specific parameter thresholds and reference ranges for stool markers (e.g., pancreatic elastase concentration, calprotectin levels, microbial composition ratios) to maintain high measurement precision. By establishing validated cutoff values and interpreting results within established clinical contexts, the non-invasive stool testing achieves diagnostic accuracy comparable to invasive methods.
Data Source
AI summary
The present invention relates to kits designed for the collection of stool samples and methods of analyzing those samples for biological markers of maldigestion, inflammation, and imbalanced gut flora.