Stool Sample Stabilizing Composition for Home Collection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing non-invasive methods for diagnosing gastrointestinal disorders require multiple steps from the patient, including separating and processing fecal samples, which can lead to reduced patient compliance and diagnostic efficacy.
Innovation Solution
A method involving collecting a fecal sample at home and combining it with a liquid composition that stabilizes proteins and nucleic acids, allowing direct delivery to a laboratory for analysis without further handling, thus simplifying the process and maintaining sample integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the patient performs multiple steps including separating and processing fecal samples at home, then the diagnostic process can be completed, but the patient compliance and ease of operation are reduced
Solution Approach 1:
The patent extracts the complex sample processing steps from the patient's responsibilities and transfers them to the laboratory setting. The patient only needs to collect the sample and add stabilizing reagent, while all separation, processing, and analysis steps are performed by laboratory personnel, thereby improving patient compliance without compromising diagnostic efficacy
Solution Approach 2:
The patent introduces a stabilizing reagent as an intermediary substance that preserves the fecal sample during transport and storage. This mediator allows the sample to remain stable without requiring complex processing by the patient, simplifying the patient's role while maintaining sample integrity for subsequent laboratory analysis
2Productivity
If the patient separates the fecal sample into multiple portions and performs immunological tests at home, then the analysis can be conducted, but the device complexity and difficulty of detecting and measuring increase
Solution Approach 1:
The patent merges multiple separate processing steps (sample separation, stabilizing, storage, and analysis) into a single integrated workflow performed at the laboratory. Instead of the patient performing multiple discrete operations, the laboratory receives the complete sample and performs all necessary analyses in sequence, reducing the number of steps the patient must execute while maintaining diagnostic throughput
Solution Approach 2:
The stabilizing reagent performs self-service by automatically preserving the sample's biochemical properties upon contact, without requiring the patient to perform additional processing steps. The sample essentially stabilizes itself through the reagent's action, reducing the complexity of patient operations while ensuring sample integrity for laboratory analysis
3Ease of operation
If the fecal sample is transported without stabilization, then the transport process is simple, but the sample integrity deteriorates due to protein denaturation and nucleic acid degradation
Solution Approach 1:
The patent applies preliminary action by adding the stabilizing reagent to the fecal sample immediately upon collection, before transport. This advance stabilization prevents protein denaturation and nucleic acid degradation during the transport process, allowing simple transport conditions to be used without compromising sample integrity. The stabilizing effect is established beforehand, eliminating the need for complex transport requirements
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 patient experience by reducing handling steps and maintaining sample integrity, while enabling efficient parallel analysis for gastrointestinal disorder diagnostics.
Implementation Method 1
combining the fecal sample with a liquid composition in a container, wherein the liquid composition prevents denaturation or degradation of fecal proteins in the fecal sample
Implementation Method 2
wherein the liquid composition maintains integrity of nucleic acids in the fecal sample
Data Source
AI summary
The present disclosure provides improved methods of processing a fecal sample by a human subject in which the fecal sample is collected at home and subsequently delivered to a medical diagnostics laboratory. As described herein, the means of collecting and processing the fecal sample can desirably reduce the number of steps undertaken by the human subject, including avoiding steps of removing or separating the fecal sample into multiple portions. Furthermore, the human subject does not have to perform an immunological test (e.g., a fecal immunochemical test (FIT) or an immunochemical fecal occult blood test (iFOBT)) at home.