Hingeable Collection Slide for Human Hemoglobin Detection
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Solution Overview
Problem
Traditional methods for detecting occult blood in stool samples, such as Guaiac-based chemical methods and immunoassays, face challenges in distinguishing between dietary-derived and human hemoglobin, leading to false-positive results and unpleasant sample collection and analysis processes.
Innovation Solution
A device comprising a collection slide with hingeably connected cards and a docking area for a test element, featuring an absorbent transfer material and reagents to elute analytes from the sample, which are then detected using a test strip with specific binding molecules for human hemoglobin, reducing direct interaction with the sample and improving accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional Guaiac-based chemical methods are used to detect hemoglobin in stool samples, then the detection process is simple, but the ability to distinguish between dietary-derived and human hemoglobin is poor, leading to false-positive results
Solution Approach 1:
The patent introduces an intermediary step where buffer solution is used to elute and transfer analytes from the sample collection area through the collection slide to the test element. This intermediary transfer mechanism allows for better separation and detection of human hemoglobin from dietary hemoglobin, improving measurement precision while maintaining manageable device complexity through the use of standard immunoassay components
Solution Approach 2:
The collection device is segmented into distinct functional areas: a sample collection area, a buffer application area, and a test element area. This segmentation allows the buffer to selectively interact with and elute analytes from the sample before reaching the detection zone, enabling more precise differentiation between human and dietary hemoglobin without requiring overly complex device architecture
2Measurement precision
If immunoassays specific for human hemoglobin are used, then false-positive results are reduced, but the sample collection and analysis process becomes more complex and requires greater interaction with the sample
Solution Approach 1:
The collection slide is designed to perform self-service functions: the buffer automatically elutes analytes from the sample collection area and transports them to the test element through the collection slide's internal structure. This self-contained mechanism reduces the need for manual sample manipulation and increases ease of operation while maintaining the precision of human-specific immunoassay detection
Solution Approach 2:
The patent merges multiple functions into a single integrated collection slide: sample collection, buffer application, analyte elution, and analyte transfer to the test element. This consolidation of functions into one component simplifies the overall操作流程, making the device easier to operate while preserving the high detection accuracy of human hemoglobin-specific immunoassays
3Productivity
If direct sample analysis is performed, then the analysis process is straightforward, but patient and operator exposure to the sample increases
Solution Approach 1:
The collection slide acts as an intermediary barrier between the sample and the operator. The buffer solution elutes analytes from the enclosed sample through the slide's porous structure, allowing analyte transfer while containing the sample itself. This maintains analysis efficiency by enabling direct immunoassay detection while minimizing harmful exposure to both patient-derived sample material and the operator
Solution Approach 2:
The buffer extraction process selectively removes only the analytes (hemoglobin molecules) from the sample matrix, leaving the bulk sample contained within the collection area. This extracted analyte solution is then transferred to the test element for analysis, maintaining high productivity by enabling direct detection while reducing exposure to the potentially harmful components of the original sample
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 device effectively reduces false-positive results and enhances the efficiency of sample collection and analysis by accurately detecting human hemoglobin while minimizing patient and operator exposure to the sample.
Implementation Method 1
a sample transfer orifice having an absorbent transfer material, which receives buffer passed through the orifices of the collection slide, and passes the eluted fluid to the test element
Data Source
AI summary
The present invention provides devices, methods, and kits for the collection of a solid or semi-solid sample and analysis for the presence, absence, or quantity of an analyte. The invention provides a collection slide having a first card and a second card. The first card has a sample collection area. The first and second cards have orifices allowing the passage of fluid through the sample collection area, and the cards are hingeably connected to each other. The invention also provides an assay device having a housing with a test element, a results window, and a docking area for receiving and engaging the collection slide. In one embodiment the collection slide and device can be used to detect the presence of fecal occult blood (human hemoglobin) in a stool sample. Many other embodiments are described herein.