Magnetic Stirrer Test Device for Rapid Cardiac Marker Detection
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Solution Overview
Problem
Current methods for detecting cardiac markers like troponin and viruses in biological fluids are slow, leading to delayed diagnosis and inappropriate treatments in heart attacks, necessitating a rapid and accurate assay for timely intervention.
Innovation Solution
A test device with a housing, test strip, and test well that includes a mixer and a conjugate with antibodies specific to the analyte and a signal entity, allowing for rapid detection and quantification of analytes in biological fluids, featuring a flow path and a trapping zone for immobilizing the analyte, and a signal sensing device for measuring the generated signal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If conventional assay methods are used for detecting cardiac markers, then measurement precision can be maintained, but the detection time is excessively long leading to delayed diagnosis
Solution Approach 1:
The assay system is divided into distinct functional modules: a test well for sample preparation and reagent mixing, a test strip with separated detection zones (flow-through zone and trapping zone), and a signal sensing device. This segmentation allows parallel processing of sample preparation and detection, significantly reducing total assay time while maintaining measurement precision
Solution Approach 2:
Reagents including antibodies and signal entities are pre-loaded into the test well and test strip before sample addition. The test strip is pre-configured with trapping antibodies in the trapping zone and detection antibodies in the flow-through zone. This preliminary preparation eliminates time-consuming setup steps during actual testing, enabling rapid diagnosis
2Loss of time
If rapid detection methods are implemented, then diagnosis time is reduced, but device complexity increases
Solution Approach 1:
The test system performs self-service through automated capillary-driven fluid flow from the test well through the test strip, automatic mixing of reagents via magnetic stirrer, and self-contained signal generation using enzyme-conjugated antibodies. The trapping zone automatically captures analyte-conjugate complexes without external intervention. This self-service capability achieves rapid detection while minimizing the need for complex external control systems
Solution Approach 2:
The patent introduces a magnetic stirrer as an intermediary component to facilitate rapid and homogeneous mixing of reagents in the test well. This simple magnetic mixing mechanism effectively replaces complex mechanical mixing systems, reducing device complexity while ensuring rapid reagent interaction for fast detection
3Productivity
If conventional assay systems are used, then device complexity is minimized, but productivity is insufficient for rapid diagnosis requirements
Solution Approach 1:
The assay system maintains continuous useful action through uninterrupted capillary flow of sample and reagents from the test well through the test strip, continuous enzymatic reaction in the flow-through zone, and ongoing signal generation and detection. The magnetic stirrer provides continuous mixing during the reaction phase. This continuity eliminates idle time between processing steps, maximizing diagnostic throughput
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
Enables rapid detection and quantification of analytes within 10 minutes, improving the speed and accuracy of diagnosing heart attacks and viral infections, such as HCV, compared to existing systems like the IMMULITE 2000 troponin assay.
Implementation Method 1
mixing the conjugate and biological fluid within the test well to form a mixture
Implementation Method 2
allowing the mixture to flow onto the test strip so that the mixture is transported to the trapping zone
Implementation Method 3
the trapping zone having irreversibly bound thereon a second antibody specific for a second epitope on the analyte
Implementation Method 4
measuring a signal generated by the signal entity
Data Source
AI summary
Disclosed is a test device and a method for qualitatively and/or quantitatively measuring the concentration of an analyte in a biological fluid sample. The test device includes a housing defining a sample port, a test well containing a stirrer and a conjugate, and a test strip disposed within the housing. The test well is also defined by being located between the sample port and the test strip. Fluid flows from the test well onto the test strip, which has a trapping zone which binds the analyte and allows for its detection. A control zone may also be included. The test device is generally adapted to use a sandwich assay. Also disclosed is a system comprising the test device and a signal sensing device; and a method for using the test device.