ST2 Biomarker Test Strip Plasma Separation and Antibody Conjugates
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Solution Overview
Problem
Current methods for detecting cardiac biomarkers, particularly ST2, in blood samples are inefficient for rapid and reliable determination, which hinders timely and informed treatment decisions in patients with non-specific symptoms like dyspnea or chest pain.
Innovation Solution
The development of test kits and apparatus featuring test strips with multiple antibodies and a specially designed housing that assist in the flow of blood samples, using a buffer to facilitate the detection of ST2 levels, allowing for quick and accurate visualization or quantitative measurement of ST2 in blood samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current methods for detecting cardiac biomarkers are used, then detection can be performed, but the detection is inefficient and not rapid enough for timely treatment decisions
Solution Approach 1:
The detection system is segmented into multiple functional components: test strips with specific antibody conjugates, buffer systems for sample preparation, and automated readers. This segmentation allows parallel processing of sample preparation, detection, and analysis, significantly improving detection efficiency and reducing the time required for treatment decisions.
Solution Approach 2:
The test strips are pre-loaded with antibody-conjugate combinations specific to ST2 biomarkers, and buffers are pre-formulated for optimal sample processing. This preliminary preparation eliminates time-consuming setup steps during actual detection, enabling rapid processing of cardiac biomarker samples and faster delivery of diagnostic results.
2Reliability
If multiple antibodies and conjugates are used in test strips, then detection accuracy and reliability improve, but device complexity increases
Solution Approach 1:
Multiple antibodies and conjugates are merged into a single integrated test strip format. The test strip combines capture antibodies, detection antibodies, and control elements in one device, allowing simultaneous multi-parameter detection. This merging maintains high detection reliability while simplifying the user interface and sample application process.
Solution Approach 2:
The test strip design incorporates universal components that can detect multiple cardiac biomarkers including ST2, using different antibody-conjugate combinations. This multi-functionality allows a single device platform to perform various cardiac biomarker detections, maintaining reliability across different assays while avoiding the need for multiple separate complex devices.
3Manufacturing precision
If specially designed housings and buffer systems are implemented, then sample flow consistency improves, but manufacturing complexity increases
Solution Approach 1:
The housing design incorporates localized flow control features such as channels, barriers, and absorption zones at specific locations within the test strip. These local structural modifications guide sample flow through the detection zones with consistent velocity and direction, ensuring uniform antigen-antibody interactions. The localized approach achieves flow precision without requiring complex overall device architecture, facilitating easier manufacturing.
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 fast and reliable detection of ST2 levels, aiding in risk stratification and treatment decisions, thereby reducing morbidity and mortality, and optimizing healthcare resource allocation.
Implementation Method 1
a plasma separation pad in fluid communication with a portion of the conjugate pad. The plasma separation pad is disposed and configured to receive the whole blood sample and to pass blood plasma from the whole blood sample to the conjugate pad while inhibiting other components of the whole blood sample from passing to the conjugate pad
Implementation Method 2
The flow of the sample within the test strips is assisted by a suitably formulated buffer
Data Source
AI summary
The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a whole blood sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad holds the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The test strip also includes a plurality of second antibodies that bind to ST2, and a plurality of third antibodies that bind to the conjugate-ST2 complexes. The plurality of second antibodies are bound to a membrane in a test location, and the plurality of third antibodies are bound to the membrane in a control location. A plasma separation pad passes blood plasma from a whole blood sample to the conjugate pad while inhibiting other components.