Multiplex Cartridge for Hormonal Assays
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Solution Overview
Problem
Current point-of-care (POC) devices for hormonal assays face challenges in achieving high sensitivity and versatility, often requiring extensive laboratory infrastructure and struggling to measure multiple analytes simultaneously with high accuracy.
Innovation Solution
A point-of-care system comprising a multiplex cartridge with a blood tube receiver, plasma separator, pumping mechanism, incubation wells with magnetic beads, and lateral flow strips, which allows for the simultaneous detection of estradiol, progesterone, testosterone, TSH, and FSH in a blood sample, providing rapid and accurate results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If automated liquid pipetting stations with ELISA techniques are used, then measurement precision and sensitivity are improved, but device complexity and infrastructure requirements increase
Solution Approach 1:
The system is divided into modular components: a handheld device for sample collection and initial processing, and a separate reading device for analysis. This segmentation allows each module to be optimized independently, reducing overall system complexity while maintaining high measurement precision through specialized functions in each segment.
Solution Approach 2:
The invention extracts the core essential functions (sample collection, plasma separation, and detection) from the complex laboratory infrastructure. By removing non-essential components and focusing only on critical functions, the system achieves gold standard sensitivity without requiring extensive laboratory equipment, automated pipetting stations, or complex environmental controls.
2Ease of operation
If fluorescence-based lateral flow assays are used in current POC devices, then ease of operation is improved, but measurement precision and sensitivity deteriorate
Solution Approach 1:
The invention applies different quality standards to different parts of the testing system. The sample collection and processing portion uses simple, easy-to-operate components for user convenience, while the detection portion employs gold standard methodology with optimized reagents and protocols to achieve high sensitivity. This local differentiation allows the system to be easy to operate overall while maintaining precise measurements at the critical detection stage.
3Productivity
If multiple hormones are measured simultaneously, then productivity is improved, but device complexity and reagent requirements increase
Solution Approach 1:
The invention merges multiple hormone assays into a single integrated testing process. All five hormones (estradiol, progesterone, testosterone, TSH, and FSH) are measured simultaneously using a unified protocol and single sample application, eliminating the need for separate testing procedures and reducing overall device complexity compared to performing multiple separate assays.
Solution Approach 2:
The testing system is designed with universal components that can handle multiple hormone detections. The lateral flow strip and processing methodology are configured to universally detect various hormones through a single integrated workflow, allowing the system to perform multiple functions (detecting different hormones) without requiring separate specialized equipment for each assay.
4Measurement precision
If plasma or serum is required for testing, then measurement precision is improved, but ease of operation and convenience deteriorate
Solution Approach 1:
The system performs preliminary plasma separation automatically within the handheld device before the actual hormone measurement. By pre-processing the blood sample to separate plasma in the field, the system eliminates the need for patients to visit laboratories for serum collection and processing, while still achieving gold standard sensitivity. This preliminary action at the point of care maintains measurement precision while dramatically improving convenience.
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 system enables rapid, accurate, and reliable detection of multiple hormonal analytes directly at the point of care, overcoming the limitations of traditional POC devices by reducing the need for laboratory infrastructure and improving sensitivity and convenience.
Implementation Method 1
a plasma separator to filter the plasma from the blood sample into the plasma chamber
Implementation Method 2
mixing the plasma with the chemical reagents through magnetic agitation produced by a magnetic field underneath the plurality of incubation wells
Implementation Method 3
measuring instrument with a fluorescence reader to detect a fluorescence signal from the plurality of lateral flow strips within the cartridge
Data Source
AI summary
The present invention relates generally to a system and method for detecting the plurality of analytes in a blood sample. The present invention involves an advanced cartridge designed for detecting multiple analytes in a blood sample. The cartridge integrates a series of components to process the blood sample, beginning with its reception and separation into plasma. The plasma is then precisely measured and directed through an incubation process, where it is mixed with reagents and incubated under controlled conditions. Following incubation, the plasma is analyzed using lateral flow strips that detect and quantify various target analytes. This cartridge system is particularly suited for point-of-care testing, providing a streamlined, automated approach to performing complex assays, including immunoassays and electrochemical assays, with enhanced accuracy and efficiency.