Assay Device Capillary Liquid Handling
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Solution Overview
Problem
Current in vitro diagnostic (IVD) devices face challenges with long turnaround times and resource constraints, particularly in point-of-need settings, due to limitations in sensitivity and the need for subjective interpretation in rapid diagnostic tests, and the requirement for benchtop equipment in gold standard methods.
Innovation Solution
A device comprising a chamber with magnetic particles and a liquid absorbing pad, allowing for capillary removal of liquids and eliminating the need for pipetting, with a mechanism to shift between closed and open positions for sealing and fluidic path formation, enabling quantitative analysis and simplifying the detection of biomarkers without specialized knowledge.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If rapid diagnostic tests based on immunochromatography are used, then the diagnosis time is reduced and ease of operation is improved, but sensitivity and measurement precision deteriorate
Solution Approach 1:
The patent combines the rapid testing format with electrochemical detection technology, merging the speed advantages of lateral flow tests with the quantitative precision of electrochemical sensors. The test strip integrates both sample flow pathways and electrochemical sensing elements, enabling simultaneous rapid testing and precise measurement.
Solution Approach 2:
The patent replaces subjective visual interpretation with objective electrochemical detection. Instead of relying on practitioner interpretation of color changes, the system uses electrochemical sensors to automatically detect and quantify the test results, eliminating subjectivity and improving measurement precision.
2Measurement precision
If quantitative tests based on immunoassays are used, then sensitivity and measurement precision are improved, but device complexity and ease of operation worsen due to requirement for specialized equipment and trained personnel
Solution Approach 1:
The device performs automatic liquid handling through capillary action, eliminating the need for manual pipetting by trained personnel. The test system self-regulates sample flow, reagent mixing, and waste removal through integrated capillary channels, making the complex quantitative analysis process as simple as dropping a sample onto the test strip.
Solution Approach 2:
The patent introduces a microfluidic capillary network as an intermediary system that automatically manages liquid transport between sample application, reaction zones, and waste collection. This intermediary structure handles the complex fluid handling requirements, shielding the user from operational complexity while maintaining quantitative precision.
3Ease of operation
If qualitative rapid tests are used, then ease of operation is improved, but reliability and measurement precision deteriorate due to subjective interpretation
Solution Approach 1:
The patent replaces the human interpretation mechanism with an electrochemical detection system. Instead of practitioners subjectively evaluating color intensity, electrochemical sensors objectively measure electrical signals generated by the immunochromatographic reaction, eliminating interpretation variability and improving reliability.
4Measurement precision
If benchtop equipment is used for gold standard methods, then measurement precision is improved, but device complexity and ease of operation worsen due to constrained-resource settings
Solution Approach 1:
The patent employs disposable test strips that integrate all necessary reagents, capillary channels, and electrochemical sensing elements in a single-use format. This eliminates the need for complex reusable benchtop equipment, cleaning protocols, and maintenance infrastructure, making gold-standard precision accessible in resource-constrained point-of-care settings.
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 provides a rapid, quantitative, and user-friendly method for detecting biomarkers, reducing the need for specialized equipment and interpretation, while allowing for efficient liquid handling and sample analysis, suitable for both professional and non-professional users.
Implementation Method 1
The liquid absorbing pad removes or drains the liquid in the chamber by capillarity
Data Source
AI summary
A device for performing an assay system, the device including a chamber comprising a first opening, and a second opening; a liquid exit; a liquid absorbing pad adjacent to the chamber; an opening assembly for shifting the device between a closed position and an open position; a sealing element;wherein:in the closed position the sealing element covers the liquid exit such that a liquid is prevented from flowing out of the chamber;and in the open position at least part of the liquid exit is uncovered by the sealing element and the device comprises a fluidic path between the chamber and the liquid absorbing pad through the uncovered part of the liquid exit.