Progressive Compression Cartridge for Analyte Detection
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Solution Overview
Problem
Current rapid IVD test devices suffer from low accuracy due to insufficient sensitivity and specificity, often resulting in false negatives and positives, especially in saliva testing, where low analyte concentrations and uneven immunoparticle movement on nitrocellulose membranes hinder effective analyte detection.
Innovation Solution
A strip-carrying cartridge with a progressive compression structure that drives high-speed liquid flow through a conjugate pad to a reaction region, utilizing mobilizable first affinity binding members and immobilized second affinity capture binding members, combined with a siphoning force component to enhance liquid flow and binding reactions, achieving up to 99.9% accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If lateral flow strip technology is used for rapid testing, then the test speed and simplicity are improved, but the accuracy falls short of 99% required for confirmatory tests
Solution Approach 1:
The device is divided into distinct functional zones including a sample application zone, a first reaction zone with immobilized capture members, and a second reaction zone with immobilized detection members. This segmentation allows each zone to perform its specific function optimally, with the first zone capturing analytes and the second zone detecting them, thereby improving both speed and accuracy simultaneously
Solution Approach 2:
Mobilizable binding members are introduced as intermediaries that facilitate the interaction between analytes and immobilized capture/detection members. These mobile binding members enhance the binding reactions by providing additional interaction opportunities, improving measurement precision while maintaining the rapid nature of the lateral flow format
2Measurement precision
If pretreatment chemicals are applied to enhance sensitivity and specificity, then the binding reactions are improved, but manufacturing complexity and uniformity difficulties increase
Solution Approach 1:
The nitrocellulose membrane is pre-treated during manufacturing with blocking agents and other reagents to prevent non-specific binding and enhance sensitivity. This preliminary action is performed once during device fabrication, eliminating the need for complex step-by-step pretreatment procedures during operation, thus improving sensitivity and specificity without adding manufacturing complexity
Solution Approach 2:
The device utilizes changes in physical parameters such as wick geometry, pore size distribution, and material composition to optimize liquid flow characteristics and binding reaction efficiency. By adjusting these parameters during manufacturing, the device achieves high sensitivity and specificity without requiring complex operational procedures or multiple pretreatment steps
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
This solution enables rapid qualitative and quantitative results with improved sensitivity and specificity, reducing false positives and negatives by ensuring uniform liquid flow and increased binding opportunities, thus providing reliable analyte concentration measurements.
Implementation Method 1
a movable compression structure adapted to progressively compress the conjugate pad in a downstream direction
Implementation Method 2
combined with a siphoning force component to enhance liquid flow
Implementation Method 3
Labeled molecular affinity binding such as immunochromatographic assays
Data Source
AI summary
A cartridge and method for conducting a labeled molecular affinity binding test such as antibody/antigen, ligand/receptor, and colorometric reactions, and other chemical reactions for which one or more analytes is present in a liquid sample formate. A progressive compression structure progressively forces a liquid flow out of a conjugate pad toward a reaction region to more thoroughly and rapidly mix the liquid, encouraging specific first affinity binding to the analytes in question. A specially dimensioned constricting passageway surrounding the reaction region including the result zones provides an additional siphoning force to the flow. These combined forces rapidly and more evenly guide the flow of liquid through the reaction region so that the rushed rate of uptake of analytes at the strip lines are more evenly distributed, adhesive attachment of non-specific molecules is largely avoided, vastly improving sensitivity and specificity, and providing quantitative results in some tests.