Progressive Compression Driven Flow Cartridge for Rapid Diagnostic Testing
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Solution Overview
Problem
Current rapid in vitro diagnostic (IVD) test devices, particularly lateral flow strips, suffer from low accuracy due to sensitivity and specificity issues, leading to false negatives and positives, especially in saliva testing, where analyte concentrations are low and non-analyte molecules interfere with binding reactions, causing uneven immunoparticle movement and competition for binding sites.
Innovation Solution
A progressive compression driven flow cartridge with a test strip configuration that includes a flexible pad and a cap with an internal ramp, enhancing specimen flow and reducing interference by using a ring and auxiliary supports to secure the test strip, allowing for faster and more accurate analysis of liquid samples, including those with high viscosity, and incorporating a swab applicator for direct sample collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If lateral flow strip technology is used for rapid testing, then the test can be conducted quickly and inexpensively, but the accuracy falls to 75-95% due to interference from non-analyte molecules
Solution Approach 1:
The device is divided into multiple functional zones along the test strip: a sample application zone, a first affinity binding reaction zone, a second affinity binding reaction zone, and a detection zone. This segmentation allows different chemical and physical processes to occur in distinct regions, enabling both rapid processing and high accuracy through controlled sequential reactions that eliminate interference from non-analyte molecules.
Solution Approach 2:
The test strip is pre-treated with specific reagents and blocking molecules in manufacturing to prevent non-specific adhesion before the actual test. The first and second affinity binding reactions are pre-configured with specific antibodies and binding members that are already in place to capture and eliminate interfering substances before they can affect the final detection, ensuring 99%+ accuracy while maintaining rapid testing.
2Measurement precision
If pretreatment with multiple reagents is applied to enhance sensitivity and specificity, then binding efficiency improves, but manufacturing complexity increases due to incompatibilities between chemicals
Solution Approach 1:
The patent optimizes the chemical parameters of the reagents used in pretreatment, including pH levels, buffer compositions, and concentrations of blocking molecules. By carefully adjusting these parameters, the invention achieves high sensitivity and specificity while ensuring that all pretreatment chemicals are compatible and can be applied in a simplified manufacturing process without mutual interference.
Solution Approach 2:
The test strip incorporates composite structures with multiple layers containing different reagents embedded in matrix materials. These composite materials allow multiple pretreatment functions (blocking, pH conditioning, binding) to be integrated into a single manufactured strip, reducing manufacturing complexity while maintaining high sensitivity and specificity through the synergistic effects of multiple reagents.
3Measurement precision
If non-specific blocking molecules are used to prevent non-specific adhesion, then false positives are reduced, but false negatives increase when blocking molecules are dislodged during manufacturing
Solution Approach 1:
The blocking molecules are applied and cured in a controlled preliminary step during manufacturing, creating a stable protective layer before subsequent reagent applications. This preliminary action ensures that blocking molecules remain in place throughout the manufacturing process and during testing, maintaining high specificity while preventing false negatives through proper sequencing of manufacturing steps.
Solution Approach 2:
The blocking molecules are incorporated into a flexible thin film or coating layer on the test strip that provides mechanical protection while allowing chemical functionality. This thin film structure prevents dislodging of blocking molecules during manufacturing handling and storage, ensuring consistent performance and reducing false negatives while maintaining the specificity provided by the blocking molecules.
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 solution significantly improves the accuracy of rapid IVD tests by ensuring uniform specimen flow and reducing interference, enabling qualitative analysis up to three times faster than traditional lateral flow devices, with the ability to detect analytes in low concentrations within minutes, suitable for applications like traffic stops.
Implementation Method 1
A progressive compression driven flow cartridge with a test strip configuration that includes a flexible pad and a cap with an internal ramp, enhancing specimen flow
Implementation Method 2
labeled molecular affinity binding, such as immunochromatography
Implementation Method 3
labeled molecular affinity binding, such as immunochromatography
Data Source
AI summary
A progressive compression driven flow cartridge for analyzing liquids is coupled with convenient sampling methods for different applications. A one-step device provides for direct sample collection upon a sample pad annexed to the cartridge. The sample pad can deliver sample to the test strips, while saving a portion of the sample pad for further laboratory confirmation use. If the sample collecting pad is not suitable to collect the sample, such as the case of biological substances inside the human body, such as within the nose or throat, a two-step device can include a long-arm swab applicator and a specialized chamber in which some amount of liquid can dissolve biological substances as specimen. The specimen can then be transferred onto the cartridge, either by application to the sample pad, or into the device through a sample window. Each method provides a qualitative analysis much faster than traditional rapid diagnostic devices.