Diagnostic Test Device Compression Mechanism
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Solution Overview
Problem
Conventional lateral flow strip tests for detecting analytes in liquids suffer from low accuracy and long test times due to issues like uneven immunoparticle movement, interference from non-analyte molecules, and lot-to-lot variation, which results in inadequate sensitivity and specificity, especially in saliva testing where analyte concentrations are low.
Innovation Solution
A diagnostic test device with a compression mechanism that sandwiches a conjugate pad within the test strip, using mobilizable labeled affinity binding members and immobilized capture binding members, to drive the liquid sample through the test strip, enhancing the flow and mixing of samples, thereby improving the formation of analyte complexes and reducing false positives and negatives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional lateral flow strip technology is used, then the test device is simple and inexpensive, but the accuracy and sensitivity are insufficient (75-95% accuracy)
Solution Approach 1:
The test strip is divided into multiple functional zones including a sample application zone, a reaction zone with immobilized capture binding members, and a detection zone. This segmentation allows each zone to perform its specific function optimally, improving overall measurement precision while maintaining relative simplicity.
Solution Approach 2:
The patent introduces mobilizable labeled affinity binding members as intermediaries that facilitate the detection process. These labeled binding members interact with analytes in the sample and are subsequently captured by immobilized capture binding members, enhancing the sensitivity and accuracy of detection without significantly complicating the device structure.
2Stability of the object's composition
If conventional capillary action is used for liquid flow, then the device structure is simple, but the flow is uneven and mixing is inadequate
Solution Approach 1:
The patent employs a compression mechanism that dynamically compresses the conjugate pad during the test process. This dynamic compression enhances liquid flow through the reaction zone, ensuring uniform distribution of the sample and adequate mixing with the affinity binding members, thereby improving flow stability.
Solution Approach 2:
The device performs preliminary compression of the conjugate pad before the liquid sample fully traverses the test strip. This preliminary action ensures that the sample is properly distributed and mixed from the outset, leading to more uniform flow characteristics throughout the test process.
3Measurement precision
If the test time is extended to improve accuracy, then sensitivity and specificity improve, but the test duration increases (currently 5-20 minutes)
Solution Approach 1:
The dynamic compression mechanism actively enhances liquid flow through the reaction zone during the test process. This increased flow rate maintains adequate contact time between analytes and binding members for high sensitivity and specificity, while reducing the overall test duration by preventing flow stagnation and ensuring efficient reaction kinetics.
Solution Approach 2:
The patent changes the flow parameters by applying compression force to the conjugate pad. This parameter change increases the velocity and uniformity of liquid flow through the test strip, allowing sufficient reaction time for high accuracy while reducing the total test time required.
4Measurement precision
If pretreatment with multiple chemicals is applied to enhance sensitivity, then accuracy improves, but manufacturing complexity and chemical incompatibility increase
Solution Approach 1:
The patent extracts the need for multiple complex pretreatment chemicals by using a simplified approach: a single compression mechanism that enhances the performance of the basic immunochromatographic reaction. This eliminates manufacturing complexities associated with multiple chemical pretreatments while maintaining high accuracy.
Solution Approach 2:
The compression mechanism enables the test system to self-optimize the flow characteristics and mixing efficiency without requiring external chemical pretreatments. The mechanical compression itself provides the necessary enhancement for high sensitivity and specificity, simplifying the manufacturing process.
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 achieves rapid qualitative and quantitative results with up to 99% accuracy by ensuring a high-speed, uniform flow of the liquid sample through the reaction region, breaking up clumps of non-analyte molecules and improving the binding of analytes to their sites, thus enhancing sensitivity and specificity.
Implementation Method 1
a cap configured to press the compression bars toward the compression cushion, thereby driving the liquid sample along the test strip
Implementation Method 2
labeled molecular affinity binding, such as immunochromatography
Implementation Method 3
immobilized capture binding members, to drive the liquid sample through the test strip
Data Source
AI summary
A rapid diagnostic test device uses driven flow technology to significantly expedite the testing time of a sample. The rapid diagnostic test device can be used to analyze liquids, such as some body fluids, by using labeled molecular affinity binding, such as immunochromatography. The test device can detect an analyte, such as an antibody or antigen, which may indicate a particular condition, the presence of a particular drug, or the like. The device includes a cover and base that combine to form an internal cavity for receiving a test strip. Compression bars in the cover and a compression cushion in the base sandwich a conjugate pad of the test strip to accelerate chemical mixtures to flow from the conjugate pad of the test strip toward fixed sites along the strip from which readings are taken.