Test Strip Assembly with Flow Separator for Saliva Analysis
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Solution Overview
Problem
Conventional lateral flow assays for detecting biochemical molecules in saliva samples face challenges due to the high viscosity of saliva, leading to aggregation, flooding, and non-specific adherence of colloidal particles, which reduces sensitivity and requires large sample volumes, complicating sample collection and pretreatment processes.
Innovation Solution
A test strip assembly with a sample sorbent strip and a reagent sorbent strip that intersect to direct fluid flow uniformly towards the test strip, preventing mixing and allowing for controlled sample and reagent interaction, integrated within a housing to manage large sample volumes and prevent flooding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional lateral flow assays are used for saliva samples, then the assay can detect analytes, but the high viscosity of saliva causes aggregation, flooding, and non-specific adherence, reducing sensitivity
Solution Approach 1:
The device segments the fluid handling into separate pathways: a sample well with sorbent material for viscosity management, a flow separator to prevent mixing, and a test strip zone. This segmentation prevents aggregation and non-specific adherence by controlling fluid flow and separation of functions.
Solution Approach 2:
A flow separator acts as an intermediary element between the sample introduction zone and the test strip. This mediator prevents direct contact between the viscous saliva sample and the test strip surface, eliminating non-specific adherence while maintaining analytical sensitivity.
2Measurement precision
If large volumes of saliva are applied to overcome low analyte concentration, then detection sensitivity improves, but the test strip floods and causes insufficient reaction
Solution Approach 1:
The device divides the fluid handling into distinct segmented zones: a sample well that can accommodate large volumes without flooding, a flow separator that controls fluid transition, and a test strip zone that receives controlled fluid amounts. This allows large sample volumes to be applied while preventing flooding of the test reaction area.
Solution Approach 2:
The flow separator introduces a vertical dimension to fluid control, using a stacked configuration where the separator physically blocks excess fluid from reaching the test strip while allowing controlled passage of the required sample volume through capillary action.
3Adaptability or versatility
If sample and reagent are introduced separately into lateral flow assay, then flexibility is reduced, but the contact point at test zone cannot be controlled
Solution Approach 1:
The test strip assembly is designed as a multi-functional integrated unit that can accommodate both separate and simultaneous introduction of sample and reagent. The flow separator and sorbent materials provide universal functionality for handling different introduction modes while maintaining controlled contact at the test zone.
4Measurement precision
If saliva samples require separate preparation steps before introduction to lateral flow device, then sample handling becomes complicated, but assay accuracy may improve
Solution Approach 1:
The device merges the sample preparation function directly into the test device by incorporating sorbent material in the sample well. This combination allows viscosity reduction and sample conditioning to occur in-line during the assay process, eliminating separate pretreatment steps while maintaining assay accuracy.
Solution Approach 2:
The sorbent material in the sample well provides self-service sample preparation by automatically reducing saliva viscosity and conditioning the sample as it is introduced. This self-service mechanism eliminates the need for external pretreatment operations while ensuring sample suitability for the lateral flow assay.
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 configuration enhances the sensitivity and accuracy of saliva-based assays by ensuring uniform fluid flow and reducing the need for extensive sample pretreatment, while maintaining compactness and ease of use.
Implementation Method 1
a sample sorbent strip having a first location for receiving the sample and a connecting portion for connecting the first location with a second location, the connecting portion defining a sample flow path to the second location
Data Source
AI summary
There is provided a test strip assembly for detecting the possible presence of at least one analyte in a sample, a device for detecting the possible presence of at least one analyte in a sample comprising the test strip assembly and methods of detecting the possible presence of at least one analyte in a sample using the device.