Immunoassay Strip Validation Zone for Sample Authentication
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current diagnostic immunoassay devices and methods lack effective means to authenticate and validate the presence and volume of biological samples, particularly bodily fluids, which is crucial for ensuring the accuracy and reliability of analyte detection.
Innovation Solution
The development of immunoassay strips and devices incorporating a validation zone, a conjugate zone with labeled primary antibodies or reagents, and a reaction zone with secondary antibodies or antigens, which react to produce colored, fluorescent, or electrochemical signals to authenticate biological samples by detecting characteristic markers and ensuring the correct volume of the sample is present.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a validation zone is added to the immunoassay device to authenticate biological samples, then sample authentication capability is improved, but device complexity increases
Solution Approach 1:
The validation zone is integrated into the existing immunoassay device structure, combining sample authentication functionality with the analytical testing function. The validation zone uses the same fluid flow path and detection membrane technology as the rest of the device, merging multiple functions into a single integrated system rather than adding separate authentication equipment.
Solution Approach 2:
The detection membrane and fluid flow system serve dual purposes: they perform the primary immunoassay function for analyte detection and simultaneously provide sample authentication by detecting characteristic markers. The same physical components (membrane, reagents, flow path) are used for both authentication and analytical functions, making the device multi-functional.
2Measurement precision
If multiple zones (validation, conjugate, reaction) are incorporated into the strip, then authentication and detection accuracy are improved, but manufacturing complexity increases
Solution Approach 1:
The detection membrane is divided into distinct functional zones (validation zone, conjugate zone, reaction zone) with specific reagents placed in each. This segmentation allows for standardized manufacturing of each zone module, which can then be assembled into the complete strip. Each zone can be pre-coated or pre-loaded with specific antibodies or markers, simplifying the overall manufacturing process through modular assembly.
Solution Approach 2:
The characteristic markers and conjugated reagents are pre-loaded onto the detection membrane during manufacturing, before the actual testing process. This preliminary preparation of reagent zones eliminates the need for complex assembly steps during device use and allows for standardized mass production of pre-configured test strips with all necessary components in place.
3Quantity of substance
If the validation zone is placed to receive sample before the sample receiving zone, then sample volume validation is improved, but fluid flow control complexity increases
Solution Approach 1:
The validation zone is positioned upstream of the sample receiving zone in the fluid flow path, allowing it to automatically intercept and validate the sample volume as it naturally flows through the device. The zone uses the sample's own flow characteristics and physical properties (such as forming a visible front or meniscus) to perform self-validation without requiring external control mechanisms, pumps, or valves.
Solution Approach 2:
The validation zone utilizes visual indicators such as color changes or formation of a visible fluid front to indicate adequate sample volume. This optical signal provides immediate feedback on sample sufficiency without requiring complex electronic sensors or control systems, leveraging simple optical detection that can be read visually or with basic imaging.
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 approach enables reliable authentication of biological samples and validation of their volume, ensuring accurate analyte detection and preventing false results by using visual or imaging-based methods to verify the presence of characteristic markers and volume thresholds.
Implementation Method 1
a conjugate zone having labels conjugated with primary antibodies or reagents specific to a plurality of characteristic markers of the biological sample and the analytes of interest
Implementation Method 2
a reaction zone having secondary antibodies or antigens or reagents specific to the primary antibodies or reagents that bind with the plurality of characteristic markers of the biological sample and analytes of interest
Implementation Method 3
The device is a lateral flow immunoassay strip or vertical flow immunoassay strip
Data Source
AI summary
An immunoassay device that authenticates a biological sample while performing an assay for an analyte or analytes of interest is provided. The device includes a sample receiving zone to receive the biological sample; a validation zone placed before or after the sample receiving zone to validate the biological sample; a conjugate zone having labels conjugated with primary antibodies or reagents specific to a plurality of characteristic markers of the biological sample and the analytes of interest; and a reaction zone having secondary antibodies or antigens or reagents specific to the primary antibodies or reagents that bind with the plurality of characteristic markers of the biological sample and analytes of interest.