Sealed Lateral Flow Immunoassay Device for Sanitary Influenza Detection
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Solution Overview
Problem
Current lateral flow assays for detecting influenza A and B face challenges such as lengthy tissue culture methods, dependence on specimen quality, and lack of sanitary handling and disposal, necessitating a device that is easy to use, assemble, and dispose of safely, while also accommodating various labeling reagents including those requiring instrumentation.
Innovation Solution
A device comprising a receptacle, holder, and test strip assembly that includes a grip member, stop feature, alignment feature, and retention features for secure placement and sanitary handling of the test strip, allowing for easy assembly and disposal, and accommodating both visually detectable and instrumentation-requiring labels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If tissue culture methods are used for influenza detection, then detection accuracy is improved, but testing time increases significantly (up to 7 days)
Solution Approach 1:
The patent employs disposable lateral flow test strips with pre-loaded reagents and detection elements. These single-use strips eliminate the need for lengthy tissue culture procedures while providing rapid results within minutes. The disposable nature ensures accuracy through standardized, pre-calibrated reagents without requiring complex laboratory infrastructure.
Solution Approach 2:
The patent replaces the mechanical and biological complexity of tissue culture systems with a simplified lateral flow immunoassay system. Instead of maintaining cell cultures and observing viral growth over days, the system uses antibody-antigen binding reactions on a membrane strip that produce visible results rapidly, substituting a complex biological system with a simpler chemical-biological hybrid system.
2Productivity
If conventional lateral flow assays are used, then rapid detection is achieved, but sanitary handling and disposal becomes problematic
Solution Approach 1:
The patent merges the test strip, holder, and disposal container into a single integrated unit. The holder encapsulates the test strip and provides a sealed environment that contains biological samples and reagents, preventing contamination during handling. After use, the entire assembly can be disposed of as a single unit, eliminating the need for separate decontamination procedures.
Solution Approach 2:
The patent employs a sealed holder structure that acts as a protective barrier, containing potentially hazardous biological materials within the device. This sealed environment prevents exposure to contaminants during the testing process and facilitates safe disposal by containing all biohazardous elements within the disposable unit.
3Measurement precision
If specialized equipment is used for instrumentation-based labels, then detection sensitivity is improved, but device complexity and ease of operation deteriorates
Solution Approach 1:
The patent designs a universal holder and receptacle system that can accommodate multiple types of test strips with different labeling technologies. The same basic device structure supports both visually detectable labels (such as colored particles) and instrumentation-requiring labels (such as fluorescent or chemiluminescent tags), allowing the system to maintain high detection sensitivity across different modalities without requiring specialized equipment for each type.
4Manufacturing precision
If complex assembly procedures are used, then manufacturing precision is improved, but ease of manufacture and user operation deteriorates
Solution Approach 1:
The patent divides the device into distinct modular components: a holder, a test strip, and a receptacle. Each component can be manufactured independently using standardized processes, then assembled through simple insertion and engagement mechanisms. This segmentation allows for precise manufacturing of individual parts while simplifying the overall assembly process, reducing the need for complex alignment procedures.
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 enables rapid, accurate, and sanitary detection of influenza A and B, reducing contamination risks and improving user accessibility, with the ability to handle multiple labeling reagents, including those requiring spectrophotometric analysis.
Implementation Method 1
Lateral flow assays (or 'flow-through' assays) are well known in the art and are described in Ching et al., U.S. Pat. No. 6,534,320, May et al., U.S. Pat. No. 6,228,660, Charlton et al, U.S. Pat. No. 5,989,921, Charlton U.S. Pat. No. 6,485,982, Charlton U.S. Pat. No. 5,714,389, Rosenstein, U.S. RE 38,430 all incorporated herein by reference. Lateral flow assays are characterized in that a liquid solution containing an analyte to be detected is transported by capillary action laterally along a membrane strip.
Data Source
AI summary
Disclosed is a diagnostic testing device that may be used to detect one or more analytes in a sample. The device comprises a receptacle and a holder for a test strip. The test strip may be, for example, a lateral flow test strip. The device and holder permit analysis of a sample, wherein the device is substantially sealed during testing and detection of results. To use, the holder containing a test strip is inserted into the receptacle containing sample to be analyzed. Capillary flow along the test strip is initiated by contact of the sample with the distal end of the test strip. The receptacle is such that results of the assay may be detected visually or using standard instrumentation such as by measuring light absorption or reflectance.