Lateral Flow Assay System with Optical Reader and Incubator
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Solution Overview
Problem
Traditional lateral flow assays face challenges in providing fast, reliable, and tamper-proof analyte detection, especially in non-laboratory settings, with issues related to contamination, operator error, and the need for improved ruggedness and ease of use.
Innovation Solution
A combined lateral flow assay system incorporating a reader and incubator with an imaging detector, optical analysis capabilities, and a removable assay module that minimizes contamination risks through air cleaning and adjustable optics, along with coding systems for automated testing and temperature control, to enhance accuracy and speed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If lateral flow assays are performed in non-laboratory settings, then speed and ease of use are improved, but contamination risks and operator error increase
Solution Approach 1:
The patent introduces an intermediary optical system with coded references that mediates between the simple lateral flow assay and the complex laboratory environment. The optical reader with coded references acts as a mediator that automates validation checks, preventing operator error and contamination while maintaining the portability and speed needed for non-laboratory settings.
Solution Approach 2:
The system implements feedback mechanisms through optical validation of coded references on test strips. The reader verifies codes before accepting results, providing immediate feedback that prevents invalid tests from being processed. This feedback loop ensures reliability without requiring complex laboratory procedures.
2Measurement precision
If automated reading systems are introduced, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The system is segmented into distinct functional modules: a portable reader unit, removable test strips with integrated codes, and separate validation logic. This segmentation allows the optical measurement system to be relatively simple while achieving high precision through the combined system architecture rather than a single complex device.
Solution Approach 2:
The patent uses optical copying and recognition of coded references on test strips. Instead of complex physical verification, the system creates an optical copy of the code and validates it digitally, simplifying the physical device while improving measurement precision through automated verification.
3Reliability
If validation systems are added to prevent fraudulent use, then test result reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The validation system operates autonomously through self-service mechanisms. The optical reader automatically validates coded references on test strips without requiring operator intervention or knowledge. The system itself performs the fraud prevention checks, maintaining ease of operation while improving reliability.
Solution Approach 2:
Validation of coded references is performed as a preliminary action before results are accepted. The system checks codes in advance, automatically rejecting fraudulent or invalid test strips before they can compromise result reliability, without adding steps to the operator's workflow.
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 system provides rapid, reliable, and tamper-proof analyte detection by reducing contamination risks, improving accuracy, and automating testing processes, while ensuring the integrity of results through advanced optical analysis and coding systems.
Implementation Method 1
The sample is carried to the opposite end of the membrane strip by a mobile phase that traverses the membrane strip, for example by capillary action.
Implementation Method 2
The presence and, in some cases, the concentration, of an analyte on a reagent strip may be determined by measuring the optical reflectance from an area of development on the strip.
Data Source
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AI summary
Lateral flow assay analysis is shown and described. In one embodiment, the lateral flow assay comprises a surface having a reflectance profile that is adapted to enable monitoring of the assay continuously until the detection of an analyte. In other embodiments, a lateral flow assay system includes an incubator and a reader, wherein the incubator incubates the assay concurrently as the reader generates a test result. Further, an assay measurement apparatus may include an optical detector to perform continuous image detection of the assay to generate a diagnostic test result.