Integrated Nucleic Acid Amplification and Detection Kit
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Solution Overview
Problem
Existing nucleic acid amplification and detection methods, such as lateral flow tests, are limited by sensitivity and require complex instrumentation, manual steps, and risk contamination, making them unsuitable for point-of-care or field-deployed diagnostics, especially for untrained users and tests requiring CLIA waiver approval.
Innovation Solution
A nucleic acid amplification and detection kit that integrates a buffer storage assembly, nucleic acid amplification assembly, and lateral flow test strip assembly, allowing for rapid and convenient sample collection, amplification, and detection within a simple, low-cost, disposable platform that contains amplified products to prevent contamination and eliminates the need for complex instrumentation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If lateral flow tests are used for nucleic acid detection, then the test can be performed with simple operation, but the sensitivity is limited and complex instrumentation is required
Solution Approach 1:
The patent combines nucleic acid amplification (PCR) and lateral flow detection into a single integrated cartridge system. The amplification reaction occurs within the same device that performs the lateral flow detection, eliminating the need for separate instrumentation and enabling sensitive detection with simple operation. The integrated design allows the amplification products to be directly detected by the lateral flow strip within the cartridge.
Solution Approach 2:
The device is segmented into distinct functional zones within the cartridge: sample application area, amplification reaction zone, and lateral flow detection zone. This segmentation allows each function to be optimized independently while maintaining overall simplicity of operation and achieving high detection sensitivity through the concentrated amplification-detection system.
2Ease of operation
If manual steps are used in the detection process, then the operation is simple, but contamination risk increases
Solution Approach 1:
The patent merges the amplification and detection steps into a single sealed cartridge, eliminating the need for manual transfer of amplified products between separate amplification and detection devices. This integration maintains procedural simplicity while preventing contamination by containing all reagents and amplified products within the closed cartridge system throughout the entire process.
Solution Approach 2:
The cartridge is designed as a disposable single-use device that is discarded after one test. This eliminates contamination risk from reuse while maintaining simplicity of operation - the user simply performs the test and discards the entire cartridge, ensuring no cross-contamination between tests.
3Measurement precision
If complex instrumentation is used for amplification and detection, then detection sensitivity improves, but device complexity increases
Solution Approach 1:
The patent combines complex PCR amplification and lateral flow detection functions into a single integrated cartridge with minimal external instrumentation required. The cartridge contains all necessary reagents, amplification components, and detection elements, reducing the external device to simple heating and reading functions while achieving high detection sensitivity.
Solution Approach 2:
The cartridge is pre-loaded with all necessary reagents and components for amplification and detection, making the system self-contained and self-sufficient. The device performs its own amplification and detection functions without requiring complex external instrumentation, achieving high sensitivity through the integrated design while minimizing external complexity.
4Productivity
If amplified products are released into the environment, then the test can be completed, but contamination of the work area occurs
Solution Approach 1:
The patent merges the waste containment function into the cartridge design itself. The cartridge is designed to contain all amplified products and waste materials within its sealed structure throughout the test process, allowing test completion while preventing environmental contamination. The integrated design includes waste absorption and containment features built into the cartridge.
Solution Approach 2:
The disposable cartridge contains all amplified products and waste within its sealed structure until disposal. After use, the entire cartridge is discarded as biological waste, ensuring that no amplified products are released into the environment during or after the test, while still allowing complete test execution.
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 kit provides a cost-effective, reliable, and user-friendly solution for nucleic acid amplification and detection, reducing the risk of contamination and enabling accurate results without complex equipment, suitable for point-of-care and field applications.
Implementation Method 1
Lateral flow tests are a form of immunoassay in which the test sample flows along a solid substrate via capillary action
Implementation Method 2
The gold particles are red in colour due to localized surface Plasmon resonance
Data Source
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Figure 5
AI summary
A nucleic acid amplification and detection kit, including: a buffer storage assembly, including a buffer storage reservoir storing a buffer solution therein; a nucleic acid amplification assembly including a nucleic acid amplification reservoir storing one or more reagents therein and configured to receive a sample containing nucleic acid for amplification therein, wherein the buffer storage assembly is configured to couple with the nucleic acid amplification assembly to seal within the nucleic acid amplification reservoir the sample containing nucleic acid and amplification products of the amplification; and a test strip assembly including a lateral flow test strip disposed therein, the test strip assembly and the coupled nucleic acid amplification and buffer storage assemblies being configured to couple with one another and including one or more solution release components to release the amplification products from the nucleic acid amplification reservoir onto the lateral flow test strip for testing, and to release the stored buffer solution from the buffer storage reservoir to flush the released amplification products along the lateral flow test strip.