Integrated Molecular Diagnostic Device for Rapid Viral Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current molecular diagnostic testing methods are inadequate for decentralized or point-of-care use due to complexity, high cost, and safety concerns, particularly for detecting viruses like influenza and SARS-COV-2, as they require trained personnel, sophisticated equipment, and are not suitable for long-term storage or pooled sample testing.
Innovation Solution
A stand-alone, disposable molecular diagnostic test device with integrated reverse transcription, amplification, and detection modules that can be actuated with minimal user input, capable of processing multiple samples and producing results within 30 minutes, using a reducing agent like N-acetylcysteine to enhance sensitivity and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If centralized laboratory-based molecular diagnostics testing is used, then measurement precision is improved, but device complexity and ease of operation worsen
Solution Approach 1:
The patent combines multiple laboratory functions (reverse transcription, amplification, detection) into a single integrated disposable device. The reaction chamber integrates heating elements, mixing mechanisms, and detection optics, eliminating the need for separate sophisticated instruments while maintaining diagnostic accuracy through integrated end-to-end processing.
Solution Approach 2:
The invention employs disposable single-use cartridges that contain all necessary reagents and processing components. Each cartridge is pre-filled with reagents for reverse transcription and amplification, eliminating the need for expensive, regulated infrastructure and sophisticated equipment while maintaining measurement precision through manufacturer-controlled reagent quality.
2Measurement precision
If centralized laboratory-based molecular diagnostics testing is used, then measurement precision is improved, but ease of operation worsens
Solution Approach 1:
The disposable device performs all complex operations automatically without user intervention. The cartridge contains pre-measured reagents and integrated mechanisms for sample processing, heating, mixing, and detection. Users simply insert the sample and receive results, with no training required on complex laboratory procedures.
Solution Approach 2:
The system separates complex laboratory functions into discrete, pre-packaged disposable cartridges. Each cartridge is independently designed and manufactured with precise reagent formulations, allowing users to obtain laboratory-grade accuracy without needing to understand or operate complex equipment.
3Productivity
If high throughput laboratory equipment is used, then productivity is improved, but loss of time worsens
Solution Approach 1:
The disposable device performs reverse transcription, amplification, and detection in continuous sequence without batch processing interruptions. The integrated reaction chamber maintains continuous heating and mixing, eliminating the time losses associated with transferring samples between different laboratory instruments and preparing new reagents for each step.
Solution Approach 2:
All reagents are pre-loaded into the disposable cartridge before use, with precise concentrations and volumes predetermined by the manufacturer. The device performs end-to-end processing from sample input to result output in a single continuous operation, eliminating the multiple preparation and transfer steps that cause delays in traditional batch processing.
4Measurement precision
If sophisticated laboratory systems are used, then measurement precision is improved, but object-affected harmful factors worsen
Solution Approach 1:
The system uses disposable single-use cartridges that are sealed and sterile until use. Each cartridge contains all reagents in a closed system, eliminating exposure risks for users. The disposable nature ensures no cross-contamination between samples and eliminates the need for users to handle hazardous reagents or operate sophisticated equipment that poses safety risks.
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 cost-effective molecular diagnostic testing for viruses in decentralized settings, including point-of-care and pooled sample analysis, with improved sensitivity and safety, and is suitable for long-term storage and shipping.
Implementation Method 1
The reverse transcription module is configured to heat a biological sample to produce a target cDNA molecule associated with an RNA virus
Implementation Method 2
The amplification module defines a reaction volume configured to receive the amplification solution and amplify the target cDNA molecule within the amplification solution
Data Source
AI summary
A stand-alone molecular diagnostic test device includes a housing, a reverse transcription module, an amplification module, and a detection module. The reverse transcription module is configured to heat a biological sample to produce a target cDNA molecule associated with an RNA virus thereby producing an amplification solution. The amplification module defines a reaction volume configured to receive the amplification solution and amplify the target cDNA molecule within the amplification solution to produce an output. The detection module is configured to receive the output from the amplification module and includes one or more probes specific to a polynucleotide sequence of the RNA virus. The one or more probes is designed to facilitate production of a signal indicating the presence of the RNA virus in the biological sample.