Automated Microfluidic Cartridge for Rapid Nucleic Acid Genotyping
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Solution Overview
Problem
Traditional hospital laboratories face challenges in quickly and cost-effectively testing biological specimens for SARS-CoV-2 due to shortages of automated test equipment and reagents, requiring specialized skills and expensive equipment, which delays results and complicates genotyping processes.
Innovation Solution
A web-based system for ordering and processing biological tests over a network, utilizing automated laboratory instrumentation and a computer-implemented method to rapidly amplify target nucleic acid sequences, providing clinically reportable results within 3.5 hours on average, with automated quality control and electronic chain of custody.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional hospital laboratories use automated test equipment and reagents for SARS-CoV-2 testing, then testing accuracy and reliability are improved, but equipment availability and cost-effectiveness deteriorate due to shortages and high costs
Solution Approach 1:
The patent employs disposable microfluidic cartridges containing pre-loaded reagents and consumables for SARS-CoV-2 testing. These single-use cartridges eliminate the need for expensive, complex automated equipment while ensuring consistent testing quality. Each cartridge is a low-cost, disposable unit that contains all necessary components (reagents, controls, sampling wells) to perform the complete testing workflow without requiring expensive laboratory infrastructure.
Solution Approach 2:
The microfluidic cartridge system is designed to be self-contained and self-regulating. The cartridges automatically manage fluid flow, reagent mixing, and reaction conditions through integrated microfluidic channels and valves. This self-service capability eliminates the need for specialized laboratory equipment and trained personnel, allowing standard healthcare workers to perform accurate viral genotyping without access to expensive automated testing systems.
2Measurement precision
If traditional laboratories perform manual genotyping tests, then specialized skills and expensive equipment are required, but testing speed and cost-effectiveness deteriorate
Solution Approach 1:
The patent replaces manual mechanical operations with automated microfluidic systems. The microfluidic cartridge automatically performs sample aspiration, reagent mixing, thermal cycling, and result detection without manual intervention. This substitution of mechanical automation for manual operations maintains high genotyping accuracy while dramatically increasing testing throughput and reducing the time required to complete each test from days to hours.
Solution Approach 2:
The system utilizes controlled temperature parameter changes through integrated heating and cooling elements in the microfluidic cartridge. The device automatically cycles through specific temperature ranges to facilitate PCR amplification and probe hybridization reactions. This precise thermal control enables accurate viral genotyping while the automated process eliminates the need for manual technique expertise and reduces testing time compared to traditional methods.
3Reliability
If traditional testing processes are used, then result accuracy is maintained, but time to obtain results deteriorates from several days to hours
Solution Approach 1:
The microfluidic cartridges are pre-assembled with all necessary reagents, controls, and sampling components before use. This preliminary preparation eliminates time-consuming setup steps in the laboratory. The pre-configured cartridges contain optimized reagent concentrations, pre-programmed fluid routing, and prepared control samples, allowing immediate testing upon sample receipt and enabling rapid turnaround from hours rather than days while maintaining result accuracy through pre-validated protocols.
Solution Approach 2:
The microfluidic system enables continuous automated processing of samples through integrated thermal cycling and fluid handling. The device performs PCR amplification, probe hybridization, and signal detection in continuous automated sequences without manual intervention between steps. This continuous operation eliminates idle time between testing steps, maintaining analytical accuracy through uninterrupted processing while reducing total testing duration from traditional multi-day workflows to hours.
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 system enables rapid, accurate, and cost-effective genotyping results, reducing the time to obtain test results from several days to approximately 4.8 hours, improving the efficiency and reliability of SARS-CoV-2 testing while streamlining the ordering and reporting process.
Implementation Method 1
A computer implemented method to provide a reportable result to a user for the presence of a target nucleic acid sequence in a sample... obtaining a fluorescent intensity value for a polymerase chain reaction amplification cycle
Implementation Method 2
obtain a fluorescent intensity value for a polymerase chain reaction amplification cycle... comparing the sample cycle threshold value to an established cycle threshold range
Data Source
AI summary
The invention is directed to a method and system to rapidly provide a clinical reportable result for the presence of a target nucleic acid sequence in a sample. The inventive subject matter includes: a method to conduct a rapid assay to provide a clinically reportable result for the presence of a target nucleic acid sequence in a sample. A clinically reportable results is one that is automatically validated. Here the testing and quality control steps are automated to avoid delay caused by human review and validation of each assay.