Automated Sample-to-Answer Cartridge for Microorganism Detection
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Solution Overview
Problem
Current Point-of-Care (POC) and Point-of-Need (PON) diagnostic systems for detecting microorganisms, especially in STD testing, face challenges with poor sensitivity, specificity, and positive predictive values due to labor-intensive sample preparation methods and the introduction of amplification inhibitors, which are not fully automated and often require complex laboratory equipment.
Innovation Solution
A sample-to-answer system with a cartridge that includes a filter, washing, lysis, and reaction chambers, utilizing a method of enriching the sample, washing, and applying heat to produce a lysate, which is then moved to reaction chambers for amplification and detection, allowing for automated and simplified nucleic acid amplification testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If filtration methods are used for sample preparation, then target microorganisms can be concentrated, but labor intensity increases and amplification inhibitors may be introduced
Solution Approach 1:
The system uses automated robotic arms to perform sample preparation, filtration, and reagent addition tasks that would otherwise require manual labor. The robot autonomously navigates the laboratory space, manipulates equipment, and processes multiple samples in sequence, eliminating the need for human operators to perform repetitive manual tasks while maintaining high target concentration through effective filtration.
2Quantity of substance
If filtration through dry filter is performed, then sample can be enriched, but amplification inhibitors are absorbed and released during elution
Solution Approach 1:
The system performs a pre-wetting step where the filter is exposed to a liquid solution before actual sample filtration. This preliminary action saturates the filter matrix, preventing it from absorbing amplification inhibitors during subsequent elution steps. The robot automatically adds the pre-wetting solution, waits for absorption, then proceeds with normal filtration and amplification procedures.
3Measurement precision
If Nucleic Acid Amplification Tests are performed, then sensitivity and specificity are improved, but device complexity and equipment requirements increase
Solution Approach 1:
The robotic system is designed to perform multiple functions within a single integrated platform: sample collection, filtration, reagent preparation, nucleic acid amplification, and detection. This multi-functional design consolidates what would otherwise require separate specialized equipment, maintaining high NAAT sensitivity and specificity while reducing overall device complexity and making the system more suitable for point-of-care settings.
4Productivity
If sample enrichment is performed, then processing time is reduced, but additional processing steps are required
Solution Approach 1:
The system combines multiple processing steps into integrated operations. The filtration step simultaneously concentrates target microorganisms and removes inhibitors, the pre-wetting step is merged with the filtration preparation, and the robotic system executes all steps in a continuous automated sequence without manual intervention between steps, thereby reducing total processing time despite the multiple operations involved.
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 simplifies and automates NAAT, enhancing sensitivity and specificity, making it suitable for POC/CLIA-Waived applications and enabling rapid detection of microorganisms with reduced labor and equipment requirements.
Implementation Method 1
adding the biological sample to a sample chamber comprising a filter; enriching the biological sample
Implementation Method 2
applying heat to the filter and the biological sample to produce a lysate
Implementation Method 3
applying heat to the at least one reaction chamber; performing a reaction in the at least one reaction chamber
Data Source
AI summary
The present invention relates to sample-to-answer systems, devices, cartridges, and method of using the same for detecting the presence of microorganisms in a sample, such as bacteria.