Sealed Diagnostic Cartridge for Automated Sample Preparation
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Solution Overview
Problem
Prior art diagnostic test systems are large, complex, costly, and require manual sample preparation steps that expose operators to hazardous samples and risk contamination, leading to incorrect results.
Innovation Solution
A disposable diagnostic test cartridge pre-loaded with reagents and a user-friendly instrument that automates sample preparation, amplification, and detection, ensuring sealed handling and reducing manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual sample preparation steps are used in prior art diagnostic test systems, then operators can perform sample handling, but operator exposure to hazardous samples and contamination risk increases
Solution Approach 1:
The system enables self-service operation where the automated instrument performs sample preparation, amplification, and detection without requiring manual intervention. The cartridge is pre-loaded with reagents and the system automatically executes the diagnostic protocol, eliminating operator exposure to hazardous samples while maintaining operational capability
Solution Approach 2:
Manual mechanical sample handling operations are replaced by an automated mechanical system with robotic sample preparation capabilities. The automated instrument performs liquid handling, mixing, and transfer operations that were previously done manually, thereby protecting operators from exposure to hazardous biological samples
2Ease of operation
If manual sample preparation steps are used, then sample handling can be performed, but risk of contamination and incorrect results increases
Solution Approach 1:
The system performs self-service sample preparation and processing through automated protocols that eliminate human intervention in critical steps. The automated execution of amplification and detection protocols reduces the risk of contamination and incorrect results while maintaining operational simplicity
Solution Approach 2:
The manual sample preparation steps that introduce contamination risk are extracted and replaced by an automated closed-system process. The cartridge-based approach encapsulates reagents and samples in a sealed environment, removing the source of contamination risk while preserving sample handling capability
3Adaptability or versatility
If prior art diagnostic test systems are used, then diagnostic testing can be performed, but system size and complexity increase
Solution Approach 1:
The system employs a nested structure where a compact cartridge containing all necessary reagents and sample preparation components is inserted into a smaller automated instrument. This nested design enables full diagnostic testing capability while significantly reducing overall system size and complexity compared to traditional standalone systems
Solution Approach 2:
Multiple functions including sample preparation, amplification, and detection are merged into a single integrated cartridge and instrument system. This consolidation eliminates the need for separate equipment for each function, reducing system complexity while maintaining comprehensive diagnostic testing capability
4Adaptability or versatility
If prior art diagnostic test systems are used, then diagnostic testing can be performed, but cost increases
Solution Approach 1:
The system uses disposable cartridges that are pre-loaded with reagents and discarded after a single use. This approach eliminates the need for expensive cleaning, sterilization, and maintenance of reusable components, significantly reducing system cost while maintaining full diagnostic testing capability
Solution Approach 2:
Reagents and sample preparation components are pre-loaded into cartridges during manufacturing before reaching the user. This preliminary preparation eliminates the need for expensive on-site reagent storage, handling, and preparation infrastructure, reducing overall system cost while preserving diagnostic testing versatility
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 safe, efficient, and accurate diagnostic testing with reduced operator exposure to hazards and contamination risks, while simplifying the testing process.
Implementation Method 1
Almost all PCR applications employ a heat-stable DNA polymerase, such as Taq polymerase, an enzyme originally isolated from the bacterium Thermus aquaticus. This DNA polymerase enzymatically assembles a new DNA strand from DNA building-blocks, the nucleotides, by using single-stranded DNA as a template and DNA oligonucleotides (also called DNA primers), which are required for initiation of DNA synthesis.
Implementation Method 2
The method relies on thermal cycling, consisting of cycles of repeated heating and cooling of the reaction for DNA melting and enzymatic replication of the DNA.
Implementation Method 3
These thermal cycling steps are necessary first to physically separate the two strands in a DNA double helix at a high temperature in a process called DNA melting.
Implementation Method 4
Many modern thermal cyclers make use of the Peltier effect, which permits both heating and cooling of the block holding the PCR tubes simply by reversing the electric current.
Data Source
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AI summary
A diagnostic test system, including: a diagnostic test assembly and a diagnostic test apparatus to perform a test on a biological or environmental sample; the diagnostic test assembly includes: a sample preparation reservoir to receive the sample into a sample preparation fluid, such that a swab carrying the sample can be used to stir the preparation fluid and to wash the swab; a sample dispensing mechanism for insertion into the sample preparation reservoir; a closure to seal the sample preparation reservoir; at least one diagnostic test reservoir coupled to the sample preparation reservoir; and at least one seal between the sample preparation reservoir and the diagnostic test reservoir to prevent fluid movement between the respective reservoirs; wherein the sample dispensing mechanism is operable to disrupt the seal to allow sample fluid to enter the diagnostic test reservoir from the sample preparation reservoir, and to dispense a predetermined amount of fluid.