High Density Biological Analysis Pouch with Barrier Layer
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Solution Overview
Problem
Traditional microbiology techniques for diagnosing infectious diseases are time-consuming, and methods like PCR face challenges with multiplex reactions and contamination issues, especially when dealing with low-pathogen samples and multiple potential causative organisms.
Innovation Solution
A self-contained, disposable plastic pouch system with a high-density reaction zone and barrier layer minimizes contamination by allowing nested PCR and other nucleic acid analyses, featuring a flexible portion with blisters connected via channels and reservoirs for efficient sample processing and reagent delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional microbiology techniques are used for pathogen diagnosis, then comprehensive pathogen detection can be achieved, but the diagnosis process takes days or weeks
Solution Approach 1:
The diagnostic process is segmented into two stages: a first-stage PCR that processes the entire sample comprehensively, and a second-stage high-density array that rapidly screens multiple potential pathogens in parallel. This segmentation allows the system to maintain comprehensive detection capability while dramatically reducing overall diagnosis time through parallel processing.
Solution Approach 2:
The first-stage PCR performs preliminary amplification of pathogen nucleic acids from the original sample before the second-stage analysis. This preliminary action ensures that even low-abundance pathogens are sufficiently amplified for detection in the subsequent high-density array screening, maintaining detection sensitivity while enabling rapid parallel testing.
2Measurement precision
If large panels of PCR assays are run for each possible causative organism, then comprehensive pathogen detection is achieved, but the cost and complexity increase significantly
Solution Approach 1:
Multiple second-stage PCR assays targeting different pathogens are merged into a single high-density array format. Instead of running separate PCR reactions for each potential pathogen, the system combines all second-stage assays in one integrated array that can be processed simultaneously, dramatically reducing complexity while maintaining comprehensive pathogen detection coverage.
Solution Approach 2:
The high-density array serves as a universal platform that can simultaneously perform multiple second-stage PCR assays for different pathogens. This multi-functional design allows a single device to replace numerous individual PCR assays, reducing both device complexity and operational complexity while maintaining comprehensive detection capability.
3Reliability
If nested secondary PCRs are performed to increase robustness, then amplification reliability improves, but the risk of contamination and handling errors increases
Solution Approach 1:
The second-stage PCR reactions are extracted from the main sample processing flow and performed in a spatially separated high-density array format. This extraction allows nested PCR to be performed with reduced contamination risk because the array format enables better physical isolation of reactions and reduces the number of times samples must be transferred between containers.
Solution Approach 2:
The high-density array is designed as a disposable component that is discarded after a single use. This eliminates the need to sterilize and reuse the array between samples, completely eliminating cross-contamination risks between samples while maintaining the robustness benefits of nested PCR. Each new sample uses a fresh array, ensuring no carryover contamination.
4Device complexity
If a single reaction well format is used, then the device is simpler, but the ability to perform high-density multiplexing is limited
Solution Approach 1:
The system transitions from a single-dimensional array of reaction wells to a two-dimensional high-density grid format. This dimensional change allows dramatically more reactions to be packed into a compact area, enabling high-density multiplexing of dozens of second-stage PCR assays simultaneously while maintaining a relatively simple overall device structure. The grid format maximizes spatial utilization efficiency.
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, sensitive, and robust amplification of multiple biological substances while reducing contamination and increasing efficiency in diagnosing infectious diseases, even with limited sample volumes.
Implementation Method 1
The barrier layer is a pierced layer (585), wherein the piercings (586) align with the high density reaction wells (582), minimizing flow through the piercings (586) absent a force of vacuum to force fluid into or out of the high density reaction wells (582)
Implementation Method 2
vacuum is provided in each reaction well (582), and the portions of the sample are introduced into each of the high density reaction wells (582) through the piercings
Data Source
Figure 1
Figure 2~2b
Figure 3~4
AI summary
Devices, containers, and methods are provided for performing biological analysis in a closed environment. Illustrative biological analyses include high density nucleic acid amplification and detection and immuno-PCR.