Chip-Based Pathogen Testing With pH-Sensitive Polymer Detection

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Solution Overview

Problem

Existing pathogen testing methods, such as those for Streptococcus pyogenes, lack sufficient accuracy and specificity, requiring laboratory analysis and professional supervision, and do not provide rapid results.

Innovation Solution

A chip-based pathogen testing assembly that uses a pH-sensitive polymer to separate regions, allowing fluid samples to traverse and indicate pathogen presence through pH changes during amplification, enabling rapid and accurate detection without medical supervision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional pathogen testing methods are used, then accuracy and specificity can be achieved, but the testing process requires laboratory facilities and medical professional supervision

Engineering Contradiction:
Improvetesting accuracyVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The testing system is divided into distinct functional modules: a sample processing module that prepares the fluid sample, a nucleic acid amplification module that detects pathogen DNA/RNA, and a pH indication module that provides visual results. This segmentation allows complex testing functions to be distributed across separate components, enabling accurate pathogen detection while simplifying user operation through automated processing and clear visual output.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A pH-sensitive indicator serves as an intermediary between the nucleic acid amplification reaction and the user. The indicator translates the chemical changes occurring during pathogen detection into visible color changes, allowing users to interpret complex laboratory results without requiring medical training or expertise in molecular biology techniques.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If traditional pathogen testing methods are used, then accurate detection can be achieved, but the testing process takes significant time

Engineering Contradiction:
Improvedetection accuracyVSAvoidtesting duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs preliminary sample processing and reagent preparation before the actual amplification reaction begins. The fluid sample is pre-treated to extract and concentrate nucleic acids, and amplification reagents are pre-mixed and staged for immediate use. This preliminary preparation reduces the overall testing time while maintaining detection accuracy by ensuring optimal conditions are established before the critical amplification phase.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The testing system utilizes phase transitions in the pH-sensitive indicator to provide rapid visual results. As the nucleic acid amplification reaction progresses and alters the pH of the reaction mixture, the indicator undergoes a phase transition from one color state to another, providing immediate visual feedback about pathogen presence without requiring additional processing or waiting time.

Inventive Principle:
Principle #36Phase transitions

3Productivity

If rapid testing is implemented, then results can be obtained quickly, but accuracy and specificity may be compromised

Engineering Contradiction:
Improvetesting speedVSAvoiddetection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The system replaces complex mechanical and manual laboratory procedures with a simplified integrated device that combines chemical amplification and optical detection. The nucleic acid amplification chemistry performs the complex molecular recognition and replication functions that would otherwise require sophisticated laboratory equipment, while the pH-sensitive color change provides automatic optical readout, eliminating the need for manual analysis and reducing both time and complexity while maintaining accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system uses color changes of a pH-sensitive indicator as a direct readout of the amplification reaction progress. As the pathogen's nucleic acid is amplified, the resulting pH change triggers an immediate color transition that provides both rapid results and accurate detection. The color change serves as a real-time indicator of reaction completion and pathogen presence, eliminating the need for additional processing steps that would slow down the testing process.

Inventive Principle:
Principle #32Color changes

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

Provides rapid and accurate pathogen detection in bodily fluids, allowing users to make immediate treatment decisions without additional facilities or medical supervision.

Implementation Method 1

a pH sensitive polymer that separates a first and second region of the chip

Methodology Applied
Scientific EffectpH sensitivity:

Implementation Method 2

after the amplification method adjusts a pH of the fluid sample

Methodology Applied
Scientific EffectpH adjustment:

Implementation Method 3

the pH sensitive polymer becomes porous in response to the pH change

Methodology Applied
Scientific EffectpH-responsive porosity change:

Data Source

PatentUS20250290157A1Pathogen testing device
Publication Date: 2025.09.18 RT MICRODX INC
  • US20250290157A1 patent drawing
  • US20250290157A1 patent drawing
  • US20250290157A1 patent drawing

AI summary

A method of detecting a pathogen in a fluid sample includes adding the fluid sample to a first region of an assembly; amplifying a polynucleotide sequence of a pathogen in the first region using an amplification method; and detecting a presence of the pathogen by one of the following. Identifying a release of a dye from a pH sensitive polymer. Or, identifying a release of a dye from the first region to a second region that are separated by a pH sensitive polymer. Or, activating a pH sensitive dye in the first region to indicate a presence of the pathogen. Or, indicating a presence of the pathogen on a lateral flow assay in a second region that is separated from the first region by a pH sensitive polymer. Each identification, activation, or indication step occurs after the amplification method adjusts a pH of the fluid sample.