Single-Tube Multiplex Reaction System for Point-of-Care Diagnostics

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Solution Overview

Problem

Current diagnostic assays are complex and require skilled technicians, specialized equipment, and remote processing, leading to delayed diagnostic results and ineffective treatment due to the need for sophisticated laboratory settings, which hinders early detection and treatment of diseases.

Innovation Solution

A method and device for performing sequential biochemical reactions in a single compartment using temperature and physical chemical changes to activate and deactivate reaction components, such as enzymes, allowing for compact, point-of-care diagnostic assays with minimal human intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If complex diagnostic assays are performed using sophisticated laboratory equipment and specialized techniques, then diagnostic accuracy and capability are improved, but device complexity and requirement for skilled technicians increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple sequential biochemical reactions (sample preparation, enzymatic reactions, amplification) that were traditionally performed in separate laboratory steps into a single integrated reaction tube. This merging eliminates the need for complex laboratory equipment and skilled technician intervention while maintaining diagnostic accuracy, as all reactions occur in one compartment under controlled temperature cycling.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The reaction system is designed to perform multiple functions within a single tube: sample lysis, nucleic acid extraction, enzymatic reactions, and amplification all occur sequentially in the same compartment. This multi-functional approach replaces the need for multiple specialized laboratory instruments and simplifies the overall diagnostic process.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If complex series of manipulations are performed in remote laboratories, then diagnostic capability is improved, but turnaround time increases due to sample transport and processing delays

Engineering Contradiction:
Improvediagnostic capabilityVSAvoidturnaround time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The diagnostic system is designed to be self-contained and self-sufficient, performing all complex biochemical manipulations automatically within the reaction tube without requiring external laboratory equipment or technician intervention. The temperature-controlled environment enables the system to self-regulate the sequential reactions, eliminating transport delays and reducing turnaround time while maintaining diagnostic capability.

Inventive Principle:
Principle #25Self-service

3Manufacturing precision

If multiple sequential reactions are performed in separate tubes, then reaction control and precision are improved, but device complexity and processing time increase

Engineering Contradiction:
Improvereaction controlVSAvoidprocessing efficiency
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent employs periodic temperature cycling to control the sequence of reactions within a single tube. Different temperature phases (denaturation, annealing, extension) are applied in a repeating cycle, enabling precise control over when each biochemical reaction occurs. This periodic thermal control allows multiple reactions to be sequentially performed in one compartment, maintaining reaction precision while improving processing efficiency by eliminating tube transfers.

Inventive Principle:
Principle #19Periodic action

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

Enables rapid, complex analytical reactions at the point of care, reducing turnaround time for diagnostic results and allowing patients to receive timely treatment in remote or emergency settings.

Implementation Method 1

A compartment, such as a tube, a micelle, an oil-in-water emulsion, or others as detailed below contains a sample and a series of enzymes that are activated by changing conditions surrounding the compartment, such as temperature

Methodology Applied
Scientific EffectTemperature-dependent enzyme activation: Enzyme

Data Source

PatentUS11224850B2Regulated multiplex reactions in a single tube
Publication Date: 2022.01.18 HARBINGER HEALTH INC
  • US11224850B2 patent drawing
  • US11224850B2 patent drawing

AI summary

The invention provided methods and devices for performing sequential, regulated multiplex reactions in a single tube without the addition or removal of contents from the tube.