Portable Nucleic Acid Detection Device for Saliva Sampling

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Solution Overview

Problem

Current point-of-care (POC) devices for nucleic acid detection are limited by their reliance on colorimetry for result indication, require nasal or oropharyngeal swab samples, lack sample preparation and pre-amplification capabilities, and necessitate patient presence for result delivery, hindering accessibility and efficiency in diagnosing genetic diseases and viruses like COVID-19.

Innovation Solution

A portable device that enables both colorimetry and fluorescence detection methods, allows saliva sample collection, performs sample preparation and pre-amplification, and communicates results electronically, enabling remote access and decentralization of diagnostic processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If RT-PCR method is used for nucleic acid detection, then detection accuracy is improved, but device complexity and infrastructure requirements increase

Engineering Contradiction:
Improvedetection accuracyVSAvoidinstrumentation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the essential detection function from complex laboratory infrastructure by implementing a portable device that performs RT-LAMP amplification and fluorescence detection in a single integrated unit, eliminating the need for complex laboratory equipment while maintaining detection accuracy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces mechanical/thermal cycling systems of RT-PCR with an isothermal amplification system using Bst polymerase that operates at constant temperature (65°C), simplifying the thermal control requirements and reducing device complexity while maintaining detection capability

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

2Reliability

If RT-PCR method is used for nucleic acid detection, then detection reliability is improved, but testing time increases

Engineering Contradiction:
Improvedetection reliabilityVSAvoidtesting time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent changes the temperature parameter from cyclic heating and cooling in RT-PCR to a constant isothermal temperature (65°C) in RT-LAMP, enabling continuous amplification without thermal cycling delays and reducing testing time while maintaining detection reliability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements continuous isothermal amplification that operates without interruption, unlike the periodic heating and cooling cycles of RT-PCR, thereby maintaining reliable detection while significantly reducing the time required to complete the amplification process

Inventive Principle:
Principle #20Continuity of useful action

3Device complexity

If colorimetry method is used for result indication, then device simplicity is improved, but information transmission capability worsens

Engineering Contradiction:
Improvedevice simplicityVSAvoidresult transmission capability
Core Design Contradiction:
Device complexityVSLoss of information

Solution Approach 1:

The patent implements a multi-functional device that combines both colorimetric detection (for local visual reading) and fluorescence detection with electronic communication capabilities (for remote data transmission), allowing the same device to serve both simple local indication and sophisticated information transmission needs

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

Solution Approach 2:

The patent introduces fluorescence probes as an intermediary mechanism that enables electronic detection and digital communication of test results, bridging the gap between simple chemical amplification and sophisticated electronic data transmission without requiring complex additional equipment

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If nasal or oropharyngeal swab samples are used, then diagnostic accuracy is improved, but patient accessibility and comfort worsen

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidpatient accessibility
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent implements a flexible sampling strategy that adapts to different patient needs and settings, allowing selection between traditional swab samples and saliva samples depending on the clinical context, thereby maintaining diagnostic accuracy while improving patient comfort and accessibility

Inventive Principle:
Principle #15Dynamics

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 device provides rapid, reliable, and accessible nucleic acid detection, reducing the need for specialized equipment and personnel, enabling quick results and remote reporting, thus enhancing diagnostic capacity and patient access to timely treatment.

Implementation Method 1

a) Positioning a data card in front of a data reader, and reading a sample heating temperature and a waiting and transition time; b) Automatically instructing a microprocessor to activate a heating element and keeping it activated until a temperature at a temperature sensor of a thermoblock is equal to the sample heating temperature specified on the data card

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 2

until a temperature at a temperature sensor of a thermoblock is equal to the sample heating temperature specified on the data card

Methodology Applied
Scientific EffectTemperature sensing: Thermistor

Implementation Method 3

The microprocessor turns off the heating element and turns on a fan for cooling the extraction tube until the temperature indicated by the temperature sensor in the thermoblock is equal to the temperature indicated on a consumable cartridge

Methodology Applied
Scientific EffectConvection cooling: Convection

Implementation Method 4

The result can be obtained by two methods: 2.a) By colorimetry, by changing the color of the reaction medium using pH indicators

Methodology Applied
Scientific EffectColorimetry: Absorption Spectroscopy

Implementation Method 5

2.b) By fluorescence, by emission of fluorescence using probes conjugated to fluorophores that anneal to the target DNA sequence

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS20220389524A1Method for detection of nucleic acid sequences from biological samples of medical, agricultural and biotechnological interest and apparatus thereof
Publication Date: 2022.12.08 HI TECH SA
  • US20220389524A1 patent drawing
  • US20220389524A1 patent drawing
  • US20220389524A1 patent drawing

AI summary

The invention refers to a method of detecting nucleic acid sequences in biological samples from medical, agricultural and biotechnological sources, and a corresponding device, that can be used in health care, in particular in laboratorial diagnosis, to detect genetic sequences, with the objective of identifying viruses and diseases arising from genetic malformations, bringing novelties of using saliva samples, making extraction of RNA from the genetic material from the sample, through a small device with low complexity and innovative design, with the advantages of portable, rapid results, with on-line connectivity to a test results center, dispensing frequent visits to the doctor, hastening the start of treatment, allowing access for groups of people and eliminating the need for a highly qualified operator.