Function Verification Cartridge for Biosensor Testing

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Solution Overview

Problem

Current biosensor systems for detecting infectious agents in food and biological samples are time-consuming, expensive, and often require specialized equipment and expertise, with limitations such as low signal-to-noise ratios, making them unsuitable for real-time, field-portable, and user-friendly applications.

Innovation Solution

A portable, self-contained testing device that includes a biosensor reagent reservoir card with living, engineered biological cells, a test cartridge base with a reaction chamber, and a fluid displacement mechanism, along with a function verification cartridge to ensure proper device functioning, enabling rapid detection of infectious agents like Escherichia coli without culturing, using a photomultiplier tube for sensitive light signal measurement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional culturing methods are used to test for infectious agents, then testing accuracy can be improved, but testing time increases significantly and specialized expertise is required

Engineering Contradiction:
Improvetesting accuracyVSAvoidtesting time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The biosensor reagent is prepared in advance with living engineered biological cells that have pre-programmed detection capabilities. This preliminary preparation eliminates the need for time-consuming culturing and specialized expertise during actual testing, while maintaining high accuracy through the pre-calibrated biosensor system

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces the mechanical culturing process with a photodetection system. The photomultiplier tube detects light signals emitted by the biosensor reagent, substituting complex biological culturing procedures with a simplified optical measurement system that provides rapid and accurate results

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

2Loss of time

If biosensor systems are used for rapid detection, then testing time is reduced, but signal-to-noise ratio decreases making the system unreliable

Engineering Contradiction:
Improvetesting timeVSAvoidsignal-to-noise ratio
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent changes the detection parameter from general biosensor signals to specific photoluminescence signals. By using living engineered biological cells that emit light upon detecting target pathogens, the system achieves both rapid detection and high signal-to-noise ratio through the distinctive optical signature of the biosensor reagent

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The biosensor reagent combines living biological cells with photoluminescent properties in a composite system. This composite approach integrates the specificity of biological recognition with the sensitivity of optical detection, achieving both speed and reliability in pathogen detection

Inventive Principle:
Principle #40Composite materials

3Difficulty of detecting and measuring

If specialized equipment and expertise are used for testing, then detection capability is improved, but device complexity and cost increase

Engineering Contradiction:
Improvedetection capabilityVSAvoidequipment complexity
Core Design Contradiction:
Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The patent extracts the complex detection capability from the equipment and embeds it in the biosensor reagent itself. The living engineered biological cells contain the detection logic and recognition elements, allowing simple equipment like a photomultiplier tube to achieve sophisticated detection that would otherwise require complex specialized instruments

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The biosensor reagent performs self-detection through its inherent photoluminescent properties when exposed to target pathogens. The system is designed to be self-contained with pre-programmed detection capabilities, eliminating the need for specialized expertise during operation while maintaining high detection capability

Inventive Principle:
Principle #25Self-service

4Reliability

If function verification is performed before each assay, then device reliability is improved, but testing time increases

Engineering Contradiction:
Improvedevice functioning verificationVSAvoidverification time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent merges the function verification process with the actual assay by using the same biosensor reagent for both purposes. The verification cartridge contains biosensor reagent that simultaneously checks device functionality and provides the detection capability needed for the assay, eliminating separate verification steps and reducing overall testing time

Inventive Principle:
Principle #5Merging (Combining)

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 allows for rapid, sensitive, and cost-effective detection of infectious agents in real-time, capable of identifying pathogens at the single-cell level, improving on-site testing capabilities and reducing the risk of contamination and recall costs.

Implementation Method 1

a sensor for measuring a detectable signal that is generated upon the reaction of a biosensor reagent with a specific target analyte

Methodology Applied
Scientific EffectPhotomultiplier tube detection: Photoelectric Effect

Implementation Method 2

a biosensor reagent, wherein the biosensor reagent includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base

Methodology Applied
Scientific EffectBioluminescence: Bioluminescence

Implementation Method 3

measuring a detectable signal that is generated upon the reaction of a biosensor reagent with a specific target analyte

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Data Source

PatentUS10866254B2Function verification cartridge for use with device for the rapid detection of analytes
Publication Date: 2020.12.15 FUNDAMENTAL SOLUTIONS CORPORATION
  • US10866254B2 patent drawing
  • US10866254B2 patent drawing
  • US10866254B2 patent drawing

AI summary

A system that rapidly detects the presence of a target analyte in a biological test sample, which includes a sensor for measuring a detectable signal generated upon the reaction of a biosensor reagent with a specific target analyte within the sample; a reservoir card that includes the biosensor reagent that further includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base; a test cartridge base configured to accept the reservoir card and to be placed within the testing device, wherein the test cartridge base further includes a reaction chamber adapted to receive both the biosensor reagent and the sample and a fluid displacement mechanism that includes a dispensing plunger, wherein actuation of the dispensing plunger displaces the biosensor reagent in the reservoir into the reaction chamber where the biosensor reagent is mixed with the sample; and a function verification cartridge adapted to be received and recognized by the testing device, and that is operative to confirm the proper functioning of the plunger and the sensor.