Endotoxin Visualization System Using Optical Microplate Analysis

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Solution Overview

Problem

Current endotoxin testing methods, particularly those using Limulus amebocyte lysate (LAL), face challenges such as instability of reagents, contamination risks, high costs, and complexity, which hinder accurate and efficient detection and visualization of endotoxin concentrations in fluid samples, especially in medical and pharmaceutical industries.

Innovation Solution

A system and method for visualizing endotoxin concentrations in fluid samples using a graphical user interface (GUI) that processes data from multi-well microplates, displaying endotoxin reactions over time through vertically-oriented bar graphs, allowing for simultaneous comparison and identification of reaction progress across multiple wells, with features like color changes indicating reaction thresholds and enabling easy identification of anomalies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional LAL testing methods are used, then endotoxin detection capability is achieved, but device complexity and operational complexity increase

Engineering Contradiction:
Improveendotoxin detection capabilityVSAvoidtesting method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical and manual testing procedures with an automated optical detection system. The system uses a sensor array to automatically measure light transmission through microplate wells, eliminating the need for manual gel clot interpretation and reducing operational complexity while maintaining endotoxin detection capability

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

Solution Approach 2:

The patent creates a visual copy representation of endotoxin reaction results through graphical user interface displays. The system generates visual representations of reaction progress across multiple wells, allowing operators to quickly assess results without complex manual analysis, thereby reducing device and operational complexity

Inventive Principle:
Principle #26Copying

2Measurement precision

If manual LAL testing procedures are used, then endotoxin concentration measurement is achieved, but time consumption increases

Engineering Contradiction:
Improveendotoxin concentration measurementVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent implements continuous automated measurement of endotoxin reactions across all microplate wells simultaneously. The optical sensor array continuously monitors reaction progress without interruption, eliminating the time loss associated with sequential manual testing procedures while maintaining accurate concentration measurement

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent measures optical properties of all wells simultaneously rather than sequentially analyzing individual wells. This excessive action of measuring all wells at once significantly reduces total testing time while providing comprehensive endotoxin concentration data for the entire sample set

Inventive Principle:
Principle #16Partial or excessive action

3Productivity

If multiple microplate wells are tested simultaneously, then productivity increases, but data visualization complexity increases

Engineering Contradiction:
Improvetesting throughputVSAvoiddata visualization complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent creates simplified visual copies of complex multi-well data through standardized graphical displays. The system generates intuitive visual representations showing reaction status for each well, allowing operators to quickly interpret results from multiple simultaneous tests without being overwhelmed by data complexity

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent uses color-coded visual indicators to represent different reaction states in microplate wells. The graphical user interface displays use distinct colors to show positive, negative, and intermediate reactions, enabling rapid interpretation of productivity data from multiple wells without increasing perceived complexity

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

This approach simplifies and enhances the visualization of endotoxin testing, reducing errors and contamination risks, while providing a cost-effective and efficient means to accurately monitor endotoxin concentrations, facilitating compliance with regulatory standards and improving workflow efficiency.

Implementation Method 1

Clotting will occur when the hemocyte lysate is exposed to the endotoxin. Hemocyte lysate is amebocyte lysate produced from the hemolymph of various horseshoe crab species

Methodology Applied
Scientific EffectLAL reaction:

Implementation Method 2

a sensor array, positioned to measure an optical property of the fluid sample in each well

Methodology Applied
Scientific EffectOptical measurement:

Data Source

PatentUS11921041B2Method and system for visualization of endotoxins in a fluid sample
Publication Date: 2024.03.05 BL TECHNOLOGY INC
  • US11921041B2 patent drawing
  • US11921041B2 patent drawing
  • US11921041B2 patent drawing

AI summary

Exemplified methods and systems facilitate presentation of data derived from measurements of endotoxins in fluid samples. In particular, the exemplified methods and systems facilitate presentation of such measurements in a graphical user interface and/or in a report for endotoxin concentrations in a fluid sample. The presentation facilitates a unified and intuitive graphic visualization that are presented within a single interactive interface and/or report.