Automated Flow Cytometry Data Analysis for Diagnostic Standardization

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Solution Overview

Problem

Flow cytometry data analysis and diagnostic report generation in healthcare settings are often manual and time-consuming, lacking standardization and efficiency, which can lead to inaccuracies and delays in diagnosing conditions like leukemia and lymphoma.

Innovation Solution

An automated system that processes flow cytometry data using a computing system to analyze cytometry datasets, assign events to populations based on parameter values, determine immunophenotypes, and generate diagnostic reports, incorporating features like data cleaning, clustering, and immunophenotyping to improve diagnostic accuracy and efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual analysis of flow cytometry data is performed by technologists and pathologists, then diagnostic interpretation can be performed, but the process is time-consuming and lacks standardization

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

Solution Approach 1:

The system enables self-service automation where the computing system automatically performs data analysis, population identification, and diagnostic report generation without requiring manual intervention by technologists or pathologists for each sample, thereby reducing analysis time while maintaining diagnostic accuracy through standardized algorithms

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system transforms manual qualitative analysis into automated quantitative analysis by converting visual data interpretation into computational parameter-based decision-making, using defined thresholds and algorithms to identify populations and generate diagnoses consistently

Inventive Principle:
Principle #35Parameter changes

2Productivity

If manual visual analysis of flow cytometry data is performed, then diagnostic reports can be generated, but standardization and efficiency are lacking

Engineering Contradiction:
Improvediagnostic throughputVSAvoidstandardization
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The automated system performs consistent analysis across all samples through self-executing algorithms, eliminating variability introduced by different human operators and ensuring standardized diagnostic criteria are applied uniformly, thereby improving both productivity and standardization simultaneously

Inventive Principle:
Principle #25Self-service

3Productivity

If automated analysis is implemented, then efficiency and standardization improve, but system complexity increases

Engineering Contradiction:
Improveanalysis efficiencyVSAvoidsystem complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system uses an intermediary computing platform that bridges the flow cytometer and diagnostic reporting, handling the complex automated analysis tasks while presenting simplified results to users, thereby improving efficiency without requiring end-users to understand the underlying system complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If manual data review is performed, then diagnostic interpretation can occur, but inaccuracies and delays may occur

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoiddiagnostic accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system incorporates feedback mechanisms where analysis results are continuously refined through algorithmic processing, population clustering validation, and automated quality control checks, ensuring high diagnostic reliability and accuracy through iterative computational verification rather than single-pass manual review

Inventive Principle:
Principle #23Feedback

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 automates the analysis and reporting process, enhancing the standardization, accuracy, and efficiency of flow cytometry diagnostics, particularly beneficial for leukemia/lymphoma evaluation by providing clear and reliable diagnostic insights.

Implementation Method 1

The antibodies are tagged with fluorochromes (e.g., fluorescent molecules) that fluoresce at a specific wavelength. Detection of the fluorescence value corresponding to a specific wavelength indicates the presence of the antibody in a fluid sample and indicates the presence of a specific antigen.

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS20240038338A1System and method for automated flow cytometry data analysis and interpretation
Publication Date: 2024.02.01 GILL KAMRAAN
  • US20240038338A1 patent drawing
  • US20240038338A1 patent drawing
  • US20240038338A1 patent drawing

AI summary

An apparatus for analyzing flow cytometry data for a fluid sample has a datastore that stores cytometry datasets, a computing system coupled to the datastore, marker pairs, a user interface coupled with the computing system, a data structure representing a bivariate coordinate system having an x-axis, a y-axis, and an area, and, event populations (an initial population and one or more subpopulations). Each cytometry dataset has a series of events about the fluid sample. Each event has parameter values associated with one of a scatter parameter and an antigen parameter. The computing system operates upon the cytometry datasets. Each marker pair has a first and a second parameter. The area has units (cluster and empty units).