MVEPI Pathogen Inactivation Evaluation Method

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Solution Overview

Problem

Current methods for evaluating pathogen inactivation effects, such as log reduction factor (log RF) and pathogen count reduction percentage, are indirect and lack standardization and comparability, failing to accurately assess the maximum inactivation capacity of different technologies.

Innovation Solution

A new evaluation method using the maximum value of effective pathogen inactivation (MVEPI) as a parameter, which involves preparing pathogen solutions of varying concentrations, applying a consistent inactivation method, detecting post-inactivation concentrations, and conducting linear fitting analysis to determine the MVEPI, allowing for direct evaluation of pathogen inactivation effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If indirect evaluation methods (log RF or pathogen count reduction percentage) are used, then the evaluation process is simple, but the evaluation lacks standardization and comparability across different inactivation methods

Engineering Contradiction:
Improvesimplicity of evaluation processVSAvoidstandardization and comparability of evaluation results
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent introduces a new evaluation parameter MVEPI (Maximum Value of Effective Pathogen Inactivation) that transforms the evaluation from indirect methods to a direct standardized measurement. This parameter change enables consistent comparison across different inactivation methods while maintaining evaluation simplicity through a unified metric.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the indirect mechanical counting methods (colony counting, plaque assays) with a direct evaluation system based on MVEPI parameter. This substitution eliminates the need for complex pathogen cultivation and counting processes, providing standardized results without sacrificing simplicity.

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

2Object-affected harmful factors

If pathogens with low initial concentrations are used, then the evaluation is safer and easier to handle, but the pathogen inactivation effect is limited and cannot reflect maximum inactivation capacity

Engineering Contradiction:
Improvesafety and ease of handlingVSAvoidability to evaluate maximum inactivation capacity
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The patent applies preliminary concentration adjustment to pathogen samples before evaluation. By optimizing the initial pathogen concentration to a specific range, the method ensures both safe handling conditions and sufficient inactivation effect for accurate MVEPI measurement, resolving the contradiction between safety and evaluation capability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces dynamic concentration selection based on the specific inactivation method being evaluated. Rather than using fixed low concentrations, the method dynamically adjusts the initial pathogen concentration to optimize both safety and the ability to measure maximum inactivation capacity for each specific scenario.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If pathogens with high initial concentrations are used, then the maximum inactivation capacity can be evaluated, but pathogens may aggregate and affect the inactivation effect

Engineering Contradiction:
Improveability to evaluate maximum inactivation capacityVSAvoidpathogen aggregation and uniformity
Core Design Contradiction:
Measurement precisionVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary dispersion treatment to high-concentration pathogen samples before inactivation evaluation. This preliminary action prevents pathogen aggregation during the inactivation process, ensuring uniform exposure to the inactivation method while maintaining high initial concentrations necessary for evaluating maximum inactivation capacity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent optimizes the initial pathogen concentration parameter to a specific range that balances two requirements: high enough to evaluate maximum inactivation capacity, but low enough to prevent significant aggregation. This parameter optimization resolves the contradiction between evaluation capability and sample stability.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20240002899A1Evaluation method of pathogen inactivation effect
Publication Date: 2024.01.04 BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
  • US20240002899A1 patent drawing
  • US20240002899A1 patent drawing
  • US20240002899A1 patent drawing

AI summary

The present disclosure provides an evaluation method of a pathogen inactivation effect, including: evaluating an inactivation effect with a maximum value of effective pathogen inactivation (MVEPI) as a standard reference index; where the MVEPI refers to a maximum of a log reduction factor after pathogen solutions of different concentrations before inactivation are treated according to a same inactivation method. The MVEPI can be obtained through the following steps: inactivating a sample containing pathogens with different initial concentrations through a pathogen inactivation method of tested pathogens; detecting changes in the concentration of pathogens with different initial concentrations before and after pathogen inactivation; and analyzing a relationship between the concentration of pathogens before inactivation and the concentration of pathogens after inactivation and the concentration before inactivation by linear fitting and other methods.