Prion Inactivation Assay via pH Neutralization and Thermal Detoxification
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Solution Overview
Problem
Current methods for inactivating unconventional transmissible agents like prions are inadequate, particularly in medical and surgical settings, as they are resistant to conventional disinfection methods and pose risks of secondary human-to-human transmission through contaminated equipment, with existing evaluation methods being complex and not representative of real-world scenarios.
Innovation Solution
A method involving incubation of prions with a liquid composition, followed by chemical and thermal detoxification, and subsequent measurement of inactivation using either in vitro or in vivo tests, which includes pH neutralization and heat treatment to ensure accurate assessment of inactivation without interfering with the prion's infectious capacity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If drastic treatments (soda, bleach, autoclaving at 134°C) are used to inactivate prions, then inactivation effectiveness is improved, but physical or chemical incompatibility with medical devices worsens
Solution Approach 1:
The patent applies parameter changes by modifying the temperature and chemical concentration parameters of the inactivation treatment. Instead of using extreme conditions (134°C autoclaving, high-concentration bleach or soda), the patent uses milder parameters (lower temperature combined with specific chemical formulations) to achieve effective prion inactivation while preventing damage to medical devices.
2Ease of operation
If conventional inactivation methods are used, then ease of operation is improved, but inactivation effectiveness against prions worsens
Solution Approach 1:
The patent introduces a chemical intermediary substance that acts as a mediator between the conventional autoclaving process and the prion inactivation goal. This chemical formulation enhances the effectiveness of milder thermal treatments, allowing conventional equipment to achieve superior inactivation results without requiring extreme conditions.
3Device complexity
If existing evaluation methods are used, then device complexity is reduced, but measurement precision of inactivation worsens
Solution Approach 1:
The patent replaces complex mechanical evaluation systems with a simplified chemical-biological assay system. Instead of using intricate physical measurement devices, the patent employs a biochemical detection method that measures prion inactivation through chemical reactions and biological responses, achieving higher precision with lower complexity.
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 allows for reliable and reproducible measurement of prion inactivation, reducing experimental biases and ensuring the safety of medical devices and equipment by effectively neutralizing prions without altering their infectious characteristics, thus addressing the limitations of existing methods.
Implementation Method 1
step b1) of chemical detoxification of the mixture by neutralization of the pH
Implementation Method 2
step b2) of thermal detoxification of the mixture at a temperature ranging from 60°C to 95°C
Implementation Method 3
a) incubate an ATNC with a composition to be tested
Data Source
Figure 1~2
AI summary
The present invention relates to a method for measuring the ability of a liquid formulation to inactivate an Unconventional Transmissible Agent (UTA), in particular a prion.