STC Stabilization Composition for Mycobacterium Viability
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Solution Overview
Problem
Current methods for collecting and processing sputum specimens for tuberculosis diagnosis face challenges such as contamination, viability loss of Mycobacterium tuberculosis, and inefficient detection due to the mucoid nature and waxy cell wall of the bacteria, leading to compromised culture sensitivity and prolonged detection times.
Innovation Solution
A composition and method using a Sample Transport Chemistry (STC) mixture with a chelating agent, denaturing agent, and salt at a pH between 6 and 11, which stabilizes and liquefies sputum samples, maintaining the viability of hardy microorganisms like Mycobacterium tuberculosis while killing background flora, allowing for efficient downstream testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sputum specimens are refrigerated and transported promptly to the laboratory, then the viability of Mycobacterium tuberculosis is maintained, but the complexity of specimen handling and transport logistics increases
Solution Approach 1:
The stabilization composition is added to the sputum specimen at the time of collection, performing the preservation action beforehand. This preliminary action allows the specimen to be stable during transport without requiring immediate refrigeration or special handling, thus maintaining viability while simplifying logistics
Solution Approach 2:
The stabilization composition acts as an intermediary substance between the specimen and the transport environment. It mediates the interaction by creating a protective chemical environment that prevents bacterial death and overgrowth of contaminants during transport, eliminating the need for complex refrigeration logistics
2Ease of operation
If sputum specimens are stored at room temperature for extended periods, then transport logistics are simplified, but the viability of Mycobacterium tuberculosis decreases and background flora overgrows
Solution Approach 1:
The stabilization composition is applied at collection to preemptively prevent the problems that would occur during room temperature storage. This preliminary protective action allows the specimen to remain stable at room temperature without viability loss or contaminant overgrowth
Solution Approach 2:
The stabilization composition performs preliminary anti-action by preventing the harmful effects of room temperature storage before they occur. It preemptively inhibits background flora growth and protects mycobacteria from death, allowing simple transport without compromising specimen quality
3Object-affected harmful factors
If traditional decontamination methods are used to remove background flora, then contamination is reduced, but the viability of Mycobacterium tuberculosis is compromised
Solution Approach 1:
The stabilization composition creates different local environments for different organisms in the specimen. It provides a selective chemical environment that is inhibitory to background flora while being non-lethal to mycobacteria, thus differentiating the fate of different organisms based on their biological characteristics
Solution Approach 2:
The composition changes the chemical parameters of the specimen environment (pH, chelation, denaturation) to create conditions that selectively affect different organisms. These parameter changes inhibit contaminants while preserving mycobacteria viability, achieving decontamination without killing the target pathogen
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 STC composition effectively preserves Mycobacterium tuberculosis viability for up to 30 days at various temperatures, reduces contamination, and enhances the sensitivity of diagnostic tests, including culture and molecular diagnostics, by stabilizing the microbiome and facilitating nucleic acid detection without the need for immediate culture or decontamination.
Implementation Method 1
a stabilization composition comprising a chelating agent, a denaturing agent, a salt and having a pH between about 6 and about 11
Implementation Method 2
a stabilization composition comprising a chelating agent, a denaturing agent, a salt and having a pH between about 6 and about 11
Data Source
AI summary
The present application is to provide a composition and method for stabilizing and maintaining the viability of hardy microorganisms from sample collection to downstream analysis. In particular, there is a method for preserving viable hardy bacteria, such as Mycobacteria, Bacillus anthracis, or Clostridium difficile, in a biological sample, comprising contacting the biological sample with a stabilization composition, wherein the stabilization composition comprises a chelating agent, a denaturing, a salt and has a pH between about 6 and about 11.