Cell-Simulating Beads for Biomolecule Isolation Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current diagnostic methods for bacterial, fungal, and viral infections are time-consuming and prone to false negatives, especially in cases of antibiotic-resistant pathogens, and lack standardized methods for nucleic acid isolation, which can lead to delayed therapeutic decisions and inaccurate results.
Innovation Solution
A cell- or virus-simulating means comprising marker molecules incorporated in a non-biological layer, capsule, bead, or particle, designed to simulate biological cells or viruses, allowing for controlled lysis and isolation of biomolecules, and used as an internal or external standard to monitor and optimize the diagnostic process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If classical culturing methods are used to detect pathogens, then the identification process is simple and cost-effective, but the detection time is too long (up to several days) and false negative results occur frequently
Solution Approach 1:
The patent applies preliminary action by incorporating control DNA into bead structures before the diagnostic process begins. These pre-prepared control elements are then released during lysis to provide immediate monitoring capabilities, eliminating the need for time-consuming post-lysis setup and enabling real-time process validation throughout the diagnostic workflow.
Solution Approach 2:
The patent uses control DNA incorporated in beads as an intermediary substance that mediates between the lysis process and detection system. This intermediary serves as a proxy to monitor lysis efficiency and contamination levels without interfering with the actual pathogen detection, providing a bridge that enables indirect quality control throughout the diagnostic process.
2Productivity
If enzymatic treatments with lytic enzymes are used to lyse cells and extract DNA, then the extraction efficiency is improved, but the process becomes time-consuming and costly
Solution Approach 1:
The patent applies self-service by designing control elements (beads with incorporated control DNA) that automatically release and function during the lysis process itself. The control DNA is released concomitantly with pathogen DNA through the same lysis mechanisms, eliminating the need for separate control setup steps and making the quality control process self-executing throughout the extraction workflow.
Solution Approach 2:
The patent merges the quality control function with the main extraction process by incorporating control DNA into bead structures that are processed together with pathogen samples. This combining of control elements with the extraction workflow eliminates separate control steps and integrates monitoring directly into the time-consuming lysis and extraction procedures.
3Reliability
If multiple process steps (lysis, extraction, amplification, detection) are performed to ensure accurate diagnostic results, then the detection accuracy is improved, but the risk of contamination and false results increases
Solution Approach 1:
The patent applies universality by designing control DNA that serves multiple functions simultaneously: monitoring lysis efficiency, detecting contamination, validating extraction completeness, and verifying amplification success. This single control element performs quality control across all major process steps, reducing the need for multiple separate control mechanisms and simplifying the overall process while maintaining comprehensive monitoring.
4Measurement precision
If standardized methods for nucleic acid isolation are implemented, then the reproducibility and accuracy of results are improved, but the adaptability to different pathogen types and sample matrices is reduced
Solution Approach 1:
The patent applies parameter changes by incorporating control DNA with specific known sequences that can be detected using standardized PCR and sequencing methods. The control elements maintain consistent physical and chemical parameters (DNA sequence, bead size, encapsulation properties) that enable standardized processing across different pathogen types and sample matrices, while the universal nature of the control DNA allows adaptation to various diagnostic protocols through parameter adjustment rather than method redesign.
Data Source
AI summary
The present invention refers to a method, a composition and a kit for isolating biomolecules from any biological sample material containing cells, virus(es), microorganism(s) or a combination thereof comprising a cell- or virus-simulating means, wherein said cell- or virus-simulating means comprises at least one type of marker molecule(s), incorporated in at least one type of a layer, capsule, bead, sphere or particle, which is not a biological cell or provided on a substrate covered by a coating.