Universal Internal Control Nucleic Acid for Multiplex Assay Interference
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Solution Overview
Problem
Current nucleic acid amplification methods in clinical diagnostics face challenges in efficiently amplifying multiple target nucleic acids simultaneously without interference, particularly in multiplex assays, due to limitations in label usage and the complexity of designing and managing multiple control nucleic acids.
Innovation Solution
A method involving the use of an internal control nucleic acid that is immobilized on a solid support material, allowing for simultaneous amplification of multiple target nucleic acids in separate reaction vessels with distinct primers, enabling independent detection and reducing the need for multiple control sequences.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple control nucleic acids are used to control different target nucleic acids in multiplex assays, then the reliability of amplification control is improved, but the device complexity and cost increase
Solution Approach 1:
The patent employs a universal internal control nucleic acid sequence that can control amplification for multiple different target nucleic acids simultaneously. This single control sequence replaces the need for multiple separate control sequences, each designed for specific targets. The control nucleic acid is incorporated into all reaction vessels and serves as a universal reference for monitoring amplification efficiency across different targets, thereby reducing complexity while maintaining reliability.
2Measurement precision
If multiple control nucleic acids with different sequences are employed for different targets, then the measurement precision for each target is improved, but the loss of time and resources increases
Solution Approach 1:
The patent merges the function of multiple separate control sequences into a single universal internal control nucleic acid that is combined with all target nucleic acids in the same reaction mixture. This consolidation eliminates the need to separately prepare, track, and manage multiple control sequences, significantly reducing setup time and resource expenditure while maintaining the ability to precisely monitor each target's amplification.
3Ease of operation
If a single internal control nucleic acid is used for multiple targets, then the ease of operation and cost are improved, but the measurement precision may be compromised
Solution Approach 1:
The patent applies local quality by making the internal control nucleic acid target-specific in its binding properties while maintaining universal applicability. The control sequence is designed with specific characteristics that allow it to function optimally for each particular target nucleic acid it controls, ensuring precise quantitative measurements for each target while still using the same control sequence across all targets in the multiplex assay.
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 simplifies the amplification process, reduces the risk of interference, and allows for the simultaneous amplification of multiple targets with improved sensitivity and specificity, while also serving as a qualitative and quantitative control, thereby streamlining diagnostic assays and reducing costs.
Implementation Method 1
combining a solid support material and the one or more samples in one or more vessels for a period of time, under conditions sufficient to permit nucleic acids comprising the target nucleic acids and the internal control nucleic acid to be immobilized on the solid support material
Data Source
AI summary
Methods are provided for the amplification of at least a first and a second target nucleic acid that may be present in at least one fluid sample using an internal control nucleic acid for qualitative and/or quantitative purposes.