Nucleic Acid Analysis System with Dynamic Threshold Adjustment
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Solution Overview
Problem
Current nucleic acid detection methods face challenges in achieving accurate results, particularly when the number of copies of a target nucleic acid is small or when there are high levels of impurities in the specimen, leading to erroneous determinations.
Innovation Solution
A nucleic acid analysis system is introduced, which includes an amplification reaction execution unit for executing nucleic acid amplification reactions and a control unit that determines whether to adjust the reaction based on detection results from positive controls, generating a determination result for the biological sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional nucleic acid detection methods are used, then the detection process is simple and quick, but test accuracy deteriorates when target nucleic acid copy numbers are low or impurities are high
Solution Approach 1:
The system performs preliminary actions by executing nucleic acid amplification reactions on multiple positive control samples with different known copy numbers before analyzing the biological sample. The control unit determines whether to adjust the detection threshold based on these preliminary results, ensuring accurate detection even when target copy numbers are low or impurities are present.
Solution Approach 2:
The control unit uses feedback from the positive control samples to dynamically adjust the detection threshold. By comparing the amplification results of control samples with known copy numbers, the system determines an appropriate threshold adjustment, which is then applied to the biological sample detection to improve accuracy while maintaining system simplicity.
2Measurement precision
If the detection threshold is fixed, then the detection process is simple and fast, but detection accuracy deteriorates when specimen conditions vary (low copy numbers or high impurities)
Solution Approach 1:
The system performs preliminary detection on positive control samples before analyzing the biological sample. This preliminary action allows the control unit to determine the appropriate threshold adjustment based on actual specimen conditions, ensuring accurate detection without requiring complex real-time adjustments during the main detection process.
Solution Approach 2:
The system changes the detection threshold parameter based on the results from positive control samples. By adjusting this key parameter according to specimen conditions (low copy numbers or high impurities), the system achieves high detection accuracy while maintaining relatively simple and fast processing through automated threshold determination.
3Reliability
If multiple positive controls with different copy numbers are used, then detection accuracy improves through threshold adjustment, but the detection process time increases
Solution Approach 1:
The system executes nucleic acid amplification reactions on multiple positive control samples as a preliminary step before biological sample analysis. This allows comprehensive threshold determination to be completed beforehand, ensuring high determination reliability for the actual sample while minimizing the time impact on the main detection process.
Solution Approach 2:
The system maintains continuity of useful action by executing all detections (positive controls and biological samples) in parallel using the same amplification reaction conditions. This approach ensures that the threshold determination process does not significantly extend the total detection time, as both control and sample analyses proceed simultaneously under optimized reaction conditions.
Data Source
AI summary
An object of the present disclosure is to improve test accuracy of a nucleic acid detection method.The present disclosure provides a nucleic acid analysis system including: an amplification reaction execution unit that executes a nucleic acid amplification reaction on a biological sample; and a control unit that controls the amplification reaction execution unit, the control unit being configured to determine whether to adjust a nucleic acid amplification reaction on the basis of a detection result of the nucleic acid amplification reaction in one or more positive controls, and to generate a determination result for the biological sample on the basis of the detection result of the nucleic acid amplification reaction in the one or more positive controls and a detection result of the nucleic acid amplification reaction in the biological sample.