Universal Primer Kit for Multiplex ALK Fusion Gene Detection
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Solution Overview
Problem
Current genetic testing methods for detecting ALK fusion genes in lung cancer require cumbersome operations due to the need for multiple primers and reaction systems for various variants, making it inefficient for diagnosing and treating lung cancer.
Innovation Solution
A primer reagent kit that includes specific forward and reverse primers (e.g., F_V1/6, F_V2, F_V3a, F_V3b, R_V/multi, R_V6) allows for the simultaneous amplification of multiple ALK fusion gene variants in a single reaction system, enabling efficient detection of variants V1, V2, V3a, V3b, and V6.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple separate reaction systems are used to detect different ALK fusion gene variants, then detection accuracy for each variant is improved, but operation complexity and time consumption increase significantly
Solution Approach 1:
The patent combines multiple separate reaction systems into a single reaction system by designing a universal primer set that can simultaneously amplify multiple ALK fusion gene variants (V1, V2, V3a, V3b, and V6). This merging approach maintains detection accuracy for each variant while significantly reducing operation complexity and time consumption.
Solution Approach 2:
The patent creates a universal primer set that serves multiple functions by being able to detect all five major ALK fusion gene variants in a single reaction. The forward primers (F_V1/6, F_V2, F_V3a, F_V3b) and reverse primers (R_V/multi, R_V6) are designed with universal binding sites that work across different variants, eliminating the need for variant-specific primer sets.
2Measurement precision
If multiple separate reaction systems are used to detect different ALK fusion gene variants, then detection accuracy for each variant is improved, but time consumption increases
Solution Approach 1:
The patent merges multiple sequential detection processes into a single parallel amplification reaction. By using the universal primer set to simultaneously amplify multiple variants in one reaction system, the total detection time is reduced from multiple sequential steps to a single concurrent process, while maintaining accurate detection of each variant.
Solution Approach 2:
The patent enables continuous detection of multiple variants without interruption by performing all amplifications in a single reaction system. The universal primers allow all five variants to be amplified simultaneously in one continuous process, eliminating the time loss associated with setting up and running multiple separate reactions sequentially.
3Productivity
If a single reaction system is used to detect multiple ALK fusion gene variants, then operation efficiency is improved, but primer design complexity increases
Solution Approach 1:
The patent resolves primer design complexity by creating a universal primer set with specific binding sites that work across all variants. The forward primers target conserved regions in the EML4 gene, while the reverse primers target conserved regions in the ALK gene, allowing a single primer set to universally amplify multiple variants without requiring complex variant-specific designs.
Solution Approach 2:
The patent simplifies primer design by changing the approach from variant-specific primers to universal primers with consistent binding parameters. By identifying conserved sequences and designing primers with uniform Tm values and binding characteristics, the patent achieves efficient amplification of multiple variants without increasing design complexity.
4Productivity
If a single reaction system is used to detect multiple ALK fusion gene variants, then operation efficiency is improved, but detection difficulty increases
Solution Approach 1:
The patent combines multiple detection tasks into a single reaction system while maintaining clear distinction between variants through specific amplification patterns. The universal primer set produces detectable amplification products for each variant, allowing efficient detection without increasing difficulty because each variant can be identified through its unique amplification signature.
Solution Approach 2:
The patent employs detection methods that produce distinguishable signals for different variants, such as gel electrophoresis banding patterns or fluorescence signals with different characteristics. This allows multiple variants to be detected in a single reaction system with clear visual or instrumental differentiation, maintaining ease of detection despite the multiplex nature of the 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
The primer reagent kit enables easy detection of multiple ALK fusion gene variants in a single reaction system, improving the efficiency of lung cancer diagnosis and treatment by simplifying the analysis process.
Implementation Method 1
A genetic testing method generally is carried out by, for example, causing nucleic acid amplification, such as PCR (Polymerase Chain Reaction), using a primer that anneals to a specific region in a target gene
Implementation Method 2
using a primer that anneals to a specific region in a target gene
Data Source
AI summary
The present disclosure provides a novel primer reagent for detecting a plurality of variants of the ALK fusion gene.