Multiplexed SARS-CoV-2 Variant Detection Assay
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Solution Overview
Problem
Current methods for detecting SARS-CoV-2 are inadequate for identifying new variants and mutations, leading to potential false negatives and reduced efficacy in diagnosing and controlling infectious disease outbreaks.
Innovation Solution
Development of assays using specific primers and probes that target multiple regions of the SARS-CoV-2 genome, including the N gene, S gene, and Orf1 regions, to differentiate between reference and variant forms, enabling accurate detection and characterization of emerging variants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current detection methods are used, then simplicity and ease of operation are maintained, but detection precision and reliability deteriorate due to inability to identify new variants
Solution Approach 1:
The patent segments the detection assay into multiple independent target regions (N gene, S gene, Orf1 regions) with specific primers and probes for each. This segmentation allows the system to detect multiple variants simultaneously while maintaining a modular structure that manages complexity through organized division of detection functions.
Solution Approach 2:
The patent creates a universal detection system that can identify multiple SARS-CoV-2 variants through a single multiplexed assay. The universal primers and probes are designed to target conserved regions while detecting variant-specific mutations, allowing one assay to perform multiple detection functions across different viral strains.
2Measurement precision
If variant-specific detection is implemented, then diagnostic accuracy improves, but loss of time increases due to need for multiple tests
Solution Approach 1:
The patent merges multiple variant detection functions into a single multiplexed PCR assay. By combining targeting of N gene, S gene, and Orf1 regions with variant-specific primers and probes in one reaction mixture, the system achieves comprehensive variant identification in a single test rather than requiring sequential testing.
Solution Approach 2:
The patent enables continuous detection of multiple variants through a single uninterrupted assay process. The multiplexed design allows simultaneous amplification and detection of different viral regions and variants in one continuous reaction, eliminating the need to stop and restart tests between different variant screenings.
3Adaptability or versatility
If multiple target regions are analyzed, then adaptability to new variants improves, but device complexity increases due to multiple primers and probes
Solution Approach 1:
The patent applies local quality by designing primers and probes with specific properties for different target regions. Each primer and probe is optimized for its specific binding site (N gene, S gene, or Orf1 region) with tailored sequences and temperatures, allowing high-specificity detection at each local target while contributing to overall system versatility.
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 proposed solution enhances the ability to detect and distinguish between SARS-CoV-2 variants, improving diagnostic accuracy and enabling timely implementation of appropriate treatment and infection control measures.
Implementation Method 1
assays using specific primers and probes that target multiple regions of the SARS-CoV-2 genome
Implementation Method 2
differentiate between reference and variant forms, enabling accurate detection
Implementation Method 3
The PCR mixture is subjected to a first polymerase chain reaction (PCR) amplification protocol
Implementation Method 4
The amplified products are subjected to gel electrophoresis to determine the presence or absence of each
Data Source
AI summary
Disclosed are compositions, assays, methods, diagnostic methods, kits and diagnostic kits for the specific and differential detection of SARS-CoV-2, including SARS-CoV-2 variants, or other coronaviruses from samples including veterinary samples, clinical samples, food samples, forensic sample, an environmental sample (e.g., soil, dirt, garbage, sewage, air, or water), including food processing and manufacturing surfaces, or a biological sample.


