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

VSEngineering 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

Engineering Contradiction:
Improvedetection precisionVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If variant-specific detection is implemented, then diagnostic accuracy improves, but loss of time increases due to need for multiple tests

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

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.

Inventive Principle:
Principle #5Merging (Combining)

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.

Inventive Principle:
Principle #20Continuity of useful action

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

Engineering Contradiction:
Improvevariant detection capabilityVSAvoidassay composition
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

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.

Inventive Principle:
Principle #3Local quality

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

Methodology Applied
Scientific EffectHybridization:

Implementation Method 2

differentiate between reference and variant forms, enabling accurate detection

Methodology Applied
Scientific EffectBase pairing:

Implementation Method 3

The PCR mixture is subjected to a first polymerase chain reaction (PCR) amplification protocol

Methodology Applied
Scientific EffectPCR amplification:

Implementation Method 4

The amplified products are subjected to gel electrophoresis to determine the presence or absence of each

Methodology Applied
Scientific EffectElectrophoresis: Electrophoresis

Data Source

PatentUS20240392394A1Compositions, kits and methods for detection of viral variant sequences
Publication Date: 2024.11.28 LIFE TECHNOLOGIES CORP
  • US20240392394A1 patent drawing
  • US20240392394A1 patent drawing
  • US20240392394A1 patent drawing

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.