SARS-COV-2 N-Protein Single-Chain Antibody for Visual Detection

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Solution Overview

Problem

Current methods for detecting SARS-COV-2, particularly using RT-PCR and ELISA, are prone to errors and require specialized equipment, making them inconvenient and less effective in remote areas, especially with the emergence of variants like Omicron that show resistance to antibody therapies.

Innovation Solution

Development of a SARS-COV-2 N protein-specific single-chain antibody (H6) and a fusion protein (H6-AP) for use in a novel detection kit, which includes a transparent ELISA plate, washing buffer, blocking solution, and color developing solution, allowing for efficient detection without complex instruments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If RT-PCR detection method is used, then detection accuracy is improved, but device complexity and ease of operation deteriorate due to requirements on technical personnel and professional equipment

Engineering Contradiction:
Improvedetection accuracyVSAvoidequipment requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention extracts the detection function from complex RT-PCR equipment to a simplified ELISA-based system using pre-coated microplates and specific antibodies, retaining detection accuracy while eliminating equipment complexity

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces antibody-antigen binding as an intermediary mechanism between the virus and detection system, replacing direct nucleic acid amplification with a more accessible immunological detection approach

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If RT-PCR detection method is used, then detection accuracy is improved, but ease of operation deteriorates due to requirements on technical personnel

Engineering Contradiction:
Improvedetection accuracyVSAvoidtechnical personnel requirements
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention employs disposable pre-coated microplates and single-use antibody reagents that eliminate the need for trained personnel to operate complex equipment, making detection accessible to anyone with basic laboratory skills

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The detection process is segmented into simple, discrete steps (sample preparation, adding reagents, incubation, reading results) that can be performed by non-experts, separating the complex antibody production from the simple detection protocol

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If conventional ELISA is used as auxiliary detection, then ease of operation is improved, but measurement precision deteriorates due to errors from sample collection to result output

Engineering Contradiction:
ImproveconvenienceVSAvoiddetection accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention performs preliminary action by pre-coating microplates with capture antibodies and pre-validating the entire detection system before use, eliminating variability introduced during sample collection and processing that causes false positives in conventional ELISA

Inventive Principle:
Principle #10Preliminary action

4Reliability

If antibody vaccines are used for prevention, then protection is provided, but reliability deteriorates over time as protection weakens and variants emerge with immune escape ability

Engineering Contradiction:
Improveprotection effectivenessVSAvoidduration of protection
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The invention implements continuous monitoring through specific antibody detection that provides feedback on current infection status and immune response, enabling timely detection of variant emergence and protection waning without relying on long-term vaccine durability

Inventive Principle:
Principle #23Feedback

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 H6-AP fusion protein enables rapid, cost-effective detection of SARS-COV-2 with high sensitivity and specificity, suitable for various environments, including remote areas, and can be produced on a large scale without expensive equipment.

Implementation Method 1

a SARS-COV-2 N protein-specific single-chain antibody... the VH and the VL are connected through the linker (Gly4Ser)3 to jointly complete the recognition and the binding of SARS-COV-2 N protein

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

fusion protein gene of a SARS-COV-2 N protein-specific single-chain antibody H6 and an AP... H6-AP fusion protein... color developing solution

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Data Source

PatentUS20250277788A1SARS-COV-2 n protein-specific single-chain antibody, and fusion protein and use thereof
Publication Date: 2025.09.04 GUIZHOU MEDICAL UNIV
  • US20250277788A1 patent drawing
  • US20250277788A1 patent drawing
  • US20250277788A1 patent drawing

AI summary

A SARS-COV-2 N protein-specific single-chain antibody, a fusion protein, and use thereof are provided. The antibody includes a heavy chain variable region VH, a linker and a light chain variable region VL which are connected in sequence; the amino acid sequence of the heavy chain variable region VH is set forth in SEQ ID NO: 4; and the amino acid sequence of the light chain variable region VL is set forth in SEQ ID NO: 6. Compared with the conventional ELISA detection, the fusion protein can greatly shorten the detection time, can catalyze the substrate to generate a color reaction which can be recognized by naked eyes, and can perform detection without special instruments.