Intradermal Spike Protein Kit for SARS-CoV-2 Immune Detection
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Solution Overview
Problem
Current methods for diagnosing SARS-CoV-2 infection, such as serological tests, have limitations in accuracy and specificity, and there is a need for a more reliable in vivo diagnostic method to detect cell-mediated immune responses to SARS-CoV-2 antigens.
Innovation Solution
The method involves administering the Spike protein or its fragments intradermally to elicit a Delayed-Type Hypersensitivity (DTH) reaction, measuring induration and erythema using ultrasound, thermal imaging, or digital image processing to assess the immune response, which is indicative of previous or ongoing SARS-CoV-2 infection or vaccination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If serological tests are used to diagnose SARS-CoV-2 infection, then the diagnostic process is simple and quick, but the accuracy and specificity are limited
Solution Approach 1:
The patent introduces an intermediary substance (SARS-CoV-2 antigen or antibody) that mediates between the patient's immune system and the detection system. This intermediary enables the formation of specific immune complexes that can be detected with high precision, resolving the contradiction between diagnostic accuracy and test complexity by providing a specific biological marker for detection
Solution Approach 2:
The patent replaces simple serological detection methods with a more sophisticated immunological assay system that uses antigen-antibody binding mechanisms. This substitution enables higher measurement precision through specific immune complex formation and detection, while the standardized assay protocol maintains operational feasibility
2Reliability
If intradermal injection of Spike protein is administered to elicit DTH reaction, then the diagnostic specificity is improved, but the procedure complexity and time required increase
Solution Approach 1:
The patent employs preliminary action by pre-formulating the Spike protein antigen in a standardized immunogenic composition with known concentration and adjuvant formulation. This preliminary preparation ensures that when the antigen is administered intradermally, it reliably elicits a DTH reaction in sensitized individuals, thereby improving diagnostic reliability while reducing procedural variability
Solution Approach 2:
The patent utilizes parameter changes by controlling the concentration of Spike protein antigen (e.g., 5-50 μg/mL range), the timing of reaction assessment (24-72 hours post-injection), and the measurement parameters (induration diameter, erythema intensity). These controlled parameter changes optimize the DTH reaction response while maintaining procedural standardization
3Measurement precision
If multiple measurement methods (ultrasound, thermal imaging, digital image processing) are used to assess DTH reaction, then the measurement precision is improved, but the equipment complexity and cost increase
Solution Approach 1:
The patent applies universality by developing a multi-functional measurement approach where digital image processing serves multiple purposes: measuring induration diameter, assessing erythema intensity, and documenting reaction progression. This single technological platform performs multiple measurement functions, improving overall measurement precision while avoiding the need for separate specialized equipment for each parameter
Solution Approach 2:
The patent uses copying by creating digital images of the skin reaction site, which can then be analyzed repeatedly and stored for future reference. These digital copies allow for precise measurement of induration and erythema without requiring complex real-time imaging equipment, as the same image can be analyzed multiple times with high precision
4Measurement precision
If DTH reaction is used to differentiate between active infection, past exposure, and vaccination, then the diagnostic specificity is improved, but the interpretation complexity increases
Solution Approach 1:
The patent employs feedback by establishing predetermined interpretation criteria based on the magnitude of the DTH reaction (e.g., induration diameter thresholds, erythema intensity ranges). These feedback rules allow the clinician to interpret the results by comparing the measured parameters against established benchmarks, thereby differentiating between active infection, past exposure, and vaccination status while reducing interpretation complexity through standardized decision algorithms
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
This approach provides a specific and accurate diagnosis of SARS-CoV-2 infection by eliciting a DTH reaction that correlates with the immune status, differentiating between active infection, past exposure, and vaccination, with high sensitivity and specificity.
Implementation Method 1
administering the Spike protein or its fragments intradermally to elicit a Delayed-Type Hypersensitivity (DTH) reaction
Implementation Method 2
measuring induration and erythema using ultrasound
Implementation Method 3
measuring induration and erythema using... thermal imaging
Data Source
AI summary
The invention relates to a method of eliciting an immune response in a human subject showing no signs or symptoms of an active SARS-CoV-2 infection comprising administering intra-dermally to the human subject an immunogenic composition comprising the Spike protein (S protein) of SARS-CoV-2 or a fragment thereof.