Skin Patch Test for SARS-CoV-2 Cellular Immunity Diagnosis
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Solution Overview
Problem
Current diagnostic methods for SARS-CoV-2 primarily focus on humoral responses, which are inefficient and short-lived, while cellular immunity, crucial for long-term protection, is not effectively assessed, particularly in asymptomatic cases and post-vaccination scenarios.
Innovation Solution
A transdermal skin patch containing recombinant SARS-CoV-2 antigen proteins, such as the Spike or RBD, is used to evoke a local skin reaction, allowing for the evaluation of cellular immune response by measuring Delayed-type hypersensitivity (DTH) reactions, which reflect the strength and persistence of cellular immunity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If humoral response tests (antibody detection) are used for SARS-CoV-2 diagnosis, then the diagnostic method is simple and widely available, but the measurement precision of actual immune protection is insufficient because antibodies do not provide efficient long-term protection
Solution Approach 1:
The patent introduces a skin patch as an intermediary device that delivers SARS-CoV-2 antigens to the skin, mediating between the need for accurate cellular immunity measurement and the requirement for a simple diagnostic tool. The patch system enables DTH reaction measurement without requiring complex laboratory equipment.
Solution Approach 2:
The patent replaces complex laboratory-based cellular immunity testing mechanisms with a simpler skin-based DTH reaction mechanism. Instead of using flow cytometry or ELISpot assays requiring specialized equipment, the invention uses observable skin inflammation reactions that can be measured with basic tools.
2Measurement precision
If cellular immunity assessment methods (such as T cell activation tests) are used, then the measurement precision of immune protection is improved, but the device complexity and difficulty of operation increase significantly
Solution Approach 1:
The skin patch serves as an intermediary that simplifies the interaction between the diagnostic system and the patient. By delivering antigens through the skin and producing local DTH reactions, it eliminates the need for complex blood sampling and laboratory processing, making cellular immunity assessment as easy as applying a patch.
Solution Approach 2:
The patent utilizes color changes in the skin (redness, swelling) as visual indicators of cellular immune response. This allows healthcare providers to assess T cell immunity through simple visual observation or basic imaging, eliminating the need for complex operational procedures.
3Ease of operation
If traditional skin patch tests are used, then the ease of operation is improved, but the measurement precision of cellular immunity against SARS-CoV-2 is insufficient without proper antigen formulation
Solution Approach 1:
The patent applies parameter changes by optimizing the antigen formulation within the skin patch, including the choice of SARS-CoV-2 antigens (S protein, RBD, N protein), adjuvants, and delivery mechanisms. These parameter optimizations ensure that the simple skin patch application produces measurable and precise DTH reactions specific to SARS-CoV-2 cellular immunity.
4Measurement precision
If multiple diagnostic tests are used to assess both humoral and cellular immunity, then the measurement precision of overall immune response is improved, but the loss of time and increased complexity increase
Solution Approach 1:
The patent makes the skin patch test multi-functional by designing it to assess SARS-CoV-2 cellular immunity while being compatible with and complementary to existing humoral response tests. This universal approach allows clinicians to evaluate both antibody and T cell immunity using a unified diagnostic strategy, reducing the need for separate specialized tests and saving time.
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 skin patch effectively assesses cellular immune responses, providing a diagnostic tool for evaluating immunological protection against SARS-CoV-2 by quantifying local skin inflammation, thus offering a more durable and specific measure of immune protection compared to humoral responses.
Implementation Method 1
the one or more antigen protein(s) enter the epidermis of the human patient wherein said antigen protein(s) is/are contacted with the immune cells of the patient developed against the SARS-CoV-2 virus, and a local skin inflammation is evoked. Preferably, the local skin inflammation is due to 'Delayed-type hypersensitivity' (DTH).
Data Source
AI summary
The invention relates to the application of a skin patch test for the detection of the specific cellular immune response against the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2). The skin patch contains a formulated version of the recombinant form of SARS-CoV-2 antigenic protein. The application of the skin patch allows to follow the local skin reaction reflecting the strength of the cellular immune reaction against SARS-CoV-2, thus the skin test is applicable to a diagnostic evaluation of the specific cellular immunity evoked by previous virus infection or by vaccination against COVID-19.