Immunochromatography Test Device for Antibody Source Identification
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Solution Overview
Problem
Conventional immunochromatographic test devices struggle to determine whether neutralizing antibodies against the novel coronavirus are produced by vaccination or natural infection, as they cannot differentiate between the two sources of antibody production.
Innovation Solution
A test device and method using two separate test pieces within a single case, where the first test piece detects the presence of S1/RBD-IgG antibodies and the second test piece detects NP-IgG antibodies, allowing for parallel and simultaneous observation of results to determine the source of antibody production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single test piece with S antigen and N antigen is used, then the test device can detect both antibodies, but it cannot determine whether the antibody is produced by vaccination or natural infection
Solution Approach 1:
The test device is divided into two separate test pieces: one for detecting S antigen-specific antibodies and another for detecting N antigen-specific antibodies. This segmentation allows the device to distinguish between vaccination-induced antibodies (S antigen only) and natural infection-induced antibodies (both S and N antigens), thereby resolving the information loss about the source of antibody production.
2Loss of information
If two separate test devices are used to detect S antigen and N antigen antibodies, then the source of antibody production can be determined, but the device complexity increases
Solution Approach 1:
Two separate test devices are merged into a single integrated test device by placing both test pieces (S antigen detection and N antigen detection) within one case. The case includes a common dropping window for specimen application and individual detection windows for each test piece, allowing simultaneous operation and simplified user operation while maintaining the ability to distinguish antibody sources.
3Measurement precision
If separate testing procedures are used for S antigen and N antigen antibodies, then accurate determination can be made, but the testing time increases
Solution Approach 1:
Both test pieces are prepared in advance with their respective antigens and capture antibodies immobilized on the membranes. The specimen is applied once to both test pieces simultaneously, and both reactions proceed in parallel. This preliminary preparation and simultaneous execution allow accurate determination of antibody sources without requiring sequential testing, thereby reducing the total testing 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
Enables quick and simple determination of the efficacy of vaccination against the novel coronavirus or the history of vaccination inoculation, effectively distinguishing between antibodies produced by vaccination and natural infection.
Implementation Method 1
A conventionally known test device for performing an immunoassay is a test device employing immunochromatography. Immunochromatography is an immunoassay that employs a property (capillary action) in which a specimen slowly flows on a porous test piece such as a cellulose membrane while dissolving a reagent therein.
Implementation Method 2
Immunochromatography is an immunoassay that employs a property (capillary action) in which a specimen slowly flows on a porous test piece such as a cellulose membrane while dissolving a reagent therein.
Data Source
AI summary
A test device by immunochromatography comprises a case including a dropping window for a specimen and a detection window, and a test piece in the case. The test piece includes first and second detection portions, and a dropping area common to the first and second detection portions. When the specimen is dropped on the dropping area through the dropping window, the specimen migrates downstream and the same specimen reaches the first and second detection portions. The first detection portion traps a complex of a first labeled body and a first antibody contained in the specimen. The second detection portion traps a complex of a second labeled body and a second antibody contained in the specimen. The first antibody is produced by vaccination or infection with a predetermined virus. The second antibody is produced by infection with the virus. Thus, a test result from each of the first and second detection portions, both visually observed through the detection window, can be determined in parallel and at the same time.