Sealed Test Device for Safe Specimen Handling
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Solution Overview
Problem
Existing test devices for biomolecule detection, such as those used in immunochromatography, pose safety risks due to the potential for specimen liquid splattering and leakage, requiring skilled operators and specialized facilities for handling high-concentration bacterial samples.
Innovation Solution
A test device with a culturing unit, test piece, and sealing mechanism that allows specimen liquid to be cultured and absorbed in a sealed environment, preventing exposure and splattering through a separating unit that breaks contact only at the time of testing, enabling safe and simple examination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the test device uses an open dropping window for specimen liquid application, then the operation is simple and quick, but the safety is insufficient due to risk of splattering and leakage
Solution Approach 1:
The device is divided into a sealed culturing unit for specimen liquid and an open test piece area for detection. The sealing unit isolates the hazardous specimen liquid during culture, while the test piece area remains accessible for simple operation. This segmentation allows both safety during culture and simplicity during testing.
Solution Approach 2:
The test piece acts as an intermediary medium that transfers the specimen liquid from the sealed culturing unit to the detection area. The specimen liquid is cultured in the sealed unit, then the test piece absorbs and transports it to the test area, eliminating the need for direct manual handling of concentrated bacterial samples.
2Measurement precision
If the specimen liquid is cultured to high concentration, then the detection sensitivity is improved, but the risk of contamination and infection increases
Solution Approach 1:
The device separates the high-concentration culture process (in sealed culturing unit) from the detection process (in open test area). The sealing unit maintains high concentration for sensitivity while preventing contamination risk, as the hazardous concentrated sample never contacts the operator during the dangerous phase.
Solution Approach 2:
The test piece serves as an intermediary that safely transfers the high-concentration specimen liquid from the sealed culture environment to the detection area. This allows the benefits of high-concentration culture for sensitivity while the sealed unit protects against contamination risks during the culture phase.
3Reliability
If the test device requires skilled operators in specialized institutions, then the safety is maintained, but the accessibility and simplicity of examination is reduced
Solution Approach 1:
The device segments the hazardous culture function into a sealed unit that can be safely handled by non-skilled personnel, while the simple test piece reading function remains accessible to everyone. This allows safety during the complex culture phase without restricting accessibility during the simple detection phase.
Solution Approach 2:
The test piece acts as an intermediary that simplifies the operation for non-skilled personnel. Instead of requiring skilled operators to manually handle dangerous concentrated samples, the test piece automatically absorbs and transports the specimen liquid, making the examination accessible to anyone while maintaining safety through the sealed culture unit.
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 solution prevents specimen liquid splattering and leakage, allowing safe and simple biomolecule detection even by non-skilled personnel, reducing the risk of contamination and infection, and enabling examination in non-specialized settings.
Implementation Method 1
a simple test device... employs a property (capillary action) in which a specimen slowly flows in a porous test piece while dissolving a reagent therein
Data Source
Figure 1(A)~1(D)
Figure 2(A)~2(C)
Figure 3(A)~3(D)
AI summary
An object is to provide a test device (10) and a test method which can prevent a specimen liquid (S2) from splattering and leaking and perform an examination simply and safely. The test device (10) includes a culturing unit (11) configured to be capable of culturing a specimen in a sealed state, a test piece (13) configured to be capable of absorbing a specimen liquid (S2) in the culturing unit (11), a separating unit (15) configured to be capable of separating the test piece (13) and the specimen liquid (S2) in a non-contact state, an opening unit (17) configured to be capable of opening at least a portion of the separating unit (15) to form a flow path (23) through which the specimen liquid (S2) reaches the test piece (13) and a case (19) configured to integrally seal at least a portion of the test piece (13) on a side closer to the separating unit (15), at least a portion of the culturing unit (11) and the separating unit (15).