Point-of-Care Biofluid Separation Device for SARS-CoV-2 Detection
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Solution Overview
Problem
Current methods for detecting SARS-CoV-2 and other diseases face challenges with low reproducibility and high false-negative rates, particularly due to the need for high viral titers in nasal and throat swabs, and the complexity of sampling procedures.
Innovation Solution
A device and method for multi-level analysis of biofluid samples, such as blood and saliva, which allows for the separation and preservation of non-cellular components at the point-of-care, using a housing with a separation member to retain cellular components and an extraction member to isolate non-cellular components, enabling more sensitive testing through RT-qPCR or dd-PCR, and potentially reducing false-negative results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If nasal or throat swabs are used for SARS-CoV-2 detection, then viral detection can be performed, but the reproducibility is low and false-negative rates are high due to the need for high viral titers in accumulated mucus
Solution Approach 1:
The device separates the blood sample into two distinct fractions: cellular components retained in the separation member and non-cellular components (plasma/serum) extracted into the extraction member. This segmentation allows independent analysis of each fraction, enabling detection of viral RNA in plasma without interference from cellular debris, thereby improving reproducibility and reducing false-negative results.
Solution Approach 2:
The device performs sample separation and preservation at the point-of-care before transport to the laboratory. By pre-separating the plasma/serum fraction and preserving it with stabilizing agents, the sample is prepared in advance for optimal PCR analysis, eliminating the need for complex laboratory centrifugation procedures and ensuring consistent detection results.
2Reliability
If complex sampling procedures are used, then comprehensive sample collection can be achieved, but the ease of operation decreases and requires trained personnel
Solution Approach 1:
The device is designed for self-service operation where the user simply applies the blood sample to the separation member and activates the extraction mechanism. The device automatically separates and preserves the plasma/serum fraction without requiring trained personnel or complex procedures, making point-of-care testing accessible to anyone while maintaining high sample quality.
Solution Approach 2:
The device extracts only the necessary non-cellular components (plasma/serum) from the blood sample at the point-of-care, eliminating the need for complex laboratory processing. This extraction approach simplifies the sampling procedure while ensuring the obtained fraction is optimal for viral RNA detection.
3Loss of time
If immediate analysis is performed without preservation, then rapid results can be obtained, but the loss of time for transport and processing increases
Solution Approach 1:
The device performs sample separation and preservation at the point-of-care before transport. By pre-preparing the plasma/serum fraction with stabilizing agents, the sample remains stable during transport, eliminating the need for immediate analysis upon arrival at the laboratory and reducing the overall time loss.
Solution Approach 2:
The device uses preservative agents as intermediaries to maintain sample stability during transport. These agents prevent degradation of viral RNA in the plasma/serum fraction, allowing the sample to withstand transport conditions without compromising detection reliability, thus bridging the time gap between sampling and analysis.
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 enables more reproducible and sensitive detection of SARS-CoV-2 and other diseases, allowing for immediate analysis and preservation of samples, potentially reducing false-negative results and improving diagnostic accuracy.
Implementation Method 1
at least one separation member configured to separate the non-cellular components of the biofluid (e.g., the plasma or serum from the blood sample or the non-cellular components of saliva) while retaining cellular components
Implementation Method 2
at least one extraction member configured to extract the non-cellular components (e.g., the plasma or serum of the blood sample or the non-cellular components of saliva) from the separation member
Data Source
Figure 1
Figure 2A~2D
Figure 3A~3D
AI summary
The present invention relates to a device (1) for separation and/or preservation of non-cellular components from a biofluid sample (2) at a point-of-care, wherein said device (1) comprises at least one separation member (50) configured to separate the non-cellular components from the sample (2) and to retain cellular components, at least one extraction member (60) configured to extract the non-cellular components from the separation member (50), at least one flow assay (70) configured to analyze the non-cellular components extracted by the extraction member (50), and a housing (10) in which the separation member (50), the extraction member (60) and the flow assay (70) are arranged, wherein the housing (10) is configured to be shifted from a first configuration (A) to a second configuration (B), wherein, in the first configuration (A), the separation member (50) and the extraction member (60) are fluidly coupled with each other so that the device (1) is configured for extracting the non-cellular components from the separation member (50) by the extraction member (60), and wherein, in the second configuration (B), the separation member (50) and the extraction member (60) are fluidly uncoupled from each other for preventing a preservative (4) added to the separation member (50) from reaching the extraction member (60) and/or the flow assay (70).