Assay Device Single Separation Membrane for HDL Analysis
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Solution Overview
Problem
Conventional point-of-care (POC) testing systems require multiple separation phases and large blood volumes to accurately determine high-density lipoprotein (HDL) levels, making them inefficient and impractical for use with limited blood samples.
Innovation Solution
An assay device with a single separation membrane containing a polyanionic non-high density lipoprotein binding reagent that concurrently separates red blood cells and non-HDL from the blood sample, allowing the HDL to pass through for detection, reducing the need for multiple layers and minimizing blood sample volume.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple separation phases and layers are used to separate red blood cells and non-HDL from HDL, then the accuracy of HDL determination is improved, but the blood volume required increases and device complexity increases
Solution Approach 1:
The patent combines multiple separation functions into a single separation membrane layer. This membrane simultaneously separates red blood cells from the blood sample and precipitates non-HDL proteins, eliminating the need for multiple separate separation phases and layers while maintaining accurate HDL determination
Solution Approach 2:
The single separation membrane performs multiple functions: it acts as a physical barrier to separate red blood cells, contains reagents to precipitate non-HDL proteins, and allows HDL to pass through to the detection layer. This multi-functional design reduces both blood volume requirements and device complexity
2Measurement precision
If multiple separation phases and layers are used to separate red blood cells and non-HDL from HDL, then the accuracy of HDL determination is improved, but the device complexity increases
Solution Approach 1:
The patent merges multiple separation phases (red blood cell separation and non-HDL precipitation) into a single integrated separation membrane layer, reducing the overall number of layers in the device while maintaining the necessary separation functions for accurate HDL analysis
Solution Approach 2:
The single separation membrane is designed to perform multiple functions simultaneously: physical separation of red blood cells, chemical precipitation of non-HDL proteins, and selective transport of HDL to the detection layer, thereby simplifying the device structure
3Measurement precision
If conventional multi-layer separation systems are used, then HDL can be accurately separated, but the assay process becomes less efficient and more time-consuming
Solution Approach 1:
The patent combines multiple separation steps into a single concurrent process that occurs within one separation membrane layer, allowing red blood cells and non-HDL to be removed simultaneously while HDL passes through, thereby improving assay efficiency and reducing processing 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 assay device enables accurate and efficient determination of HDL levels using a compact POC system that requires less blood volume, improving the efficiency and cost-effectiveness of HDL analysis.
Implementation Method 1
The separation membrane contains a first reagent for precipitating a first protein contained in the blood fluid sample, where the first reagent comprises a polyanionic non-high density lipoprotein binding reagent
Implementation Method 2
the separation membrane also separates red blood cells from the blood fluid sample
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
This present disclosure provides devices for analyzing a blood fluid sample. The present disclosure contemplates an assay device that includes a separation membrane and a detection membrane. The separation membrane contains a first reagent for precipitating a first protein contained in the blood fluid sample, where the separation membrane also separates red blood cells from the blood fluid sample. Further, the detection membrane is configured to elicit a quantifiable response in the presence of a second protein present in the blood fluid sample. The quantifiable response corresponds to an amount of the second protein present in the detection membrane. In addition, it is to be understood that the separation membrane concurrently precipitates the first protein and separates the red blood cells from the blood fluid sample that reaches the detection membrane. Methods for manufacturing the assay device and performing an assay using the assay device are also provided.