Lateral Flow Test Housing for Consistent Urine Sample Distribution
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Solution Overview
Problem
Existing rapid diagnostic test devices for analytes in liquid samples, particularly for HCG and LH in urine, suffer from inaccurate results due to varying urine volumes collected and improper handling, leading to inconsistent test outcomes.
Innovation Solution
A test device design featuring a diversion element, a transparent non-absorbent membrane covering the nitrocellulose membrane, and a blocking element to control urine flow, ensuring consistent liquid distribution and preventing premature moistening of the testing area, thereby maintaining capillary function and improving accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If women urinate directly on the diversion element, then the device is easy to operate, but the amount of urine collected varies greatly (1 ml to 200 ml or more) affecting test accuracy
Solution Approach 1:
The patent introduces a sample application pad as an intermediary component between the diversion element and the testing area. This pad receives the urine sample from the diversion element and controls its transfer to the testing area, preventing both excessive and insufficient sampling. The intermediary pad ensures consistent analyte detection regardless of the total urine volume collected on the diversion element.
2Speed
If urine flows directly to the testing area, then the detection is rapid, but the testing area may be moistened in advance causing inaccurate results
Solution Approach 1:
The patent applies a transparent non-absorbent membrane to the testing area in advance to prevent premature moistening. This protective layer is applied before the urine sample reaches the testing area, allowing rapid sample flow while preventing the nitrocellulose membrane from becoming wet too early, which would cause analyte diffusion and inaccurate results.
Solution Approach 2:
The transparent non-absorbent membrane acts as a protective intermediary layer between the urine sample and the nitrocellulose testing area. It allows the sample to reach the testing area rapidly while preventing direct contact that would cause premature moistening and analyte diffusion.
3Reliability
If a transparent non-absorbent membrane covers the nitrocellulose membrane, then premature moistening is prevented, but the device complexity increases
Solution Approach 1:
The patent uses a thin, transparent non-absorbent membrane that is flexible and can be applied directly to the testing area. This thin film structure provides protection against premature moistening while adding minimal complexity to the device. The membrane's flexibility allows it to conform to the testing area shape and be easily integrated into the existing device structure.
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 device provides rapid and accurate test results for HCG and LH in urine by controlling urine volume and flow, reducing false negatives, and ensuring consistent test performance across different operators.
Implementation Method 1
a transparent non-absorbent membrane covers the nitrocellulose membrane to prevents the nitrocellulose membrane from being moistened in advance by the liquid sample
Implementation Method 2
a label-containing label pad... one end of the label pad is overlapped on the nitrocellulose membrane
Implementation Method 3
labels are dissolved by liquid to be released from the label pad
Implementation Method 4
a lateral flow testing element having a nitrocellulose membrane in a testing area
Data Source
Figure 1~2B
Figure 3
Figure 4
AI summary
The present invention provides a test device. The device includes a testing element and a house configured to accommodate the testing element, where the house is formed by folding a paper-made card, and the testing element is located in the housing. The housing is allowed to be in different change states to test or assay an analyte in a sample.