Vertical Flow Diagnostic Device with Breakable Reagent Cartridge
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Solution Overview
Problem
Existing point-of-care diagnostic devices require multiple manual additions of reagents and buffers, which increases the time and potential for errors in testing, and limits their use in certain environments due to refrigeration requirements.
Innovation Solution
A downward or vertical flow diagnostic device with a breakable cartridge housing liquid reagents that flow vertically onto a reaction zone, combined with a matrix for reconstituting dried indicator reagents, reducing the need for manual reagent delivery and allowing storage at room temperature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual addition of reagents and buffers is used in flow-through devices, then the device can provide rapid results and be compact, but the amount of time required to complete the assay increases and the potential for error increases
Solution Approach 1:
The patent applies preliminary action by pre-storing reagents in dried form within the device structure. The indicator reagent is dried on a membrane in the reaction zone, and the buffer is pre-loaded in a reservoir. This eliminates the need for manual addition during the assay, allowing users to simply apply the sample and obtain results without handling multiple reagents, thus reducing both time and error potential.
2Reliability
If refrigeration is required for reagent storage, then reagent stability is maintained, but the environments in which the device can be used are limited
Solution Approach 1:
The patent applies parameter changes by transforming the reagent from liquid to dried form. This phase change allows the reagent to be stored at room temperature without refrigeration while maintaining stability. The dried indicator reagent on the membrane and the pre-loaded buffer remain stable until the assay is performed, at which point the buffer reconstitutes the indicator reagent in situ.
3Measurement precision
If multiple washing steps are performed in flow-through devices, then detection accuracy is improved, but the overall time required to successfully complete the assay increases
Solution Approach 1:
The patent extracts the washing function from separate manual steps and integrates it into the sample flow path. The sample buffer naturally washes unbound indicator reagent away from the reaction zone as it flows through the device, eliminating the need for separate washing steps. This maintains detection accuracy by removing excess reagent while significantly reducing assay completion 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
This design minimizes manual handling of reagents, decreases testing time, and allows for more versatile use in various environments by automating reagent delivery and storage conditions.
Implementation Method 1
an absorbent zone in vertical communication with the reaction zone, the absorbent zone comprising an absorbent material positioned underneath the reaction zone for facilitating the downward or vertical flow of the fluid test sample through the reaction zone and into the absorbent zone
Implementation Method 2
a channel connecting the breakable cartridge to the test area, whereby liberating the liquid reagent from the breakable cartridge causes the reagent to flow vertically or downwardly through the channel onto the test area
Data Source
AI summary
A downward or vertical flow-through rapid diagnostic device and assay are provided. The device comprises a test area and reagent storage area, which are linked via a channel. The test area further comprises a reaction zone and an absorbent zone. A capture reagent is immobilized on the reaction zone to detect a target analyte in the fluid test sample. The fluid test sample flows downward or vertically through the reaction zone and into the absorbent zone, with the capture reagent and target analyte forming a two-membered complex that is concentrated in the reaction zone. The reagent storage area comprises a breakable cartridge positioned directly and vertically above the test area and a channel. A reagent used in the assay is housed in the breakable cartridge. Once liberated, the reagent passes through the channel and flows to test area for depositing on the reaction zone. The storage of predetermined amounts of reagents in the diagnostic device reduces the number of manual operations required to produce a result.