Analytical Test Strip Transparent Opaque Top Layer Fill Verification
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Solution Overview
Problem
Existing electrochemical-based analytical test strips do not provide a clear visual indication of when the sample has completely filled the working portion, leading to potential errors in analyte determination due to the inability to distinguish between the working and non-working portions of the sample-receiving chamber.
Innovation Solution
The test strip features a top layer with a transparent or translucent first portion and an opaque second portion, allowing users to visually verify the filling of the working portion while preventing observation of the non-working portion, thereby minimizing fill errors and ensuring accurate sample application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the sample-receiving chamber is designed with a larger total volume to ensure adequate sampling, then the sample volume capacity is improved, but the user cannot distinguish between the working portion and non-working portion, leading to fill errors
Solution Approach 1:
The top layer is divided into a transparent first portion and an opaque second portion, segmenting the viewing capability to distinguish between the working portion and non-working portion of the sample-receiving chamber. This allows the chamber to have a larger total volume while ensuring users only assess filling of the working portion through the transparent window.
Solution Approach 2:
The top layer has different optical properties in different regions: the first portion is transparent to allow viewing of the working portion for fill verification, while the second portion is opaque to mask the non-working portion. This local differentiation in transparency ensures users focus only on the relevant working area.
2Ease of operation
If the top layer is made completely transparent to allow full viewing of the sample-receiving chamber, then the ease of operation is improved, but the user may incorrectly assess filling status by viewing the non-working portion, reducing reliability
Solution Approach 1:
The top layer implements local quality by having a transparent first portion for viewing the working portion and an opaque second portion to mask the non-working portion. This provides sufficient visual verification capability where needed while preventing erroneous assessment from irrelevant areas.
Solution Approach 2:
The top layer is segmented into transparent and opaque regions, creating a windowed view that guides user attention to only the working portion for fill verification, thereby maintaining ease of operation while improving reliability.
3Reliability
If the top layer is made completely opaque to prevent viewing of the non-working portion, then the fill error rate is reduced, but the user cannot visually verify the working portion filling status, reducing ease of operation
Solution Approach 1:
The top layer is segmented into a transparent first portion and an opaque second portion, providing a selective viewing window that enables visual verification of the working portion while masking the non-working portion to prevent fill errors.
Solution Approach 2:
The top layer has different optical properties in different regions: transparent where viewing is needed (first portion over working portion) and opaque where viewing should be prevented (second portion over non-working portion), optimizing both reliability and ease of operation locally.
Data Source
AI summary
An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion. The first portion is configured such that a user can view the working portion of the sample-receiving chamber through the first portion of the top layer, while the opaque second portion is configured to preclude a user from viewing the non-working portion of the sample-receiving chamber.