Dry Analytical Element Multistep Coating Hemolysis Reduction
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Solution Overview
Problem
Existing dry analytical elements for body fluid component measurement are influenced by hemolysis, leading to measurement errors due to hemoglobin and other pigments, which previous methods have not adequately addressed.
Innovation Solution
A dry analytical element is produced using a multistep coating process where a low-viscosity solution containing oxidase is applied first, followed by a high-viscosity solution with other reagents to the spreading layer, reducing the impact of hemolysis and improving measurement accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single coating solution containing all reagents is applied to the spreading layer, then the manufacturing process is simple, but measurement precision deteriorates due to hemolysis interference
Solution Approach 1:
The single coating solution is divided into two separate coating solutions: a first coating solution containing oxidase and a second coating solution containing other reagents. This segmentation allows each reagent to be optimally positioned in the spreading layer, reducing hemolysis interference while maintaining a relatively simple two-step coating process.
Solution Approach 2:
Different regions of the spreading layer are assigned different reagent compositions. The first coating solution creates a region with oxidase that is optimally positioned to handle hemolyzed components, while the second coating solution creates a region with other reagents. This local differentiation improves measurement precision by addressing hemolysis interference at the source.
2Stability of the object's composition
If oxidase is mixed with other reagents in the same coating solution, then the reagent composition is homogeneous, but hemolysis interference increases due to improper reagent distribution
Solution Approach 1:
The homogeneous reagent mixture is segmented into two separate coating solutions applied in sequence. The first coating solution contains oxidase and is applied first to create an initial layer, followed by the second coating solution containing other reagents. This segmentation enables optimal spatial distribution of reagents, reducing hemolysis interference while maintaining composition stability.
Solution Approach 2:
The oxidase-containing first coating solution is applied preliminarily before the other reagents. This preliminary action positions the oxidase in an optimal location within the spreading layer structure, allowing it to effectively handle hemolyzed components before other reagents are introduced, thereby reducing hemolysis interference.
3Productivity
If a conventional single-step coating method is used, then production efficiency is high, but measurement reliability deteriorates due to hemolysis effects
Solution Approach 1:
The conventional single-step coating is segmented into two sequential coating steps. While this increases process time slightly, it dramatically improves measurement reliability by reducing hemolysis interference through optimized reagent distribution. The first coating solution with oxidase is applied, followed by the second coating solution with other reagents, creating a structured layout that enhances reliability.
Solution Approach 2:
The coating process parameters are changed from a single-step to a two-step process, with each step using a different coating solution with specific viscosity and composition characteristics. This parameter change optimizes reagent distribution and positioning, significantly improving measurement reliability while maintaining acceptable production efficiency.
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 significantly reduces hemolysis interference, allowing for precise body fluid component measurement even with hemolyzed specimens, eliminating the need for repeated blood sampling and minimizing technique-dependent variations.
Implementation Method 1
an oxidase, which is selected depending on a predetermined analyte such as cholesterol, reacts with an analyte in the presence of oxygen such that hydrogen peroxide is generated
Implementation Method 2
an oxidase, which is selected depending on a predetermined analyte such as cholesterol, reacts with an analyte in the presence of oxygen such that hydrogen peroxide is generated
Implementation Method 3
The generated hydrogen peroxide oxidizes a preferable oxidation/reduction indicator in the presence of a substance having peroxidative activity such that color conversion due to oxidization is observed
Implementation Method 4
a pigment such as hemoglobin or bilirubin causes a positive or negative error depending on measurement wavelength. In addition, it has been widely known that absorption by such pigment varies with time during measurement
Data Source
AI summary
It is an object of the present invention to reduce influence of hemolysis in a dry analytical element used for measurement of components in a body fluid sample such as blood. The present invention provides a method for producing a dry analytical element for body fluid component measurement comprising at least a reagent layer containing an H2O2 color developing reagent and a spreading layer provided on the reagent layer, which comprises steps of providing a spreading layer substrate on the reagent layer containing an H2O2 color developing reagent and preparing a spreading layer by coating a low-viscosity solution containing oxidase to the spreading layer substrate and then coating a high-viscosity solution containing other reagent components than oxidase thereto.