Strip for measuring blood lipids

Inventors

HYUN, Kyung Hwan • Lee, Jung Hyun • KIM, Gi Wook

Assignees

GC Medical Science Corp

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Publication Number

US-11408901-B2

Patent

Publication Date

2022-08-09

Expiration Date


Abstract

The present invention relates to a strip for measuring blood lipids. The strip for measuring blood lipids, of the present invention, presses, with an optimal pressure or to an optimal height, a contact surface of a protruding part of a measurement layer disposed between an upper cover and a lower substrate, so as to improve the uniform diffusion of a biological sample, thereby having an effect of increasing measurement result accuracy of the biological sample.

Core Innovation

A strip for measuring blood lipids includes an upper cover and a lower substrate that form a recessed part and a protruding part. The upper cover comprises an upper opening window and a protruding part formed along edges of the upper opening window, and the lower substrate is coupled to the upper cover and comprises the recessed part to receive the protruding part surrounding an external circumference of the protruding part.

A measurement layer is aligned over the recessed part of the lower substrate and is exposed through the upper opening window for observation. The measurement layer comprises a compressed portion and a non-compressed portion, and the compressed portion is compressed between the recessed part of the lower substrate and the protruding part of the upper cover. The non-compressed portion has a thickness of 0.85 mm to 0.95 mm, and the compression portion has a thickness in a range of 0.5 to 0.8 mm.

The measurement layer further includes components for diffusion, lipid-separation, and reaction, where the lipid-separation filters materials other than lipids and the reaction produces an optical change for measurement. The optical change is described as color development, discoloration, or an increase or decrease in fluorescence intensity resulting from reaction with a biological sample, and the strip is described for measuring blood lipids such as total cholesterol, triglycerides, and high-density lipoprotein cholesterol.

Claims Coverage

The independent claim set includes one independent claim that defines the overall strip structure and the compressed measurement-layer geometry for uniform spreading of a biological sample. Dependent claims refine the measurement layer composition, the optical change mechanism, the separation materials/reagent, and selected blood-lipid targets.

Recessed-and-protruding cover/substrate compression for uniform spreading

An upper cover comprising an upper opening window and a protruding part formed along edges of the upper opening window; a lower substrate coupled to the upper cover and comprising a recessed part to receive the protruding part by surrounding an external circumference of the protruding part; and a measurement layer aligned over the recessed part and exposed through the upper opening window for observation, wherein the measurement layer includes a compressed portion and a non-compressed portion and the compressed portion is compressed between the recessed part and the protruding part.

Thickness-defined compressed versus non-compressed measurement layer

The non-compressed portion has a thickness of 0.85 mm to 0.95 mm and the compression portion has a thickness in a range of 0.5 to 0.8 mm, so that the measurement layer compressed between the recessed part and the protruding part uniformly spreads a biological sample supplied to the measurement layer in all directions with regard to the measurement layer.

Diffusion, lipid-separation, and reaction measurement-layer functionality

A measurement layer that includes a diffusion layer, a lipid-separating layer that filters out materials other than lipids, and a reaction layer that reacts with blood after the non-lipid materials have been filtered.

Reagent-produced optical change for lipid measurement

A reaction layer with a reagent that reacts with lipids in a biological sample to produce an optical change.

Optical change as color development/discoloration or fluorescence intensity change

The optical change is selected from color development, discoloration, or an increase or decrease in fluorescence intensity resulting from reaction with a biological sample.

Separation layer materials and precipitating-reagent approach

A separation layer made from selected materials including paper pads, glass fibers, polyester, nitrocellulose, or polysulfonate, and containing a reagent to precipitate substances other than blood lipids.

Target blood lipids include total cholesterol, triglycerides, and/or HDL cholesterol

The one or more blood lipids include total cholesterol, triglycerides, and/or high-density lipoprotein cholesterol.

Across the claim set, the core inventive concept is compressing a measurement layer between a recessed lower substrate and a protruding upper cover so the compressed layer uniformly spreads a biological sample in all directions. The claim coverage is further narrowed by defining diffusion/lipid-separation/reaction sublayers, specifying optical change outputs, naming separation-material and precipitating-reagent options, and limiting targets to specified blood lipids.

Stated Advantages

Uniform spreading of a biological sample in all directions with regard to the measurement layer when the measurement layer is compressed between the recessed part and the protruding part.

Improved reproducibility of measurement results as indicated by comparative results using coefficient of variation (CV%).

Documented Applications

Measuring blood lipids such as total cholesterol, triglycerides, and/or high-density lipoprotein cholesterol using an exposed measurement layer observed through an upper opening window.

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