Vertical Flow Assay Device for Point-of-Care Glycemic Analysis
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Solution Overview
Problem
Current glucose detection methods require refrigeration, power sources, and specialized equipment, limiting their use for point-of-care glycemic management and failing to efficiently detect multiple glycemic analytes simultaneously from different sample types.
Innovation Solution
A vertical flow assay device that uses gravity to flow a fluid sample through absorbent layers containing reagents, providing a visual indication of glycemic analytes like glucose, glycated hemoglobin, and insulin without the need for refrigeration or a power source, allowing detection of multiple analytes from a single sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional glucose detection methods are used, then reliable glucose concentration measurement is achieved, but the device requires refrigeration, power sources, and specialized equipment
Solution Approach 1:
The patent employs disposable test strips containing dried reagents that do not require refrigeration or power sources. Each test strip is a single-use, self-contained unit with all necessary components for glucose detection, eliminating the need for complex equipment while maintaining reliable results at the point of care
Solution Approach 2:
The test strips are designed to be self-contained with dried reagents that automatically react with the blood sample upon application. The chemical reactions occur spontaneously without requiring external power sources, refrigeration, or complex processing equipment, enabling reliable glucose detection through simple patient application
2Adaptability or versatility
If traditional test strips are used, then glucose concentration is detected, but multiple glycemic analytes cannot be detected simultaneously
Solution Approach 1:
The test strip design incorporates multiple detection zones on a single strip, each containing reagents specific to different glycemic analytes (glucose, glycated hemoglobin, insulin). This allows simultaneous detection of multiple analytes from a single blood sample application, providing comprehensive glycemic management information without requiring multiple separate tests
Solution Approach 2:
The test strip is divided into distinct detection zones or regions, with each zone containing reagents specific to a particular analyte. This segmentation allows independent detection of multiple analytes simultaneously while maintaining a simple single-strip format that does not increase overall device complexity for the user
3Measurement precision
If refrigeration and power sources are required, then accurate analyte detection is maintained, but portability and point-of-care usability are limited
Solution Approach 1:
The use of disposable test strips with dried, stable reagents eliminates the need for refrigeration and power sources. The strips maintain measurement precision through chemical stability while enabling true point-of-care usability by patients and technicians without specialized equipment or environmental controls
Solution Approach 2:
The reagents are pre-dried and stabilized on the test strip during manufacturing, preparing them for immediate use at the point of care. This preliminary preparation ensures measurement precision is maintained without requiring refrigeration or power sources during storage or use, enabling simple patient application
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
Enables quick, reliable, and portable detection of glycemic analytes, providing a visual indication of analyte concentrations above a threshold, suitable for point-of-care use by technicians and patients without specialized equipment.
Implementation Method 1
The fluid sample is delivered to the absorbent body within the detection zone and is retained and stabilized by a downward flow by gravity
Implementation Method 2
The detection zone includes a color indicator that provides a visual indication that the analyte is present in an amount above a predetermined concentration
Data Source
AI summary
A glycemic management related analyte detecting assay device (10) and method are provided for detecting and quantifying analyte concentrations in a fluid sample. The assay device includes an absorbent body containing an assay forming a detection zone for receiving a fluid test sample. The absorbent body is provided in a chamber of the device. The assay can detect one or more of a glycemic analyte selected from the group consisting of fasting plasma blood glucose, oral glucose, % glycated hemoglobin, and fasting insulin concentrations. In one embodiment, a container includes an absorbent body having a plurality of superimposed membranes (30, 32, 34, 36) where each membrane contains a reactant and a color indicator for detecting the presence of a selected analyte above a predetermined concentration in the fluid sample. The absorbent body and/or the assay include a color indicator that is able to provide a visual indication of the presence of one or more glycemic analytes present in the test sample.