Fluorescent Particle Analysis Cartridge Design
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Solution Overview
Problem
Current methods for identifying and enumerating analytes, such as CD4+ T-helper lymphocytes, in complex sample matrices are costly and inaccessible in resource-limited settings due to the need for central lab-based equipment and techniques like flow cytometry.
Innovation Solution
A particle identification system that includes a cartridge with fluorescently labeled particles, illumination for stimulating emission, and an imager for generating wavelength-filtered electronic images, processed to determine fluorescently labeled particles using dimmest separation lines and local background analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If flow cytometry is used for CD4 cell counting, then measurement precision is improved, but device complexity and operational costs increase
Solution Approach 1:
The patent creates a simplified copy of flow cytometry functionality using digital imaging and image processing algorithms. Instead of requiring complex flow cytometry equipment, the system uses a digital microscope or camera to capture images of cells on a slide, then applies computational algorithms to identify and count CD4 cells based on their morphological features and fluorescent labeling patterns.
Solution Approach 2:
The patent replaces the mechanical fluid flow system of flow cytometry with a static imaging system. Cells are fixed on a slide rather than flowing through a chamber, eliminating the need for complex fluidics, pumps, and flow control mechanisms while maintaining cell analysis capability through digital image capture and processing.
2Measurement precision
If flow cytometry is used for CD4 cell counting, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The patent implements automated image processing algorithms that automatically identify, segment, and count cells without requiring manual intervention or expertise. The system self-calibrates by identifying cell boundaries, nuclei, and fluorescent markers through computational analysis, eliminating the need for trained operators to manually analyze flow cytometry data or adjust complex instrument parameters.
Solution Approach 2:
The patent performs preliminary cell fixation and labeling on a simple slide format before imaging, allowing the analysis system to work with static, pre-prepared samples rather than requiring real-time flow analysis. This preliminary preparation simplifies the operational process by decoupling sample preparation from analysis, allowing non-experts to load slides without specialized training.
3Measurement precision
If flow cytometry is used for CD4 cell counting, then measurement precision is improved, but loss of time increases
Solution Approach 1:
The patent segments the CD4 cell counting function into a portable, standalone device that can be deployed at point-of-care locations. By dividing the centralized lab-based flow cytometry system into distributed imaging stations with embedded processing capability, the system eliminates transport time for both samples and equipment, allowing immediate local analysis while maintaining accurate cell counting through digital imaging and automated image processing.
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 accurate and cost-effective identification and enumeration of analytes in a portable, point-of-care setting, reducing operational and transport costs while maintaining the accuracy of traditional methods.
Implementation Method 1
a cartridge for containing a sample with fluorescently labeled particles; illumination for illuminating a region within the cartridge to stimulate emission from fluorescently labeled particles in the region
Data Source
AI summary
A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.