Lateral Flow Assay for Open-Globe Eye Injury Detection
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Solution Overview
Problem
Current diagnostic methods for open-globe ocular injuries are inadequate, particularly for less skilled care providers and in scenarios where optical inspection is challenging due to patient guarding, swelling, or other obstructions.
Innovation Solution
A fieldable open-globe eye detection system that includes a sampler tool and a substrate with a sample receiver, target recognition element specific to intraocular fluid, signal producing molecule, flow path, test element, control element, and blood filter, which allows for the detection of α-crystallin A in fluid samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If optical inspection methods are used to diagnose open-globe injuries, then diagnostic accuracy can be achieved, but the method becomes impossible when patients guard their injuries, have swelling, or have obstructions
Solution Approach 1:
The patent extracts the diagnostic function from direct optical inspection of the eye and relocates it to a fluid sample analysis system. The assay device takes out the need for direct visual access to the injured eye by detecting intraocular fluid biomarkers in a separate sample, allowing diagnosis without manipulating or viewing the obstructed eye directly
Solution Approach 2:
The patent introduces an intermediary substance (intraocular fluid sample) that carries diagnostic information from the injured eye to the assay device. Instead of directly observing the eye, the system uses a mediator fluid containing biomarkers that can be analyzed separately, bridging the gap between the obstructed eye and the diagnostic instrument
2Reliability
If the Seidel Test with fluorescein dye is used to detect intraocular fluid leakage, then diagnosis can be performed, but false negative results occur due to small wounds closing, ocular contents plugging openings, or color dilution
Solution Approach 1:
The patent changes the detection parameter from visual color assessment (subjective and prone to dilution errors) to quantitative biomarker detection. Instead of relying on color intensity which can be diluted or obscured, the system measures specific biomarker concentrations (such as alpha-crystallin) that provide objective, quantifiable results regardless of wound size or plug formation
Solution Approach 2:
The patent replaces the mechanical/optical Seidel Test (which requires manual dye application and visual inspection) with a biochemical detection system. The new system uses immunological or molecular recognition methods to detect intraocular fluid biomarkers, substituting the mechanical inspection process with a more sensitive biochemical assay that is not affected by wound closure or plugging
3Measurement precision
If slit-lamp inspection or CT scan are used to detect full-thickness eye wall disruption, then diagnostic accuracy improves, but device complexity and cost increase
Solution Approach 1:
The patent employs a disposable lateral flow assay device that provides high-resolution diagnostic capability at low cost. Instead of requiring expensive, complex imaging equipment like CT scanners or slit-lamps, the system uses a single-use test strip that delivers accurate biomarker detection through simple sample application, making advanced diagnostics accessible in resource-limited settings
4Loss of information
If ultrasound is used to detect open-globe injuries, then diagnostic information can be obtained, but increasing pressure on a ruptured eye could lead to further extrusion of contents
Solution Approach 1:
The patent extracts the diagnostic information from direct mechanical interaction with the injured eye (ultrasound pressure) and obtains it instead through chemical/biomarker analysis of a fluid sample. By taking out the need for pressure-based imaging, the system eliminates the harmful effect of pressure-induced extrusion while still acquiring comprehensive diagnostic information about intraocular fluid presence
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
The system enables rapid and accurate detection of open-globe injuries, even in challenging conditions, thereby facilitating timely intervention and reducing the risk of vision loss.
Implementation Method 1
a target recognition element specific to intraocular fluid in fluidic communication with the sample receiver, wherein the target recognition element is configured to bind to a target analyte
Implementation Method 2
a signal producing molecule configured to signal the binding of the target recognition element specific to intraocular fluid with the target analyte
Implementation Method 3
a blood filter upstream of the test element on the flow path configured to filter red blood cells from fluid
Data Source
AI summary
Methods, kits, and devices for detecting open-globe eye injuries are described. A device including a target recognition element specific for intraocular fluid, appropriate for use in the field is described. A method for detecting an open-globe eye injury by detecting proteins found in intraocular fluid is also described. A device may include a soft absorbent swab for sample collection, a lateral flow assay device, and a blood filter to improve device performance.