Rapid Diagnostic Device with Channeled Construct for Malaria Antigen Detection
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Solution Overview
Problem
Current rapid diagnostic tests (RDTs) for malaria face challenges due to background noise from hemoglobin, which reduces sensitivity, and use limited blood sample volumes, leading to false negatives and increased costs with existing methods for sample separation.
Innovation Solution
A rapid diagnostic testing device incorporating a channeled construct for separating blood cells from plasma, coupled with a lateral flow unit, allowing for larger sample volumes and improved analyte detection by excluding red blood cells and enhancing signal intensity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If hemoglobin is present in the sample, then the RDT can be performed using whole blood, but background noise increases and detection sensitivity decreases
Solution Approach 1:
The invention extracts and removes red blood cells from the whole blood sample using a magnetic separation approach. Magnetic beads are used to bind to red blood cells, and an external magnet separates the bound cells from the plasma containing the analyte of interest. This extraction eliminates the background noise from hemoglobin while preserving the target analyte in the plasma fraction.
2Productivity
If only 5 μL of blood sample is used, then the test can be completed quickly, but the detection sensitivity decreases and false negative results increase
Solution Approach 1:
The invention performs preliminary magnetic separation of red blood cells from the blood sample before the actual diagnostic test. By pre-processing the sample to remove interfering cells, the subsequent test can use larger sample volumes (up to 500 μL) to enhance analyte detection without compromising testing efficiency. The magnetic separation step is designed to be rapid and integrated into the overall testing workflow.
3Measurement precision
If existing methods for removal of red blood cells are used, then background noise is reduced, but the number of steps increases and cost increases
Solution Approach 1:
The invention merges the sample preparation step (red blood cell removal) with the diagnostic test setup by using magnetic separation that can be integrated into the lateral flow assay platform. The magnetic beads used for cell separation can also serve as the detection label in the immunoassay, combining two functions into a single reagent system. This integration reduces the number of separate steps and materials needed compared to traditional methods.
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 device improves detection sensitivity up to ten times by processing larger sample volumes and reducing background noise, leading to more accurate results with minimal sample loss and cost-effective analyte detection.
Implementation Method 1
The size exclusion separation element has a first surface and a second surface... the size exclusion separation element allows plasma to pass through the size exclusion separation element from the first side to the second side, while blood cells in the blood sample are retained by the size exclusion separation element
Implementation Method 2
The lateral flow unit comprises: a sample receiving zone operatively coupled to the channeled construct for receiving the partially purified biological sample... a conjugate zone... wherein the conjugate zone comprises a conjugate particle for binding with the analyte; and a detection zone... wherein the detection zone comprises at least one binding agent for detecting the analyte by capturing the analyte
Data Source
AI summary
A rapid diagnostic testing device for testing of a biological sample is provided. The device comprises a channeled construct, at least one lateral flow unit, and a cassette housing. The channeled construct is configured to receive a biological sample to form at least partially purified biological sample. The lateral flow unit is at least partially disposed in the cassette housing. The lateral flow unit comprises: a sample receiving zone, a conjugate zone and a detection zone. The sample receiving zone is operatively coupled to the channeled construct for receiving the partially purified biological sample comprising at least one analyte. The conjugate zone comprising a conjugate particle to bind the analyte is disposed adjacent to the first side of the sample receiving zone. The detection zone is disposed adjacent to the second side of the sample receiving zone and comprises at least one binding agent for detecting the analyte.