Preloaded Detection Particles for Lower-LOD Rapid Tests
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Solution Overview
Problem
Existing rapid detection tests (RDTs) have high limit of detection (LOD) thresholds, requiring a higher amount of target analyte for detection, which limits their effectiveness in early detection of pathogens and other analytes.
Innovation Solution
Preloading detectable labels in the test region of RDT devices to a concentration below the detection threshold, combined with capture agents and additional detection particles that bind to the target analyte, allowing for additive signal accumulation to reach the detection threshold.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional RDT methods are used, then the test can be performed rapidly and simply, but the limit of detection is high requiring larger amounts of target analyte
Solution Approach 1:
The patent preloads detection particles with detectable labels onto the test region membrane before actual testing. This preliminary placement of detection particles creates a reservoir that accumulates signal over time, enabling detection at lower analyte concentrations without complicating the test procedure for the user.
Solution Approach 2:
The patent changes the concentration parameter of detection particles by placing them at specific concentrations below the detection threshold initially, then allowing accumulation over time. This parameter change enables the system to detect lower analyte concentrations while maintaining the simplicity of the test format.
2Measurement precision
If detection particles are placed at high concentration, then detection sensitivity increases, but the detection threshold is reached too quickly and early detection capability is lost
Solution Approach 1:
The patent applies partial action by placing detection particles at a concentration that is partially sufficient for immediate detection but intentionally below the threshold. This allows gradual accumulation of signal over time, maintaining sensitivity while extending the detection window for early detection applications.
Solution Approach 2:
By preliminarily placing detection particles at controlled sub-threshold concentrations, the system prepares the test region to accumulate signal gradually. This preliminary setup enables both high sensitivity through particle accumulation and extended detection time for early diagnosis.
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
Lowering the LOD, enabling early detection of target analytes with lower sample loads, facilitating rapid and sensitive detection in point-of-care settings.
Implementation Method 1
Preloading detectable labels in the test region of RDT devices to a concentration below the detection threshold, combined with capture agents and additional detection particles that bind to the target analyte, allowing for additive signal accumulation to reach the detection threshold.
Data Source
AI summary
Examples are directed to rapid detection test (RDT) devices, apparatuses, and methods of forming RDT devices and/or apparatuses that include detection particles preloaded in a test region. An example RDT apparatus includes a substrate, and a test region disposed on a first portion of the substrate. The test region including: a first set of detection particles that exhibit a first detectable label, and a set of capture agents configured to bind to a target analyte in a biological sample, each of the set of capture agents including a first ligand configured to bind to the target analyte. The RDT apparatus further includes a second set of detection particles that exhibit a second detectable label, wherein each of the second set of detection particles includes a label protein including a second ligand configured to bind to the target analyte.