On-board Control Detection for Point-of-Care Diagnostics
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Solution Overview
Problem
Existing point-of-care diagnostic devices face challenges in ensuring the accuracy of test results due to potential interference between control and test reactions, particularly when external voltages are applied, which can compromise the viability of the testing system.
Innovation Solution
An on-board control system that utilizes a reagent-free of N-oxide or nitroso compounds, generating a control signal without external voltage, allowing for the assessment of control system viability without interfering with the test reaction, using an electrochemical control reaction with ferricyanide and a neutralizing agent to prevent electrical interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external voltage is applied to assess control system viability, then control system viability can be determined, but test reaction accuracy deteriorates due to electrical interference
Solution Approach 1:
The device is divided into separate control system and test system components, each with dedicated reagent strips and detection mechanisms. The control system uses a first reagent strip with control reagents while the test system uses a second reagent strip with test reagents, allowing independent assessment without cross-interference.
Solution Approach 2:
A neutralizing agent is introduced as an intermediary substance that counteracts the effects of external voltage on the test reaction. The neutralizing agent is applied to the test reagent strip to prevent electrical interference from affecting test accuracy when external voltage is used for control assessment.
2Productivity
If control reagent contains N-oxide or nitroso compound, then control reaction can proceed, but harmful interference is generated in the test reaction
Solution Approach 1:
The harmful N-oxide or nitroso compounds are extracted or removed from the control reagent formulation. The control reaction is redesigned to use alternative reagents that do not contain these harmful substances, eliminating the source of interference while maintaining control reaction functionality.
Solution Approach 2:
The control reaction is modified to use reagents that produce a detectable signal without the harmful side effects. By converting the control reaction mechanism to use benign reagents, the system turns a potentially harmful approach into a safe and effective one.
3Ease of operation
If control and test reactions are performed simultaneously, then device operation is simplified, but signal interference between reactions occurs
Solution Approach 1:
Different regions of the device are assigned different functions with distinct chemical and electrical properties. The control reagent strip and test reagent strip are spatially separated with dedicated detection zones, allowing each reaction to proceed with its own optimal conditions without signal interference.
Solution Approach 2:
The control and test reactions are allowed to proceed to different extents or at different rates. By controlling the timing and extent of each reaction separately, the system can detect control signals and test signals without them interfering with each other, even when both reactions are active.
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
This solution ensures the accuracy of test results by independently assessing the control system's viability, reducing the risk of external voltage interference and maintaining the integrity of the test reaction, thus ensuring reliable measurements in point-of-care diagnostics.
Implementation Method 1
The control reaction can generate an electromotive force. For example, the electromotive force can be generated by dissolution of the at least one reagent into the sample.
Implementation Method 2
The neutralizing effect can comprise at least one selected from a chemical reaction and a physical effect.
Implementation Method 3
The physical effect can comprise at least one selected from precipitation and diffusion.
Data Source
AI summary
Embodiments disclosed herein relate to a sensor comprising an on-board control system and a testing system. The on-board system can determine viability of the control system or the testing system. Also disclosed are methods of using such a sensor.