Automated IVD Leakage Testing with Conductive Probe Detection
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Solution Overview
Problem
Existing automated in-vitro diagnostic (IVD) devices face challenges in detecting fluidic system leaks accurately and efficiently, leading to imprecise pipetting, cross-contamination, and device contamination, without increasing device complexity or cost.
Innovation Solution
An automated method using an electrically conductive probe interacting with a reference element to detect leaks by measuring electrical signals during a predetermined time period, without additional components, and triggering maintenance actions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pressure sensors are added to detect leaks, then leak detection capability is improved, but device complexity and cost increase
Solution Approach 1:
The patent reuses the existing liquid level sensor from the fluid supply for dual purposes: both for its original liquid level detection function and for leak detection by monitoring back flow. This eliminates the need for additional pressure sensors and reduces device complexity while maintaining leak detection capability
Solution Approach 2:
The system uses its own existing components (liquid level sensor and fluid supply) to perform leak detection without requiring external or additional sensing devices. The fluid supply itself serves as the detection medium through back flow monitoring
2Device complexity
If liquid level sensor is used in fluid supply for leak detection, then device complexity is reduced, but detection sensitivity decreases for small leakages
Solution Approach 1:
The system performs a preliminary leak detection phase by monitoring back flow before proceeding to a secondary detection phase using the probe and reference element. This two-stage approach ensures small leaks are captured in the initial sensitive monitoring phase
Solution Approach 2:
The patent transitions from monitoring liquid level changes in the fluid supply to directly monitoring electrical signal changes between the probe and reference element. This dimensional shift from volumetric measurement to electrical field measurement significantly enhances detection sensitivity for minor leaks
3Measurement precision
If fluid supply volume is increased to enable back flow detection, then small leakages can be detected, but device volume and complexity increase
Solution Approach 1:
The system performs a preliminary leak detection phase by monitoring back flow before proceeding to a secondary detection phase using the probe and reference element. This two-stage approach ensures small leaks are captured in the initial sensitive monitoring phase
Solution Approach 2:
The patent transitions from monitoring liquid level changes in the fluid supply to directly monitoring electrical signal changes between the probe and reference element. This dimensional shift from volumetric measurement to electrical field measurement significantly enhances detection sensitivity for minor leaks
4Object-affected harmful factors
If manual decontamination procedures are performed, then device contamination is addressed, but operational downtime increases
Solution Approach 1:
The system performs preliminary maintenance actions by automatically identifying and isolating leaking components before manual intervention is required. This preliminary detection and isolation minimizes the scope of manual decontamination needed and reduces overall downtime
Solution Approach 2:
The system provides feedback about leak locations and severity, enabling targeted maintenance actions. This feedback mechanism allows operators to focus decontamination efforts only on affected areas rather than performing comprehensive manual decontamination of the entire device
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 method provides high sensitivity and broad detection range for leaks from 1 mL/sec to 10 μL/sec, detects leaks faster, and identifies the leaking component, ensuring precise pipetting and reducing operational burden.
Implementation Method 1
activating a pump to provide a fluid from the fluid supply into the probe
Implementation Method 2
an electrically conductive probe fluidically connected to a fluid supply via a fluidic conduit and interacting electrically with a reference element
Data Source
AI summary
An automated method for performing a leakage test of a fluidic system of an in-vitro diagnostic device as well as an automated in-vitro diagnostic device comprising a controller configured to perform the leakage test. The method comprises activating a pump to provide a fluid from a fluid supply into an electrically conductive probe. The probe is positioned so that a tip of the probe is at a predetermined distance from a reference surface of a reference element. In case of leakage, an electrical signal or change in an electrical signal or a change of the electric or magnetic field between the probe and the reference element is detected in a predetermined measuring time period and at least one maintenance action is triggered.