Microfluidic Test Strip Electrode Monitoring for Sample Sufficiency

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Solution Overview

Problem

Current devices for measuring hydration levels and other physiological parameters in bodily fluids are invasive, expensive, and impractical for point-of-care settings, and saliva analysis is challenged by bubbles and non-uniform flow, making it difficult to determine if a sample is adequate for measurement.

Innovation Solution

A method and system using electrodes to apply a periodic signal during sample collection, monitor signal stability, and determine sample sufficiency before initiating analysis, with configurations to assess flow rate and viscosity, ensuring complete channel filling and stable signal consistency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional laboratory testing methods are used to measure hydration levels and physiological parameters, then measurement precision and reliability are improved, but device complexity, cost, and invasiveness increase

Engineering Contradiction:
Improvehydration level measurement accuracyVSAvoidtesting system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the essential measurement function from complex laboratory equipment by using a simple test strip with electrodes that can be applied directly to saliva samples. The test strip contains only the necessary components (electrodes, fluidic channel) to perform the measurement, eliminating the need for complex laboratory instrumentation while maintaining measurement capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs disposable test strips that are inexpensive and single-use, replacing expensive, complex, and reusable laboratory equipment. Each test strip is a low-cost, disposable device that performs the measurement and is then discarded, eliminating the need for costly maintenance, calibration, and sterilization of complex instruments.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Ease of operation

If saliva samples with bubbles and non-uniform flow are used for measurement, then ease of sampling is improved, but measurement reliability deteriorates

Engineering Contradiction:
Improvesample collection easeVSAvoidmeasurement reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by assessing sample adequacy before performing the actual measurement. The system evaluates whether the saliva sample has properly filled the fluidic channel and reached sufficient volume prior to initiating the electrochemical measurement, ensuring reliable results while maintaining easy sampling.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback by continuously monitoring the sample collection process through electrode signals. The system provides real-time feedback on sample adequacy, allowing users to know when sufficient saliva has been collected, thereby ensuring measurement reliability without complicating the sampling procedure.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If extensive sample processing is performed to normalize saliva characteristics, then measurement precision is improved, but productivity and ease of operation worsen

Engineering Contradiction:
Improveanalyte measurement accuracyVSAvoidtesting speed
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent applies self-service by allowing the test strip to automatically adapt to the natural variability of saliva samples without requiring external processing. The electrodes and measurement system are designed to work with saliva as-is, accepting its natural viscosity and flow characteristics, thereby eliminating the need for preprocessing steps while maintaining measurement accuracy.

Inventive Principle:
Principle #25Self-service

4Productivity

If point-of-care testing is implemented without sample sufficiency assessment, then productivity is improved, but measurement reliability deteriorates

Engineering Contradiction:
Improvetesting throughputVSAvoidmeasurement reliability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent performs the sample sufficiency assessment as a preliminary step that occurs automatically and rapidly before the actual measurement. This preliminary evaluation ensures that only adequate samples proceed to measurement, maintaining high reliability while minimizing impact on overall testing speed through efficient, automated assessment.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent maintains continuity of useful action by seamlessly integrating the sample assessment process with the measurement process. The same electrodes and electronic system are used for both assessment and measurement without interruption, ensuring that the preliminary assessment does not create significant delays while guaranteeing measurement reliability.

Inventive Principle:
Principle #20Continuity of useful action

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

Ensures accurate and reliable measurement by confirming sample adequacy through stable signal consistency, allowing non-invasive, cost-effective point-of-care testing of bodily fluids like saliva, sweat, and blood.

Implementation Method 1

applying a periodic signal with a first electrode located at a first location in a microfluidic channel of the test strip; monitoring the applied periodic signal with a second electrode located at a second location in the microfluidic channel

Methodology Applied
Scientific EffectElectrical signal monitoring: Conduction (electrical)

Data Source

PatentUS12461003B2Biological fluid sample assessment
Publication Date: 2025.11.04 MX3 DIAGNOSTICS INC
  • US12461003B2 patent drawing
  • US12461003B2 patent drawing
  • US12461003B2 patent drawing

AI summary

A method of assessing a bodily fluid sample on a test strip may involve applying a periodic signal with a first electrode located at a first location in a microfluidic channel of the test strip, monitoring the applied periodic signal with a second electrode located at a second location in the microfluidic channel, and using a third electrode located at a third location in the microfluidic channel as a reference electrode. The method may also include: collecting the bodily fluid sample in the microfluidic channel; continuing to apply the periodic signal, monitor the periodic signal and use the third electrode as a reference electrode while collecting the bodily fluid sample; and determining that the bodily fluid sample is sufficient for analyzing, based at least in part on the applied and monitored periodic signal.