Diagnostic Test Strip Control Circuit for Measurement Accuracy
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Solution Overview
Problem
Existing electrochemical test strips for monitoring fluid constituents, such as glucose, lack reproducibility in sensitivity and accuracy, leading to inconsistent results due to variations in manufacturing processes.
Innovation Solution
Incorporating a control circuit with embedded temperature and humidity sensors, lot coding, authentication, and inhibit logic into diagnostic test strips, which communicate with a meter to ensure authenticity, prevent reuse, and adjust measurements based on environmental conditions, thereby ensuring accurate and consistent results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If test strips are manufactured with biological reagents, then the ability to measure analyte concentration is achieved, but sensitivity and accuracy become inconsistent across different strips
Solution Approach 1:
The patent applies preliminary action by pre-programming each test strip with a unique identification code and calibration parameters during manufacturing. The control circuit on each strip stores this information in non-volatile memory, allowing the meter to retrieve and apply strip-specific calibration data before measurement, thereby compensating for manufacturing variations and ensuring consistent accuracy across all strips.
Solution Approach 2:
The patent implements parameter changes by allowing the system to dynamically adjust measurement parameters based on the specific test strip inserted. The meter reads the strip's identification code and automatically selects or adjusts calibration parameters, measurement ranges, and processing algorithms to match that particular strip's characteristics, optimizing measurement precision for each individual strip.
2Ease of manufacture
If test strips are made simple without control circuits, then manufacturing cost is reduced, but the ability to ensure authenticity and prevent reuse is lost
Solution Approach 1:
The patent applies universality by designing a control circuit that performs multiple functions within a single integrated component. The control circuit simultaneously provides authentication through unique identification codes, prevents reuse through memory flags, stores calibration data, and communicates with the meter. This multi-functional approach adds reliability without proportionally increasing manufacturing complexity, as a single IC chip handles all these tasks.
Solution Approach 2:
The patent implements self-service by enabling the test strip's control circuit to autonomously perform authentication and anti-reuse functions without external intervention. The strip independently stores its identification code, validates its own authenticity when inserted into the meter, and sets internal flags to prevent reuse. This self-contained approach simplifies the overall system architecture while ensuring reliable authentication.
3Measurement precision
If environmental sensors are added to the test strip, then measurement accuracy under varying conditions is improved, but device complexity increases
Solution Approach 1:
The patent applies merging by integrating environmental sensors (temperature and humidity) directly into the test strip's control circuit rather than treating them as separate components. The sensors are physically and electrically combined with the authentication memory and processing circuitry on the same substrate, allowing environmental data to be collected and processed alongside other strip functions without adding significant complexity. The control circuit simultaneously manages authentication, data storage, and environmental monitoring.
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 solution provides accurate, reliable, and reproducible measurements of analytes like glucose by ensuring the test strips are used once and within optimal environmental conditions, reducing user error and improving the consistency of results.
Implementation Method 1
the control circuit including an embedded temperature sensor
Implementation Method 2
the strip having an embedded humidity sensor
Implementation Method 3
a reaction between the analyte and suitable chemistry can take place... a meter in electrical communication with the test strip to measure an electrical signal generated by the reaction
Data Source
AI summary
A system for measuring a property of a sample in a liquid which includes a test strip and a meter is provided. Some embodiments relate to a diagnostic test strip for collecting a sample, the strip having a plurality of electrodes for measuring a property of the sample, and the strip having a control circuit at a distal region of the strip, the control circuit configured to communicate with a controller of a meter, the control circuit including an embedded temperature sensor, a memory for lot coding and authentication of the test strip, and an inhibit logic for inhibiting the test from being used more than once; and a diagnostic meter for receiving the test strip, the meter having a controller programmed to communicate with the control circuit.