Test Strip Discrimination of Control Solution from Blood
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Solution Overview
Problem
Existing methods for determining analyte concentrations in physiological samples, such as blood, often struggle to distinguish between control solutions and actual samples, leading to skewed results when control solutions are used for system calibration.
Innovation Solution
A system and method that utilize a test strip with electrodes and a test meter to apply specific potentials and measure current transients, calculating interferent and residual reaction indices to differentiate between blood samples and control solutions based on redox species concentration and reaction kinetics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If control solution tests are performed to ensure system functionality, then system reliability is improved, but measurement precision deteriorates because control solution glucose concentration is stored in memory and skews average concentration calculations
Solution Approach 1:
The patent segments test results into two distinct categories: control solution results and patient test results. By automatically identifying control solutions through multiple measurements and statistical analysis, the system separates control data from patient data, preventing control results from skewing patient average calculations while maintaining separate tracking for quality control purposes
Solution Approach 2:
The patent introduces an intermediary identification process that measures multiple test results and uses statistical analysis to determine whether each result is from a control solution or a patient sample. This intermediary step acts as a filter between the raw measurement and the stored result, preventing misclassification and ensuring accurate averaging of only patient results
2Measurement precision
If manual flagging of control fluids is implemented, then measurement precision is improved by excluding control results from averages, but device complexity increases due to additional user interaction requirements
Solution Approach 1:
The patent implements a self-service system where the test meter automatically performs multiple measurements, conducts statistical analysis, identifies control solutions versus patient samples, and flags results without user intervention. The system serves itself by autonomously determining which results to include in average calculations, eliminating the need for manual flagging while maintaining measurement precision
Solution Approach 2:
The patent employs feedback mechanisms where the system continuously monitors test results, compares measurements against established criteria, and automatically adjusts result classification based on the feedback from multiple measurements. This closed-loop system enables automatic control solution identification and exclusion from patient averages without requiring user input
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
Enables accurate discrimination between blood samples and control solutions, ensuring that analyte concentration measurements are stored and displayed correctly, improving the reliability of analyte concentration determination in medical testing.
Implementation Method 1
The component to be analyzed is allowed to react with a reagent to form an oxidizable (or reducible) substance in an amount proportional to the analyte concentration. The quantity of the oxidizable (or reducible) substance present is then estimated electrochemically
Implementation Method 2
A first test potential is applied between the first electrode and the second electrode and a first current transient is then measured. A second test potential is applied between the first electrode and the second electrode and a second current transient is then measured
Data Source
AI summary
Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or an aqueous non-blood sample based on at least two characteristics (e.g., amount of interferent present and reaction kinetics). The method can also include calculating a discrimination criteria based upon at least two characteristics. Various aspects of a system for distinguishing between blood samples and an aqueous non-blood sample are also provided herein.