Reagent Stability Prediction Using Fluid Volume Correlation

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Solution Overview

Problem

Reagents in diagnostic analyzers degrade over time, especially as their volume decreases, leading to instability and potential errors in analysis due to faster evaporation and concentration changes, necessitating a method to determine the remaining usable time.

Innovation Solution

A method to calculate the remaining time a fluid can be used by determining the amount of fluid in a container and using a predetermined correlation between fluid volume and stability, considering both the initial expiration time and the length of use, with alerts for operators when reagents are near expiration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If reagent is stored in a container and used over time, then the amount of reagent decreases, but the stability of the reagent deteriorates due to faster evaporation and degradation

Engineering Contradiction:
Improveamount of reagentVSAvoidstability of reagent
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The system performs preliminary determination of the correlation between reagent volume and stability before actual use. By pre-establishing the relationship between remaining volume and degradation rate, the system can predict stability issues before they occur, allowing for proactive reagent replacement rather than reactive problem-solving

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors the remaining reagent volume and uses this feedback to calculate updated stability predictions. The controller adjusts the remaining usable time calculation based on real-time volume measurements, creating a closed-loop system that adapts to the actual state of the reagent

Inventive Principle:
Principle #23Feedback

2Duration of action of moving object

If reagent volume is reduced to extend usage time, then the duration of reagent use increases, but the reliability of analysis decreases due to increased evaporation and degradation

Engineering Contradiction:
Improveduration of reagent useVSAvoidreliability of analysis
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The system pre-determines the correlation between reagent volume and stability under various storage conditions. By establishing this relationship in advance through experimentation or modeling, the system can reliably predict when reagent stability will fall below acceptable thresholds, ensuring analysis reliability is maintained throughout the extended usage period

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system dynamically changes the parameter of remaining usable time based on the current reagent volume. As volume decreases, the calculated remaining time is adjusted to reflect increased degradation rates, effectively adapting the usage timeline to the actual stability characteristics of the remaining reagent

Inventive Principle:
Principle #35Parameter changes

3Productivity

If standard expiration times are used for reagents, then the device complexity is low, but the productivity is reduced due to premature discarding of still-useful reagents

Engineering Contradiction:
Improveproductivity of analyzerVSAvoidcomplexity of reagent monitoring system
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system performs self-monitoring of reagent volume and automatic calculation of remaining usable time without requiring external intervention. The controller autonomously determines when reagent stability may be compromised and alerts operators accordingly, eliminating the need for manual tracking or complex external monitoring infrastructure

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The existing controller in the diagnostic analyzer is enhanced to perform multiple functions: it continues to control the analysis workflow while also monitoring reagent volume, calculating stability predictions, and managing reagent replacement alerts. This multi-functionality avoids adding separate dedicated hardware systems

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 reagents remain stable for a predictable duration, reducing analysis errors and allowing for timely reagent replenishment, extending the usable life of reagents beyond standard expiration times by monitoring fluid volume and use time.

Implementation Method 1

lower remaining volume will evaporate more quickly resulting in a faster rate of reagent degradation

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS8606525B2Determining useful life of a fluid using inventory information
Publication Date: 2013.12.10 ORTHO CLINICAL DIAGNOSTICS INC
  • US8606525B2 patent drawing

AI summary

A method for determining the remaining time a fluid in a container can be used. The method includes: determining the amount of fluid in the container; and determining the remaining time based on the amount of fluid in the container. Preferably, the step of determining the remaining time is calculated by using the determined amount of fluid and a predetermined first correlation of remaining time vs. amount of fluid in the container. In a preferred embodiment, the fluid is a reagent in a reagent pack used in a diagnostic analyzer. A method for measuring the presence or concentration of an analyte in a sample on an automated diagnostic analyzer includes: providing a reagent storage container on the analyzer; providing a measurement station for taking a measurement of the sample; determining the amount of reagent remaining in a reagent storage container; calculating the remaining time of the reagent by using the determined amount of reagent and a predetermined first correlation of remaining time vs. amount of fluid in the container; if the time the reagent has been in the reagent container is greater than the remaining time, then discarding the reagent, otherwise adding reagent to the sample; and taking a measurement of the sample to determine the presence or concentration of the analyte.