Prozone Effect Detection in Photometric Assays

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Solution Overview

Problem

Current methods for detecting the prozone effect in photometric assays are costly, labor-intensive, and often result in false alarms, and are not applicable to all assays, such as the albumin assay, leading to reduced throughput and increased reagent consumption.

Innovation Solution

A method that involves generating a calibration curve at specific wavelengths and reaction times, measuring optical signals simultaneously at these wavelengths, calculating a reaction rate ratio, and comparing it to predetermined limit values to detect the prozone effect without the need for additional reagents or sample dilution, allowing for accurate and efficient detection within automated lab analyzers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sample dilution method is used to detect prozone effect, then detection accuracy is improved, but labor costs and reagent costs increase

Engineering Contradiction:
Improveprozone effect detection accuracyVSAvoidlabor time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system uses the existing optical signal data from the routine assay measurement to automatically detect prozone effect through kinetic analysis. The analyzer self-evaluates the reaction kinetics without requiring external intervention, sample dilution, or additional reagents, thereby resolving the contradiction between detection accuracy and labor time consumption.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If antigen re-addition method is used to detect prozone effect, then detection accuracy is improved, but reagent costs and workflow complexity increase

Engineering Contradiction:
Improveprozone effect detection accuracyVSAvoidreagent consumption
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The method utilizes the optical signal data already generated during the routine assay to detect prozone effect through kinetic analysis. No additional antigen reagent is consumed, and the existing assay reagents serve dual purposes: both analyte quantification and prozone detection, thereby eliminating the contradiction between detection accuracy and reagent consumption.

Inventive Principle:
Principle #25Self-service

3Productivity

If kinetic method is used to detect prozone effect, then detection speed is improved, but false alarm rate increases

Engineering Contradiction:
Improvedetection speedVSAvoidfalse alarm rate
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system dynamically adjusts the evaluation parameters including time points for kinetic analysis, wavelength selections, and threshold values based on assay-specific characteristics. This parameter optimization enables rapid detection while minimizing false alarms by tailoring the kinetic analysis parameters to each specific assay's reaction profile.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system incorporates feedback mechanisms where the kinetic analysis results are continuously refined based on comparison with control samples and historical data. The analyzer adjusts its evaluation criteria based on the observed reaction patterns, thereby maintaining high detection speed while reducing false alarm rates through adaptive feedback control.

Inventive Principle:
Principle #23Feedback

4Measurement precision

If multiple wavelengths are measured simultaneously, then prozone detection accuracy is improved, but device complexity increases

Engineering Contradiction:
Improveprozone detection accuracyVSAvoidmeasurement system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The photometric analyzer is designed with multi-wavelength measurement capability that serves dual functions: both routine analyte quantification and prozone effect detection. The same optical system and detectors used for standard measurements are utilized for kinetic analysis at multiple wavelengths, eliminating the need for separate dedicated equipment and thereby resolving the contradiction between detection accuracy and device complexity.

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

This approach provides a cost-effective, rapid, and accurate method for detecting the prozone effect, reducing false alarms and enabling simultaneous analyte quantification, thereby improving assay efficiency and reducing reagent consumption.

Implementation Method 1

the specific analyte is quantified from the change in the optical signal of the reaction mixture after the interaction of the analyte with analyte specific assay reagents

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

the specific analyte is quantified from the change in the optical signal of the reaction mixture

Methodology Applied
Scientific EffectPhotometric detection: Absorption Spectroscopy

Implementation Method 3

excessively high concentrations of analyte, which saturates the binding sites of the antibodies, thus preventing the formation of detectable antibody-analyte-antibody complexes

Methodology Applied
Scientific EffectBinding site saturation:

Data Source

PatentUS10809258B2Method for the detection of the prozone effect of photometric assays
Publication Date: 2020.10.20 ROCHE DIAGNOSTICS OPERATIONS INC
  • US10809258B2 patent drawing
  • US10809258B2 patent drawing
  • US10809258B2 patent drawing

AI summary

A method for determination of the amount of a specific analyte in a sample which may show a prozone effect by photometric assays, wherein the specific analyte is quantified from the change in the optical signal of the reaction mixture after the interaction of the analyte with analyte specific assay reagents. The optical signal is measured simultaneously for the specific analyte in the sample to be determined at the wavelength used for the determination of the analyte and at least at an additional specific wavelength used for the detection of the prozone effect over the complete reaction time. The reaction rate ratio R is calculated by using the signals obtained at the wavelength used for the detection of the prozone effect. By comparison of the calculated ratio value R with predetermined limit values it is judged if a prozone effect is present in the sample.