FFE Separation for Insulin Analog Quantification
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Solution Overview
Problem
Current methods for diagnosing and quantifying insulin analogs and endogenous human insulin in patients are invasive, costly, and often rely on indirect, cumbersome techniques like LC-MS/MS, with limited availability of specific assays, leading to cross-reactivity issues and inability to differentiate between various insulin forms.
Innovation Solution
A method involving free flow electrophoresis (FFE) for quantitative separation of insulin analogs and endogenous insulin into distinct fractions, allowing for accurate measurement using cross-reactive immunoassays and reducing sample preparation requirements, enabling simultaneous detection of multiple analytes without extensive sample processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If LC-MS/MS is used for insulin analog measurement, then measurement precision is improved, but device complexity and cost increase
Solution Approach 1:
The patent applies segmentation by dividing the complex LC-MS/MS analysis into two separate steps: first, FFE separation divides the insulin mixture into distinct fractions (analog-containing fraction and non-analog-containing fraction), and second, a simpler immunoassay measures insulin in each fraction. This segmentation allows using less complex equipment while achieving accurate differentiation between insulin analogs and endogenous insulin.
Solution Approach 2:
The patent introduces FFE separation as an intermediary step between sample collection and immunoassay measurement. This intermediary process physically separates insulin analogs from endogenous insulin before measurement, enabling the use of simpler, cross-reactive immunoassays that would otherwise be unable to distinguish between different insulin forms.
2Measurement precision
If specific immunoassays for each insulin analog are developed, then measurement precision is improved, but device complexity and development time increase
Solution Approach 1:
Instead of developing separate specific immunoassays for each insulin analog, the patent segments the sample physically using FFE separation. This produces distinct fractions where each fraction contains primarily one type of insulin form, allowing the use of a single cross-reactive immunoassay for all measurements while achieving analog-specific precision through the separation step.
Solution Approach 2:
The patent extracts insulin analogs from the complex mixture into separate fractions using FFE separation. By taking out the analogs into distinct fractions, the method eliminates the need for complex specific immunoassays, as the physical separation already provides the differentiation that would otherwise require highly specific antibodies.
3Ease of operation
If cross-reactive insulin assays are used, then ease of operation is improved, but measurement precision deteriorates due to inability to differentiate insulin forms
Solution Approach 1:
The patent combines the simplicity of cross-reactive immunoassays with FFE separation that segments the insulin mixture into distinct fractions. The separation step ensures that when cross-reactive assays measure insulin in each fraction, they are measuring primarily one type of insulin form, thereby maintaining measurement precision while preserving ease of operation.
Solution Approach 2:
FFE separation acts as an intermediary that enables the use of simple cross-reactive immunoassays to achieve precise measurements. The separation process prepares the sample in advance, so that when cross-reactive assays are applied to separated fractions, they accurately reflect the concentration of specific insulin forms without the interference that would normally reduce precision.
4Measurement precision
If invasive procedures or biopsies are used for diagnosis, then measurement precision is improved, but object-generated harmful factors increase
Solution Approach 1:
The patent replaces invasive mechanical procedures (biopsies, surgical sampling) with a non-invasive blood sampling approach combined with FFE separation and immunoassay. This substitution eliminates the harmful effects of invasive procedures while maintaining diagnostic precision through the sensitive detection capabilities of the FFE-immunoassay method.
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 less invasive, cost-effective, and more accurate method for diagnosing and quantifying insulin forms, enhancing sensitivity and specificity by reducing background interference and enabling multiplex analysis of insulin analogs and endogenous insulin in a single sample.
Implementation Method 1
A method involving free flow electrophoresis (FFE) for quantitative separation of insulin analogs and endogenous insulin into distinct fractions
Data Source
AI summary
The present invention provides diagnostic in vitro methods as well as kits and devices to be used in the methods of the present invention for diagnosis or prognosis of a pathologic condition characterized by the presence/absence of an endogenous hormone and/or hormone analog(s) thereof involved in diabetes or metabolic syndrome. The methods comprise a quantitative separation of at least those analytes of interest whose common presence interferes with measuring the presence/absence or concentration of one of the analytes of interest by a subsequent analytical method.