Ultra-Sensitive hGH Assay for Cardiovascular Risk Prediction

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Solution Overview

Problem

Current methods for predicting cardiovascular risk and mortality are limited by the pulsatile release of growth hormone (hGH) and the inability to accurately measure low plasma concentrations, which hampers the interpretation of hGH levels in relation to cardiovascular morbidity and mortality.

Innovation Solution

Development of an ultra-sensitive assay for plasma hGH measurements with a sensitivity of 2 pg/ml, allowing for accurate determination of fasting hGH levels and its isoforms, which correlates with cardiovascular risk and mortality, enabling short-term prediction of cardiovascular events and total mortality within 2.5 years.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional hGH assays are used, then the assay is simpler and less expensive, but the measurement precision is insufficient for low plasma concentrations

Engineering Contradiction:
Improvedetection sensitivity of hGHVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by modifying the assay's detection parameters to achieve ultra-sensitivity. Specifically, it uses a chemiluminescence detection method with signal amplification techniques, changing the detection parameter from conventional immunoassay levels to ultra-sensitive levels (detecting down to 0.1-10 pg/ml), thereby resolving the contradiction between measurement precision and device complexity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces conventional mechanical/chemical detection methods with chemiluminescence detection. Instead of using traditional colorimetric or fluorescent methods, it employs chemiluminescent labels that emit light upon chemical reaction, substituting the detection mechanism to achieve higher sensitivity without proportionally increasing complexity

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If fasting plasma samples are analyzed, then the cardiovascular risk prediction is more accurate, but the pulsatile release of hGH causes low and sometimes undetectable concentrations

Engineering Contradiction:
Improvecardiovascular risk prediction accuracyVSAvoidplasma hGH concentration
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the detection parameter threshold to accommodate low fasting hGH concentrations. By establishing ultra-sensitive detection capabilities (0.1-10 pg/ml) and setting appropriate reference ranges for fasting states, it enables reliable cardiovascular risk prediction despite the low quantity of hGH present in fasting plasma

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses chemiluminescent labels as intermediaries to amplify the detection signal from low hGH concentrations. The chemiluminescent marker acts as a mediator that converts the scarce hGH molecules into detectable light signals, enabling measurement of trace amounts that would otherwise be undetectable

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2943795B1Fasting levels of growth hormone as a predictive marker of cardiovascular risk
Publication Date: 2021.02.24 SPHINGOTEC GMBH
  • EP2943795B1 patent drawingFigure 1
  • EP2943795B1 patent drawingFigure 2
  • EP2943795B1 patent drawing

AI summary

Subject matter of the present invention is a method for predicting the cardiovascular risk or the total mortality risk in a subject comprising: determining the fasting level of growth hormone (hGH), and/or its isoforms in a bodily fluid obtained from said subject; and correlating said fasting level of growth hormone (hGH), and/or its isoforms with a cardiovascular risk or the total mortality risk, wherein an enhanced level is predictive for an enhanced risk.