Multiplexed PTH Diagnostic System for Intraoperative Kinetics Monitoring
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Solution Overview
Problem
Current diagnostic methods for endocrinological disorders, such as primary hyperparathyroidism, face challenges in accurately measuring hormone concentrations due to variations in hormone metabolism and clearance, leading to inconsistent test results and limited understanding of protein kinetics, which can impact surgical outcomes and treatment effectiveness.
Innovation Solution
A multiplexed diagnostic system and method that uses recognition elements to bind to target molecules and their variants in a sample, allowing for the detection of specific epitopes and determination of concentrations through signal analysis, enabling accurate quantification of whole and intact parathyroid hormone (PTH) levels, even in complex clinical samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional sandwich immunoassays are used to measure hormone concentrations, then selectivity and sensitivity for the hormone of interest can be achieved, but test results become inconsistent due to variations in hormone metabolism and clearance
Solution Approach 1:
The patent divides the measurement into multiple independent channels, each targeting a specific hormone form (intact PTH, whole PTH, fragments). Multiple recognition elements with different specificities are used simultaneously to measure different forms of the hormone, allowing consistent measurement despite metabolic variations.
Solution Approach 2:
The assay system is designed to perform multiple measurement functions simultaneously - measuring intact hormone, whole hormone, and fragments in a single test. This multi-functional approach provides comprehensive hormone status information that accounts for individual metabolic differences.
2Device complexity
If single-form protein diagnostics are used, then test simplicity is maintained, but understanding of protein kinetics and metabolism is limited
Solution Approach 1:
The patent combines multiple measurement capabilities into a single integrated diagnostic system. Multiple recognition elements and detection channels are merged into one assay that simultaneously provides information about intact hormone, whole hormone, and fragments, delivering comprehensive kinetics data without requiring multiple separate tests.
3Measurement precision
If central lab analysis is used for intraoperative PTH measurements, then measurement accuracy is maintained, but specimen turnaround time and costs increase
Solution Approach 1:
The patent enables the surgical site to perform its own PTH measurements using a portable system that brings laboratory-capable testing directly to the operating room. The system is self-contained with all necessary reagents, recognition elements, and detection components integrated into a portable device that can be used at the point of care.
4Productivity
If portable low-cost PTH assays are developed, then costs and turnaround time are reduced, but measurement precision and reliability may be compromised
Solution Approach 1:
The patent replaces complex mechanical laboratory instrumentation with a portable system that uses integrated recognition elements and signal detection. The system substitutes sophisticated mechanical separation and analysis equipment with a streamlined approach using specific binding elements and optical/electrical detection, maintaining reliability while reducing cost and complexity.
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 rapid, accurate, and cost-effective intraoperative PTH assays, reducing surgical risks and costs by enabling precise monitoring of PTH levels during surgery, improving diagnostic accuracy and treatment decisions.
Implementation Method 1
exposing the sample to one or more recognition elements that bind to the target molecule and/or the at least one variant
Data Source
AI summary
Disclosed are methods and systems for determining concentrations of a target molecule and a variant thereof in a sample. The sample can comprise or be suspected to comprise a target molecule and at least one variant thereof and is exposed to one or more recognition elements that bind to the target molecule and/or the at least one variant. A signal is detected that is associated with the binding of the target molecule and/or a signal is detected that is associated with the binding of the at least one variant to the one or more recognition elements. The concentration of the target molecule and/or the at least one variant thereof is determined based on the signals. The system can comprise a receiver adapted to receive a sample comprising or suspected to comprise a target molecule and the at least one variant thereof, the receiver comprising one or more recognition elements that bind to one or more epitopes in the target molecule and/or the at least one variant thereof.