Analyte Detection Device Using Three-Reagent Kinetic Assay
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Solution Overview
Problem
Existing analyte detection systems using piezo/pyroelectric transducers face challenges in accuracy and precision due to natural variations in components and environmental factors, such as temperature and humidity, and interference from substances like lipids and heterophilic antibodies in bodily fluids, which affect measurement accuracy and require frequent calibration.
Innovation Solution
A device incorporating a radiation source, a pyroelectric or piezoelectric transducer, and a system of three reagents - a first reagent with binding sites proportional to analyte concentration, a second reagent with lower affinity for the labelled reagent, and a third reagent with affinity independent of analyte concentration - to improve detection accuracy and precision by using positive and negative controls.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a piezo/pyroelectric transducer is used to detect binding events, then the measurement process can be initiated by pulsing electromagnetic radiation and light absorption causes localized heating, but the system suffers from imprecision and inaccuracy due to natural variations in components and environmental factors
Solution Approach 1:
The patent implements feedback by continuously monitoring the binding kinetics in real-time and using this information to adjust and refine the measurement process. The system tracks the rate of change of signal over time, allowing dynamic compensation for variations in components and environmental conditions, thereby improving both precision and reliability of the measurements
Solution Approach 2:
The patent applies parameter changes by monitoring the kinetic binding process at different time points and using the rate of change of signal over time as a measurement parameter. This kinetic approach, rather than equilibrium measurement, allows the system to capture dynamic information that compensates for component variations and environmental factors, enhancing measurement consistency
2Productivity
If kinetic binding of a labelled reagent is monitored in situ by monitoring the rate of change of signal over time, then the binding events can be detected without separation steps, but unwanted movement of the labelled reagent or particles in the measurement chamber can interfere with the signal measurement
Solution Approach 1:
The patent extracts the measurement function from the bulk solution by focusing detection on the transducer surface where specific binding events occur. By using a transducer that detects binding at the surface, the system separates the specific signal (bound labelled reagent) from the background noise (unbound labelled reagent and other particles), thereby maintaining high productivity while improving signal measurement accuracy
Solution Approach 2:
The patent introduces the transducer surface as an intermediary between the labelled reagent and the detection system. This intermediary provides a fixed reference point for measurement, allowing the system to distinguish between labelled reagent that is specifically bound to the surface and labelled reagent that is merely present in the solution, thus eliminating interference from unwanted particle movement
3Adaptability or versatility
If measurements are carried out in bodily fluids, then the analyte concentration can be determined in complex samples, but interfering factors such as lipids, bilirubin and heterophilic antibodies, or natural variations in viscosity and hematocrit affect the measurement
Solution Approach 1:
The patent uses feedback mechanisms to monitor and compensate for interference from bodily fluid components. By continuously tracking the kinetic binding process and comparing it against expected patterns, the system can identify and correct for effects caused by lipids, bilirubin, heterophilic antibodies, and variations in viscosity or hematocrit, maintaining measurement precision across diverse sample types
Solution Approach 2:
The patent employs parameter changes by measuring the rate of change of signal over time during the kinetic binding process. This dynamic measurement approach, rather than relying on equilibrium signals, allows the system to distinguish between specific binding events and non-specific interference from bodily fluid components, thereby maintaining detection accuracy in complex samples
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
The device enhances detection accuracy and precision by compensating for natural variability and environmental conditions, allowing for homogeneous assays without the need for washing steps and improving the dynamic range of analyte detection in complex samples.
Implementation Method 1
a transducer having a pyroelectric or piezoelectric element and electrodes which is capable of transducing energy generated by non-radiative decay into an electrical signal
Implementation Method 2
a transducer having a pyroelectric or piezoelectric element and electrodes which is capable of transducing energy generated by non-radiative decay into an electrical signal
Implementation Method 3
the labelled reagent being capable of absorbing the electromagnetic radiation generated by the radiation source to generate energy by non-radiative decay
Data Source
AI summary
This invention relates to a device for detecting an analyte in a sample comprising: a radiation source adapted to generate a series of pulses of electromagnetic radiation; a transducer having a pyroelectric or piezoelectric element and electrodes which is capable of transducing energy generated by non-radiative decay into an electrical signal; a detector which is capable of detecting the electrical signal generated by the transducer; a first reagent proximal to the transducer, the first reagent having a binding site which is capable of binding a labelled reagent proportionally to the concentration of the analyte in the sample, which labelled reagent being capable of absorbing the electromagnetic radiation generated by the radiation source to generate energy by non-radiative decay; a second reagent proximal to the transducer, the second reagent having a lower affinity for the labelled reagent under the conditions of the assay than the first reagent; and a third reagent proximal to the transducer, the third reagent having a binding site which is capable of binding the labelled reagent, wherein the third reagent has an affinity for the labelled reagent which is less influenced than the first reagent by the concentration of the analyte or the complex or derivative of the analyte.