Internal Calibrator Assay for Analyte Concentration
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Solution Overview
Problem
Current assays require the preparation of calibration curves to determine analyte concentration, which is time-consuming and prone to variations in assay conditions, necessitating multiple calibration runs and increased reagent use.
Innovation Solution
The use of a single internal calibrator, such as a tracer analyte labeled with a detectable marker, allows for the determination of analyte concentration by measuring signal intensities and applying a correction factor, eliminating the need for calibration curves and reducing assay complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If calibration curves are prepared using multiple analyte calibrators with known concentrations, then accurate analyte concentration determination is achieved, but the assay becomes time-consuming and requires increased reagent use
Solution Approach 1:
The patent extracts the essential calibration function from the complex multi-point calibration curve and concentrates it into a single internal calibrator molecule. This internal calibrator contains both a capture moiety and a detection moiety, allowing it to serve as a built-in reference that eliminates the need for separate external calibration curves while maintaining measurement accuracy.
Solution Approach 2:
The internal calibrator serves multiple functions simultaneously: it acts as a reference standard for calibration, a control for assay performance, and a normalization factor for signal interpretation. This multi-functional design replaces what previously required multiple separate components (multiple calibrators, control samples, and calibration curves).
2Reliability
If multiple calibration runs are performed to account for variations in assay conditions, then measurement reliability is improved, but device complexity and reagent consumption increase
Solution Approach 1:
The internal calibrator is pre-incorporated into the assay mixture before the actual measurement begins. This preliminary incorporation ensures that the calibration reference is present throughout the entire assay process, automatically accounting for any variations in conditions without requiring separate calibration runs or complex procedural adjustments.
Solution Approach 2:
The internal calibrator acts as an intermediary reference element that mediates between the analyte signal and the detection system. By providing a consistent reference point within the assay matrix, it compensates for variations in assay conditions and eliminates the need for multiple external calibration runs.
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 simplifies calibration procedures, reduces reagent use, and improves assay precision by accounting for variations in assay conditions, enabling accurate analyte concentration determination with fewer calibration runs.
Implementation Method 1
a tracer analyte labeled with a first detectable marker and an analyte-binding molecule labeled with a second detectable marker are contacted with a sample suspected of containing the analyte to form a tracer analyte/first analyte-binding molecule/second analyte-binding molecule sandwich complex. The signal attributable to the first detectable marker and the second detectable marker are then measured
Data Source
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AI summary
Provided herein are kits and methods for assays with internal calibration.