Lateral Flow Assay Calibration Without Control Lines
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Solution Overview
Problem
Sandwich-type assays, such as lateral-flow assays, face limitations due to the Hook effect, which restricts the dynamic operational concentration zone and leads to incorrect results at high analyte concentrations, and are unsuitable for multiplexing tests that require multiple test lines, as they depend on a control line that can't be independently implemented for each test line.
Innovation Solution
A method that involves calibrating the test device by measuring the signal over time using different concentrations, defining calibration functions, and setting criteria to determine the usability of the sample measurement, allowing for early reporting of results and controlling the measurement progression without needing a control line, thus overcoming the Hook effect and enabling multiplexing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a control line is used to ensure test usability, then measurement reliability is improved, but device complexity and inability to support multiplexing worsen
Solution Approach 1:
The patent removes the control line component from the test device structure entirely. Instead of including a control line to verify usability, the system relies on calibration functions stored in memory that were established during manufacturing. The processor evaluates measurement signals against these pre-established calibration criteria, eliminating the need for physical control line structures while maintaining reliability verification through software-based calibration checks.
Solution Approach 2:
The patent replaces the mechanical/physical control line structure with a software-based calibration evaluation system. The control function is transferred from a physical test line component to a digital processing system that compares measurement signals against stored calibration data. This substitution enables multiplexing capabilities since the calibration-based verification does not require additional physical test line structures.
2Measurement precision
If calibration is performed at multiple time points during development, then measurement precision is improved, but measurement time increases
Solution Approach 1:
The patent performs calibration measurements at multiple time points during the manufacturing process and stores the resulting calibration functions in memory before the test device is used. This preliminary calibration action establishes the reference data needed for accurate measurements. During actual use, the device only needs to retrieve and apply these pre-established calibration functions, avoiding the need to perform time-consuming multi-time-point calibration during each measurement session.
Solution Approach 2:
The patent performs more calibration measurements than the minimum single time-point measurement during manufacturing, collecting data at multiple time points to establish robust calibration functions. This excessive calibration action during manufacturing creates a comprehensive reference dataset that enables accurate measurements during use without requiring equivalent measurement time. The time investment is made during manufacturing rather than during end-user measurement sessions.
Data Source
AI summary
A method is disclosed for measuring a sample, in which the sample to be analysed is measured using a measuring device in connection with a development of a measurement of the sample. On the basis of the measurement, information concerning an usability of the measurement and/or an analysis result is formed in connection with a development of a measurement of the sample using a calibration comprising a set of criteria and the corresponding information is reported.


