Normalization Target for Optical Analyzer Variability
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Solution Overview
Problem
Existing optical analyzers for lateral flow immunoassay devices suffer from inter-instrument and operator variability, leading to a lack of precision and accuracy in detecting analytes, necessitating a system that can objectively analyze signals with improved sensitivity and accuracy.
Innovation Solution
An apparatus and method that utilize an embedded normalization target within the optical instrument, allowing for precise calibration and adjustment of test signals through a single continuous scan, which compares the current signal to a stored normalization value to enhance precision and accuracy by reducing variability and noise.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If optical instruments are used to read lateral flow devices, then sensitivity is improved, but inter-instrument and operator variability increases leading to reduced precision
Solution Approach 1:
A normalization target is introduced as an intermediary element that mediates between the test signal and the measurement system. This target provides a reference signal that accounts for instrument-specific variations, allowing signals from different instruments to be normalized to a common scale and thereby reducing inter-instrument variability
Solution Approach 2:
The system implements feedback by measuring the normalization target signal and using it to adjust or normalize the test signal. This feedback mechanism compensates for instrument variability by comparing the actual instrument response against the expected normalization target response and applying appropriate corrections
2Measurement precision
If multiple separate scans are performed for calibration and testing, then measurement accuracy can be improved, but measurement time and operational complexity increase
Solution Approach 1:
The calibration target and test sample are combined into a single measurement configuration that can be scanned simultaneously in one continuous pass. This merging of functions allows the instrument to collect both normalization and test data during a single scan operation, eliminating the need for separate calibration and measurement scans
Solution Approach 2:
The single scan system is designed to perform multiple functions simultaneously: it measures the normalization target for variability compensation, measures the test sample for analyte detection, and collects reference signals all during one operational cycle. This multi-functionality maintains accuracy while reducing measurement time
Data Source
AI summary
Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.