Analyzer-to-Analyzer Variations in Assaying Ultralow Concentrated Biomarkers Associated with Neurodegenerative
Kun-Hung Lee1, Ming-Hung Hsu1, Hsin-Hsien Chen1
1MagQu Co., Ltd., New Taipei City 231, Taiwan.
ACS Measurement Science Au
|December 25, 2023
Summary
This study developed characterization methods to ensure consistent performance of high-temperature superconducting quantum interference device (high-Tc SQUID) based analyzers for Alzheimer's and Parkinson's disease biomarker assays. Results show minimal variations among three tested analyzers, validating the proposed characterization approach.
Area of Science:
- Biomedical Engineering
- Quantum Sensing
- Biomarker Detection
Background:
- High-temperature superconducting quantum interference device (high-Tc SQUID) magnetometers enable ultrasensitive immunoassays.
- An alternating current (AC) magnetosusceptometer analyzer using immunomagnetic reduction (IMR) is approved for clinical use in Taiwan and Europe for Alzheimer's disease (AD) and Parkinson's disease (PD) biomarker assays.
- Mass production necessitates addressing analyzer-to-analyzer performance variations, yet standard characterization methods are lacking.
Purpose of the Study:
- To propose and validate key characterization methods for high-Tc SQUID-based AC magnetosusceptometer analyzers.
- To assess analyzer-to-analyzer performance variations for clinical applications.
- To ensure consistent and reliable biomarker assay results for AD and PD.
Main Methods:
- Development of an AC magnetosusceptometer analyzer utilizing a high-Tc SQUID magnetometer.
- Characterization of three analyzers based on output signal stability, signal-to-noise ratio, and control sample measurements.
- Assay of AD and PD biomarkers (amyloid peptides, total tau, phosphorylated tau, alpha-synuclein) in human plasma and reference samples.
Main Results:
- One-way ANOVA revealed no significant differences (p > 0.05) in proposed characterizations among the three analyzers.
- High correlations (r > 0.8) were observed in measured biomarker concentrations across the three analyzers when assaying reference samples.
- The proposed characterization methods demonstrated feasibility in ensuring consistent performance.
Conclusions:
- The proposed characterization methods are effective in evaluating and ensuring consistent performance of high-Tc SQUID-based AC magnetosusceptometers.
- The study validates the reliability of these analyzers for ultrasensitive immunoassays of AD and PD biomarkers.
- This work supports the mass production and clinical utility of these advanced diagnostic tools.
