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The Simoa HD-1 Analyzer: A Novel Fully Automated Digital Immunoassay Analyzer with Single-Molecule Sensitivity and
David H Wilson1, David M Rissin2, Cheuk W Kan2
1Quanterix Corporation, Lexington, MA, USA dwilson@quanterix.com.
Journal of Laboratory Automation
|June 17, 2015
Summary
A new automated instrument enhances digital immunoassay sensitivity to the attomolar range, enabling earlier disease detection. This breakthrough in protein biomarker analysis promises significant advancements in diagnostics and therapeutics.
Area of Science:
- Biomarker Discovery
- Molecular Diagnostics
- Assay Technology
Background:
- Early disease detection relies on identifying low-abundance protein biomarkers.
- Conventional immunoassays have detection limits in the femtomolar range (10^-13 M).
- Digital immunoassay technology offers attomolar sensitivity (10^-16 M) but often requires manual procedures.
Purpose of the Study:
- To introduce a fully automated laboratory instrument for digital immunoassays using single-molecule array (Simoa) technology.
- To enable high-throughput, sensitive, and multiplexed digital assays for various research areas.
- To demonstrate the clinical potential of automated digital immunoassays for early disease detection.
Main Methods:
- Development of a novel automated instrument for Simoa digital immunoassays.
- Creation of singleplex and multiplexed assays for 16 protein biomarkers.
- Validation of assay performance, including sensitivity and throughput (66 samples/h).
Main Results:
- The automated instrument achieves single-molecule sensitivity and multiplexing capabilities.
- Average sensitivity improvement over conventional ELISA was over 1200-fold, with <10% coefficient of variation.
- Demonstrated utility in traumatic brain injury and infectious disease diagnostics.
Conclusions:
- Automated digital immunoassays significantly enhance biomarker detection sensitivity and throughput.
- This technology has the potential to revolutionize early diagnosis and therapeutic monitoring across multiple disease areas.
- The platform is well-suited for routine clinical use, advancing precision medicine.
