2014 AACC, CHICAGO, IL

David H. Wilson, Cheuk W. Kan, Andrew J. Rivnak, Todd G. Campbell, Tomasz Piech, David M. Rissin, Purvish P. Patel, Evan P. Ferrell, Erica Frew, Gail Provuncher, Alfred Schroff, Raymond E. Meyer, Mathew Fishburn, Lei Chang, David R. Fournier, and David C. Duffy

Quanterix Corporation, Lexington, MA USA

Objective: The aim of this work was to develop the next generation immunoassay analyzer capable of several orders of magnitude greater sensitivity than current best-in-class conventional immunoassay systems. The technology utilizes single molecule array (Simoa) technology to usher in fully automated digital immunoassay and multiplexing capability to the clinical laboratory. Simoa technology isolates individual paramagnetic beads in arrays of femtoliter-sized wells and detects single enzyme-labeled proteins on these beads using sequential fluid flows in microfabricated polymer array assemblies for ultra-sensitive signal measurements. These array assemblies have been incorporated into a low cost disk consumable. The array approach for assay signal quantification allows for rapid digital data acquisition and high throughput, enabling development of a fully automated system for low-cost measurement of clinically relevant biomarkers with high precision and unprecedented sensitivity across a broad dynamic range.