title: The Simoa HD-1 Analyzer: A Novel Fully Automated Digital Immunoassay Analyzer with Single-Molecule Sensitivity and Multiplexing.
abstract: Disease detection at the molecular level is driving the emerging revolution of early diagnosis and treatment. A challenge facing the field is that protein biomarkers for early diagnosis can be present in very low abundance. The lower limit of detection with conventional immunoassay technology is the upper femtomolar range (10(-13) M). Digital immunoassay technology has improved detection sensitivity three logs, to the attomolar range (10(-16) M). This capability has the potential to open new advances in diagnostics and therapeutics, but such technologies have been relegated to manual procedures that are not well suited for efficient routine use. We describe a new laboratory instrument that provides full automation of single-molecule array (Simoa) technology for digital immunoassays. The instrument is capable of single-molecule sensitivity and multiplexing with short turnaround times and a throughput of 66 samples/h. Singleplex and multiplexed digital immunoassays were developed for 16 proteins of interest in cardiovascular, cancer, infectious disease, neurology, and inflammation research. The average sensitivity improvement of the Simoa immunoassays versus conventional ELISA was >1200-fold, with coefficients of variation of <10%. The potential of digital immunoassays to advance human diagnostics was illustrated in two clinical areas: traumatic brain injury and early detection of infectious disease.
authors.affiliation: Quanterix Corporation, Lexington, MA, USA dwilson@quanterix.com.
authors.forename: David H
authors.initials: DH
authors.lastname: Wilson
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Rissin
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Cheuk W
authors.initials: CW
authors.lastname: Kan
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Fournier
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Piech
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Todd G
authors.initials: TG
authors.lastname: Campbell
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Raymond E
authors.initials: RE
authors.lastname: Meyer
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Fishburn
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Cabrera
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Purvish P
authors.initials: PP
authors.lastname: Patel
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Erica
authors.initials: E
authors.lastname: Frew
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Yao
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Chang
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: Evan P
authors.initials: EP
authors.lastname: Ferrell
authors.affiliation: Stratec Biomedical, Birkenfeld, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: von Einem
authors.affiliation: Stratec Biomedical USA, Inc., Newberry Park, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: McGuigan
authors.affiliation: Stratec Biomedical, Birkenfeld, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Reinhardt
authors.affiliation: Stratec Biomedical, Birkenfeld, Germany.
authors.forename: Heiko
authors.initials: H
authors.lastname: Sayer
authors.affiliation: Stratec Biomedical, Birkenfeld, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Vielsack
authors.affiliation: Quanterix Corporation, Lexington, MA, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Duffy
mesh_terms: D057205:Automation, Laboratory / Q000295:instrumentation* / Q000379:methods*; D019411:Clinical Laboratory Techniques / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation; D013997:Time Factors
keywords: HD-1; Simoa; digital immunoassay; multiplexing; single-molecule array