Quanterix Receives FDA Emergency Use Authorization for SARS-CoV-2 N Protein Antigen Test
Antigen test available on Simoa HD-X Analyzer® intended for qualitative detection of the nucleocapsid protein (N protein) from SARS-CoV-2 in nasopharyngeal swab specimens
Full suite of Research Use Only Assays Also Available for SARS-CoV-2 Acute and Long Hauler Surveillance and Profiling Studies
The Simoa SARS-CoV-2 N Protein Antigen Test detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein) which is known to be elevated in respiratory fluids during the initial acute phase of the infection. Direct detection of antigen proteins from the virus may be a more meaningful measure of infection status than detection of RNA by rRT-PCR because genetic material can linger even after the virus has left the body, resulting in increased risk of false positives1. In clinical studies, the test demonstrated a sensitivity of 97.7% (positive percent agreement) and specificity of 100% (negative percent agreement) up to 14 days following onset of symptoms.
Under the current EUA, the SARS-CoV-2 N Protein Antigen Test is intended for use with nasopharyngeal (NP) samples in individuals suspected of COVID-19 by their healthcare providers.
FDA authorization of the Simoa SARS-CoV-2 N Protein Antigen Test for NP samples is an important early step in a project funded by the NIH Rapid Acceleration of Diagnostics (RADx) initiative to apply Simoa digital biomarker technology to decentralized SARS-CoV-2 antigen detection in non-invasive sample types. An ultimate aim of this
“As case counts and positivity rates rise globally, the COVID-19 testing landscape is of critical importance,” said
Simoa RUO assays for
“In addition to direct viral antigen and antibody detection capabilities, researchers around the world require the most sensitive and specific assays for both immune monitoring and disease profiling applications,” said Hrusovsky. “Our expanded RUO portfolio of ultrasensitive assays also includes customizable panels of up to 10 critical biomarkers for cytokine and chemokine profiling and for carefully monitoring cytokine storms. Our team is working diligently to facilitate research being done on patients with non-resolving immune responses (or COVID-19 long haulers), as well as those with associated vascular and neurological effects. Blood-based biomarkers including antigen, IgG, Nf-L, GFAP, in addition to angiogenesis panels can accurately quantify viral load, immune response, organ damage and level of inflammation from minimally invasive samples at ultra-sensitive levels.”
Simoa (single molecule array technology) is a revolutionary digital approach to immunoassays which allows single molecules to be counted for protein biomarker research applications, changing the way in which the biology of health and disease is studied by giving scientists the ability to closely examine critical biomarkers. In doing so,
For more information on Quanterix’ Simoa technology, visit https://www.quanterix.com/technology. To learn more about Quanterix’ infectious disease research and RUO assay development solutions, visit https://www.quanterix.com/therapeutic-areas/infectious-disease.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings with the