Quansys Biosciences Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance
LOGAN, Utah, Nov. 5, 2020 /PRNewswire/ -- Quansys Biosciences announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based IgG antibody test. A positive IgG antibody result identifies patients who have been exposed to the SARS-CoV-2 virus and, as part of their recovery, demonstrated an adaptive immune response.
The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) Assay simultaneously detects human IgG antibodies that recognize the S1 and S2 subunits of the SARS-CoV-2 spike protein from the same sample. The S1 subunit is of particular interest as it contains the receptor binding domain necessary for viral entry into human cells, and the viral domain associated with neutralizing antibodies. The accuracy of testing for the S1 subunit alone was adequate for EUA requirements, nonetheless, adding the S2 subunit measurement to the clinical call increased accuracy to 97.4% sensitivity and 99.7% specificity. Tests offering a high level of specificity result in fewer false positive calls, which is vital when disease prevalence is low. "High quality tests are essential as we work to better control the SARS-CoV-2 pandemic. In addition, improved quality and accuracy of the assay is vital to correctly evaluate the spread of this virus, which varies across communities," noted Adam Brown, CEO of Quansys Biosciences.
The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) Assay is available for immediate use. Sites adopting this assay are quickly guided to optimal capacity by the highly competent Quansys Assay Technical Team. Quansys' manufacturing capabilities and supply chain are designed to meet high volume demand. The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) assay can be ordered directly from Quansys Biosciences.
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SOURCE Quansys Biosciences