Quansys Biosciences Receives EUA for COVID-19 Antibody Test, Provides Exceptional Clinical Performance
November 13, 2020
Quansys Biosciences has received emergency use authorization (EUA) from the FDA for its COVID-19 antibody test. The test allows simultaneous detection of human antibodies to the SARS-CoV-2 S1 protein and the SARS-CoV-2 S2 protein, which has shown measurable improvement in clinical performance, compared to tests using a single protein.
“This is very welcome news, said Kelvyn Cullimore, president and CEO of BioUtah. “Quansys Biosciences, based in Logan, is not only responding to COVID-19, but improving the tools we have to fight the virus.”
The accuracy of testing for the S1 subunit alone was adequate for EUA requirements. Adding the S2 subunit measurement increased accuracy to 97.4% sensitivity and 99.7% specificity. Tests offering a high level of specificity result in fewer false positive results, 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.
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