Quansys receives FDA Emergency Use Authorization for antibody test

Logan-based Quansys Biosciences has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based IgG coronavirus 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.

Quansys’ Q-Plex SARS-CoV-2 Human IgG Assay simultaneously detects human IgG antibodies that recognize the S1 and S2 subunits of the SARS-CoV-2 spike protein from the same sample, Adam Brown, CEO of Quansys Biosciences, said. The accuracy of testing for the S1 subunit alone was adequate for EUA requirements, but adding the S2 subunit measurement increased accuracy to 97.4 percent sensitivity and 99.7 percent specificity. Tests offering a high level of specificity result in fewer false positive calls, which is vital when disease prevalence is low, Brown said.

“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,” said Brown.

The Q-Plex test is available for immediate use and Quansys’ manufacturing capabilities and supply chain are designed to meet high volume demand, according to Brown.