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FDA Grants Emergency Use Authorization for Quansys Bio Coronavirus Immunoassay

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Quansys Biosciences' Q-Plex SARS-CoV-2 Human IgG (4 Plex) immunoassay.

The ELISA-based test is designed to detect immunoglobulin G against SARS-CoV-2 in human serum and plasma. Samples are prepared on a 96-well microplate that is arrayed with four spots in each well — for SARS-CoV-2 spike glycoprotein 1 and 2, as well as positive and negative controls — and then imaged using Quansys' Q-View Imager Pro or Q-View Imager LS instruments with its Q-View software.

Up to 90 samples can be tested in under two hours, according to the Logan, Utah-based company.

The immunoassay may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.