OraSure Technologies said the FDA has requested additional information as part of its review of the company’s application for Emergency Use Authorization for its laboratory-based oral fluid Covid-19 antibody test.
- The OraSure SARS-CoV-2 Antibody ELISA is intended for qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device
- The company intends to resubmit two separate EUAs for the ELISA and the oral specimen collection device
- In addition, the FDA has requested that additional analytical studies be conducted on sample collection and stability
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