Thank you for your interest in the development of diagnostics for SARS-CoV-2. On Aprill 11, 2020, the FDA updated the frequently asked questions to include the following new information:
- What is the difference between the types of tests available for SARS-CoV-2?
- Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection?
- If antibody tests are not used for diagnosis or exclusion of SARS-CoV-2 infection, what is their purpose?
- Can I offer my SARS-CoV-2 antibody test kit in the US without an EUA?
- I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA?
- I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. If my validation is complete, can I notify FDA and begin testing while I prepare and submit an EUA?
- I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Is there an EUA template for COVID-19 antibody tests?
- What are the current recommendations regarding minimum testing for demonstrating performance of a new SARS-CoV-2 antibody assay?
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