 The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about tests and treatments. Q: Are there any at-home tests for COVID-19? A: Yes. The FDA has authorized one completely at-home test. An at-home test is one in which you can collect a sample and test it at home. The test gives results in 30 minutes or less. The FDA has also authorized tests that allow you to collect your sample at-home and then mail it to a laboratory for analysis. All COVID-19 tests for at-home use require a prescription. Q: What is a monoclonal antibody? A: Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies for COVID-19 may block the virus that causes COVID-19 from attaching to human cells, making it more difficult for the virus to reproduce and cause harm. Monoclonal antibodies may also neutralize a virus. Q: Is bamlanivimab, a monoclonal antibody, FDA-approved to treat COVID-19? A: No. Bamlanivimab is not FDA-approved to treat any diseases or conditions, including COVID-19. But the FDA did issue an emergency use authorization (EUA) for bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years and older weighing at least 40 kilograms, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Learn more about EUAs in this video. Q: Is Olumiant (baricitinib) approved by the FDA to treat COVID-19? A: No. Olumiant is not FDA-approved for the treatment of COVID-19. But the FDA did issue an emergency use authorization (EUA) authorizing Olumiant for emergency use by health care providers, in combination with Veklury (remdesivir), for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients ages 2 years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
For more information see Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) in Combination with Veklury (remdesivir) for Treatment of Mild to Moderate COVID-19. Q: Are the monoclonal antibodies casirivimab and imdevimab FDA-approved to treat COVID-19? A: No. Casirivimab and imdevimab are not FDA-approved to treat any diseases or conditions, including COVID-19. But the FDA did issue an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients ages 12 years or older weighing at least 40 kilograms (about 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes people age 65 or older or who have certain chronic medical conditions. Learn more about casirivimab and imdevimab for COVID-19. | 
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