The U.S. Food and Drug Administration (FDA) uses diagnostic tests to diagnose, prevent and treat COVID-19, medical devices such as ventilators and personal protective equipment (PPE) - surgical masks, face shields, respirators, gowns, and including gloves - responsible for organizing.

  The FDA is committed to ensuring that patients and healthcare professionals have timely and sustained access to high-quality diagnostic and therapeutic medical devices to effectively respond to the COVID-19 pandemic.

In Vitro Diagnostic Tests: COVID-19 Tests Including Antibody Tests

  In vitro diagnosis is tests performed on samples taken from the human body, such as mucus glands from the nose or throat, or blood taken from a finger stitch or by a phlebotomist. In vitro diagnosis can detect diseases or other conditions and can be used to monitor a person's overall health to cure, treat, or prevent diseases. Patients and their doctors rely on the FDA to ensure that the in vitro diagnoses they use to make medical decisions are accurate, reliable, and clinically meaningful.

  On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and conditions exist that justify authorization for immediate use of in vitro diagnosis of the novel coronavirus (2019) (2019 -ncov). Rapid detection of COVID-19 cases in the United States requires extensive diagnostic tests to check for the emergence of this rapidly spreading, serious disease.