Tuesday, April 7, 2020

Coronavirus (COVID-19) Update: Serological Tests

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.
Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. In other words, the test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19 and why it should not be used as the sole basis to diagnose COVID-19.

Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection and can return to work. In addition, these test results can aid in ...

Coronavirus (COVID-19) Update: Daily Roundup April 7, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued a guidance for remote ophthalmic assessment and monitoring devices. These devices include visual acuity charts, visual field devices, general use ophthalmic cameras, and tonometers. The guidance will help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to ...