SILVER SPRING, Md.,
April 7, 2020 /PRNewswire/ --
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
determining who may donate a part of their blood called
convalescent plasma, which may serve as a possible treatment for
those who are seriously ill from COVID-19. This is why Vice
President Mike Pence called on the
laboratory community to develop serological tests for COVID-19.
In March, the FDA issued a policy to allow developers of certain
serological tests to begin to market or use their tests once they
have performed the appropriate evaluation to determine that their
tests are accurate and reliable. This includes allowing developers
to market their tests without prior FDA review if certain
conditions outlined in the guidance document are met. The FDA
issued this policy to allow early patient access to certain
serological tests with the understanding that the FDA has not
reviewed and authorized them.
The FDA can also authorize tests for COVID-19 under an Emergency
Use Authorization (EUA). To date, FDA has authorized one EUA for a
serological test that is intended for use by clinical
laboratories.
Since the FDA issued the policy, over 70 test developers have
notified the agency that they have serological tests available for
use. However, some firms are falsely claiming that their
serological tests are FDA approved or authorized, or falsely
claiming that they can diagnose COVID-19. The FDA will take
appropriate action against firms making false claims or marketing
tests that are not accurate and reliable.
Additional Resources:
Media Contact: Stephanie
Caccomo
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/coronavirus-covid-19-update-serological-tests-301037192.html
SOURCE U.S. Food and Drug Administration