- Click to share on Facebook (Opens in a new window)
- Click to share on Twitter (Opens in a new window)
- Click to share on LinkedIn (Opens in a new window)
- Click to email a friend (Opens in a new window)
Why did the FDA approve a covid-19 treatment without testing? 2:28
(CNN) - The US Food and Drug Administration (FDA) issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood.
That type of test, called a serology test, could identify previous coronavirus infections, although it may be less effective in identifying recent ones.
The licensed test, from a manufacturer called Cellex Inc., requires blood to be drawn through a vein, and the test itself can only be performed in a certified laboratory.
- LOOK: The innovation that was not: a company falsely claimed to have FDA clearance for its coronavirus blood tests
Because antibodies can take time to develop, the FDA previously warned against using antibody tests to definitively diagnose coronavirus.
But by issuing what is known as an emergency use authorization for the new test, the FDA noted that the benefits of using the new blood test outweighed the risks.
"Based on all the scientific evidence available to the FDA, it is reasonable to believe that your product may be effective in diagnosing covid-19," the agency said, adding that "the known and potential benefits of your product when used to diagnose covid-19, overcomes the known and potential risks of your product. "
Unlike most coronavirus tests, which generally require a swab and look for signs of the virus itself, antibody tests look for our body's response to a virus.
- MORE: FDA Calls for Heartburn Drug Zantac to be Recalled Immediately
The FDA stated in its letter that the initial antibodies against the coronavirus are "generally detectable in the blood several days after the initial infection," but the agency cautioned that "levels over the course of infection are not well characterized."
The US Centers for Disease Control and Prevention. USA (CDC) say they are also working to develop a serology test, or a blood test that can look for antibodies, that would develop even in people with mild or no symptoms.
Such tests may allow officials to better understand how prevalent coronavirus infections really are, because they can identify people who had been previously infected but showed few or no symptoms.
On Tuesday, a company called Bodysphere falsely claimed that an FDA Emergency Use Authorization was issued for an antibody test that could detect the coronavirus within two minutes of a blood stick.
- MORE: FDA Accelerates Use of Coronavirus Blood Plasma Treatment
Multiple media outlets reported on the announcement, but later retracted its articles after the FDA confirmed that such a test had not been authorized at the time. On Wednesday, the company acknowledged that the test had not received authorization.
The FDA guidance issued last month allows antibody tests to be manufactured and distributed without such authorizations. But any explicit FDA clearance, such as that issued to Cellex, is a sign that regulators have confidence in the validation data of a test and believe that its benefits outweigh its risks.
coronavirusFDA
