(CNN) — The Food and Drug Administration of United States (FDA, for its acronym in English) issued its first authorization of emergency use for a test coronavirus that looks for antibodies in the blood.
This type of test, called serology test, could identify past infections by coronaviruses, although it may be less effective in identifying recent.
The test is authorised by a manufacturer called Cellex Inc., requires that you remove blood through a vein, and the test itself can only be performed in a certified laboratory.
Because antibodies may take time to develop, the FDA warned previously against the use of antibody tests to definitively diagnose the coronavirus.
But by issuing what is known as the authorization of emergency use for the new test, the FDA noted that the benefits of using the new blood test outweighed the risks.
“According to the totality of scientific evidence available to FDA, it is reasonable to believe that their product can be effective for diagnosing covid-19,” stated the agency, adding that “the known benefits and potential of your product when used to diagnose covid-19, it exceeds the known risks and potential of your product”.
Unlike the majority of the evidence of coronavirus, which generally require a swab and look for signs of the virus, the antibody tests are looking for our body’s response to a virus.
The FDA said in its letter that the antibodies initials against the coronavirus are “generally detectable in the blood several days after the initial infection,” but the agency warned that “the levels in the course of the infection are not well characterized”.
The Centers for Control and Prevention of Diseases of EE. UU. (CDC, for its acronym in English) say that also work to develop a serology test, or a blood test that can look for antibodies, which develop even in people with mild symptoms or without symptoms.
Such tests may allow officials to better understand how truly are infections prevalent by coronavirus, because they can identify people that had been infected previously but who showed few or no symptoms.
On Tuesday, a company called Bodysphere falsely claimed that is issued an Authorization of Emergency Use of the FDA for an antibody test that could detect the coronavirus in two minutes from a pinprick of blood.
Multiple media outlets reported on the announcement, but then retracted their articles after the FDA confirmed that such a test had not been authorized at that time. On Wednesday, the company acknowledged that the test had not received the authorization.
The FDA guidance issued last month, allows testing of antibodies are manufactured and distributed without any such authorizations. But any explicit authorization from the FDA, as issued to Cellex, it is a sign that regulators have confidence in the data validation of a test and believe that their benefits outweigh their risks.