FDA Approves First Serological Test For COVID-19; Test Not A Diagnostic Tool

The US Food and Drug Administration approved a serological test to identify whether a person has been infected with COVID-19.

According to CNN, these blood tests are more effective in determining past coronavirus infections than recent ones and since the antibodies in the blood can take a while to develop, the FDA previously warned that the tests cannot be used as a definitive diagnostic tool for COVID-19 infections.

“We’re going to announce today, our first approval of a serology test that will, in laboratories, allow the labs to determine exposure in the antibodies,” FDA Commissioner Dr. Stephen Hahn said on CBS News Radio.

Cellex Inc. manufactured the test and it requires blood extracted from the veins to be subsequently taken to a certified laboratory for testing.

In a New York Post article, it was reported that the FDA issued an Emergency Use Authorization for the test, which means that its benefits trumps the risks.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise M. Hinton said in a Wednesday letter to James X. Li, the CEO of Cellex.

Serology tests such as this one can help officials understand how widespread the virus is and allows them to identify those people who may have been infected but are asymptomatic, CNN reported.