The United States Food and Drug Administration said Monday it had authorized the first new Covid-19 antibody test that had independent validation from the federal government.
The test, made by New Jersey-based EUROIMMUN US Inc., looks for antibodies to the novel coronavirus to see if people have been infected and recovered.
“The testing was performed at the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center (FFRDC) sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI),” the FDA said in a statement.
What is an antibody test?: Antibody tests look for evidence that someone has been infected with a virus, usually in the past. They can be used to see how many people in the population have been infected, even if they did not show symptoms. The tests could also reveal if people develop any kind of lasting immunity to the virus.
Antibody tests are different from the tests usually used to detect current infections. Those tests look for evidence of the virus itself in a patient.
Questions over inaccuracy: Public health experts have complained that most of the antibody tests now on the market are inaccurate. Even a test that claims to have 95% accuracy can miss up to half of the cases if the virus is not very common in the population being tested.
“The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection,” the FDA said in a letter to EUROIMMUN.
Source: CNN