News & Events
FDA tightens COVID-19 antibody test policy
- May 31, 2020
- Posted by: Wiley M. Wagner
- Category: Science
Today, the U.S. Federal Food and Drug Administration has issued an urgent statement stating that in relation to the so-called COVID-19 antibody tests, it is necessary to implement a more serious and stringent control policy, since at the moment they are already becoming a bit of a mass replacing standard diagnostic tests for the presence of coronavirus – although at its core they are not. It was with the goal of combating misinformation and fake positive mass test results that the FDA commission decided to introduce tighter controls on such tests.
First of all, it is worth noting that the tests for determining coronavirus antibodies – in particular, antibodies produced by the immune system after defeating COVID-19 – are very different from standard tests for coronavirus itself, since they can only detect the presence or absence of these antibodies. If antibodies are present in the human body, then this means that he is either ill, or is currently more coronavirus, depending on their number and chemical configuration.
In addition, experts draw attention to the fact that not all commercially available tests for COVID-19 antibodies in the United States are subject to strict standards of quality and accuracy, since some, after short trials, began to demonstrate a rather high percentage of false positive results, and some and was completely unable to give any answer about the presence or absence of these antibodies.
One way or another, a conceptually new stage is now beginning to combat such diagnostic tests for the presence of antibodies, since the current problematic trend cannot but cause serious concerns about the health and safety of the vast majority of US residents, not to mention the inhabitants of European states, which may also indirectly be infected with coronavirus and not even show any visible symptoms.