Antibody Testing: Risks and Concerns
Monday, May 4, 2020
Antibody tests have generated a significant amount of discussion in the healthcare industry. Everyone is anxious to get back to work and reduce the “social” distancing mandate. This type of testing, a simple blood test, potentially, has the ability to identify those individuals who are or may be infected with the COVID-19 virus. However, the Food and Drug Administration (FDA) has issued a warning that healthcare providers should be aware of the limitations of serological tests intended to detect the antibodies associated with COVID-19.
To date, only one test has been approved by the FDA. Serological tests (antibody tests) detect antibodies present in the blood when the body is responding to a specific infection, like COVID-19. These tests detect the body’s immune response to the infection rather than detecting the virus itself.
It is important to recognize the limitations of the serological tests, not to mention the fact that only FDA-approved tests should be used. More than 70 companies have signed up to sell antibody tests. These companies are supposed to state that their tests are not FDA-approved and cannot rule out whether someone is currently infected. The problem with faulty tests is that they may assure patients they are immune when they aren’t. Your patient/employee may then proceed to return to work, reduce social distancing, etc.; a false sense of security for your patient/employee can result in a claim for you. Currently, it is unclear what level of antibodies are necessary for patients to be immune or just how long that immunity might last.
The tests are currently of value to researchers.
Stay tuned for additional information as research continues.