FDA Warns of COVID-19 Antibody Testing Limitations

As more antibody tests become available for COVID-19, FDA wants to be sure people – healthcare providers especially – understand that these tests are not intended to diagnose SARS-CoV-2 infection. The agency issued a letter warning to healthcare providers on Tuesday explaining the limitations of serological testing and why those tests results should not be used as the sole basis to diagnose COVID-19. Serological tests (also referred to as antibody tests) are designed to detect antibodies present in the blood when the body is responding to a specific infection, such as COVID-19. These tests are supposed to detect the body's immune response to the infection caused by the virus rather than detecting the virus itself. According to FDA, experience with other viruses suggests that individuals whose blood contains antibodies associated with SARS-CoV-2 infection—provided they are recovered and not currently infected with the virus—may be able to resume work and other daily activities in society. Serological test results may also help determine who may qualify to donate blood that can be used to manufacture convalescent plasma as a potential treatment for those who are seriously ill from COVID-19. That said, based on the underlying scientific principles of antibody tests, FDA said it does not expect that an antibody test can be shown to definitevly diagnose or exclude SARS-CoV-2...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 Regulatory and Compliance Source Type: news