FDA Answers Most Frequent Regulatory Questions about COVID-19 Testing

The weeds of misinformation about COVID-19 are tall and thick, but an update to FDA's frequently-asked questions page should clear some things up, both for test makers and the general public. Because this is such a fluid situation, we have also included the date in parentheses beside each question to indicate when the information was last updated by FDA. Q: What is the difference between the types of available SARS-CoV-2 tests (May 4) The term diagnostic test is generally used to refer to molecular or antigen tests, both of which can be used to diagnose infection with the SARS-CoV-2 virus.  Molecular tests, also called Nucleic acid amplification tests (NAAT), detect the presence of viral RNA, and antigen tests detect the presence of viral proteins that are part of the SARS-CoV-2 virus. FDA-authorized NAAT tests for SARS-CoV-2 meet the standard for an emergency use authorization (EUA), and based on the current available data, FDA said it believes those tests are highly accurate. This means that a positive or a negative result from a NAAT test is likely to be true. The terms serological or antibody tests are generally used to refer to tests that detect antibodies to the SARS-CoV-2 virus. Because the antibodies are part of the body’s immune response to exposure and not the virus itself, such testing cannot be used for diagnosis of infection. Antibodies to SARS-CoV-2 are generally detectable...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 Regulatory and Compliance Source Type: news