There are two kinds of people who have SARS-CoV-2 antibodies in their systems: Those who are currently infected with COVID-19 (both symptomatic and asymptomatic), and those who were infected but have recovered. Being able to identify and distinguish between these two groups will go a long way in determining how and how soon people can emerge from self-isolation and the world can go back to normal. That is why so many are investing so much hope and energy in serology testing. Here is an overview of the FDA’s strategy to promote serology testing for COVID-19. Importance of Serology COVID-19 Testing Antibodies remain in the body long after the infection they were created to fight disappears. The principle method being used to diagnose COVID-19, reverse transcriptase polymerase chain reaction (RT-PCR) testing, detects viral material that is present during a current infection. By contrast, blood-based serology tests indicate whether a person had COVID-19 but since recovered. In addition to furnishing invaluable data about particular populations, the capability to identify healthy individuals who carry COVID-19 antibodies and are thus presumably safe to “let out” is integral to the coming challenge of gradually peeling back social distancing. FDA Regulation of Serology Testing Not surprisingly, […]