FNL pivots expertise to tackle SARS-CoV-2 serology challenges
The HPV Serology Laboratory is using its expertise to address the novel coronavirus. The laboratory was established to develop and standardize blood and other tests for antibodies to cancer-causing human papillomavirus (HPV) strains. Today a large part of the lab is being used to evaluate serology tests for COVID-19 antibodies. The laboratory staff is working with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), National Institutes of Health and several other government agencies to independently evaluate serology tests submitted to the FDA by outside companies and organizations. Validated serology tests can be used to identify people who have antibodies against SARS-CoV-2 in their blood. The HPV Serology Laboratory provides evaluation results to the FDA to help inform the FDA’s regulatory decision-making.
Serology tests are key to understanding many areas of COVID-19
Serology testing can detect the immune system’s response to infection, and has become key in understanding COVID-19’s natural history of infection. The laboratory is working with colleagues at the National Cancer Institute and National Institute of Allergy and Infectious Diseases, the CDC, and several academic medical centers to evaluate existing serology tests and generate serology assay standards that other academic and commercial laboratories can use.
Serology tests can identify people who have had an infection and may also be used as an aid to screen blood from recovered COVID-19 patients, whose plasma could be used in potential treatments or to evaluate immune responses to COVID-19 vaccines. Studies are underway to address questions that will better inform the appropriate use of these tests. Scientists seek to determine whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection. They are also investigating the duration for which any immunity may last. Validated serology tests are crucial for further studies of SARS-CoV-2 infection, including studies of populations who have been infected, immunity, and potential vaccines.