Diagnostic Testing and Vaccine Analysis – Key Components for Battling the COVID-19 Pandemic - Workshop Session Two

Diagnostic testing for active SARS-CoV-2 infection, testing for past infection, and analyses of potential vaccines are critical enablers of the treatment, understanding, and control of SARS-CoV-2. Diagnostic and other tests have also been key components of recent fights against viruses such as MERS-CoV, Zika, Influenza H7N9, and Ebola. Nucleic acid tests, serological tests, serum antibody tests, and neutralizing serum antibody tests are examples of population testing that have been employed for COVID-19 diagnostic testing. The current tests that have been given approval or authorization by Regulatory Authorities and are being used by vaccine manufacturers have been developed and reviewed in a timecritical fashion. There are many potential learnings regarding development, commercialization, supply, and regulation that can be taken from the SARS-CoV2-related activities of the past year and from work on previous pandemic diagnostics. These leanings can potentially be applied to both additional SARSCoV-2 undertakings and activities related to future pandemics; across industry, regulatory, and academic environments; and to diagnostics, vaccines, and therapeutics. At the same time, there remain many questions and points for further discussion. This session will discuss evolution and use of SARS-CoV-2 diagnostics and other tests from industry, regulatory, and patient care perspectives.