The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Monday's report: FDA clarifies differences between surveillance, screening, and diagnostic testing.

Monday, 6 July 2020

• The U.S. Food and Drug Administration (FDA) updated its FAQs for COVID-19 to provide clarity regarding the differences between surveillance, screening, and diagnostic testing.

  • Surveillance – Surveillance includes ongoing systematic activities (collection, analysis, and interpretation) essential to planning, implementing, and evaluating data to monitor or characterize an infectious disease outbreak. An example of surveillance testing includes randomly selecting and sampling 1% of individuals in a city to determine local infection trends. FDA generally does not regulate surveillance testing.

  • Screening – Screening occurs at the individual level even if there is no reason to suspect infection, such as broad testing of asymptomatic individuals without known exposure. This would include a workplace plan to test all employees regardless of exposure or symptoms to determine who may return to work or the type of individual protective measures to take. FDA regulates screening tests as in vitro diagnostic devices.

  • Diagnostic testing – These tests are intended to diagnose an infection in patients suspected of COVID-19 by their healthcare provider. This includes symptomatic individuals, individuals who have had a recent exposure, high-risk individuals, such as healthcare providers with known exposure, or testing to determine resolution of infection. (Authored by Christine Zimmerman)

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