Serial screening and SARS-CoV-2

April 21, 2021

The federal government has added more tools recently to the COVID-19 testing arsenal for serial screening initiatives.

As the United States races to outpace the spread of new SARS-CoV-2 variants through a massive vaccination effort, it makes sense to both manage and monitor the activity of the virus using a wide variety of testing types and strategies.

Serial screening at the individual level will help us control community transmission of SARS-Cov-2 and resume activities safely. When combined with population-level surveillance activities, genetic sequencing, and serology testing, serial screening plays a role in monitoring where SARS-CoV-2 is spreading and how well prior infections and vaccines protect people from COVID-19 – both now and in the future.

Clinical labs will help their communities with these testing efforts. They will continue to test respiratory specimens from people suspected of being infected with SARS-CoV-2, as well as blood samples from people who have developed immunity either through infection or vaccination.

But laboratorians also can help provide expert advice for serial testing efforts that occur outside the walls of the lab. As people become vaccinated and communities resume pre-pandemic activities, more testing – or at least specimen collection – will occur in homes, businesses, schools, and other community settings.

The government has approved point-of-care (POC) and in-home tests to help with these efforts.

The U.S. Food and Drug Administration (FDA) in early April issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, which the agency said is the first antibody test authorized for use with dried blood spot samples collected at home. The samples are then sent to Symbiotica’s laboratory for analysis.

The FDA also approved in April amended EUA requests for multiple tests, expanding over-the-counter (OTC) and point-of-care serial testing options for COVID-19. The approved tests include Quidel QuickVue At-Home OTC COVID-19 test (OTC at-home serial screening), Abbott BinaxNOW COVID-19 Antigen Self Test (OTC at-home serial screening), Abbott BinaxNOW COVID-19 Ag Card 2 Home Test (OTC at-home serial screening with telehealth), Abbott BinaxNOW COVID-19 Ag 2 Card (POC serial screening without a prescription), and BD Veritor System for Rapid Detection of SARS-CoV-2 (POC serial screening with a prescription).

The Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) also have gotten involved in serial testing efforts.

They launched “Say Yes! COVID Test,” which will be rolled out in Pitt County, NC, and Chattanooga, TN. Residents will have access to free rapid antigen tests that they will administer themselves three times a week for one month. NIH plans to provide the tests and evaluate if frequent self-administered COVID-19 testing helps reduce community transmission of SARS-CoV-2.

Those community members also may choose to volunteer for a survey-based research study that will determine whether frequent self-administered testing makes a difference in behavior, knowledge about preventing spread of the virus, and thoughts about COVID-19 vaccination.

These announcements are probably just the beginning. I expect that we will hear about other initiatives in upcoming months. As laboratorians know, testing of all types plays a big role in allowing the so-called “new normal” life to happen safely.

I welcome your comments, questions, and opinions – please send them to me at [email protected]