Challenge

SARS-CoV-2 social distancing protocols have had a negative impact on the U.S. blood supply, creating the imperative to assess whether individuals with potential SARS-CoV-2 exposure or asymptomatic infection need to be deferred from blood donation.

The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) jointly funded the REDS Epidemiology, Surveillance, and Preparedness of the Novel SARS-CoV-2 Epidemic program (RESPONSE) through the Recipient Epidemiology and Donor Evaluation Study IV–Pediatric (REDS-IV-P) program.  RESPONSE addresses key issues related to blood safety and furthers our understanding of SARS-CoV-2 natural history and pathogenesis.

Solution

To address these objectives, the RESPONSE program is:

• Conducting serosurveys to study antibody reactivity;
• Enrolling SARS-CoV-2-positive subjects in a longitudinal cohort study to answer fundamental questions on the evolution of viremia and early immune response; and
• Establishing a shareable biorepository for future research.

Westat, as the Data Coordinating Center for the REDS-IV-P program, is using its suite of tools to support all aspects of the RESPONSE protocols, including: subject enrollment and consent; online surveys; data entry forms; biospecimen management; and monitoring, reporting, and analyzing study data. These tools provide flexibility, responsiveness, and capacity with respect to the study protocols, while also ensuring high-quality data for analysis. Our statisticians are using advanced statistical techniques to extrapolate seroprevalence from sampled blood donors to the general population.

Results

Serosurveys conducted in 6 U.S. regions showed increased seroreactivity between March and August 2020. Analysis published in the journal Transfusion also showed that SARS-CoV-2 does not appear to pose a threat to the nation’s blood supply. See the National Institutes of Health news release: U.S. blood donations are safe under current COVID-19 screening guidelines.

Westat and other partners are now using the same statistical approach developed for RESPONSE to support the Centers for Disease Control and Prevention (CDC) in conducting a national serosurvey in 60+ U.S. regions. Learn more about our work conducting the Multistate Assessment of SARS-CoV-2 Seroprevalence in Blood Donors, the largest nationwide COVID-19 seroprevalence survey.

Data collected from the ongoing RESPONSE longitudinal cohort will lead to a better understanding of SARS-CoV-2 immune response and the dynamics of antibody persistence.