REDS Epidemiology, Surveillance, and Preparedness of the Novel SARS-CoV-2 Epidemic (RESPONSE)

Leveraging access to the blood supply and blood donors, the REDS-IV-P program began conducting the RESPONSE study (REDS-IV-P Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic) in early 2020 in order to 1) evaluate if SARS-CoV-2 RNA was found in blood donations in the U.S. using an assay that could potentially be used to screen the blood supply if evidence of SARS-CoV-2 transfusion-transmission became apparent – currently this risk is theoretical, 2) conduct serosurveys using optimized assays/algorithms to monitor antibody reactivity in blood donor populations over time, 3) enroll SARS-CoV-2 positive donors and others into a longitudinal cohort study to answer fundamental questions about the evolution of viremia and immune responses, and 4) establish a sharable biorepository that includes specimens collected early on in the infection and potentially large volumes of plasma from infected/convalescent donors.

Screening for SARS-CoV-2 RNAemia has been completed using a SARS-CoV-2 nucleic acid test (NAT) performed on retained blood donor minipool samples from six geographic regions in the US. The study has also conducted serosurveillance (i.e. testing for antibody directed against the SARS-CoV2 spike protein) of donations from the same six regions to document accruing seroincidence in blood donor populations and to project these rates in the general population. To enrich for donors with acute SARS-CoV-2 infection, another part of the study is focusing on donors reporting post-donation information (PDI) consistent with COVID-19 by testing plasma from all available PDI donations for SARS-CoV-2 RNA by NAT. Subjects who are diagnosed with COVID-19 based on PDI reports or who test positive by SARS-CoV-2 NAT on index donation plasma are being enrolled into a longitudinal follow-up study which is collecting multiple samples for nine-months to one-year post-infection.

The specific aims of the RESPONSE study are to:

  • Establish the incidence of SARS-CoV-2 RNAemia in blood donations from the American Red Cross (ARC) regions in Los Angeles, Boston, and Minneapolis metropolitan areas, Bloodworks Northwest (BWNW), New York Blood Center (NYBC), and Vitalant San Francisco Bay Area, monthly between March and September of 2020
  • Conduct serosurveys to study antibody reactivity in same six areas as above monthly for March to August 2020
  • Document rates of Post Donation Information (PDI) reports to determine PDI rates relevant to SARS-CoV-2 clinical disease and test index donation plasma from PDI donors for SARS-CoV-2 RNA
  • Enroll SARS-CoV-2 infected subjects into a longitudinal cohort study to answer fundamental questions on the evolution of viremia, early immune responses and waning of immunity over 9-12 months of follow-up
  • Establish a sharable biorepository of samples from all of the above Aims for future research

This project, led by the REDS-IV-P Center for Transfusion Laboratory Studies (Vitalant Research Institute, VRI), represents a collaboration between REDS-IV-P investigators and several blood collection organizations including the American Red Cross (ARC), Bloodworks Northwest (BWNW), New York Blood Center (NYBC), and Vitalant. These four organizations collect blood donations from the six metropolitan areas that were included in the study. The team of researchers at VRI and their collaborators are responsible for routing residual plasma from minipools and individual serum samples to VRI and ARC laboratories for SARS-CoV-2 NAT and antibody testing. Three of these blood organizations (ARC, NYBC, and Vitalant) are enrolling subjects into the longitudinal cohort study and ARC is tracking rates of PDI reports over time. Westat, as the REDS-IV-P Data Coordinating Center, has coordinated protocol, MOP and systems development; is aggregating, managing, monitoring, and providing quality control for all data; and is performing data analysis.

The REDS-IV-P is a program funded by the National Heart, Lung, and Blood Institute (NHLBI)