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 is conducting the RESPONSE study (REDS-IV-P Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic) to 1) evaluate available assays 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 RNAemia will be performed using SARS-CoV-2 NAT testing of retained blood donor minipool samples from six outbreak regions. The study will conduct serosurveillance of donations from the same six outbreak regions to document accruing seroincidence in blood donor populations. To enrich for donors with acute SARS-CoV-2 infection, the study will focus on donors reporting post-donation information (PDI) consistent with COVID-19.  Plasma from all PDI donations will be tested for SARS-CoV-2 RNA by NAT. Subjects who were diagnosed with COVID-19 based on PDI reports or test positive by SARS-CoV-NAT on index donation plasma will be enrolled into a longitudinal follow-up study to collect multiple samples over 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 Bloodworks Northwest (BWNW), New York Blood Center (NYBC), Vitalant San Francisco Bay Area, and the American Red Cross (ARC) regions in Los Angeles, Boston, and Minneapolis metropolitan areas, monthly for 6 months
  • Conduct serosurveys to study antibody reactivity in same six areas as above monthly for 6 months
  • Evaluate assays that could potentially be used to screen the blood supply for SARS-CoV-2 RNA and antibodies
  • 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
  • Collect information on lookback studies in recipients of blood products from PDI donors found to have RNA in their index donation plasma
  • Enroll SARS-CoV-2 positive subjects into a longitudinal cohort study to answer fundamental questions on the evolution of viremia, early immune responses and waning of immunity over one year 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 Bloodworks Northwest (BWNW), New York Blood Center (NYBC), Vitalant, and the American Red Cross (ARC). These four organizations span six metropolitan areas: Seattle (BWNW), New York City (NYBC), the San Francisco Bay area (Vitalant), and Boston, Minneapolis, and Los Angeles (ARC). The team of researchers at VRI and their collaborators will be responsible for routing residual plasma from minipools and individual serum samples to VRI and ARC laboratories for SARS-CoV-2 NAT and antibody testing. These blood organizations will track rates of PDI reports over 1 year and also enroll subjects into the longitudinal cohort study. Westat, as the DCC, will coordinate protocol, MOP and systems development; aggregate, manage, monitor, and provide quality control for all data; and perform analysis.