Rapid development of a de novo convalescent plasma program in response to a global pandemic: A large southeastern U.S. blood center's experience.

BACKGROUND: During the pandemic in the spring of 2020 with no vaccine or treatment for SARS-CoV-2 and its associated disease, COVID-19, convalescent plasma from recovered COVID-19 (CCP) patients offered a potential therapy. In March 2020, the United States (U.S.) Food and Drug Administration (FDA) authorized CCP under emergency Investigational New Drug (eIND) exemption and an IRB-approved Expanded Access Program (EAP) to treat severe COVID-19. Hospital demand grew rapidly in the Southeastern U.S., resulting in backlogs of CCP orders. We describe a large U.S. blood center's (BC) rapid implementation of a CCP program in response to community needs. STUDY DESIGN AND METHODS: From April 2 to May 17, 2020, CCP was collected by whole blood or apheresis. Initial manual approaches to donor intake, collection, and distribution were rapidly replaced with automated processes. All CCP donors and products underwent FDA-required screening and testing. RESULTS: A total of 619 CCP donors (299 females, 320 males) presented for CCP donation (161 [25.7%] whole blood, 466 [74.3%] plasmapheresis) resulting in 1219 CCP units. Production of CCP increased as processes were automated and streamlined, from a mean of 11 donors collected/day for the first month to a mean of 25 donors collected/day in the subsequent 2 weeks. Backlogged orders were cleared, and inventory began to accumulate 4 weeks after project initiation. CONCLUSION: The BC was able to implement an effective de novo CCP collection program within 6 weeks in response to a community need in a global pandemic. Documentation of the experience may inform preparedness for future pandemics.

Selecting COVID-19 convalescent plasma for neutralizing antibody potency using a high-capacity SARS-CoV-2 antibody assay.

BACKGROUND: Efficacy of COVID-19 convalescent plasma (CCP) is hypothesized to be associated with the concentration of neutralizing antibodies (nAb) to SARS-CoV-2. High capacity serologic assays detecting binding antibodies (bAb) have been developed; nAb assays are not adaptable to high-throughput testing. We sought to determine the effectiveness of using surrogate bAb signal-to-cutoff ratios (S/Co) in predicting nAb titers using a pseudovirus reporter viral particle neutralization (RVPN) assay. METHODS: CCP donor serum collected by three US blood collectors was tested with a bAb assay (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and a nAb RVPN assay. Prediction effectiveness of various CoV2T S/Co criteria was evaluated for RVPN nAb NT50 titers using receiver operating characteristics. RESULTS: Seven hundred and fifty-three CCPs were tested with median CoV2T S/Co and NT50 of 71.2 of 527.5. Proportions of donors with NT50 over target nAb titers were 86% ≥1:80, 76% ≥1:160, and 62% ≥1:320. Increasing CoV2T S/Co criterion reduced the sensitivity to predict NT50 titers, while specificity to identify those below increased. As target NT50 titers increase, the CoV2T assay becomes less accurate as a predictor with a decline in positive predictive value and rise in negative predictive value. CONCLUSION: Selection of a clinically effective nAb titer will impact availability of CCP. Product release with CoV2T assay S/Co criterion must balance the risk of releasing products below target nAb titers with the cost of false negatives. A two-step testing scheme may be optimal, with nAb testing on CoV2T samples with S/Cos below criterion.

The effect of COVID-19 on blood donation habits.

BACKGROUND: Blood centers (BCs) rely on schools and businesses. Shelter-in-place orders closed them. This study determined how COVID-19 affected donation habits. STUDY DESIGN AND METHODS: Two periods were reviewed (May 1 through June 30, 2018 vs 2019 [control] and 2019 vs 2020 [study-COVID period]). These donations were reviewed: first-time, repeat (donation ≤ 2 years), and lapsed (no donation > 2 years); sex; age; ethnicity; and ABO blood groups at high school and college drives. Testing all donors for SARS-CoV-2 antibodies started May 18, 2020. RESULTS: In the study period donations significantly increased (control P = .683, study P ≤ .0001) and comparing sex (control male P = .716, female P = .657; study male P = .004, female P ≤ .0001). In the study period there was a significant decrease in Hispanic (P = .001) and African American (P < .0001) donations also seen among high school and college drives and an increase in Caucasian (P < .0001) donations. There was a significant increase in first-time (P < .0001) and lapsed donors (P < .0001) in the study period vs control (first-time P = .087, lapsed P = .308) and a significant decrease in donors not more than 30 years (study 16-20 P < .0001, 21-30 P < .0001). There was a significant increase in all blood types in the study period (P < .0001) and in donations after implementation of SARS-CoV-2 antibody testing (P = .001). CONCLUSIONS: Significant changes occurred in donation habits in the study vs the control periods. These included increased total donations, comparing sexes, first-time and lapsed donors, all blood types, and Caucasian donations. Significant decreases were seen in Hispanic and African American donations and those not more than 30 years old.