Hospital-Based Donor Recruitment and Predonation Serologic Testing for COVID-19 Convalescent Plasma

  1. Joanna Balcerek
  2. Evelin Trejo
  3. Kendall Levine
  4. Paul Couey
  5. Zoe V Kornberg
  6. Camille Rogine
  7. Charlotte Young
  8. P Jonathan Li
  9. Brian R Shy
  10. Jordan E Taylor
  11. Sara Bakhtary
  12. Terence Friedlander
  13. Kara L Lynch
  14. Caryn Bern
  15. Jonathan H Esensten

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Abstract

Objectives

Serologic testing for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in potential donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) may not be performed until after blood donation. A hospital-based recruitment program for CCP may be an efficient way to identify potential donors prospectively

Methods

Patients who recovered from known or suspected COVID-19 were identified and recruited through medical record searches and public appeals in March and April 2020. Participants were screened with a modified donor history questionnaire and, if eligible, were asked for consent and tested for SARS-CoV-2 antibodies (IgG and IgM). Participants positive for SARS-CoV-2 IgG were referred for CCP collection.

Results

Of 179 patients screened, 128 completed serologic testing and 89 were referred for CCP donation. IgG antibodies to SARS-CoV-2 were detected in 23 of 51 participants with suspected COVID-19 and 66 of 77 participants with self-reported COVID-19 confirmed by polymerase chain reaction (PCR). The anti–SARS-CoV-2 IgG level met the US Food and Drug Administration criteria for “high-titer” CCP in 39% of participants confirmed by PCR, as measured by the Ortho VITROS IgG assay. A wide range of SARS-CoV-2 IgG levels were observed.

Conclusions

A hospital-based CCP donor recruitment program can prospectively identify potential CCP donors. Variability in SARS-CoV-2 IgG levels has implications for the selection of CCP units for transfusion.

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  1. Version published to 10.1093/ajcp/aqaa268
  2. ScreenIT

    SciScore for 10.1101/2020.07.20.20158048: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: IRB approval: This study received UCSF Institutional Review Board approval on 4/17/2020 (#20-30637).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    7 This assay measures antibodies to the virus spike protein receptor binding domain (RBD) as described previously.
    virus spike protein receptor binding domain (RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    All potential donor information was recorded and stored exclusively in REDCap (v 9.5.25).
    REDCap
    suggested: (REDCap, RRID:SCR_003445)
    Donor Testing: Blood was collected by venipuncture and serum was tested for SARS-CoV-2 IgG and IgM using a Pylon 3D automated immunoassay system (ET Healthcare, Palo Alto, CA).
    ET Healthcare
    suggested: None
    All data analysis was performed using Prism (v8.4.2).
    Prism
    suggested: (PRISM, RRID:SCR_005375)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    One limitation of this study is that we did not determine neutralizing antibody titers, anti-SARS-CoV-2 IgA levels, Ig subtypes, or antibody affinities. Other groups have shown correlation between antibody levels to the spike protein receptor binding domain and neutralization titer.10,11 Further work to characterize the functional heterogeneity of antibodies in different CCP donors is important to guide clinical use of CCP. Due to the variability in anti-SARS-CoV-2 IgG levels, selection of specific units of CCP with higher antibody levels and neutralization titers may be required for clinical efficacy. Prospective testing of segments from CCP units in hospital blood bank inventories or labelling of units with antibody levels by blood suppliers could help with this selection. This approach would give patients a higher potential dose of antibodies with lower volume and donor exposure. However, requiring higher anti-SARS-CoV-2 antibody levels in CCP units may restrict CCP supply and may be costly for blood centers if many collected units fall below a designated cutoff. Another consideration for using CCP is the amount of anti-SARS-CoV-2 antibody that a COVID-19 patient has already made. In 16 COVID19+ ICU patients at our institution we found anti-SARS-CoV-2 IgG levels at a median of 3595 RFU (range 2086 – 4009).8 These levels are far higher than levels measured in our CCP donors median 144 RFU (range 5-2520). Therefore, the clinical utility of transfusion of CCP in ICU patients ...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.07.20.20158048v1 on medRxiv