Optimizing the implementation of a participant-collected, mail-based SARS-CoV-2 serological survey in university-affiliated populations: lessons learned and practical guidance

  1. Estee Y. Cramer
  2. Teah Snyder
  3. Johanna Ravenhurst
  4. Andrew A. Lover

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Abstract

The rapid spread of SARS-CoV-2 is largely driven by pre-symptomatic or mildly symptomatic individuals transmitting the virus. Serological tests to identify antibodies against SARS-CoV-2 are important tools to characterize subclinical infection exposure.

During the summer of 2020, a mail-based serological survey with self-collected dried blood spot (DBS) samples was implemented among university affiliates and their household members in Massachusetts, USA. Described are challenges faced and novel procedures used during the implementation of this study to assess the prevalence of SARS-CoV-2 antibodies amid the pandemic.

Important challenges included user-friendly remote and contact-minimized participant recruitment, limited availability of some commodities and laboratory capacity, a potentially biased sample population, and policy changes impacting the distribution of clinical results to study participants. Methods and lessons learned to surmount these challenges are presented to inform design and implementation of similar sero-studies.

This study design highlights the feasibility and acceptability of self-collected bio-samples and has broad applicability for other serological surveys for a range of pathogens. Key lessons relate to DBS sampling, supply requirements, the logistics of packing and shipping packages, data linkages to enrolled household members, and the utility of having an on-call nurse available for participant concerns during sample collection. Future research might consider additional recruitment techniques such as conducting studies during academic semesters when recruiting in a university setting, partnerships with supply and shipping specialists, and using a stratified sampling approach to minimize potential biases in recruitment.

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  1. Version published to 10.1186/s12889-022-14234-1
  2. ScreenIT

    SciScore for 10.1101/2021.08.13.21262052: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: If participants were eligible and agreed to participate, they were asked to electronically sign an informed consent document.
    Sex as a biological variablenot detected.
    RandomizationAfter a three-week enrollment period, the survey was locked, and a randomized subset of participants was selected to receive a bio-sample collection kit.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    A single bloodspot per participant was transferred to an ELISA plate and assayed for IgM and IgG SARS-CoV-2 antibodies as described in published protocols.
    IgG SARS-CoV-2
    suggested: None
    For this survey, samples with an optical density ≥ 2.49 above daily control values were considered positive for SARS-CoV-2 IgG antibodies.
    SARS-CoV-2 IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    The bloodspot cards were removed from return bags and matched to individuals in REDCap using the name provided on the outgoing shipping label.
    REDCap
    suggested: (REDCap, RRID:SCR_003445)
    Analyses were performed with R version 4.0.321 and SAS version 9.4 (SAS Institute, Cary, NC, USA).
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.08.13.21262052v1 on medRxiv