Analysis of accumulated SARS-CoV-2 seroconversion in North Carolina: The COVID-19 Community Research Partnership

  1. John C. Williamson
  2. Thomas F. Wierzba
  3. Michele Santacatterina
  4. Iqra Munawar
  5. Austin L. Seals
  6. Christine Ann Pittman Ballard
  7. Martha Alexander-Miller
  8. Michael S. Runyon
  9. Lewis H. McCurdy
  10. Michael A. Gibbs
  11. Amina Ahmed
  12. William H. Lagarde
  13. Patrick D. Maguire
  14. Robin King-Thiele
  15. Terri Hamrick
  16. Abdalla Ihmeidan
  17. Shakira Henderson
  18. T. Ryan Gallaher
  19. Diane Uschner
  20. Sharon L. Edelstein
  21. David M. Herrington
  22. John W. Sanders
  23. on behalf of the North Carolina sites of the COVID-19 Community Research Partnership

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Abstract

The COVID-19 Community Research Partnership is a population-based longitudinal syndromic and sero-surveillance study. The study includes over 17,000 participants from six healthcare systems in North Carolina who submitted over 49,000 serology results. The purpose of this study is to use these serology data to estimate the cumulative proportion of the North Carolina population that has either been infected with SARS-CoV-2 or developed a measurable humoral response to vaccination.

Methods

Adult community residents were invited to participate in the study between April 2020 and February 2021. Demographic information was collected and daily symptom screen was completed using a secure, HIPAA-compliant, online portal. A portion of participants were mailed kits containing a lateral flow assay to be used in-home to test for presence of anti-SARS-CoV-2 IgM or IgG antibodies. The cumulative proportion of participants who tested positive at least once during the study was estimated. A standard Cox proportional hazards model was constructed to illustrate the probability of seroconversion over time up to December 20, 2020 (before vaccines available). A separate analysis was performed to describe the influence of vaccines through February 15, 2021.

Results

17,688 participants contributed at least one serology result. 68.7% of the population were female, and 72.2% were between 18 and 59 years of age. The average number of serology results submitted per participant was 3.0 (±1.9). By December 20, 2020, the overall probability of seropositivity in the CCRP population was 32.6%. By February 15, 2021 the probability among healthcare workers and non-healthcare workers was 83% and 49%, respectively. An inflection upward in the probability of seropositivity was demonstrated around the end of December, suggesting an influence of vaccinations, especially for healthcare workers. Among healthcare workers, those in the oldest age category (60+ years) were 38% less likely to have seroconverted by February 15, 2021.

Conclusions

Results of this study suggest more North Carolina residents may have been infected with SARS-CoV-2 than the number of documented cases as determined by positive RNA or antigen tests. The influence of vaccinations on seropositivity among North Carolina residents is also demonstrated. Additional research is needed to fully characterize the impact of seropositivity on immunity and the ultimate course of the pandemic.

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  1. Version published to 10.1371/journal.pone.0260574
  2. ScreenIT

    SciScore for 10.1101/2021.03.11.21253226: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All participants provided informed consent for study procedures, including those required to secure a blood sample for serology testing.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The kits contained a lateral flow assay (LFA) to be used in-home to test for presence of anti-SARS-CoV-2 IgM or IgG antibodies.
    anti-SARS-CoV-2 IgM or IgG
    suggested: None
    In the first three months of the study, participants received a LFA by Syntron Bioresearch Inc., which detects IgM and IgG antibodies to the SARS-CoV-2 nucleocapsid antigens.
    SARS-CoV-2 nucleocapsid antigens.
    suggested: (Proteintech Cat# 28769-1-AP, RRID:AB_2881212)
    which detects IgM and IgG antibodies to the spike protein and nucleocapsid antigens.
    IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Beginning in July 2020, participants received a LFA by Innovita Biological Technology Co.,
    Innovita Biological
    suggested: None

    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:
    There are other limitations to this study that need to be acknowledged. The demographics of the CCRP study population do not match that of the general population in North Carolina. There was an imbalance in sex and race, with over-representation of females and Whites. There was under-representation of young adults less than age 30. Not to mention, adolescent and pediatric residents (age <18 years) were not studied in the CCRP. For these reasons, it may not be appropriate to generalize these results to all populations in North Carolina. The performance characteristics of LFAs in the detection of anti-SARS-CoV-2 antibodies should be considered in the interpretation of these data. The sensitivity/specificity of the Syntron LFA are: IgM 93.3%/97.5%, IgG 73.3%/100%, IgM or IgG 96.7%/97.5%. The sensitivity/specificity of the Innovita LFA are: IgM 93.3%/98.8%, IgG 93.3%/98.8%, IgM or IgG 100%/97.5%. While these performance characteristics evoke some concern about the accuracy of test results, the pattern of increasing probability of seropositivity over time along with the apparent influence of vaccinations provide some measure of internal validity. Not to mention, LFAs were possibly the only practical method of determining serology status for a study population of this magnitude. Population immunity (“herd immunity”) is the point at which the incidence of infection decreases once a certain amount of the population has acquired immunity. Public health experts are particularly interes...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04342884RecruitingCOVID-19 Community Research Partnership

    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 10.1101/2021.03.11.21253226 on medRxiv