Assessment of a Laboratory-Based SARS-CoV-2 Antibody Test Among Hemodialysis Patients: A Quality Improvement Initiative

  1. Dena E. Cohen
  2. Gilbert Marlowe
  3. Gabriel Contreras
  4. Marie A. Sosa
  5. Jair Munoz Mendoza
  6. Oliver Lenz
  7. Zain Mithani
  8. Jorge L. Posada
  9. Julio A. Fernandez-Bombino
  10. Luis Garcia-Mayol
  11. Michael T. Lemont
  12. Anne Marie V. Miles
  13. Steven Zeig
  14. Pura M. Teixeiro
  15. Nery Queija
  16. Jean S. Jeanty
  17. Katie Swanzy
  18. Misha J. Palecek
  19. Mahesh Krishnan
  20. Jeffrey A. Giullian
  21. Steven M. Brunelli

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Abstract

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  1. ScreenIT

    SciScore for 10.1101/2020.08.03.20163642: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Therefore, according to title 45, part 46 of the US Department of Health and Human Services’ Code of Federal Regulations, this study was deemed exempt from institutional review board (IRB) or ethics committee approval (Quorum IRB, Seattle, WA).
    Consent: We adhered to the Declaration of Helsinki and informed consent was not required.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Indirect chemiluminescence immunoassays for anti-SARS-CoV2 IgM and IgG antibodies (Diazyme Laboratories, Inc) were performed according to the manufacturer’s protocol at a centralized, accredited clinical laboratory (DaVita Labs).
    anti-SARS-CoV2 IgM
    suggested: None
    IgG antibodies (Diazyme Laboratories, Inc)
    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:
    This study should be interpreted in the context of its limitations. The number of COVID-19+ and COVID-19- patients available for analysis was small. Patients were sampled at only one time point, precluding longitudinal analysis of antibody concentrations following symptom onset. The date of symptom onset among symptomatic patients was abstracted from data collected for administrative purposes. The results reported here pertain only to the specific antibody test used and cannot be generalized to other laboratory-based assays or to point- of-care lateral flow immunoassays.

    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.

  2. Version published to 10.1681/asn.20203110s1271b
  3. Version published to 10.1101/2020.08.03.20163642v1 on medRxiv