Prospective Observational COVID-19 Screening and Monitoring of Asymptomatic Cancer Center Health-Care Workers with a Rapid Serological Test

  1. Angelo Virgilio Paradiso
  2. Simona De Summa
  3. Nicola Silvestris
  4. Stefania Tommasi
  5. Antonio Tufaro
  6. Angela Maria Vittoria Larocca
  7. Vincenzo D’Addabbo
  8. Donata Raffaele
  9. Vito Cafagna
  10. Vito Michele Garrisi
  11. Giuseppe De Palma

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Abstract

Health-care workers (HCW) are at high risk for SARS-CoV-2 infection and, if asymptomatic, for transmitting the virus to fragile cancer patients. We monitored all asymptomatic HCWs of a cancer institute (94% of all employees agreed to enter the study) with the rapid serological test, VivaDiagTM, identifying SARS-CoV-2 associated-IgM/IgG. The tests were performed at time 0 (n = 606) and after 14 days (n = 393). Overall, the VivaDiagTM results of nine HCWs (1.5%) were positive, with one confirmed to be SARS-CoV-2-positive after oropharyngeal swab testing by RT-PCR. At time 0, all nine cases showed IgM expression while IgG was detected in only one. After 14 days, IgM persisted in all the cases, while IgG became evident in four. A chemiluminescence immunoassay (CLIA) confirmed IgM positivity in 5/13 VivaDiagTM positive cases and IgG positivity in 4/5 VivaDiagTM positive cases. Our study suggests that the VivaDiagTM test can be of help in identifying SARS-CoV-2 infected people in cohorts of subjects with a high prevalence.

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  1. Version published to 10.3390/diagnostics11060975
  2. ScreenIT

    SciScore for 10.1101/2020.05.05.20086017: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ethical Committee of the IstitutoTumori G. Paolo II, IRCCS, Bari with Protocol number CE 872/2020.
    Consent: After signing the written informed consent, all participants filled out a questionnaire collecting information on presence of clinical symptoms and their possible risk of COVID-19 infection (contact with confirmed SARS-CoV2 positive individuals or visits to areas with active SARS-CoV-2 circulation).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Operators who took part to the second part of the study did not statistically for clinical characteristics from the whole starting series SARS-CoV-2 rapid IgG-IgM Test: SARS-CoV-2 rapid IgG-IgM combined antibody test kit, Viva-DiagTM, was designed and manufactured by Viva-Check BIOTECH (VivaChek Biotech, Hangzhou) is a lateral flow qualitative immunoassay for the rapid determination of the presence of both anti-SARS-CoV-2-IgM and anti-SARS-CoV-2-IgG in blood.
    anti-SARS-CoV-2-IgM
    suggested: None
    anti-SARS-CoV-2-IgG
    suggested: None
    A surface antigen from SARS-CoV-2 which can specifically bind to SARS-CoV-2 antibodies (including both IgM and IgG) is conjugated to colloidal gold nanoparticles and sprayed onto conjugate pads.
    SARS-CoV-2
    suggested: None
    The presence of SARS-CoV-2 IgG and IgM antibodies is indicated by a red/purple line that appears in the specific region for those antibodies on the device.
    IgM
    suggested: None
    Briefly, the kit permits the indirect chemiluminescence qualitative-semiquantitative in vitro immunoassay of IgG and IgM antibodies against SARS-CoV-2in human blood.
    SARS-CoV-2in human blood.
    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: 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.

    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. ScreenIT

    SciScore for 10.1101/2020.04.15.20057786: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ethical Committee of the IstitutoTumori G. Paolo II, IRCCS, Bari with Protocol number CE 872/2020 together with the informed consent form which explained that quantitative serum immunoglobulin tests would be performed on the same blood samples and standard RT-PCR assays carried out on swab samples in caseswhere suspected infection was flagged up by the VivaDiag™ test.
    Consent: After signingtheir written informed consent form, all participantsfilled in a questionnaire which collected information on their possible risk ofCOVID-19 infection(contact with confirmed positive individualsor visits to areas with activeSARS-CoV-2 circulation).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    A surface antigen from SARS-CoV-2 which can specifically bind to SARS-CoV-2 antibodies (including both IgM and IgG) is conjugated to colloidal gold nanoparticles and sprayed onto conjugate pads.
    SARS-CoV-2
    suggested: None
    The SARS-CoV-2 rapid IgG-IgM combined antibody test strip has two mouse anti-human monoclonal antibodies (anti-IgG and anti-IgM) stripped on two separated test lines.
    anti-human monoclonal antibodies
    suggested: None
    anti-IgG
    suggested: None
    anti-IgM
    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: 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.

    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.

  4. Version published to 10.1101/2020.05.05.20086017 on medRxiv
  5. Version published to 10.1101/2020.04.15.20057786 on medRxiv