Diagnosis value of SARS‐CoV‐2 antigen/antibody combined testing using rapid diagnostic tests at hospital admission

  1. Nicolas Veyrenche
  2. Karine Bolloré
  3. Amandine Pisoni
  4. Anne‐Sophie Bedin
  5. Anne‐Marie Mondain
  6. Jacques Ducos
  7. Michel Segondy
  8. Brigitte Montes
  9. Patrick Pastor
  10. David Morquin
  11. Alain Makinson
  12. Vincent Le Moing
  13. Philippe Van de Perre
  14. Vincent Foulongne
  15. Edouard Tuaillon

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Abstract

The implementation of rapid diagnostic tests (RDTs) may enhance the efficiency of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) testing, as RDTs are widely accessible and easy to use. The aim of this study was to evaluate the performance of a diagnosis strategy based on a combination of antigen and immunoglobulin M (IgM) or immunoglobulin G (IgG) serological RDTs. Plasma and nasopharyngeal samples were collected between 14 March and 11 April 2020 at hospital admission from 45 patients with reverse transcription polymerase chain reaction (RT‐PCR) confirmed COVID‐19 and 20 negative controls. SARS‐CoV‐2 antigen (Ag) was assessed in nasopharyngeal swabs using the Coris Respi‐Strip. For IgM/IgG detection, SureScreen Diagnostics and Szybio Biotech RDTs were used in addition to laboratory assays (Abbott Alinity i SARS‐CoV‐2 IgG and Theradiag COVID‐19 IgM enzyme‐linked immunosorbent assay). Using the Ag RDT, 13 out of 45 (29.0%) specimens tested positive, the sensitivity was 87.0% for cycle threshold ( C t ) values ≤25% and 0% for C t values greater than 25. IgG detection was associated with high C t values and the amount of time after the onset of symptoms. The profile of isolated IgM on RDTs was more frequently observed during the first and second week after the onset of symptoms. The combination of Ag and IgM/IgG RDTs enabled the detection of up to 84.0% of COVID‐19 confirmed cases at hospital admission. Antigen and antibody‐based RDTs showed suboptimal performances when used alone. However when used in combination, they are able to identify most COVID‐19 patients admitted in an emergency department.

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  1. ScreenIT

    SciScore for 10.1101/2020.09.19.20197855: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The cohort received an institutional ethics committee approval (CPP Ile de France III, n°2020-A00935−34; ClinicalTrials.gov Identifier: NCT04347850).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    This lateral flow assay uses colloidal gold nanoparticles sensitized with monoclonal antibodies directed against highly conserved SARS-CoV-2 nucleoprotein antigens.
    SARS-CoV-2 nucleoprotein antigens.
    suggested: None
    These RDTs use a chromatographic immunoassay format and are dedicated to the qualitative detection of IgG and IgM antibodies directed against SARS-CoV-2 in human whole blood, serum and plasma.
    IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    COVID-19 confirmed-subjects were grouped according to the average value of the Cycle Threshold (CT), CT ≤ 25, 25 < CT < 35 and CT ≥ 35. Laboratory IgG and IgM immunoassays: Plasma samples were tested using the SARS-CoV-2 IgG immunoassay on the Alinity i system (Abbott, Illinois, USA).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Analyses were performed using GraphPad Prism 8.0 (GraphPad Prism Software Inc., San Diego, California).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04347850RecruitingA Cohort of Patients With Possible or Confirmed SARS-CoV-2 (…

    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 10.1002/jmv.26855
  3. Version published to 10.1101/2020.09.19.20197855 on medRxiv