The importance of determining SARS-CoV-2 N-Ag serodiagnostics for the management of COVID-19 pneumonia in hospital settings

  1. YuS Lebedin
  2. OV Lyang
  3. AG Galstyan
  4. AV Panteleeva
  5. VV Belousov
  6. DV Rebrikov

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Abstract

A new coronavirus infection caused by the SARS-CoV-2 virus, which appeared in December 2019, has claimed the lives of 2.5 million people in almost a year. The high contagiousness of this virus has led to its wide and rapid spread around the world. As of February 2021, the total number of cases is 111 million people; more than 4 million cases of SARS-CoV-2 infection have been registered in the Russian Federation. To successfully combat the emerging pandemic, it is necessary to quickly diagnose the disease at an early stage, which will prevent the further spread of this virus and prescribe the necessary treatment on time. The aim of the work was to evaluate the use of the SARS-CoV-2 nucleocapsid antigen (N-Ag) and respective antibodies as diagnostic markers in pneumonia patients. The study was conducted at the height of COVID-19 pandemic in Moscow, Russia. It included 425 emergency patients with clinical signs of COVID-19 pneumonia, of which 280 (66%) were positive for either serum N-Ag and/or its respective antibodies. We demonstrate the total prevalence of N-Ag seroconversion in SARS-CoV-2associated pneumonia patients within 3–5 days after hospital admission. The results indicate high feasibility of SARS-CoV-2 serodiagnostics in emergency patients.

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  1. ScreenIT

    SciScore for 10.1101/2020.09.24.20200303: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study protocol was reviewed and approved: by the Local Ethics Committee of the Pirogov Russian State Medical University (meeting #194 from March 16 2020, Protocol No.2020/07); the study was conducted in accordance with the Declaration of Helsinki.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Serum IgG antibodies: against nucleocapsid antigen (N-IgG) were detected by solid-phase enzyme immunoassay.
    antibodies: against nucleocapsid antigen ( N-IgG
    suggested: None
    After 3 washes with 0.1% Tween-20 in 0.9% sodium chloride, the wells were exposed to the conjugate of murine monoclonal antibodies XG78 against human IgG (gamma chain) with horseradish peroxidase (XEMA) for 30 minutes.
    human IgG
    suggested: None
    Serum IgM antibodies: against nucleocapsid antigen (N-IgM) were detected by reverse solid phase enzyme immunoassay.
    antibodies: against nucleocapsid antigen ( N-IgM )
    suggested: None
    Software and Algorithms
    SentencesResources
    The color development was stopped by 5% sulfuric acid and the optical density (OD) at 450 nm was measured in a plate reader (Multiskan MC, Thermo Labsystems).
    Thermo Labsystems
    suggested: (Bioscreen C MBR, RRID:SCR_007172)

    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.

  2. Version published to 10.24075/brsmu.2021.009
  3. Version published to 10.1101/2020.09.24.20200303v1 on medRxiv