Evaluation of the auxiliary diagnostic value of antibody assays for the detection of novel coronavirus (SARS‐CoV‐2)

  1. Gao Yong
  2. Yuan Yi
  3. Li Tuantuan
  4. Wang Xiaowu
  5. Li Xiuyong
  6. Li Ang
  7. Han Mingfeng

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Abstract

The spread of severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) has taken on pandemic proportions, affecting over 100 countries in a matter of weeks. The goal of this study was to assess the diagnostic values of different methods of detecting and estimating the SARS‐CoV‐2 infection, and the auxiliary diagnostic potential of antibody assays. By retrospectively analyzing the data of viral RNAs and serum immunoglobulin M‐immunoglobulin G antibodies against SARS‐CoV‐2 from 38 cases with confirmed coronavirus disease 2019 in the Second People's Hospital of Fuyang, we found that, in the early phase of the illness, the viral RNA was most abundant in the sputum specimens, followed by that in the throat swabs, while the antibody assays identified fewer positive cases at this stage. However, the sensitivity of the antibody assays overtook that of RNA test from the eighth day of disease onset. Simultaneous use of antibody assay and reverse transcription‐quantitative real‐time polymerase chain reaction improved the sensitivity of the diagnoses. Moreover, we found that most of these cases with no detectable viral RNA load during the early stages were able to be seropositive after 7 days. Our findings indicate that the antibody detection could be used as an effective supplementary indicator of SARS‐CoV‐2 infection in suspected cases with no detectable viral RNA, and in conjunction with nucleic acid detection in confirming the infection.

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  1. Version published to 10.1002/jmv.25919
  2. ScreenIT

    SciScore for 10.1101/2020.03.26.20042044: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Written informed consent was waived by the Ethics Commission of the designated hospital for emerging infectious disease and the urgent need to collect data. qRT-PCR Assay for SARS-CoV-2: Respiratory specimens including throat swabs and sputum were collected, and then the throat swabs were placed into a sterile test tube with 1 mL sterile saline, the sputum samples were added equal volume of acetylcysteine and shaken at room temperature for 30 min to be fully liquefied.
    IRB: Written informed consent was waived by the Ethics Commission of the designated hospital for emerging infectious disease and the urgent need to collect data. qRT-PCR Assay for SARS-CoV-2: Respiratory specimens including throat swabs and sputum were collected, and then the throat swabs were placed into a sterile test tube with 1 mL sterile saline, the sputum samples were added equal volume of acetylcysteine and shaken at room temperature for 30 min to be fully liquefied.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Viral RNAs and serum IgM-IgG antibodies against SARS-CoV-2 were measured by qRT-PCR (Real-Time Reverse Transcription Polymerase Chain Reaction Assay) and GICA assay (Colloidal Gold Antibodies Test), respectively.
    antibodies against SARS-CoV-2 were measured by qRT-PCR (Real-Time Reverse Transcription Polymerase Chain Reaction Assay)
    suggested: None
    Colloidal Gold Antibodies Test for SARS-CoV-2: Serum IgG and IgM antibodies against SARS-CoV-2 were tested by using a GICA kits according to the manufacturer’s protocol (Innovita Biological Technology Co., Ltd.).
    SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical Analysis: All analyses were performed using SPSS 19.0.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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. Version published to 10.1101/2020.03.26.20042044v1 on medRxiv