Comparison and analysis of various complementary diagnosis methods for the current situation and problems of COVID-19 diagnosis

  1. Hee Jin Huh
  2. Seok Lae Chae
  3. Dong-Min Kim

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Abstract

We evaluated and compared the diagnostic performance of fluorescence immunoassay (FIA) and two types of serological diagnostic tests: enzyme-linked immunosorbent assay (ELISA) and immunochromatographic assay (ICA) for detection of SARS-CoV-2 antigen and antibody to diagnose COVID-19 infections. This study is aimed to analyze and compare the current status and problems of COVID-19 diagnosis and various alternative diagnostic methods that are viable. The enrolled subjects in our study population were tested with real-time polymerase chain reaction (RT-PCR). ELISA and immunochromatographic diagnostic kit were used to diagnose 362 positive and 3010 negative SARS-CoV-2 specimens, and antigen fluorescence immunoassay kit was used on 62 positive and 70 negative SARS-CoV-2 RT-PCR confirmed samples for diagnosis. As a result, categorizing by the patient symptom onset days, PCL COVID19 Total Ab EIA (ELISA) showed the sensitivity of 93.4% from 15 to 21 days, 94.2% from over 22 days, and the specificity of 99.97%. PCL COVID19 IgG/IgM Rapid Gold (ICA) had a sensitivity of 86.9%, 97.4%, and the specificity of 98.14% respectively. PCL COVID19 Ag Rapid FIA sensitivity was 93.8% from 0 to 7 days, 71.4% from 8 to 12 days and specificity was 98.57%. In conclusion, COVID-19 Ab ELISA and ICA, and COVID-19 Ag FIA are all complementary and applicable diagnostic methods to resolve the current problems of COVID-19 diagnosis.

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  1. ScreenIT

    SciScore for 10.1101/2021.01.14.21249620: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    RT-PCR confirmation assay: Nasopharyngeal swabs were obtained from each patient for RT-PCR, which was performed using the CFX96™ Real-time PCR detection system (Bio-Rad Laboratories, Hercules, CA) with the Allplex™ 2019-nCoV Assay kit (Seegene Inc., Seoul, Korea) according to the manufacturer’s instructions.
    Bio-Rad Laboratories
    suggested: (Bio-Rad Laboratories, RRID:SCR_008426)
    The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.
    SARS-CoV-2
    suggested: (Active Motif Cat# 91351, RRID:AB_2847848)
    A diagnostic value test of the ELISA and rapid antibody method was performed with MedCalc software, version 19.5.1 (Mariakerke, Belgium).
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)

    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:
    While RT-PCR remains an effective microbial diagnostics technique, however, when used alone in the areas of confirming COVID-19, there are some limitations or weaknesses, such as the inability to differentiate virus viability and the development of indeterminate or false-negative results due to low target cell numbers in specimens16. To manage these problems, different methods of diagnosis were required for suspected and supervised COVID-19 infections. From the aforementioned reasons, complementary diagnosis is required in addition to the RT-PCR-based diagnostic method. Among them, COVID-19 Ab Enzyme-Linked Immunosorbent Assay (ELISA), COVID-19 Ab Immunochromatographic rapid test, and COVID-19 Antigen Fluorescent Immunoassay rapid test can be used. ELISA has proven its validity as a diagnostic method for a long time since it was published by Peter Perlmann and Eva Engvall in 1971. The fact that ELSIA can be implemented to a large-scale automatized equipment makes it a suitable complementary diagnosis method regarding the current issue with the COVI-19 pandemic. Immunochromatography was developed with the aim of detecting antigens in blood in the late 1960s and has been validated as a diagnostic method for various infections. The advantages of immunochromatography are its simple test methods, significantly shorter time required to prepare samples and reagents compared to other methods, and inexpensive equipment required for making a diagnosis. Also, it can be applied in variou...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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 10.1101/2021.01.14.21249620v1 on medRxiv