COMPARISON OF PERFORMANCE CHARACTERISTICS BETWEEN LATERAL FLOW, ELISAAND ELECTROCHEMILUMINESCENCE IMMUNOASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES AMONG HEALTHCARE WORKERS

  1. Shincy M R
  2. Vandana Govindan
  3. Sudhakar H H
  4. Padmapriya K
  5. Venkatesha V T
  6. K L Ravikumar

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Abstract

Background: The detection of SARS-CoV-2 IgG is important to determine the course of COVID-19. Medical professionals and researchers have been urging the need for wide and rapid testing of citizens in order to plan measures that can contain the spread of the virus. Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. Although RTPCR is considered to be the gold standard, serological tests based on antibodies could be very helpful for on-time detection. We performed one to one assessment of electrochemiluminescence immunoassay, enzyme immunoassay (EIAs), and point-of-care lateral ow assay (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody. Materials and Methods: 611 healthcare workers were recruited between November and December 2020 at Central Research Laboratory, KIMS. ® Collected serum samples were analysed using three commercially available assays: the Elecsys , Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assay following the manufacturer's protocol to measure the IgG titer of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Results:The kits displayed a sensitivity of 91.8%, 79.5% ,61.2% and a specicity of 80.2%, 64.1% ,61.7% in order. Conclusion: ® Our results indicate a high sensitivity and specicity for the Elecsys assay compared to Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assays.

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  1. Version published to 10.36106/ijsr/0101617
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    SciScore for 10.1101/2021.04.29.21256260: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: 2.1 Materials: This study was conducted at Central Research Laboratory, Kempegowda Institute of Medical Science Hospital& Research Centre (CRL, KIMSH&RC) and the protocol has the approval of institutional ethics committee KIMS/IEC/A044/M/2020.
    Consent: Written informed consent was taken from the participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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:
    It is important to understand their performance characteristics, limitations, and whether these antibodies convey immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts (26,27). There is an urgent need to validate these assays taking into account variables that will affect the sensitivity and specificity of the different immunoassays. The major issue faced by the commercially available assays in the market is the very little correlation in their sensitivity and specificity. The present study was designed to evaluate the sensitivity and specificity of three different methodologies for COVID 19 antibody testing with kits available in the open market. Lateral flow immunoassays have the advantage of decreased technical requirement, short turnaround time, affordability, lower sampling, and specimen preparation risk. Lateral flow immunoassays have been developed to detect anti covid IgM and IgG antibodies separately or simultaneously (28). With a large number of commercially available devices from different companies, variable sensitivity and specificity are reported in the publications (29,30,31). Serum sample set of 611 individuals obtained from 73 positive patients defined by positive RT-PCR and covid 19 symptoms and 538 negatives were evaluated with LFIA. The assay sensitivity was 61.2% and the specificity was 61.7%. Our study reports the lowest sensitivity of LFIAs among the three tests which is less than reported by...

    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.

    Results from scite Reference Check: We found no unreliable references.

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  3. Version published to 10.1101/2021.04.29.21256260v1 on medRxiv