A prospective, single-center study to evaluate the clinical performance of Meril ABFind in individuals vaccinated against COVID-19

  1. Jayanthi Shastri
  2. Sachee Agrawal
  3. Nirjhar Chatterjee
  4. Harsha Gupta

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Abstract

Background

Accurate rapid antibody detection kits requiring minimum infrastructure are beneficial in detecting post-vaccination antibodies in large populations. ChAdOx1-nCOV (COVISHIELD™) and BBV-152 (Covaxin™) vaccines are primarily used in India.

Methods

In this single-centre prospective study, performance of Meril ABFind was investigated by comparing with Abbott SARS-CoV-2 IgG II Quant (Abbott Quant), GenScript cPass SARS-CoV-2 neutralization antibody detection kit (GenScript cPass), and COVID Kawach MERILISA (MERILISA) in 62 vaccinated health care workers (HCW) and 40 pre-pandemic samples.

Results

In the vaccinated subjects, Meril ABFind kit displayed high sensitivity of 93.3% (CI, 89.83%-96.77%), 94.92% (CI, 91.88%-97.96%), and 90.3% (CI, 86.20%-94.4%) in comparison to Abbott Quant, MERILISA, and GenScript cPass respectively. The results of the Meril ABFind in the COVISHIELD-vaccinated group were excellent with 100% sensitivity in comparison to the other three kits. In the Covaxin-vaccinated group, Meril ABFind displayed sensitivity ranging from 80% to 88.9%. In control samples, there were no false positives detected by Meril ABFind, while Abbott Quant, MERILISA, and GenScript cPass reported 2.5%, 10.0%, and 12.5% false positives, respectively. In the pre-pandemic controls, specificity of Meril ABFind was 100%, Abbott Quant 97.5%, MERILISA 90%, and GenScript cPass 87.5%.

Conclusion

The Meril ABFind kit demonstrated satisfactory performance when compared with the three commercially available kits and was the only kit without false positives in the pre-pandemic samples. This makes it a viable option for rapid diagnosis of post vaccination antibodies.

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  1. ScreenIT

    SciScore for 10.1101/2022.01.15.22269231: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the Institutional Review Board of Kasturba Hospital of Infectious Diseases, Mumbai, India; IRB number 05/2021.
    Consent: Written informed consent was obtained from all study participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    This detection kit utilizes a colloidal gold labeled SARS-CoV-2 recombinant Receptor Binding Domain (rRBD) which binds with the SARS-CoV-2 neutralizing antibody of IgG class if present in the sample to give a colored band.
    SARS-CoV-2 recombinant Receptor Binding Domain
    suggested: None
    SARS-CoV-2 neutralizing antibody of IgG
    suggested: None
    For pre-pandemic control samples, all the samples were considered as true negative as the samples were collected in 2018 before the emergence of SARS-CoV-2 and therefore antibodies against SARS-CoV-2 could not be present in these samples.
    SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    2.3 Serological Tests: All the samples were tested first using Abbott SARS-CoV-2 IgG II Quant (Abbott Quant).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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.

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

    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 10.1101/2022.01.15.22269231v1 on medRxiv