Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population

  1. Caitlin Greenland-Bews
  2. Rachel L. Byrne
  3. Sophie I. Owen
  4. Rachel L. Watkins
  5. Daisy Bengey
  6. Kate Buist
  7. Karina Clerkin
  8. Camille Escadafal
  9. Lorna S. Finch
  10. Susan Gould
  11. Emanuele Giorgi
  12. Andy Hodgkinson
  13. Larysa Mashenko
  14. Darren Powell
  15. Helen R. Savage
  16. Caitlin R. Thompson
  17. Lance Turtle
  18. Jahanara Wardale
  19. Dominic Wooding
  20. Thomas Edwards
  21. Ana Cubas Atienzar
  22. Emily R. Adams

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Background

Rapid determination of an individual’s antibody status can be beneficial in understanding an individual’s immune response to SARS-CoV-2 and for initiation of therapies that are only deemed effective in sero-negative individuals. Antibody lateral flow tests (LFTs) have potential to address this need as a rapid, point of care test.

Methods

Here we present a proof-of-concept evaluation of eight LFT brands using sera from 95 vaccinated individuals to determine sensitivity for detecting vaccination generated antibodies. Samples were analysed on eight different brands of antibody LFT and an automated chemiluminescent microparticle immunoassay (CMIA) that identifies anti-spike antibodies which was used as our reference standard.

Results

All 95 (100%) participants tested positive for anti-spike antibodies by the chemiluminescent microparticle immunoassay (CMIA) reference standard post-dose two of their SARS-CoV-2 vaccine: BNT162b2 (Pfizer/BioNTech, n = 60), AZD1222 (AstraZeneca, n = 31), mRNA-1273 (Moderna, n = 2) and Undeclared Vaccine Brand (n = 2). Sensitivity increased from dose one to dose two in six out of eight LFTs with three tests achieving 100% sensitivity at dose two in detecting anti-spike antibodies.

Conclusions

These tests are demonstrated to be highly sensitive to detect raised antibody levels in vaccinated individuals. RDTs are low cost and rapid alternatives to ELISA based systems.

Article activity feed

  1. Version published to 10.1186/s12879-023-08033-1
  2. ScreenIT

    SciScore for 10.1101/2022.04.04.22273232: (What is this?)

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

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    Antibodies
    SentencesResources
    Although all tests used in this study detect both IgM and IgG antibodies, IgG was the focus of this investigation and results from IgM are not included.
    IgG
    suggested: None
    SARS-CoV-2 IgG II CMIA (Abbott, Ireland) was used to quantify anti-S-RBD IgG antibodies in serum samples.
    anti-S-RBD IgG
    suggested: None
    When using these assays, individuals positive for anti-nucleocapsid IgG antibodies are considered to have been naturally infected with SARS-CoV-2 and will also test positive for anti-S-RBD IgG antibodies.
    anti-nucleocapsid IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    SARS-CoV-2 IgG II CMIA (Abbott, Ireland) was used to quantify anti-S-RBD IgG antibodies in serum samples.
    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.

  3. Version published to 10.1101/2022.04.04.22273232v2 on medRxiv
  4. Version published to 10.1101/2022.04.04.22273232v1 on medRxiv