Accuracy of four lateral flow immunoassays for anti SARS-CoV-2 antibodies: a head-to-head comparative study

  1. Hayley E Jones
  2. Ranya Mulchandani
  3. Sian Taylor-Phillips
  4. A E Ades
  5. Justin Shute
  6. Keith R Perry
  7. Nastassya L Chandra
  8. Tim Brooks
  9. Andre Charlett
  10. Matthew Hickman
  11. Isabel Oliver
  12. Stephen Kaptoge
  13. John Danesh
  14. Emanuele Di Angelantonio
  15. David Wyllie

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

No abstract available

Article activity feed

  1. Version published to 10.1016/j.ebiom.2021.103414
  2. ScreenIT

    SciScore for 10.1101/2021.01.30.21250777: (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
    All EDSAB-HOME samples were first tested with two laboratory immunoassays: Roche Elecsys®, which measures total (including IgG and IgM) antibodies against the Nucleoprotein, and EuroImmun, which measures IgG antibodies against the S protein S1 domain.
    IgM) antibodies against the Nucleoprotein,
    suggested: None
    Among individuals who were positive on Roche Elecsys®, we also plotted the relationship between sensitivity and anti-Nucleoprotein (Roche Elecsys®) and anti-S1 (EuroImmun) antibody indices.
    anti-Nucleoprotein
    suggested: None
    anti-S1 (EuroImmun)
    suggested: None
    Software and Algorithms
    SentencesResources
    We analysed blood samples from 2,847 key workers participating in the EDSAB-HOME study and 1,995 pre-pandemic blood donors from the COMPARE study (24), in a laboratory setting.
    COMPARE
    suggested: (COMPARE, RRID:SCR_000855)

    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:
    A limitation is that tests were conducted in a laboratory setting, with the majority reading across three expert readers being taken as the result. For devices with discrepancies between readers, the accuracy of a single reader can be expected to lower (21). Accuracy may be lower still if devices were read by individuals with less or no training, and may differ if device reading technologies were used. SureScreen IgG band, followed by OrientGene IgG band, had the highest concordance across readers. An ongoing difficulty in this field is the ambiguity as to whether the true parameters of interest are sensitivity and specificity to previous infection, to presence of specific antibodies, or to “immunity”. Although most individuals seroconvert (15), both the anti-S and anti-N antibody response appears to be highly specific to SARS-CoV-2 (12), and there is now evidence that presence of antibody response correlates with reduced risk (3, 4), these three potential “target conditions” are unlikely to coincide exactly, particularly given declining antibody responses over time. Our estimates are best interpreted as sensitivity and specificity to “recent” SARS-CoV-2 infection (Approach 1) or to presence of an antibody response (Approach 2), which we expect to correlate very highly. Estimates of sensitivity based on a laboratory immunoassay reference standard may be slightly biased due to errors made by the reference standard. We explored this with sensitivity analyses using two alternati...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    ISRCTN56609224NANA
    ISRCTN90871183NANA

    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 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 10.1101/2021.01.30.21250777v1 on medRxiv