Wellcome Open Research (Jun 2020)

Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel [version 1; peer review: 2 approved]

  • Emily R. Adams,
  • Mark Ainsworth,
  • Rekha Anand,
  • Monique I. Andersson,
  • Kathryn Auckland,
  • J. Kenneth Baillie,
  • Eleanor Barnes,
  • Sally Beer,
  • John I. Bell,
  • Tamsin Berry,
  • Sagida Bibi,
  • Miles Carroll,
  • Senthil K. Chinnakannan,
  • Elizabeth Clutterbuck,
  • Richard J. Cornall,
  • Derrick W. Crook,
  • Thushan de Silva,
  • Wanwisa Dejnirattisai,
  • Kate E. Dingle,
  • Christina Dold,
  • Alexis Espinosa,
  • David W. Eyre,
  • Helen Farmer,
  • Maria Fernandez Mendoza,
  • Dominique Georgiou,
  • Sarah J. Hoosdally,
  • Alastair Hunter,
  • Katie Jefferey,
  • Dominic F. Kelly,
  • Paul Klenerman,
  • Julian Knight,
  • Clarice Knowles,
  • Andrew J. Kwok,
  • Ullrich Leuschner,
  • Robert Levin,
  • Chang Liu,
  • César López-Camacho,
  • Jose Martinez,
  • Philippa C. Matthews,
  • Hannah McGivern,
  • Alexander J. Mentzer,
  • Jonathan Milton,
  • Juthathip Mongkolsapaya,
  • Shona C. Moore,
  • Marta S. Oliveira,
  • Fiona Pereira,
  • Elena Perez,
  • Timothy Peto,
  • Rutger J. Ploeg,
  • Andrew Pollard,
  • Tessa Prince,
  • David J. Roberts,
  • Justine K. Rudkin,
  • Veronica Sanchez,
  • Gavin R. Screaton,
  • Malcolm G. Semple,
  • Jose Slon-Campos,
  • Donal T. Skelly,
  • Elliot Nathan Smith,
  • Alberto Sobrinodiaz,
  • Julie Staves,
  • David I. Stuart,
  • Piyada Supasa,
  • Tomas Surik,
  • Hannah Thraves,
  • Pat Tsang,
  • Lance Turtle,
  • A. Sarah Walker,
  • Beibei Wang,
  • Charlotte Washington,
  • Nicholas Watkins,
  • James Whitehouse,
  • National COVID Testing Scientific Advisory Panel

DOI
https://doi.org/10.12688/wellcomeopenres.15927.1
Journal volume & issue
Vol. 5

Abstract

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Background: The COVID-19 pandemic caused >1 million infections during January-March 2020. There is an urgent need for reliable antibody detection approaches to support diagnosis, vaccine development, safe release of individuals from quarantine, and population lock-down exit strategies. We set out to evaluate the performance of ELISA and lateral flow immunoassay (LFIA) devices. Methods: We tested plasma for COVID (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) IgM and IgG antibodies by ELISA and using nine different LFIA devices. We used a panel of plasma samples from individuals who have had confirmed COVID infection based on a PCR result (n=40), and pre-pandemic negative control samples banked in the UK prior to December-2019 (n=142). Results: ELISA detected IgM or IgG in 34/40 individuals with a confirmed history of COVID infection (sensitivity 85%, 95%CI 70-94%), vs. 0/50 pre-pandemic controls (specificity 100% [95%CI 93-100%]). IgG levels were detected in 31/31 COVID-positive individuals tested ≥10 days after symptom onset (sensitivity 100%, 95%CI 89-100%). IgG titres rose during the 3 weeks post symptom onset and began to fall by 8 weeks, but remained above the detection threshold. Point estimates for the sensitivity of LFIA devices ranged from 55-70% versus RT-PCR and 65-85% versus ELISA, with specificity 95-100% and 93-100% respectively. Within the limits of the study size, the performance of most LFIA devices was similar. Conclusions: Currently available commercial LFIA devices do not perform sufficiently well for individual patient applications. However, ELISA can be calibrated to be specific for detecting and quantifying SARS-CoV-2 IgM and IgG and is highly sensitive for IgG from 10 days following first symptoms.