Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel

Derrick W. Crook*, Gavin R. Screaton, 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, Thushan de Silva, Wanwisa Dejnirattisai, Kate E. DingleChristina 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, 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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

47 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number139
JournalWellcome Open Research
Volume5
Early online date11 Jun 2020
DOIs
Publication statusE-pub ahead of print - 11 Jun 2020

Bibliographical note

Funding Information:
This work uses data and samples provided by patients and collected by the NHS as part of their care and support. We are extremely grateful to the frontline NHS clinical and research staff and volunteer medical students, who collected this data in challenging circumstances; and the generosity of the participants and their families for their individual contributions. We would like to thank Carla Wright and Rosie McMahon for administrative assistance.

Publisher Copyright:
© 2020 Adams ER et al.

Keywords

  • Antibodies
  • COVID-19
  • ELISA
  • Epidemiology
  • Exposure
  • IgG
  • IgM
  • Immunoassay
  • Lateral flow
  • SARS-CoV-2
  • Serology

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