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

DOI: 10.12688/wellcomeopenres.15927.1 DOI Help

Authors: Emily R. Adams (Liverpool School of Tropical Medicine) , Mark Ainsworth (Oxford University Hospitals NHS Foundation Trust) , Rekha Anand (NHS Blood and Transplant Birmingham) , Monique I. Andersson (Oxford University Hospitals NHS Foundation Trust) , Kathryn Auckland (University of Oxford) , J. Kenneth Baillie (University of Edinburgh) , Eleanor Barnes (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Sally Beer (Oxford University Hospitals NHS Foundation Trust) , John I. Bell (University of Oxford) , Tamsin Berry (Department of Health and Social Care, UK Government) , Sagida Bibi (University of Oxford) , Miles Carroll (University of Oxford; Public Health England) , Senthil K. Chinnakannan (University of Oxford) , Elizabeth Clutterbuck (University of Oxford) , Richard J. Cornall (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Derrick W. Crook (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Thushan De Silva (University of Sheffield) , Wanwisa Dejnirattisai (University of Oxford) , Kate E. Dingle (University of Oxford) , Christina Dold (University of Oxford) , Alexis Espinosa (Oxford University Hospitals NHS Foundation Trust) , David W. Eyre (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Helen Farmer (Department of Health and Social Care, UK Government) , Maria Fernandez Mendoza (Oxford University Hospitals NHS Foundation Trust) , Dominique Georgiou (Oxford University Hospitals NHS Foundation Trust) , Sarah J. Hoosdally (University of Oxford) , Alastair Hunter (NHS Blood and Transplant Basildon) , Katie Jefferey (Oxford University Hospitals NHS Foundation Trust) , Dominic F. Kelly (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Paul Klenerman (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Julian Knight (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Clarice Knowles (Department of Health and Social Care, UK Government) , Andrew J. Kwok (University of Oxford) , Ullrich Leuschner (NHS Blood and Transplant Oxford) , Robert Levin (Worthing Hospital) , Chang Liu (University of Oxford) , César López-Camacho (University of Oxford) , Jose Martinez (Oxford University Hospitals NHS Foundation Trust) , Philippa C. Matthews (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Hannah Mcgivern (University of Oxford) , Alexander J. Mentzer (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Jonathan Milton (University of Oxford) , Juthathip Mongkolsapaya (University of Oxford) , Shona C. Moore (University of Liverpool) , Marta S. Oliveira (University of Oxford) , Fiona Pereira (Imperial College London) , Elena Perez (Oxford University Hospitals NHS Foundation Trust) , Timothy Peto (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Rutger J. Ploeg (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Andrew Pollard (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Tessa Prince (University of Liverpool) , David J. Roberts (John Radcliffe Hospital) , Justine K. Rudkin (University of Oxford) , Veronica Sanchez (Oxford University Hospitals NHS Foundation Trust) , Gavin R. Screaton (University of Oxford) , Malcolm G. Semple (University of Liverpool; Alder Hey Children's Hospital) , Jose Slon-Campos (University of Oxford) , Donal T. Skelly (Oxford University Hospitals NHS Foundation Trust; University of Oxford) , Elliot Nathan Smith (Department of Health and Social Care, UK Government) , Alberto Sobrinodiaz (Oxford University Hospitals NHS Foundation Trust) , Julie Staves (Oxford University Hospitals NHS Foundation Trust) , David I. Stuart (University of Oxford) , Piyada Supasa (University of Oxford) , Tomas Surik (University of Oxford) , Hannah Thraves (Oxford University Hospitals NHS Foundation Trust) , Pat Tsang (John Radcliffe Hospital) , Lance Turtle (University of Liverpool; Royal Liverpool University Hospital) , A. Sarah Walker (University of Oxford) , Beibei Wang (University of Oxford) , Charlotte Washington (NHS Blood and Transplant Birmingham) , Nicholas Watkins (NHS Blood and Transplant Cambridge) , James Whitehouse (Department of Health and Social Care, UK Government)
Co-authored by industrial partner: No

Type: Journal Paper
Journal: Wellcome Open Research , VOL 5

State: Published (Approved)
Published: June 2020

Open Access Open Access

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.

Journal Keywords: COVID-19; SARS-CoV-2; serology; IgG; IgM; antibodies; immunoassay; ELISA; lateral flow; exposure; epidemiology

Diamond Keywords: COVID-19; Viruses

Subject Areas: Biology and Bio-materials, Medicine


Technical Areas:

Added On: 30/03/2021 15:00

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afaecf7d-0afc-4069-9bf2-68f1dc88d184_15927_-_rosie_mcmahon.pdf

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Life Sciences & Biotech Health & Wellbeing Infectious Diseases Pathogens

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