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

Wellcome Open Research

article

Emily R. Adams¹  Mark Ainsworth²  Rekha Anand³  Monique I. Andersson²  Thushan de Silva⁴  Wanwisa Dejnirattisai⁵  Kate E. Dingle⁵  Christina Dold⁶  Alexis Espinosa²  David W. Eyre²  Helen Farmer⁷  Maria Fernandez Mendoza²  Dominique Georgiou²  Sarah J. Hoosdally⁵  Alastair Hunter⁸  Katie Jefferey²  Dominic F. Kelly²  Paul Klenerman²  Julian Knight²  Clarice Knowles⁷  Andrew J. Kwok⁵  Ullrich Leuschner⁹  Robert Levin^1,10  Chang Liu⁵  César López-Camacho⁵  Jose Martinez²  Philippa C. Matthews²  Hannah McGivern^1,11  Alexander J. Mentzer²  Jonathan Milton^1,11  Juthathip Mongkolsapaya⁵  Shona C. Moore^1,12  Marta S. Oliveira^1,11  Fiona Pereira^1,13  Elena Perez²  Timothy Peto²  Rutger J. Ploeg²  Andrew Pollard²  Tessa Prince^1,12  David J. Roberts⁹  Justine K. Rudkin⁵  Veronica Sanchez²  Gavin R. Screaton⁵  Malcolm G. Semple^1,12  Jose Slon-Campos⁵  Donal T. Skelly²  Elliot Nathan Smith⁷  Alberto Sobrinodiaz²  Julie Staves²  David I. Stuart⁵  Piyada Supasa⁵  Tomas Surik^1,11  Hannah Thraves²  Pat Tsang⁹  Lance Turtle^1,12  A. Sarah Walker⁵  Beibei Wang⁵  Charlotte Washington³  Nicholas Watkins^1,18  James Whitehouse⁷  Kathryn Auckland⁵  J. Kenneth Baillie^1,19  Eleanor Barnes²  Sally Beer²  John I. Bell⁵  Tamsin Berry⁷  Sagida Bibi⁶  Miles Carroll⁵  Senthil K. Chinnakannan⁵  Elizabeth Clutterbuck⁶  Richard J. Cornall²  Derrick W. Crook² 

[1] Liverpool School of Tropical Medicine;Oxford University Hospitals NHS Foundation Trust;NHS Blood and Transplant Birmingham, Vincent Drive;Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield;Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford;Department of Paediatrics, Oxford Vaccine Group, University of Oxford;Department of Health and Social Care;NHS Blood and Transplant Basildon;NHS Blood and Transplant Oxford, John Radcliffe Hospital;Worthing Hospital;Nuffield Department of Surgical Sciences, University of Oxford;NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Faculty of Health and Life Sciences, University of Liverpool;Imperial College London;Alder Hey Children's Hospital;Nuffield Department of Clinical Neurosciences, University of Oxford;Diamond Light Source, Harwell Science and Innovation Campus;Tropical & Infectious Disease Unit, Royal Liverpool University Hospital ,(member of Liverpool Health Partners);NHS Blood and Transplant Cambridge;Roslin Institute, University of Edinburgh;Public Health England

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

DOI  :  10.12688/wellcomeopenres.15927.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: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.

【 授权许可】

CC BY