Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel
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Published:2020-06-11
Issue:
Volume:5
Page:139
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ISSN:2398-502X
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Container-title:Wellcome Open Research
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language:en
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Short-container-title:Wellcome Open Res
Author:
Adams Emily R., Ainsworth Mark, Anand Rekha, Andersson Monique I.ORCID, Auckland Kathryn, Baillie J. Kenneth, Barnes Eleanor, Beer SallyORCID, Bell John I., Berry Tamsin, Bibi Sagida, Carroll Miles, Chinnakannan Senthil K.ORCID, Clutterbuck Elizabeth, Cornall Richard J.ORCID, Crook Derrick W.ORCID, de Silva Thushan, Dejnirattisai Wanwisa, Dingle Kate E.ORCID, Dold Christina, Espinosa Alexis, Eyre David W., Farmer Helen, Fernandez Mendoza Maria, Georgiou Dominique, Hoosdally Sarah J., Hunter Alastair, Jefferey KatieORCID, Kelly Dominic F., Klenerman Paul, Knight Julian, Knowles Clarice, Kwok Andrew J., Leuschner Ullrich, Levin Robert, Liu Chang, López-Camacho CésarORCID, Martinez Jose, Matthews Philippa C.ORCID, McGivern HannahORCID, Mentzer Alexander J.ORCID, Milton Jonathan, Mongkolsapaya Juthathip, Moore Shona C., Oliveira Marta S., Pereira Fiona, Perez Elena, Peto Timothy, Ploeg Rutger J.ORCID, Pollard AndrewORCID, Prince TessaORCID, Roberts David J., Rudkin Justine K.ORCID, Sanchez Veronica, Screaton Gavin R., Semple Malcolm G.ORCID, Slon-Campos Jose, Skelly Donal T.ORCID, Smith Elliot Nathan, Sobrinodiaz Alberto, Staves Julie, Stuart David I.ORCID, Supasa Piyada, Surik Tomas, Thraves Hannah, Tsang Pat, Turtle LanceORCID, Walker A. Sarah, Wang Beibei, Washington Charlotte, Watkins Nicholas, Whitehouse James,
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.
Funder
NIHR Oxford Biomedical Research Centre National Institute for Health Research Public Health England NIHR Health Protection Research Unit in Emerging and Zoonotic Infections UK Government Department of Health and Social Care National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance Wellcome Trust Medical Research Council
Publisher
F1000 Research Ltd
Subject
General Biochemistry, Genetics and Molecular Biology,Medicine (miscellaneous)
Cited by
170 articles.
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