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

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Adams, Emily ORCID: https://orcid.org/0000-0002-0816-2835, Ainsworth, Mark, Anand, Rekha, Andersson, Monique I., Auckland, Kathryn, Baillie, J. Kenneth, Barnes, Eleanor, Beer, Sally, Bell, John I., Berry, Tamsin, Bibi, Sagida, Carroll, Miles, Chinnakannan, Senthil K., Clutterbuck, Elizabeth, Cornall, Richard J., Crook, Derrick W., de Silva, Thushan, Dejnirattisai, Wanwisa, Dingle, Kate E., Dold, Christina, Espinosa, Alexis, Eyre, David W., Farmer, Helen, Fernandez Mendoza, Maria, Georgiou, Dominique, Hoosdally, Sarah J., Hunter, Alastair, Jefferey, Katie, Kelly, Dominic F., Klenerman, Paul, Knight, Julian, Knowles, Clarice, Kwok, Andrew J., Leuschner, Ullrich, Levin, Robert, Liu, Chang, López-Camacho, César, Martinez, Jose, Matthews, Philippa C., McGivern, Hannah, Mentzer, Alexander J., Milton, Jonathan, Mongkolsapaya, Juthathip, Moore, Shona C., Oliveira, Marta S., Pereira, Fiona, Perez, Elena, Peto, Timothy, Ploeg, Rutger J., Pollard, Andrew, Prince, Tessa, Roberts, David J., Rudkin, Justine K., Sanchez, Veronica, Screaton, Gavin R., Semple, Malcolm G., Slon-Campos, Jose, Skelly, Donal T., Smith, Elliot Nathan, Sobrinodiaz, Alberto, Staves, Julie, Stuart, David I., Supasa, Piyada, Surik, Tomas, Thraves, Hannah, Tsang, Pat, Turtle, Lance, Walker, A. Sarah, Wang, Beibei, Washington, Charlotte, Watkins, Nicholas and Whitehouse, James (2020) 'Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel'. Wellcome Open Research, Vol 5, p. 139.

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Official URL: https://wellcomeopenresearch.org/articles/5-139

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.

Item Type:	Article
Subjects:	QW Microbiology and Immunology > QW 4 General works. Classify here works on microbiology as a whole. QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 575 Antibodies WA Public Health > WA 105 Epidemiology WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 505 Viral respiratory tract infections
Faculty: Department:	Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.12688/wellcomeopenres.15927.1
Depositing User:	Cathy Waldron
Date Deposited:	07 Apr 2021 09:56
Last Modified:	16 Apr 2021 13:20
URI:	https://archive.lstmed.ac.uk/id/eprint/17449

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