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

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.

• Authors: 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, Derrick W Crook, Thushan de Silva, Wanwisa Dejnirattisai, Kate E Dingle, Christina 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, Gavin R Screaton, 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, National COVID Testing Scientific Advisory Panel
• Journal: Wellcome open research (Wellcome Open Res) Vol. 5 Pg. 139 ( 2020) ISSN: 2398-502X [Print] England
• PMID: 33748431 (Publication Type: Journal Article)
• Copyright: Copyright: © 2020 Adams ER et al.