Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel [version 1; peer review: 2 approved]



Adams, Emily R, Ainsworth, Mark, Anand, Rekha, Andersson, Monique I, Auckland, Kathryn, Baillie, J Kenneth, Barnes, Eleanor, Beer, Sally, Bell, John I, Berry, Tamsin
et al (show 62 more authors) (2020) Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel [version 1; peer review: 2 approved]. Wellcome Open Research, 5.

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Abstract

The COVID-19 pandemic caused &gt;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.</ns4:p><ns4:p> <ns4:bold>Methods:</ns4:bold> 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).</ns4:p><ns4:p> <ns4:bold>Results: </ns4:bold>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.</ns4:p><ns4:p> <ns4:bold>Conclusions:</ns4:bold> 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
Uncontrolled Keywords: COVID-19, SARS-CoV-2, serology, IgG, IgM, antibodies, immunoassay, ELISA, lateral flow, exposure, epidemiology
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences
Depositing User: Symplectic Admin
Date Deposited: 11 May 2021 07:00
Last Modified: 20 Oct 2021 19:10
DOI: 10.12688/wellcomeopenres.15927.1
Open Access URL: https://doi.org/10.12688/wellcomeopenres.15927.1
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3119244

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