@article{National_COVID_Testing_Scientific_Advisory_Panel-2020_31818,
title = {Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel},
author = {National COVID Testing Scientific Advisory Panel and Crook, D. and Screaton, G. and Adams, E. and Ainsworth, M. and Anand, R. and Andersson, M. and Auckland, K. and Baillie, J. and Barnes, E. and Beer, S. and Bell, J. and Berry, T. and Bibi, S. and Carroll, M. and Chinnakannan, S. and Clutterbuck, E. and Cornall, R. and de Silva, T. and Dejnirattisai, W. and Dingle, K. and Dold, C. and Espinosa, A. and Eyre, D. and Farmer, H. and Mendoza, M. and Georgiou, D. and Hoosdally, S. and Hunter, A. and Jeffery, K. and Kelly, D. and Klenerman, P. and Knight, J. and Knowles, C. and Kwok, A. and Leuschner, U. and Levin, R. and Liu, C. and López-Camacho, C. and Martinez, J. and Matthews, P. and McGivern, H. and Mentzer, A. and Milton, J. and Mongkolsapaya, J. and Moore, S. and Oliveira, M. and Pereira, F. and Perez, E. and Peto, T. and Ploeg, R. and Pollard, A. and Prince, T. and Roberts, D. and Rudkin, J. and Sanchez, V. and Semple, M. and Slon-Campos, J. and Skelly, D. and Smith, E. and Sobrinodiaz, A. and Staves, J. and Stuart, D. and Supasa, P. and Surik, T. and Thraves, H. and Tsang, P. and Turtle, L. and Walker, A. and Wang, B. and Washington, C. and Watkins, N. and Whitehouse, J.},
month = {jun},
year = {2020},
abstract = {Background: 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. 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.},
volume = {5},
journal = {Wellcome Open Research},
publisher = {Wellcome Open Research},
url = {https://doi.org/10.12688/wellcomeopenres.15927.1},
}
