tetano
Editor, Senior Moderator
Wellcome Open Res
. 2020 Jun 11;5:139.
doi: 10.12688/wellcomeopenres.15927.1. eCollection 2020.
Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel
Emily R Adams[SUP] 1 [/SUP], Mark Ainsworth[SUP] 2 [/SUP], Rekha Anand[SUP] 3 [/SUP], Monique I Andersson[SUP] 2 [/SUP], Kathryn Auckland[SUP] 4 [/SUP], J Kenneth Baillie[SUP] 5 [/SUP], Eleanor Barnes[SUP] 2 4 [/SUP], Sally Beer[SUP] 2 [/SUP], John I Bell[SUP] 4 [/SUP], Tamsin Berry[SUP] 6 [/SUP], Sagida Bibi[SUP] 7 [/SUP], Miles Carroll[SUP] 4 8 [/SUP], Senthil K Chinnakannan[SUP] 4 [/SUP], Elizabeth Clutterbuck[SUP] 7 [/SUP], Richard J Cornall[SUP] 2 4 [/SUP], Derrick W Crook[SUP] 2 4 [/SUP], Thushan de Silva[SUP] 9 [/SUP], Wanwisa Dejnirattisai[SUP] 4 [/SUP], Kate E Dingle[SUP] 4 [/SUP], Christina Dold[SUP] 7 [/SUP], Alexis Espinosa[SUP] 2 [/SUP], David W Eyre[SUP] 2 4 [/SUP], Helen Farmer[SUP] 6 [/SUP], Maria Fernandez Mendoza[SUP] 2 [/SUP], Dominique Georgiou[SUP] 2 [/SUP], Sarah J Hoosdally[SUP] 4 [/SUP], Alastair Hunter[SUP] 10 [/SUP], Katie Jefferey[SUP] 2 [/SUP], Dominic F Kelly[SUP] 2 7 [/SUP], Paul Klenerman[SUP] 2 4 [/SUP], Julian Knight[SUP] 2 4 [/SUP], Clarice Knowles[SUP] 6 [/SUP], Andrew J Kwok[SUP] 4 [/SUP], Ullrich Leuschner[SUP] 11 [/SUP], Robert Levin[SUP] 12 [/SUP], Chang Liu[SUP] 4 [/SUP], C?sar L?pez-Camacho[SUP] 4 [/SUP], Jose Martinez[SUP] 2 [/SUP], Philippa C Matthews[SUP] 2 4 [/SUP], Hannah McGivern[SUP] 13 [/SUP], Alexander J Mentzer[SUP] 2 4 [/SUP], Jonathan Milton[SUP] 13 [/SUP], Juthathip Mongkolsapaya[SUP] 4 [/SUP], Shona C Moore[SUP] 14 [/SUP], Marta S Oliveira[SUP] 13 [/SUP], Fiona Pereira[SUP] 15 [/SUP], Elena Perez[SUP] 2 [/SUP], Timothy Peto[SUP] 2 4 [/SUP], Rutger J Ploeg[SUP] 2 13 [/SUP], Andrew Pollard[SUP] 2 7 [/SUP], Tessa Prince[SUP] 14 [/SUP], David J Roberts[SUP] 11 [/SUP], Justine K Rudkin[SUP] 4 [/SUP], Veronica Sanchez[SUP] 2 [/SUP], Gavin R Screaton[SUP] 4 [/SUP], Malcolm G Semple[SUP] 14 16 [/SUP], Jose Slon-Campos[SUP] 4 [/SUP], Donal T Skelly[SUP] 2 17 [/SUP], Elliot Nathan Smith[SUP] 6 [/SUP], Alberto Sobrinodiaz[SUP] 2 [/SUP], Julie Staves[SUP] 2 [/SUP], David I Stuart[SUP] 4 18 [/SUP], Piyada Supasa[SUP] 4 [/SUP], Tomas Surik[SUP] 13 [/SUP], Hannah Thraves[SUP] 2 [/SUP], Pat Tsang[SUP] 11 [/SUP], Lance Turtle[SUP] 14 19 [/SUP], A Sarah Walker[SUP] 4 [/SUP], Beibei Wang[SUP] 4 [/SUP], Charlotte Washington[SUP] 3 [/SUP], Nicholas Watkins[SUP] 20 [/SUP], James Whitehouse[SUP] 6 [/SUP], National COVID Testing Scientific Advisory Panel
Affiliations
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.
Keywords: COVID-19; ELISA; IgG; IgM; SARS-CoV-2; antibodies; epidemiology; exposure; immunoassay; lateral flow; serology.
. 2020 Jun 11;5:139.
doi: 10.12688/wellcomeopenres.15927.1. eCollection 2020.
Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel
Emily R Adams[SUP] 1 [/SUP], Mark Ainsworth[SUP] 2 [/SUP], Rekha Anand[SUP] 3 [/SUP], Monique I Andersson[SUP] 2 [/SUP], Kathryn Auckland[SUP] 4 [/SUP], J Kenneth Baillie[SUP] 5 [/SUP], Eleanor Barnes[SUP] 2 4 [/SUP], Sally Beer[SUP] 2 [/SUP], John I Bell[SUP] 4 [/SUP], Tamsin Berry[SUP] 6 [/SUP], Sagida Bibi[SUP] 7 [/SUP], Miles Carroll[SUP] 4 8 [/SUP], Senthil K Chinnakannan[SUP] 4 [/SUP], Elizabeth Clutterbuck[SUP] 7 [/SUP], Richard J Cornall[SUP] 2 4 [/SUP], Derrick W Crook[SUP] 2 4 [/SUP], Thushan de Silva[SUP] 9 [/SUP], Wanwisa Dejnirattisai[SUP] 4 [/SUP], Kate E Dingle[SUP] 4 [/SUP], Christina Dold[SUP] 7 [/SUP], Alexis Espinosa[SUP] 2 [/SUP], David W Eyre[SUP] 2 4 [/SUP], Helen Farmer[SUP] 6 [/SUP], Maria Fernandez Mendoza[SUP] 2 [/SUP], Dominique Georgiou[SUP] 2 [/SUP], Sarah J Hoosdally[SUP] 4 [/SUP], Alastair Hunter[SUP] 10 [/SUP], Katie Jefferey[SUP] 2 [/SUP], Dominic F Kelly[SUP] 2 7 [/SUP], Paul Klenerman[SUP] 2 4 [/SUP], Julian Knight[SUP] 2 4 [/SUP], Clarice Knowles[SUP] 6 [/SUP], Andrew J Kwok[SUP] 4 [/SUP], Ullrich Leuschner[SUP] 11 [/SUP], Robert Levin[SUP] 12 [/SUP], Chang Liu[SUP] 4 [/SUP], C?sar L?pez-Camacho[SUP] 4 [/SUP], Jose Martinez[SUP] 2 [/SUP], Philippa C Matthews[SUP] 2 4 [/SUP], Hannah McGivern[SUP] 13 [/SUP], Alexander J Mentzer[SUP] 2 4 [/SUP], Jonathan Milton[SUP] 13 [/SUP], Juthathip Mongkolsapaya[SUP] 4 [/SUP], Shona C Moore[SUP] 14 [/SUP], Marta S Oliveira[SUP] 13 [/SUP], Fiona Pereira[SUP] 15 [/SUP], Elena Perez[SUP] 2 [/SUP], Timothy Peto[SUP] 2 4 [/SUP], Rutger J Ploeg[SUP] 2 13 [/SUP], Andrew Pollard[SUP] 2 7 [/SUP], Tessa Prince[SUP] 14 [/SUP], David J Roberts[SUP] 11 [/SUP], Justine K Rudkin[SUP] 4 [/SUP], Veronica Sanchez[SUP] 2 [/SUP], Gavin R Screaton[SUP] 4 [/SUP], Malcolm G Semple[SUP] 14 16 [/SUP], Jose Slon-Campos[SUP] 4 [/SUP], Donal T Skelly[SUP] 2 17 [/SUP], Elliot Nathan Smith[SUP] 6 [/SUP], Alberto Sobrinodiaz[SUP] 2 [/SUP], Julie Staves[SUP] 2 [/SUP], David I Stuart[SUP] 4 18 [/SUP], Piyada Supasa[SUP] 4 [/SUP], Tomas Surik[SUP] 13 [/SUP], Hannah Thraves[SUP] 2 [/SUP], Pat Tsang[SUP] 11 [/SUP], Lance Turtle[SUP] 14 19 [/SUP], A Sarah Walker[SUP] 4 [/SUP], Beibei Wang[SUP] 4 [/SUP], Charlotte Washington[SUP] 3 [/SUP], Nicholas Watkins[SUP] 20 [/SUP], James Whitehouse[SUP] 6 [/SUP], National COVID Testing Scientific Advisory Panel
Affiliations
- PMID: 33748431
- PMCID: PMC7941096
- DOI: 10.12688/wellcomeopenres.15927.1
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.
Keywords: COVID-19; ELISA; IgG; IgM; SARS-CoV-2; antibodies; epidemiology; exposure; immunoassay; lateral flow; serology.