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Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel.
Adams, Emily R; 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.
  • Adams ER; Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
  • Ainsworth M; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Anand R; NHS Blood and Transplant Birmingham, Vincent Drive, Birmingham, B15 2SG, UK.
  • Andersson MI; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Auckland K; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Baillie JK; Roslin Institute, University of Edinburgh, Edinburgh, EH25 9RJ, UK.
  • Barnes E; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Beer S; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Bell JI; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Berry T; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Bibi S; Department of Health and Social Care, UK Government, London, UK.
  • Carroll M; Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, OX3 7LE, UK.
  • Chinnakannan SK; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Clutterbuck E; Public Health England, Porton Down, Salisbury, SP4 0JG, UK.
  • Cornall RJ; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Crook DW; Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, OX3 7LE, UK.
  • de Silva T; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Dejnirattisai W; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Dingle KE; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Dold C; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Espinosa A; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX, UK.
  • Eyre DW; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Farmer H; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Fernandez Mendoza M; Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, OX3 7LE, UK.
  • Georgiou D; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Hoosdally SJ; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Hunter A; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Jefferey K; Department of Health and Social Care, UK Government, London, UK.
  • Kelly DF; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Klenerman P; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Knight J; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Knowles C; NHS Blood and Transplant Basildon, Burnt Mills Industrial Estate, Basildon, SS13 1FH, UK.
  • Kwok AJ; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Leuschner U; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Levin R; Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, OX3 7LE, UK.
  • Liu C; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • López-Camacho C; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Martinez J; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Matthews PC; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • McGivern H; Department of Health and Social Care, UK Government, London, UK.
  • Mentzer AJ; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Milton J; NHS Blood and Transplant Oxford, John Radcliffe Hospital, Oxford, UK.
  • Mongkolsapaya J; Worthing Hospital, Worthing, BN11 2DH, UK.
  • Moore SC; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Oliveira MS; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Pereira F; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Perez E; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
  • Peto T; Nuffield Department of Medicine and NIHR Oxford Biomedical Research Centre,, University of Oxford, Oxford, OX3 9DU, UK.
  • Ploeg RJ; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, UK.
  • Pollard A; Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 9DU, UK.
Wellcome Open Res ; 5: 139, 2020.
Article in English | MEDLINE | ID: covidwho-1140800
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

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Language: English Journal: Wellcome Open Res Year: 2020 Document Type: Article Affiliation country: Wellcomeopenres.15927.1

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Language: English Journal: Wellcome Open Res Year: 2020 Document Type: Article Affiliation country: Wellcomeopenres.15927.1