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

Author:

,Adams Emily R,Ainsworth Mark,Anand Rekha,Andersson Monique I,Auckland Kathryn,Baillie J Kenneth,Barnes Eleanor,Beer Sally,Bell John,Berry Tamsin,Bibi Sagida,Carroll Miles,Chinnakannan Senthil,Clutterbuck Elizabeth,Cornall Richard J,Crook Derrick WORCID,De Silva Thushan,Dejnirattisai Wanwisa,Dingle Kate E,Dold Christina,Espinosa Alexis,Eyre David WORCID,Farmer Helen,Fernandez Mendoza Maria,Georgiou Dominique,Hoosdally Sarah J,Hunter Alistair,Jeffrey Katie,Klenerman Paul,Knight Julian,Knowles Clarice,Kwok Andrew J,Leuschner Ullrich,Levin Robert,Liu Chang,Lopez-Camacho Cesar,Martinez Garrido Jose Carlos,Matthews Philippa CORCID,McGivern Hannah,Mentzer Alexander JORCID,Milton Jonathan,Mongkolsapaya Juthathip,Moore Shona C,Oliveira Marta S,Pereira Fiona,Perez Lopez Elena,Peto Timothy,Ploeg Rutger J,Pollard Andrew,Prince Tessa,Roberts David J,Rudkin Justine K,Sanchez Veronica,Screaton Gavin R,Semple Malcolm G,Skelly Donal T,Slon-Campos Jose,Smith Elliot Nathan,Sobrino Diaz Alberto Jose,Staves Julie,Stuart David,Supasa Piyada,Surik Tomas,Thraves Hannah,Tsang Pat,Turtle Lance,Walker A Sarah,Wang Beibei,Washington Charlotte,Watkins Nicholas,Whitehouse James

Abstract

ABSTRACTBackgroundThe 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.MethodsWe tested plasma for COVID (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).ResultsELISA 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.ConclusionsCurrently 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.

Publisher

Cold Spring Harbor Laboratory

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