Evaluation of antibody testing for SARS-Cov-2 using ELISA and lateral flow immunoassays

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

The first cases of infection with a novel coronavirus, subsequently designated SARS-CoV-2, emerged in Wuhan, China on December 31 st , 2019. 1 Despite intensive containment efforts, there was rapid international spread and three months later, SARS-CoV-2 had caused over 1 million confirmed infections and 60,000 reported deaths. 2 Containment efforts have relied heavily on population quarantine ('lock-down') measures to restrict movement and reduce individual contacts. 3, 4 To develop public health strategies for exit from lock-down, diagnostic testing urgently needs to be scaled-up, including both mass screening and screening of specific high-risk groups (contacts of confirmed cases, and healthcare workers and their families), in parallel with collecting robust data on recent and past SARS-CoV-2 exposure at individual and population levels. 2 Laboratory diagnosis of infection has mostly been based on real-time RT-PCR, typically targeting the viral RNA-dependent RNA polymerase (RdRp) or nucleocapsid (N) genes using swabs collected from the upper respiratory tract. 5, 6 This requires specialist equipment, skilled laboratory staff and PCR reagents, creating diagnostic delays. RT-PCR from upper respiratory tract swabs may also be falsely negative due to quality or timing; viral loads in upper respiratory tract secretions peak in the first week of symptoms, 7 but may have declined below the limit of detection in those presenting later. 8 In individuals who have recovered, RT-PCR provides no information about prior exposure or immunity.