Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant
Petra Mlčochová, Dami A. Collier, Allyson V. Ritchie, Sonny Michael Assennato, Myra Hosmillo, Neha Goel, Bo Meng, Krishna Chatterjee, Vivien Mendoza, Nigel Temperton, L. Kiss, Leo C. James, Katarzyna A. Ciazynska, Xiaoli Xiong, John A. G. Briggs, James A. Nathan, Federica Mescia, Laura Bergamaschi, Hongyi Zhang, Petros Barmpounakis, Nikos Demeris, Richard Skells, Paul Lyons, John R. Bradley, S. C. Deng X Fau Baker, Jean Pierre Allain, Kenneth G. C. Smith, Rachel Bousfield, Michael J. Wilson, Dominic Sparkes, Glenn Amoroso, Effrossyni Gkrania‐Klotsas, Susie Hardwick, Adrian Boyle, Ian Goodfellow, Ravindra K. Gupta, Stephen Baker, John R. Bradley, Gordon Dougan, Ian Goodfellow, Ravi Gupta, Paul J. Lehner, Paul Lyons, Nicholas J. Matheson, Kenneth G. C. Smith, Mark Toshner, Michael P. Weekes, Mark Toshner, Martin D. Curran, Surendra Palmar, Hongyi Zhang, David Enoch, Daniel Chapman, Ashley Shaw, Sherly Jose, Areti Bermperi, Julie Ann Zerrudo, Evgenia Kourampa, Laura Watson, Jieniean Worsley, Caroline Saunders, Ranalie de Jesus, Jason Domingo, Ciro Pasquale, Bensi Vergese, Phoebe Vargas, Marivic Fabiculana, Marlyn Perales, Lee Mynott, Elizabeth Blake, Amy Bates, Anne-Laure Vallier, Alexandra Williams, David Phillips, Edmund Chiu, Alex Overhill, Nicola Ramenatte, Jamal Sipple, Steven A. Frost, Helena Knock, Richard E. Hardy, Emily Foster, Fiona Davidson, Viona Rundell, Purity Bundi, Richmond Abeseabe, Sarah Clark, Isabel Vicente, Laura Watson, Jieniean Worsley, Anne Elmer, Carla Ribeiro, Jenny Kourampa, Sherly Jose, Jane Kennet, Jane Rowlands, Anne Meadows, Criona O’Brien, Rebecca Rastall, Cherry Crucusio
Abstract
Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8-92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.