Combined point of care nucleic acid and antibody testing for SARS-CoV-2 following emergence of D614G Spike Variant

Mlcochova, Petra; Collier, Dami; Ritchie, Allyson; Assennato, Sonny M.; Hosmillo, Myra; Goel, Neha; Meng, Bo; Chatterjee, Krishna; Mendoza, Vivien; Temperton, Nigel; Kiss, Leo; James, Leo C.; Ciazynska, Katarzyna A.; Xiong, Xiaoli; Briggs, John AG.; Nathan, James A.; Mescia, Federica; Bergamaschi, Laura; Zhang, Hongyi; Barmpounakis, Petros; Demeris, Nikos; Skells, Richard; Lyons, Paul A.; Bradley, John; Baker, Steven; Allain, Jean Pierre; Smith, Kenneth GC.; Bousfield, Rachel; Wilson, Michael; Sparkes, Dominic; Amoroso, Glenn; Gkrania-Klotsas, Effrosyni; Hardwick, Susie; Boyle, Adrian; Goodfellow, Ian; Gupta, Ravindra K.; Baker, Stephen; Dougan, Gordon; Gupta, Ravi; Lehner, Paul J.; Lyons, Paul; Matheson, Nicholas J.; Smith, Kenneth G.C.; Toshner, Mark; Weekes, Michael P.; Brown, Nick; Curran, Martin; Palmar, Surendra; Enoch, David; Chapman, Daniel; Shaw, Ashley; Jose, Sherly; Bermperi, Areti; Zerrudo, Julie Ann; Kourampa, Evgenia; Watson, Laura; Worsley, Jieniean; Saunders, Caroline; de Jesus, Ranalie; Domingo, Jason; Pasquale, Ciro; Vergese, Bensi; Vargas, Phoebe; Fabiculana, Marivic; Perales, Marlyn; Mynott, Lee; Blake, Elizabeth; Bates, Amy; Vallier, Anne-Laure; Williams, Alexandra; Phillips, David; Chiu, Edmund; Overhill, Alex; Ramenatte, Nicola; Sipple, Jamal; Frost, Steven; Knock, Helena; Hardy, Richard; Foster, Emily; Davidson, Fiona; Rundell, Viona; Bundi, Purity; Abeseabe, Richmond; Clark, Sarah; Vicente, Isabel; Elmer, Anne; Ribeiro, Carla; Kourampa, Jenny; Kennet, Jane; Rowlands, Jane; Meadows, Anne; O’Brien, Criona; Rastall, Rebecca; Crucusio, Cherry; Hewitt, Sarah; Price, Jane; Calder, Jo; Canna, Laura; Bucke, Ashlea; Tordesillas, Hugo; Harris, Julie; Ruffolo, Valentina; Graves, Barbara; Butcher, Helen; Caputo, Daniela; Le Gresley, Emma; Dunmore, Benjamin J.; Martin, Jennifer; Legchenko, Ekaterina; Treacy, Carmen; Huang, Christopher; Wood, Jennifer; Sutcliffe, Rachel; Hodgson, Josh; Shih, Joy; Graf, Stefan; Tong, Zhen; Tilly, Tobias; O’Donnell, Ciara; Hunter, Kelvin; Pointon, Linda; Pond, Nicole; Wylot, Marta; Jones, Emma; Fawke, Stuart; Bullman, Ben; Turner, Lori; Jarvis, Isobel; Omarjee, Ommar; De Sa, Aloka; Marsden, Joe; Betancourt, Ariana; Perera, Marianne; Epping, Maddie; Richoz, Nathan; Bower, Georgie; Sharma, Rahul; Nice, Francesca; Huhn, Oisin; Yarkoni, Natalia Savoinykh; Romashova, Nika; Lewis, Daniel; Hinch, Andrew; Cossetti, Chiara; Strezlecki, Mateusz; Grenfell, Richard; Stark, Hannah; Walker, Neil; Stirrups, Kathy; Ovington, Nigel; Dewhust, Eleanor; Li, Emily; Papadia, Sofia

Rapid COVID-19 diagnosis in hospital is essential, though complicated by 30-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant now 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% (95CI 57.8-92.9%) by rapid NAAT alone. Combined point of care antibody test and rapid NAAT is not impacted by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.