Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant

Mlcochova, P.; Collier, D.; Ritchie, A.; Assennato, S. M.; Hosmillo, M.; Goel, N.; Meng, B.; Chatterjee, K.; Mendoza, V.; Temperton, N.; Kiss, L.; James, L. C.; Ciazynska, K. A.; Xiong, X.; Briggs, J. A. G.; Nathan, J. A.; Mescia, F.; Bergamaschi, L.; Zhang, H.; Barmpounakis, P.; Demeris, N.; Skells, R.; Lyons, P. A.; Bradley, J.; Baker, S.; Allain, J. P.; Smith, K. G. C.; Bousfield, R.; Wilson, M.; Sparkes, D.; Amoroso, G.; Gkrania-Klotsas, E.; Hardwick, S.; Boyle, A.; Goodfellow, I.; Gupta, R. K.; Baker, S.; Dougan, G.; Gupta, R.; Lehner, P. J.; Lyons, P.; Matheson, N. J.; Toshner, M.; Weekes, M. P.; Brown, N.; Curran, M.; Palmar, S.; Enoch, D.; Chapman, D.; Shaw, A.; Jose, S.; Bermperi, A.; Zerrudo, J. A.; Kourampa, E.; Watson, L.; Worsley, J.; Saunders, C.; de Jesus, R.; Domingo, J.; Pasquale, C.; Vergese, B.; Vargas, P.; Fabiculana, M.; Perales, M.; Mynott, L.; Blake, E.; Bates, A.; Vallier, A. -L.; Williams, A.; Phillips, D.; Chiu, E.; Overhill, A.; Ramenatte, N.; Sipple, J.; Frost, S.; Knock, H.; Hardy, R.; Foster, E.; Davidson, F.; Rundell, V.; Bundi, P.; Abeseabe, R.; Clark, S.; Vicente, I.; Elmer, A.; Ribeiro, C.; Kourampa, J.; Kennet, J.; Rowlands, J.; Meadows, A.; O'Brien, C.; Rastall, R.; Crucusio, C.; Hewitt, S.; Price, J.; Calder, J.; Canna, L.; Bucke, A.; Tordesillas, H.; Harris, J.; Ruffolo, V.; Graves, B.; Butcher, H.; Caputo, D.; Le Gresley, E.; Dunmore, B. J.; Martin, J.; Legchenko, E.; Treacy, C.; Huang, C.; Wood, J.; Sutcliffe, R.; Hodgson, J.; Shih, J.; Graf, S.; Tong, Z.; Tilly, T.; O'Donnell, C.; Hunter, K.; Pointon, L.; Pond, N.; Wylot, M.; Jones, E.; Fawke, S.; Bullman, B.; Turner, L.; Jarvis, I.; Omarjee, O.; De Sa, A.; Marsden, J.; Betancourt, A.; Perera, M.; Epping, M.; Richoz, N.; Bower, G.; Sharma, R.; Nice, F.; Huhn, O.; Savoinykh Yarkoni, N.; Romashova, N.; Lewis, D.; Hinch, A.; Cossetti, C.; Strezlecki, M.; Grenfell, R.; Stark, H.; Walker, N.; Stirrups, K.; Ovington, N.; Dewhust, E.; Li, E.; Papadia, S.; Kingston, N.; Lever, A.; Torok, E.; Hamilton, W.; Hall, G.; Jahun, A.; Chaudhry, Y.; Pinckert, M.; Georgana, I.; Yakovleva, A.; Caller, L.; Caddy, S.; Feltwell, T.; Khokhar, F.; Meredith, L.; Holdcroft, C.; Parmar, S.

doi:10.1016/j.xcrm.2020.100099

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.