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. L.; Briggs, John A. G.; Nathan, J. A.; Mescia, F.; Bergamaschi, L.; Zhang, H. Y.; 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.; Cambridge Inst Therapeutic, Immunol

doi:10.1016/j.xcrm.2020.100099

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

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Mlcochova, P., Collier, D., Ritchie, A., Assennato, S. M., Hosmillo, M., Goel, N., et al. (2020). Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant. Cell Reports Medicine, 1(6): 100099. doi:10.1016/j.xcrm.2020.100099.

Cite as: https://hdl.handle.net/21.11116/0000-0009-723F-1

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 wildtype 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.