Journal
CELL REPORTS MEDICINE
Volume 1, Issue 6, Pages -Publisher
CELL PRESS
DOI: 10.1016/j.xcrm.2020.100099
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Funding
- Wellcome Trust [WT108082AIA, 207498/Z/17/Z]
- National Institute for Health Research (NIHR) Cambridge Biomedical Research Centre and the Cambridge Clinical Trials Unit (CCTU)
- Medical Research Council (MRC) (UK) [U105181010]
- Wellcome Investigator Award
- European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme [ERC-CoG-648432 MEMBRANEFUSION]
- MRC [MC_UP_1201/16]
- MRC [MC_U105181010, MC_UP_1201/16] Funding Source: UKRI
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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.
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