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Cell Rep Med. 2020 Sep 22;1(6):100099. doi: 10.1016/j.xcrm.2020.100099. Epub 2020 Sep 01.

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

Cell reports. Medicine

Petra Mlcochova, Dami Collier, Allyson Ritchie, Sonny M Assennato, Myra Hosmillo, Neha Goel, Bo Meng, Krishna Chatterjee, Vivien Mendoza, Nigel Temperton, Leo 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 A Lyons, John Bradley, Steven Baker, Jean Pierre Allain, Kenneth G C Smith, Rachel Bousfield, Michael Wilson, Dominic Sparkes, Glenn Amoroso, Effrosyni Gkrania-Klotsas, Susie Hardwick, Adrian Boyle, Ian Goodfellow, Ravindra K Gupta,

Affiliations

  1. Cambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge, UK.
  2. Department of Medicine, University of Cambridge, Cambridge, UK.
  3. Division of Infection and Immunity, University College London, London WC1E 6BT, UK.
  4. Diagnostics for the Real World EU, Chesterford Research Park, UK.
  5. Department of Pathology, University of Cambridge, Cambridge, UK.
  6. NIHR Cambridge Clinical Research Facility, Cambridge, UK.
  7. Viral Pseudotype Unit, Medway School of Pharmacy, University of Kent, Kent, UK.
  8. Medical Research Council Laboratory of Molecular Biology, Cambridge, UK.
  9. Clinical Microbiology & Public Health Laboratory, Cambridge University NHS Hospitals Foundation Trust, Cambridge, UK.
  10. Department of Statistics, Athens University of Economics and Business, Athens, Greece.
  11. Cambridge Clinical Trials Unit-Cancer Theme, University of Cambridge, Cambridge, UK.
  12. National Institutes for Health Research Cambridge Biomedical Research Centre, Cambridge, UK.
  13. Department of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge, UK.
  14. Department of Emergency Medicine, Cambridge University NHS Hospitals Foundation Trust, Cambridge, UK.
  15. Africa Health Research Institute, Durban, South Africa.

PMID: 32905045 PMCID: PMC7462534 DOI: 10.1016/j.xcrm.2020.100099

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.

© 2020 The Author(s).

Keywords: COVID-19; D614G; SARS-CoV-2; point of care testing; rapid diagnoses

Conflict of interest statement

The authors declare no competing interests.

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