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Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests
Mary A Rodgers; Rahul Batra; Luke B Snell; David J Daghfal; Richard Roth; Shihai Huang; Stephen Kovacs; Gaia Nebbia; Sam Douthwaite; Gavin A Cloherty.
Afiliación
  • Mary A Rodgers; Abbott Diagnostics
  • Rahul Batra; Guys and St Thomas NHS Foundation
  • Luke B Snell; Guys and St Thomas NHS Foundation
  • David J Daghfal; Abbott Diagnostics
  • Richard Roth; Abbott Rapid Diagnostics
  • Shihai Huang; Abbott Molecular Diagnostics
  • Stephen Kovacs; Abbott Rapid Diagnostics
  • Gaia Nebbia; Guys and St Thomas NHS Foundation
  • Sam Douthwaite; Guys and St Thomas NHS Foundation
  • Gavin A Cloherty; Abbott Diagnostics
Preprint en Inglés | medRxiv | ID: ppmedrxiv-21256045
ABSTRACT
BackgroundViral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. ObjectivesTo evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect the SARS-CoV-2 B.1.1.7, B.1.351 and the P.1 variants. Study designVirus variant culture stock dilutions (B.1.1.7, BEI NR-54011; B.1.351, BEI NR-54008 and 54009; P.1, BEI NR-54982) and clinical samples from patients with confirmed B.1.1.7 variant infection were run on the Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. ResultsCultured virus stocks and B.1.1.7 clinical samples were detected with molecular, antigen, and serologic assays in the expected ranges, confirming in silico predictions. The ratio between genome equivalents (GE) and calculated median tissue culture infectious dose (TCID50) were 31-to 83-fold higher for B.1.1.7 cultures compared to B.1.351 and P.1 cultures, demonstrating that GE are more consistent units between cultures than TCID50. ConclusionsAbbott molecular and antigen assays effectively detect B.1.1.7, B.1.351, and P.1 variant infections and Abbott serologic assays detect B.1.1.7 antibodies in patient sera. Future studies with SARS-CoV-2 virus cultures should use quantitative viral load values to compare detection of variants. HighlightsO_LIAbbott SARS-CoV-2 molecular and antigen assays detect B.1.1.7, B.1.351, and P.1 variants C_LIO_LIAbbott SARS-CoV-2 antibody assays detect B.1.1.7 antibodies in recovered patient sera C_LIO_LIQuantitation of viral load in genome equivalents allows comparison of assay performance C_LI
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Texto completo: Disponible Colección: Preprints Base de datos: medRxiv Tipo de estudio: Estudio diagnóstico / Experimental_studies / Estudio pronóstico Idioma: Inglés Año: 2021 Tipo del documento: Preprint
Texto completo: Disponible Colección: Preprints Base de datos: medRxiv Tipo de estudio: Estudio diagnóstico / Experimental_studies / Estudio pronóstico Idioma: Inglés Año: 2021 Tipo del documento: Preprint
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