OraSure InteliSwab™ Rapid Antigen Test Performance with the SARS-CoV-2 Variants of Concern—Alpha, Beta, Gamma, Delta, and Omicron
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Date
2022
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Journal ISSN
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Publisher
viruses
Abstract
The emergence of SARS-CoV-2 in the human population and the resulting COVID-19 pandemic
have led to the development of various diagnostic tests. The OraSure InteliSwab™ COVID-19
Rapid Test is a recently developed and FDA emergency use-authorized rapid antigen-detecting
test that functions as a lateral flow device targeting the nucleocapsid protein. Due to SARS-CoV-2
evolution, there is a need to evaluate the sensitivity of rapid antigen-detecting tests for new variants,
especially variants of concern such as Omicron. In this study, the sensitivity of the OraSure
InteliSwab™ Test was investigated using cultured strains of the known variants of concern (VOCs, Alpha,
Beta, Gamma, Delta, and Omicron) and the ancestral lineage (lineage A). Based on dilution series
in cell culture medium, an approximate limit of detection for each variant was determined. The Ora-
Sure InteliSwab™ Test showed an overall comparable performance using recombinant nucleocapsid
protein and different cultured variants, with recorded limits of detection ranging between 3.77 105
and 9.13 105 RNA copies/mL. Finally, the sensitivity was evaluated using oropharyngeal swabs
from Syrian golden hamsters inoculated with the six VOCs. Ultimately, the OraSure InteliSwab™
COVID-19 Rapid Test showed no decrease in sensitivity between the ancestral SARS-CoV-2 strain
and any VOCs including Omicron.
Description
Research Article
Keywords
SARS-CoV-2, COVID-19, rapid antigen-detecting test, variants of concern, Delta, Omicron