| Autor: |
Weishampel ZA; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Young J; OraSure Technologies Inc., Research and Development, Bethlehem, PA 18015, USA., Fischl M; OraSure Technologies Inc., Research and Development, Bethlehem, PA 18015, USA., Fischer RJ; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Donkor IO; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA.; Noguchi Memorial Institute for Medical Research, Epidemiology Department, University of Ghana, Legon, GHAN., Riopelle JC; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Schulz JE; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Port JR; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Saturday TA; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., van Doremalen N; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Berry JD; OraSure Technologies Inc., Research and Development, Bethlehem, PA 18015, USA., Munster VJ; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA., Yinda CK; Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, MT 59840, USA. |
| Abstrakt: |
The emergence of SARS-CoV-2 in the human population and the resulting COVID-19 pandemic has 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 like 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 OraSure InteliSwab ® Test showed an overall comparable performance using recombinant nucleocapsid protein and different cultured variants with recorded limits of detection ranging between 3.77 × 10 5 and 9.13 × 10 5 RNA copies/mL. Finally, the sensitivity was evaluated using oropharyngeal swabs from Syrian golden hamsters inoculated with the 6 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. |
