A SARS-CoV-2 Nucleocapsid Variant that Affects Antigen Test Performance.

ABSTRACT: More than one year into a global pandemic, SARS-CoV-2 is now defined by a variety of rapidly evolving variant lineages. Several FDA authorized molecular diagnostic tests have been impacted by viral variation, while no reports of viral variation affecting antigen test performance have occurred to date. While determining the analytical sensitivity of the Quidel Sofia SARS Antigen FIA test (Sofia 2), we uncovered a high viral load specimen that repeatedly tested negative by this antigen test. Whole genome sequencing of the specimen uncovered two mutations, T205I and D399N, present in the nucleocapsid protein of the isolate. All six SARS-CoV-2 positive clinical specimens available in our laboratory with a D399N nucleocapsid mutation and C_T < 31 were not detected by the Sofia 2 but d

SUBMITTER: Bourassa L 

PROVIDER: S-EPMC8219478 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature