Abstract
Mutations in the nucleocapsid of SARS-CoV-2 may interfere with antigen detection by diagnostic tests. We used several methods to evaluate the effect of various SARS-CoV-2 nucleocapsid mutations on the performance of the Panbio™ and BinaxNOW™ lateral flow rapid antigen tests and a prototype high-throughput immunoassay that utilizes Panbio antibodies. Variant detection was also evaluated by immunoblot and BIAcore™ assay. A panel of 23 recombinant nucleocapsid antigens (rAgs) were produced that included mutations found in circulating SARS-CoV-2 variants, including variants of concern. All mutant rAgs were detected by all assays, at a sensitivity equivalent to wild-type control (Wuhan strain). Thus, using a rAg approach, we found that the SARS-CoV-2 nucleocapsid mutations examined do not directly impact antigen detection or antigen assay performance.
Keywords: BinaxNOW; Panbio; SARS-CoV-2; antigen; immunoassay; lateral flow assay; nucleocapsid; recombinant protein; variant.
【저자키워드】 SARS-CoV-2, Antigen, immunoassay, lateral flow assay, nucleocapsid, Variant., Recombinant protein, PanBio, BinaxNOW, 【초록키워드】 antibodies, Mutation, variant, variants of concern, lateral flow, sensitivity, rapid antigen test, diagnostic tests, mutant, antigen detection, nucleocapsid antigen, Wuhan strain, wild-type, SARS-CoV-2 nucleocapsid, circulating SARS-CoV-2 variants, immunoblot, approach, produced, examined, assays, evaluated, interfere, evaluate the effect, the SARS-CoV-2, 【제목키워드】 Mutation, Rapid diagnostic test, antigen detection, SARS-CoV-2 nucleocapsid, evaluate,