title: Rapid Molecular Detection and Differentiation of Influenza Viruses A and B.
abstract: Influenza is a contagious respiratory illness caused by influenza viruses A and B in humans and causes a significant amount of morbidity and mortality every year. The Influenza A and B assay was the first CLIA-waived molecular rapid flu test available. The Influenza A and B test works by employing isothermal amplification with influenza-specific primers followed by target detection with molecular beacon probes. Here, the performance of the Influenza A and B assay on frozen, archived nasopharyngeal swab (NPS) specimens stored in viral transport medium (VTM) were compared to a respiratory panel assay. The performance of the Influenza A and B assay was evaluated by comparing the results to the respiratory panel reference method. The sensitivity for total influenza virus A was 67.5% (95% CI (CI), 56.6-78.5) and the specificity was 86.9% (CI, 71.0-100). For influenza virus B testing, the sensitivity and specificity were 90.2% (CI, 68.5-100) and 98.8% (CI, 68.5-100), respectively. This system has the advantage of a significantly shorter test time than any other currently available molecular assay and the simple, pipette-free procedure runs on a fully integrated, closed, small-footprint system. Overall, the Influenza A and B assay evaluated in this study has the potential to serve as a point-of-care rapid influenza diagnostic test.
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: Caitlin C
authors.initials: CC
authors.lastname: Otto
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: Samuel E
authors.initials: SE
authors.lastname: Kaplan
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Stiles
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: Albina
authors.initials: A
authors.lastname: Mikhlina
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: Cindy
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center.
authors.forename: N Esther
authors.initials: NE
authors.lastname: Babady
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center; tangy@mskcc.org.
authors.forename: Yi-Wei
authors.initials: YW
authors.lastname: Tang
mesh_terms: D006801:Humans; D009980:Influenza A virus / Q000235:genetics* / Q000302:isolation & purification; D009981:Influenza B virus / Q000235:genetics* / Q000302:isolation & purification; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D025202:Molecular Diagnostic Techniques; D009305:Nasopharynx / Q000821:virology; D019095:Point-of-Care Systems; D012367:RNA, Viral / Q000032:analysis / Q000302:isolation & purification / Q000378:metabolism; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral