title: Evaluation of Alere i Influenza A&B for rapid detection of influenza viruses A and B.
abstract: Rapid and accurate diagnosis of influenza is important for infection control, as well as for patient management. Alere i Influenza A&B is an isothermal nucleic acid amplification-based integrated system for detection and differentiation of influenza virus A and influenza virus B. The performance of the Alere i Influenza A&B was screened using frozen nasopharyngeal-swab specimens collected in viral transport medium (VTM) that were originally tested fresh with the FilmArray Respiratory Panel (RP) assay during the 2012-2013 influenza outbreak. In total, 360 VTM specimens were selected for Alere i Influenza A&B testing: 40 influenza virus A H1N1-2009 (influenza virus A-1), 40 influenza virus A H3N2 (influenza virus A-3), 37 influenza virus A "equivocal" or "no subtype detected" (influenza virus A-u), 41 influenza virus B, and 202 influenza virus-negative specimens, as initially determined by the FilmArray RP assay. The Alere assay showed sensitivities of 87.2%, 92.5%, 25.0%, and 97.4% for influenza virus A-1, influenza virus A-3, influenza virus A-u, and influenza virus B, respectively, after discordant resolution by Prodesse ProFLU+ PCR. The specificities were 100% for both influenza virus A and influenza virus B. In general, the Alere i Influenza A&B provided good sensitivity, although the assay did show poorer sensitivity with samples determined to have low influenza virus A titers by Prodesse ProFlu+ PCR (a mean real-time PCR threshold cycle [CT] value of 31.9 ± 2.0), which included the majority of the samples called influenza virus A "equivocal" or "no subtype detected" by a single BioFire FilmArray RP test. The integrated, rapid, and simple characteristics of the Alere i Influenza A&B assay make it a potential candidate for point-of-care testing, with a test turnaround time of less than 15 min.
authors.affiliation: Department of Laboratory Medicine, Futian Hospital, Guangdong Medical College, Shenzhen, China Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: Shuping
authors.initials: S
authors.lastname: Nie
authors.affiliation: Ionian Technologies, San Diego, California, USA.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Roth
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Stiles
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: Albina
authors.initials: A
authors.lastname: Mikhlina
authors.affiliation: Department of Laboratory Medicine, Futian Hospital, Guangdong Medical College, Shenzhen, China.
authors.forename: Xuedong
authors.initials: X
authors.lastname: Lu
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, New York, USA tangy@mskcc.org.
authors.forename: Yi-Wei
authors.initials: YW
authors.lastname: Tang
authors.affiliation: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors.forename: N Esther
authors.initials: NE
authors.lastname: Babady
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009980:Influenza A virus / Q000302:isolation & purification*; D009981:Influenza B virus / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009305:Nasopharynx / Q000821:virology; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D012189:Retrospective Studies; D012680:Sensitivity and Specificity