title: A prospective study to assess the diagnostic performance of the Sofia(®) Immunoassay for Influenza and RSV detection.
abstract: BACKGROUND
  Respiratory viruses RSV and influenza A and B viruses are responsible for important disease outbreaks during the winter season in temperate climate regions. Rapid diagnostic tests (RDTs) are assays designed to yield a rapid diagnosis, which facilitates patient management. The Sofia Influenza A+B Fluorescence Immunoassay and Sofia RSV Fluorescence Immunoassay are RDTs for Influenza and RSV detection that employ a new technology to enhance their sensitivity.
  
  
  OBJECTIVE
  Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR.
  
  
  METHODS
  A prospective evaluation was carried out on 1065 respiratory samples for Sofia Influenza A+B FIA and on 261 samples for Sofia RSV FIA from November 2013 to April 2014.
  
  
  RESULTS
  The sensitivities of the Sofia Influenza A+B FIA for influenza A and influenza B detection were, respectively, 75.3% (244/324) and 50.0% (8/16). The sensitivity of the Sofia RSV FIA was 92.1% (128/139). There were no differences in Sofia FIA performance depending on the virus subtype.
  
  
  CONCLUSIONS
  The results showed high sensitivity and specificity values for influenza A and RSV detection, but values were lower for influenza B. More information is needed regarding the performance for influenza B given the small number of positive samples assessed.
authors.affiliation: Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: microsaragg@gmail.com.
authors.forename: Sara
authors.initials: S
authors.lastname: Gomez
authors.affiliation: Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Columbiana
authors.initials: C
authors.lastname: Prieto
authors.affiliation: Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Lola
authors.initials: L
authors.lastname: Folgueira
mesh_terms: D005455:Fluorescent Antibody Technique; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D009980:Influenza A virus / Q000235:genetics / Q000276:immunology*; D009981:Influenza B virus / Q000235:genetics / Q000276:immunology*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D011446:Prospective Studies; D015203:Reproducibility of Results; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis* / Q000821:virology*; D018113:Respiratory Syncytial Virus, Human / Q000235:genetics / Q000276:immunology*; D012680:Sensitivity and Specificity