title: Performance of influenza rapid point-of-care tests in the detection of swine lineage A(H1N1) influenza viruses.
abstract: BACKGROUND
  In April 2009, an A(H1N1) influenza virus of swine lineage was detected in humans in the USA, and in just over a month has infected over 10,000 people in more than 40 countries.
  
  
  OBJECTIVE
  To determine the performance of the Binax Now, BD Directigen EZ, and the Quidel QuickVue influenza rapid point-of-care (POC) tests for the detection of the recently emerged swine lineage A(H1N1) virus.
  
  
  METHODS
  Swine lineage A(H1N1) and human seasonal influenza strains were cultured and then diluted to specific infectivity titres. Viral dilutions were assayed by the rapid POC tests and by real-time RT-PCR.
  
  
  RESULTS
  All three of the rapid POC tests successfully detected the swine lineage A(H1N1) viruses at levels between 10(3) and 10(5) TCID(50)/ml (tissue culture infectious dose(50)), with the BD Directigen test demonstrating marginally greater sensitivity than the other two tests. Viral infectivity and RNA load data for viruses at the detection limit of the rapid test kits, suggested that both the Quidel and the Binax tests were less sensitive for the detection of swine lineage A(H1N1) viruses than for human seasonal strains. In comparison the BD Directigen demonstrated similar sensitivity when detecting swine lineage A(H1N1) and human seasonal viruses.
  
  
  CONCLUSIONS
  The three rapid POC tests all detected the emergent swine lineage A(H1N1) virus when it was present at high virus concentrations. Early diagnosis of infection can assist in the rapid treatment. However the tests are significantly less sensitive than PCR assays and as such, negative results should be verified by a laboratory test.
authors.affiliation: WHO Collaborating Centre for Reference and Research on Influenza, 10 Wreckyn St, North Melbourne, Victoria, Australia.
authors.forename: Aeron C
authors.initials: AC
authors.lastname: Hurt
authors.forename: Chantal
authors.initials: C
authors.lastname: Baas
authors.forename: Yi-Mo
authors.initials: YM
authors.lastname: Deng
authors.forename: Sally
authors.initials: S
authors.lastname: Roberts
authors.forename: Anne
authors.initials: A
authors.lastname: Kelso
authors.forename: Ian G
authors.initials: IG
authors.lastname: Barr
mesh_terms: D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D025202:Molecular Diagnostic Techniques / Q000379:methods; D019095:Point-of-Care Systems; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic