title: Multicenter prospective evaluation of a novel rapid immunochromatographic diagnostic kit specifically detecting influenza A H1N1 2009 virus.
abstract: BACKGROUND
  Definitive diagnosis is crucial in reducing morbidity and mortality from pandemic influenza A H1N1 2009 (A/H1N1/2009), especially in high-risk populations. We recently developed a rapid diagnosis kit (RDK) capable of specifically detecting A/H1N1/2009.
  
  
  OBJECTIVE
  To evaluate the diagnostic capability of the RDK in a multicenter, prospective trial.
  
  
  METHODS
  Samples were obtained by nasal swab from patients with suspected influenza. The diagnostic capability of the RDK was compared with that of the standard, real-time reverse transcription-polymerase chain reaction (RT-PCR) method.
  
  
  RESULTS
  Of 266 patients who met the criteria, 122 and 92 were positive for A/H1N1/2009 influenza by PCR and by the newly developed RDK, respectively. The sensitivity, specificity and positive and negative predictive values of the RDK were 73.0%, 97.9%, 96.7% and 81.0%, respectively. A/H1N1/2009 detection rates by the RDK were significantly lower in samples obtained from patients more than 3 days after onset than in samples obtained between 1 and 2 days.
  
  
  CONCLUSIONS
  The A/H1N1/2009-specific RDK is a reliable test that can be used easily at a patient's bedside for rapid diagnosis of A/H1N1/2009. This test will be of key importance in the control of A/H1N1/2009.
authors.affiliation: Surgical Operation Department, National Center for Global Health and Medicine, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Kawachi
authors.forename: Takeji
authors.initials: T
authors.lastname: Matsushita
authors.forename: Takeyuki
authors.initials: T
authors.lastname: Sato
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nunoi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Noguchi
authors.forename: Setsuo
authors.initials: S
authors.lastname: Ota
authors.forename: Nobuko
authors.initials: N
authors.lastname: Kanemoto
authors.forename: Keigo
authors.initials: K
authors.lastname: Nakatani
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nishiguchi
authors.forename: Akihiko
authors.initials: A
authors.lastname: Yuge
authors.forename: Hideaki
authors.initials: H
authors.lastname: Imamura
authors.forename: Hirotake
authors.initials: H
authors.lastname: Kitajima
authors.forename: Kenji
authors.initials: K
authors.lastname: Narahara
authors.forename: Kazuo
authors.initials: K
authors.lastname: Suzuki
authors.forename: Tohru
authors.initials: T
authors.lastname: Miyoshi-Akiyama
authors.forename: Teruo
authors.initials: T
authors.lastname: Kirikae
mesh_terms: D000293:Adolescent; D017677:Age Distribution; D000911:Antibodies, Monoclonal / Q000276:immunology*; D000956:Antigens, Viral / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D002846:Chromatography, Affinity; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D007564:Japan; D008297:Male; D058873:Pandemics; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic / Q000592:standards* / Q000821:virology; D012680:Sensitivity and Specificity; D017678:Sex Distribution; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D000956:Antigens, Viral; D011933:Reagent Kits, Diagnostic