title: Development of a sensitive novel diagnostic kit for the highly pathogenic avian influenza A (H5N1) virus.
abstract: BACKGROUND
  Sporadic emergence of the highly pathogenic avian influenza (HPAI) H5N1 virus infection in humans is a serious concern because of the potential for a pandemic. Conventional or quantitative RT-PCR is the standard laboratory test to detect viral influenza infections. However, this technology requires well-equipped laboratories and highly trained personnel. A rapid, sensitive, and specific alternative screening method is needed.
  
  
  METHODS
  By a luminescence-linked enzyme immunoassay, we have developed a H5N1 HPAI virus detection kit using anti-H5 hemagglutinin monoclonal antibodies in combination with the detection of a universal NP antigen of the type A influenza virus. The process takes 15 minutes by use of the fully automated luminescence analyzer, POCube.
  
  
  RESULTS
  We tested this H5/A kit using 19 clinical specimens from 13 patients stored in Vietnam who were infected with clade 1.1 or clade 2.3.4 H5N1 HPAI virus. Approximately 80% of clinical specimens were H5-positive using the POCube system, whereas only 10% of the H5-positive samples were detected as influenza A-positive by an immunochromatography-based rapid diagnostic kit.
  
  
  CONCLUSIONS
  This novel H5/A kit using POCube is served as a rapid and sensitive screening test for H5N1 HPAI virus infection in humans.
authors.affiliation: Department of Immunology, National Institute of Infectious Diseases, Shinjuku Tokyo 162-8640, Japan. yyokota@nih.go.jp.
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Tsunetsugu-Yokota
authors.forename: Kengo
authors.initials: K
authors.lastname: Nishimura
authors.forename: Shuhei
authors.initials: S
authors.lastname: Misawa
authors.forename: Mie
authors.initials: M
authors.lastname: Kobayashi-Ishihara
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Ikuyo
authors.initials: I
authors.lastname: Takayama
authors.forename: Kazuo
authors.initials: K
authors.lastname: Ohnishi
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Itamura
authors.forename: Hang L K
authors.initials: HL
authors.lastname: Nguyen
authors.forename: Mai T Q
authors.initials: MT
authors.lastname: Le
authors.forename: Giang T
authors.initials: GT
authors.lastname: Dang
authors.forename: Long T
authors.initials: LT
authors.lastname: Nguyen
authors.forename: Masato
authors.initials: M
authors.lastname: Tashiro
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Kageyama
mesh_terms: D006801:Humans; D007124:Immunoenzyme Techniques; D053124:Influenza A Virus, H5N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000821:virology*; D010614:Pharynx / Q000821:virology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014744:Vietnam
chemical_list: D011933:Reagent Kits, Diagnostic