title: Development of two types of rapid diagnostic test kits to detect the hemagglutinin or nucleoprotein of the swine-origin pandemic influenza A virus H1N1.
abstract: Since its emergence in April 2009, pandemic influenza A virus H1N1 (H1N1 pdm), a new type of influenza A virus with a triple-reassortant genome, has spread throughout the world. Initial attempts to diagnose the infection in patients using immunochromatography (IC) relied on test kits developed for seasonal influenza A and B viruses, many of which proved significantly less sensitive to H1N1 pdm. Here, we prepared monoclonal antibodies that react with H1N1 pdm but not seasonal influenza A (H1N1 and H3N2) or B viruses. Using two of these antibodies, one recognizing viral hemagglutinin (HA) and the other recognizing nucleoprotein (NP), we developed kits for the specific detection of H1N1 pdm and tested them using clinical specimens of nasal wash fluid or nasopharyngeal fluid from patients with influenza-like illnesses. The specificities of both IC test kits were very high (93% for the HA kit, 100% for the NP kit). The test sensitivities for detection of H1N1 pdm were 85.5% with the anti-NP antibody, 49.4% with the anti-HA antibody, and 79.5% with a commercially available influenza A virus detection assay. Use of the anti-NP antibody could allow the rapid and accurate diagnosis of H1N1 pdm infections.
authors.affiliation: Department of Virology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.
authors.forename: Rika
authors.initials: R
authors.lastname: Mizuike
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Sasaki
authors.forename: Koichi
authors.initials: K
authors.lastname: Baba
authors.forename: Hisahiko
authors.initials: H
authors.lastname: Iwamoto
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Shibai
authors.forename: Mieko
authors.initials: M
authors.lastname: Kosaka
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Kubota-Koketsu
authors.forename: Cheng-Song
authors.initials: CS
authors.lastname: Yang
authors.forename: Anariwa
authors.initials: A
authors.lastname: Du
authors.forename: Akikazu
authors.initials: A
authors.lastname: Sakudo
authors.forename: Muneo
authors.initials: M
authors.lastname: Tsujikawa
authors.forename: Mikihiro
authors.initials: M
authors.lastname: Yunoki
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Ikuta
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification; D000914:Antibodies, Viral / Q000302:isolation & purification; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000032:analysis* / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D051379:Mice; D008807:Mice, Inbred BALB C; D009297:Nasal Mucosa / Q000821:virology; D009305:Nasopharynx / Q000821:virology; D019590:Nucleocapsid Proteins; D016601:RNA-Binding Proteins / Q000032:analysis* / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013997:Time Factors; D014758:Viral Core Proteins / Q000032:analysis* / Q000302:isolation & purification
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; C048842:NP protein, Influenza A virus; D019590:Nucleocapsid Proteins; D016601:RNA-Binding Proteins; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins; C483468:hemagglutinin, human influenza A virus