title: Development of rapid immunochromatographic test for hemagglutinin antigen of H7 subtype in patients infected with novel avian influenza A (H7N9) virus.
abstract: BACKGROUND
  Since human infection with the novel H7N9 avian influenza virus was identified in China in March 2013, the relatively high mortality rate and possibility of human-to-human transmission have highlighted the urgent need for sensitive and specific assays for diagnosis of H7N9 infection.
  
  
  RESULTS
  We developed a rapid diagnostic test for the novel avian influenza A (H7N9) virus using anti-hemagglutinin (HA) monoclonal antibodies specifically targeting H7 in an immunochromatographic assay system. The assay limit of detection was 103.5 pfu/ml or 103TCID50 of H7N9 virus. The assay specifically detected H7N9 viral isolates and recombinant HA proteins of H7 subtypes including H7N7 and H7N9, but did not react with non-H7 subtypes including H1N1, H3N2, H5N1, H5N9, and H9N2. The detection sensitivity was 59.4% (19/32) for H7N9 patients confirmed by RT-PCR. Moreover, the highest sensitivity of 61.5% (16/26) was obtained when testing H7N9 positive sputum samples while 35.7% (5/14) of nasopharyngeal swabs and 20% (2/10) of fecal samples tested positive. No false positive detection was found when testing 180 H7N9 negative samples.
  
  
  CONCLUSIONS
  Our novel rapid assay can specifically detect H7 HA antigen, facilitating rapid diagnosis for prevention and control of the on-going H7N9 epidemic.
authors.affiliation: School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China; National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Keren
authors.initials: K
authors.lastname: Kang
authors.affiliation: National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Li
authors.initials: L
authors.lastname: Chen
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Xiang
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Beijing Institute of Microbiology and Epidemiology, Beijing, China.
authors.forename: Chengfeng
authors.initials: C
authors.lastname: Qin
authors.affiliation: National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Zanwu
authors.initials: Z
authors.lastname: Zhan
authors.affiliation: National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Jihua
authors.initials: J
authors.lastname: Wang
authors.affiliation: National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Wenmei
authors.initials: W
authors.lastname: Li
authors.affiliation: School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China.
authors.forename: Emmanuel E
authors.initials: EE
authors.lastname: Dzakah
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Weijuang
authors.initials: W
authors.lastname: Huang
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yuelong
authors.initials: Y
authors.lastname: Shu
authors.affiliation: Beijing Institute of Microbiology and Epidemiology, Beijing, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Jiang
authors.affiliation: Beijing Institute of Microbiology and Epidemiology, Beijing, China.
authors.forename: Wuchun
authors.initials: W
authors.lastname: Cao
authors.affiliation: School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China.
authors.forename: Mingquan
authors.initials: M
authors.lastname: Xie
authors.affiliation: School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China.
authors.forename: Xiaochun
authors.initials: X
authors.lastname: Luo
authors.affiliation: National Engineering Laboratory of Point-of-Care Tests, Guangzhou Wondfo Biotech Co. Ltd, Guangzhou, China.
authors.forename: Shixing
authors.initials: S
authors.lastname: Tang
mesh_terms: D002681:China; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000235:genetics / Q000276:immunology*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000235:genetics / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000235:genetics / Q000276:immunology; D053124:Influenza A Virus, H5N1 Subtype / Q000235:genetics / Q000276:immunology; D053126:Influenza A Virus, H7N7 Subtype / Q000235:genetics / Q000276:immunology; D064766:Influenza A Virus, H7N9 Subtype / Q000235:genetics / Q000276:immunology*; D053127:Influenza A Virus, H9N2 Subtype / Q000235:genetics / Q000276:immunology; D007251:Influenza, Human
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; C109963:hemagglutinin, avian influenza A virus