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Development of Two Types of Rapid Diagnostic Test Kits to Detect the Hemagglutinin or Nucleoprotein of the Swine-Origin Pandemic Influenza A Virus H1N

tetano

Editor, Senior Moderator
Clin Vaccine Immunol. 2011 Jan 12. [Epub ahead of print]
Development of Two Types of Rapid Diagnostic Test Kits to Detect the Hemagglutinin or Nucleoprotein of the Swine-Origin Pandemic Influenza A Virus H1N1.

Mizuike R, Sasaki T, Baba K, Iwamoto H, Shibai Y, Kosaka M, Kubota-Koketsu R, Yang CS, Du A, Sakudo A, Tsujikawa M, Yunoki M, Ikuta K.

Department of Virology, Research Institute for Microbial Diseases, Osaka University, Suita, Osaka 565-0871; Baba Pediatric Clinic, Kadoma, Osaka 571-0046; Tanaka Kikinzoku Kogyo Corporation, LTD., Hiratsuka, Kanagawa 254-0076; Alfresa Pharma Corporation, Ibaraki, Osaka 567-0806; Laboratory of Biometabolic Chemistry, School of Health Sciences, Faculty of Medicine, University of the Ryukyus, Nishihara, Okinawa 903-0215; and Osaka Research Laboratory, Benesis Corporation, Yodogawa-ku, Osaka 532-8505, Japan.
Abstract

Since its emergence in April 2009, pandemic flu H1N1 (H1N1 pdm), a new type of influenza A virus with a triple reassortant genome, has spread throughout the world. Initial attempts to diagnose 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), the other 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 illness. The specificity of both IC test kits was very high (93% for HA kit and 100% for 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 detection assay. Use of the anti-NP antibody could allow for the rapid and accurate diagnosis of H1N1 pdm infections.

PMID: 21228147 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21228147
 
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