Abstract

BackgroundSince 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.Methodology/Principal FindingsWe 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/SignificanceOur novel rapid assay can specifically detect H7 HA antigen, facilitating rapid diagnosis for prevention and control of the on-going H7N9 epidemic.

Highlights

  • The novel H7N9 avian influenza virus was first isolated from three patients with severe lower respiratory tract disease of unknown cause in China in March 2013 [1]

  • Recombinant HA proteins of H7N9 (A/Anhui/1/2013) and H7N7 were kindly provided by Dr Ling Chen of the State Key Laboratory of Respiratory Diseases (Guangzhou, China) while inactivated H1N1, H5N9, and H9N2 virus lysates were obtained from South China University of Technology (Guangzhou, China)

  • All 7 dilutions of H7N9 sample tested positive by our rapid diagnostic test (RDT), and no false positive results were observed for the 20 H7N9 negative samples including inactive H1N1, H3N2 and influenza B viruses (Table 2)

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Summary

Introduction

The novel H7N9 avian influenza virus was first isolated from three patients with severe lower respiratory tract disease of unknown cause in China in March 2013 [1]. As of November 6th, 2013, a total of 139 cases of H7N9 infection had been laboratoryconfirmed, causing 45 deaths in mainland China and 1 in Taiwan [2,3]. Severe lower respiratory tract infection was predominant in human H7N9 infection, and a relatively high mortality of about 32.4% (45/139) was observed as of November6th, 2013 [1,2,4,5]. 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

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