Abstract
A novel avian influenza A H7N9-subtype virus emerged in China in 2013 and threatened global public health. Commercial kits that specifically detect avian influenza A (H7N9) virus RNA are urgently required to prepare for the emergence and potential pandemic of this novel influenza virus. The safety and effectiveness of three commercial molecular diagnostic assays were evaluated using a quality-control panel and clinical specimens collected from over 90 patients with confirmed avian influenza A (H7N9) virus infections. The analytical performance evaluation showed that diverse influenza H7N9 viruses can be detected with high within- and between-lot reproducibility and without cross-reactivity to other influenza viruses (H1N1 pdm09, seasonal H1N1, H3N2, H5N1 and influenza B). The detection limit of all the commercial assays was 2.83 Log10 copies/μl [0.7 Log10TCID50/mL of avian influenza A (H7N9) virus strain A/Zhejiang/DTID-ZJU01/2013], which is comparable to the method recommended by the World Health Organization (WHO). In addition, using a WHO-Chinese National Influenza Center (CNIC) method as a reference for clinical evaluation, positive agreement of more than 98% was determined for all of the commercial kits, while negative agreement of more than 99% was observed. In conclusion, our findings provide comprehensive evidence for the high performance of three commercial diagnostic assays and suggest the application of these assays as rapid and effective diagnostic tools for avian influenza A (H7N9) virus in the routine clinical practice of medical laboratories.
Highlights
Since February 2013, confirmed cases of human infection by a novel avian influenza A H7N9-subtype virus have been continuously identified in China
A set of samples (P1, P2, P3, P4 and P5) that were produced from a total of five different H7N9 virus strains were used to evaluate the analytical sensitivity, reproducibility and detection performance of the kits for diverse positive samples
Twelve negative samples (N1 to N12) that were positive for other influenza viruses were used to evaluate the analytical specificity of the assays; these samples included influenza A seasonal H1N1, H1N1 pdm09, H3N2, H5N1 and influenza B viruses
Summary
Since February 2013, confirmed cases of human infection by a novel avian influenza A H7N9-subtype virus have been continuously identified in China. As of November 16, 2014, a total of 457 confirmed cases had been reported, including 177 deaths [1] This is the first time that avian influenza A H7N9-subtype virus infection has been reported in humans [2]. The virus has been identified as a novel reassortant influenza virus that differs genetically from the other previously identified avian influenza A H7N9-subtype viruses. It carries six internal genes originating from the avian H9N2 influenza viruses but has the hemagglutinin (HA) and neuraminidase (NA) genes from the avian H7 and N9 influenza viruses, respectively [3]. Considering the probable lack of pre-existing immunity among humans to this newly emerged H7N9 virus, this virus poses a great threat to national and global public health
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
