title: Evaluation of Commercial Diagnostic Assays for the Specific Detection of Avian Influenza A (H7N9) Virus RNA Using a Quality-Control Panel and Clinical Specimens in China.
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.
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China.
authors.forename: Dawei
authors.initials: D
authors.lastname: Shi
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China.
authors.forename: Shu
authors.initials: S
authors.lastname: Shen
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China; WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People's Republic of China.
authors.forename: Xingliang
authors.initials: X
authors.lastname: Fan
authors.affiliation: Beijing Institute of Radiation Medicine, Beijing, People's Republic of China.
authors.forename: Suhong
authors.initials: S
authors.lastname: Chen
authors.affiliation: Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, People's Republic of China; WHO Collaborating Center for Reference and Research on Influenza, Beijing, People's Republic of China.
authors.forename: Dayan
authors.initials: D
authors.lastname: Wang
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China; WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People's Republic of China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China; WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People's Republic of China.
authors.forename: Xing
authors.initials: X
authors.lastname: Wu
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China.
authors.forename: Lili
authors.initials: L
authors.lastname: Li
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China.
authors.forename: Dongting
authors.initials: D
authors.lastname: Bai
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China.
authors.forename: Chuntao
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China; WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People's Republic of China.
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
mesh_terms: D006801:Humans; D064766:Influenza A Virus, H7N9 Subtype / Q000235:genetics*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards*; D011786:Quality Control; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods / Q000592:standards; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods / Q000592:standards
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic