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
Identifieur interne : 000401 ( Pmc/Checkpoint ); précédent : 000400; suivant : 000402Evaluation 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
Auteurs : Dawei Shi [République populaire de Chine] ; Shu Shen [République populaire de Chine] ; Xingliang Fan [République populaire de Chine] ; Suhong Chen [République populaire de Chine] ; Dayan Wang [République populaire de Chine] ; Changgui Li [République populaire de Chine] ; Xing Wu [République populaire de Chine] ; Lili Li [République populaire de Chine] ; Dongting Bai [République populaire de Chine] ; Chuntao Zhang [République populaire de Chine] ; Junzhi Wang [République populaire de Chine]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
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.
Url:
DOI: 10.1371/journal.pone.0137862
PubMed: 26361351
PubMed Central: 4567293
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
PMC:4567293Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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</title><author><name sortKey="Shi, Dawei" sort="Shi, Dawei" uniqKey="Shi D" first="Dawei" last="Shi">Dawei Shi</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Shen, Shu" sort="Shen, Shu" uniqKey="Shen S" first="Shu" last="Shen">Shu Shen</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Fan, Xingliang" sort="Fan, Xingliang" uniqKey="Fan X" first="Xingliang" last="Fan">Xingliang Fan</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Chen, Suhong" sort="Chen, Suhong" uniqKey="Chen S" first="Suhong" last="Chen">Suhong Chen</name><affiliation wicri:level="3"><nlm:aff id="aff003"><addr-line>Beijing Institute of Radiation Medicine, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Institute of Radiation Medicine, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wang, Dayan" sort="Wang, Dayan" uniqKey="Wang D" first="Dayan" last="Wang">Dayan Wang</name><affiliation wicri:level="3"><nlm:aff id="aff004"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff005"><addr-line>WHO Collaborating Center for Reference and Research on Influenza, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Reference and Research on Influenza, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Li, Changgui" sort="Li, Changgui" uniqKey="Li C" first="Changgui" last="Li">Changgui Li</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wu, Xing" sort="Wu, Xing" uniqKey="Wu X" first="Xing" last="Wu">Xing Wu</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Li, Lili" sort="Li, Lili" uniqKey="Li L" first="Lili" last="Li">Lili Li</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Bai, Dongting" sort="Bai, Dongting" uniqKey="Bai D" first="Dongting" last="Bai">Dongting Bai</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Zhang, Chuntao" sort="Zhang, Chuntao" uniqKey="Zhang C" first="Chuntao" last="Zhang">Chuntao Zhang</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wang, Junzhi" sort="Wang, Junzhi" uniqKey="Wang J" first="Junzhi" last="Wang">Junzhi Wang</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26361351</idno><idno type="pmc">4567293</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4567293</idno><idno type="RBID">PMC:4567293</idno><idno type="doi">10.1371/journal.pone.0137862</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000A64</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000A64</idno><idno type="wicri:Area/Pmc/Curation">000A64</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000A64</idno><idno type="wicri:Area/Pmc/Checkpoint">000401</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000401</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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</title><author><name sortKey="Shi, Dawei" sort="Shi, Dawei" uniqKey="Shi D" first="Dawei" last="Shi">Dawei Shi</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Shen, Shu" sort="Shen, Shu" uniqKey="Shen S" first="Shu" last="Shen">Shu Shen</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Fan, Xingliang" sort="Fan, Xingliang" uniqKey="Fan X" first="Xingliang" last="Fan">Xingliang Fan</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Chen, Suhong" sort="Chen, Suhong" uniqKey="Chen S" first="Suhong" last="Chen">Suhong Chen</name><affiliation wicri:level="3"><nlm:aff id="aff003"><addr-line>Beijing Institute of Radiation Medicine, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Beijing Institute of Radiation Medicine, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wang, Dayan" sort="Wang, Dayan" uniqKey="Wang D" first="Dayan" last="Wang">Dayan Wang</name><affiliation wicri:level="3"><nlm:aff id="aff004"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff005"><addr-line>WHO Collaborating Center for Reference and Research on Influenza, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Reference and Research on Influenza, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Li, Changgui" sort="Li, Changgui" uniqKey="Li C" first="Changgui" last="Li">Changgui Li</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wu, Xing" sort="Wu, Xing" uniqKey="Wu X" first="Xing" last="Wu">Xing Wu</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Li, Lili" sort="Li, Lili" uniqKey="Li L" first="Lili" last="Li">Lili Li</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Bai, Dongting" sort="Bai, Dongting" uniqKey="Bai D" first="Dongting" last="Bai">Dongting Bai</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Zhang, Chuntao" sort="Zhang, Chuntao" uniqKey="Zhang C" first="Chuntao" last="Zhang">Chuntao Zhang</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Wang, Junzhi" sort="Wang, Junzhi" uniqKey="Wang J" first="Junzhi" last="Wang">Junzhi Wang</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>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</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing</wicri:regionArea><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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 Log<sub>10</sub> copies/μl [0.7 Log<sub>10</sub>TCID<sub>50</sub>/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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Gao, R" uniqKey="Gao R">R Gao</name></author><author><name sortKey="Cao, B" uniqKey="Cao B">B Cao</name></author><author><name sortKey="Hu, Y" uniqKey="Hu Y">Y Hu</name></author><author><name sortKey="Feng, Z" uniqKey="Feng Z">Z Feng</name></author><author><name sortKey="Wang, D" uniqKey="Wang D">D Wang</name></author><author><name sortKey="Hu, W" uniqKey="Hu W">W Hu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Liu, D" uniqKey="Liu D">D Liu</name></author><author><name sortKey="Shi, W" uniqKey="Shi W">W Shi</name></author><author><name sortKey="Shi, Y" uniqKey="Shi Y">Y Shi</name></author><author><name sortKey="Wang, D" uniqKey="Wang D">D Wang</name></author><author><name sortKey="Xiao, H" uniqKey="Xiao H">H Xiao</name></author><author><name sortKey="Li, W" uniqKey="Li W">W Li</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Watanabe, T" uniqKey="Watanabe T">T Watanabe</name></author><author><name sortKey="Kiso, M" uniqKey="Kiso M">M Kiso</name></author><author><name sortKey="Fukuyama, S" uniqKey="Fukuyama S">S Fukuyama</name></author><author><name sortKey="Nakajima, N" uniqKey="Nakajima N">N Nakajima</name></author><author><name sortKey="Imai, M" uniqKey="Imai M">M Imai</name></author><author><name sortKey="Yamada, S" uniqKey="Yamada S">S Yamada</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhang, Q" uniqKey="Zhang Q">Q Zhang</name></author><author><name sortKey="Shi, J" uniqKey="Shi J">J Shi</name></author><author><name sortKey="Deng, G" uniqKey="Deng G">G Deng</name></author><author><name sortKey="Guo, J" uniqKey="Guo J">J Guo</name></author><author><name sortKey="Zeng, X" uniqKey="Zeng X">X Zeng</name></author><author><name sortKey="He, X" uniqKey="He X">X He</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhu, H" uniqKey="Zhu H">H Zhu</name></author><author><name sortKey="Wang, D" uniqKey="Wang D">D Wang</name></author><author><name sortKey="Kelvin, Dj" uniqKey="Kelvin D">DJ Kelvin</name></author><author><name sortKey="Li, L" uniqKey="Li L">L Li</name></author><author><name sortKey="Zheng, Z" uniqKey="Zheng Z">Z Zheng</name></author><author><name sortKey="Yoon, Sw" uniqKey="Yoon S">SW Yoon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Li, Q" uniqKey="Li Q">Q Li</name></author><author><name sortKey="Zhou, L" uniqKey="Zhou L">L Zhou</name></author><author><name sortKey="Zhou, M" uniqKey="Zhou M">M Zhou</name></author><author><name sortKey="Chen, Z" uniqKey="Chen Z">Z Chen</name></author><author><name sortKey="Li, F" uniqKey="Li F">F Li</name></author><author><name sortKey="Wu, H" uniqKey="Wu H">H Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Xiao, Xc" uniqKey="Xiao X">XC Xiao</name></author><author><name sortKey="Li, Kb" uniqKey="Li K">KB Li</name></author><author><name sortKey="Chen, Zq" uniqKey="Chen Z">ZQ Chen</name></author><author><name sortKey="Di, B" uniqKey="Di B">B Di</name></author><author><name sortKey="Yang, Zc" uniqKey="Yang Z">ZC Yang</name></author><author><name sortKey="Yuan, J" uniqKey="Yuan J">J Yuan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ge, Y" uniqKey="Ge Y">Y Ge</name></author><author><name sortKey="Wu, B" uniqKey="Wu B">B Wu</name></author><author><name sortKey="Qi, X" uniqKey="Qi X">X Qi</name></author><author><name sortKey="Zhao, K" uniqKey="Zhao K">K Zhao</name></author><author><name sortKey="Guo, X" uniqKey="Guo X">X Guo</name></author><author><name sortKey="Zhu, Y" uniqKey="Zhu Y">Y Zhu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kang, X" uniqKey="Kang X">X Kang</name></author><author><name sortKey="Wu, W" uniqKey="Wu W">W Wu</name></author><author><name sortKey="Zhang, C" uniqKey="Zhang C">C Zhang</name></author><author><name sortKey="Liu, L" uniqKey="Liu L">L Liu</name></author><author><name sortKey="Feng, H" uniqKey="Feng H">H Feng</name></author><author><name sortKey="Xu, L" uniqKey="Xu L">L Xu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Li, Y" uniqKey="Li Y">Y Li</name></author><author><name sortKey="Wu, T" uniqKey="Wu T">T Wu</name></author><author><name sortKey="Qi, X" uniqKey="Qi X">X Qi</name></author><author><name sortKey="Ge, Y" uniqKey="Ge Y">Y Ge</name></author><author><name sortKey="Guo, X" uniqKey="Guo X">X Guo</name></author><author><name sortKey="Wu, B" uniqKey="Wu B">B Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Liu, J" uniqKey="Liu J">J Liu</name></author><author><name sortKey="Nian, Qg" uniqKey="Nian Q">QG Nian</name></author><author><name sortKey="Li, J" uniqKey="Li J">J Li</name></author><author><name sortKey="Hu, Y" uniqKey="Hu Y">Y Hu</name></author><author><name sortKey="Li, Xf" uniqKey="Li X">XF Li</name></author><author><name sortKey="Zhang, Y" uniqKey="Zhang Y">Y Zhang</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Zhang, J" uniqKey="Zhang J">J Zhang</name></author><author><name sortKey="Feng, Y" uniqKey="Feng Y">Y Feng</name></author><author><name sortKey="Hu, D" uniqKey="Hu D">D Hu</name></author><author><name sortKey="Lv, H" uniqKey="Lv H">H Lv</name></author><author><name sortKey="Zhu, J" uniqKey="Zhu J">J Zhu</name></author><author><name sortKey="Cao, M" uniqKey="Cao M">M Cao</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhu, Z" uniqKey="Zhu Z">Z Zhu</name></author><author><name sortKey="Fan, H" uniqKey="Fan H">H Fan</name></author><author><name sortKey="Qi, X" uniqKey="Qi X">X Qi</name></author><author><name sortKey="Qi, Y" uniqKey="Qi Y">Y Qi</name></author><author><name sortKey="Shi, Z" uniqKey="Shi Z">Z Shi</name></author><author><name sortKey="Wang, H" uniqKey="Wang H">H Wang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chen, E" uniqKey="Chen E">E Chen</name></author><author><name sortKey="Chen, Y" uniqKey="Chen Y">Y Chen</name></author><author><name sortKey="Fu, L" uniqKey="Fu L">L Fu</name></author><author><name sortKey="Chen, Z" uniqKey="Chen Z">Z Chen</name></author><author><name sortKey="Gong, Z" uniqKey="Gong Z">Z Gong</name></author><author><name sortKey="Mao, H" uniqKey="Mao H">H Mao</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Li, Q" uniqKey="Li Q">Q Li</name></author><author><name sortKey="Zhou, L" uniqKey="Zhou L">L Zhou</name></author><author><name sortKey="Zhou, M" uniqKey="Zhou M">M Zhou</name></author><author><name sortKey="Chen, Z" uniqKey="Chen Z">Z Chen</name></author><author><name sortKey="Li, F" uniqKey="Li F">F Li</name></author><author><name sortKey="Wu, H" uniqKey="Wu H">H Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wang, S" uniqKey="Wang S">S Wang</name></author><author><name sortKey="Wang, X" uniqKey="Wang X">X Wang</name></author><author><name sortKey="Chen, S" uniqKey="Chen S">S Chen</name></author><author><name sortKey="Guan, W" uniqKey="Guan W">W Guan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Meng, Z" uniqKey="Meng Z">Z Meng</name></author><author><name sortKey="Han, R" uniqKey="Han R">R Han</name></author><author><name sortKey="Hu, Y" uniqKey="Hu Y">Y Hu</name></author><author><name sortKey="Yuan, Z" uniqKey="Yuan Z">Z Yuan</name></author><author><name sortKey="Jiang, S" uniqKey="Jiang S">S Jiang</name></author><author><name sortKey="Zhang, X" uniqKey="Zhang X">X Zhang</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Chen, Y" uniqKey="Chen Y">Y Chen</name></author><author><name sortKey="Liang, W" uniqKey="Liang W">W Liang</name></author><author><name sortKey="Yang, S" uniqKey="Yang S">S Yang</name></author><author><name sortKey="Wu, N" uniqKey="Wu N">N Wu</name></author><author><name sortKey="Gao, H" uniqKey="Gao H">H Gao</name></author><author><name sortKey="Sheng, J" uniqKey="Sheng J">J Sheng</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hatchette, Tf" uniqKey="Hatchette T">TF Hatchette</name></author><author><name sortKey="Drews, Sj" uniqKey="Drews S">SJ Drews</name></author><author><name sortKey="Bastien, N" uniqKey="Bastien N">N Bastien</name></author><author><name sortKey="Li, Y" uniqKey="Li Y">Y Li</name></author><author><name sortKey="German, G" uniqKey="German G">G German</name></author><author><name sortKey="Antonishyn, N" uniqKey="Antonishyn N">N Antonishyn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kalthoff, D" uniqKey="Kalthoff D">D Kalthoff</name></author><author><name sortKey="Bogs, J" uniqKey="Bogs J">J Bogs</name></author><author><name sortKey="Harder, T" uniqKey="Harder T">T Harder</name></author><author><name sortKey="Grund, C" uniqKey="Grund C">C Grund</name></author><author><name sortKey="Pohlmann, A" uniqKey="Pohlmann A">A Pohlmann</name></author><author><name sortKey="Beer, M" uniqKey="Beer M">M Beer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nie, K" uniqKey="Nie K">K Nie</name></author><author><name sortKey="Zhao, X" uniqKey="Zhao X">X Zhao</name></author><author><name sortKey="Ding, X" uniqKey="Ding X">X Ding</name></author><author><name sortKey="Li, Xd" uniqKey="Li X">XD Li</name></author><author><name sortKey="Zou, Sm" uniqKey="Zou S">SM Zou</name></author><author><name sortKey="Guo, Jf" uniqKey="Guo J">JF Guo</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chantratita, W" uniqKey="Chantratita W">W Chantratita</name></author><author><name sortKey="Sukasem, C" uniqKey="Sukasem C">C Sukasem</name></author><author><name sortKey="Kaewpongsri, S" uniqKey="Kaewpongsri S">S Kaewpongsri</name></author><author><name sortKey="Srichunrusami, C" uniqKey="Srichunrusami C">C Srichunrusami</name></author><author><name sortKey="Pairoj, W" uniqKey="Pairoj W">W Pairoj</name></author><author><name sortKey="Thitithanyanont, A" uniqKey="Thitithanyanont A">A Thitithanyanont</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Corman, V" uniqKey="Corman V">V Corman</name></author><author><name sortKey="Eickmann, M" uniqKey="Eickmann M">M Eickmann</name></author><author><name sortKey="Landt, O" uniqKey="Landt O">O Landt</name></author><author><name sortKey="Bleicker, T" uniqKey="Bleicker T">T Bleicker</name></author><author><name sortKey="Brunink, S" uniqKey="Brunink S">S Brunink</name></author><author><name sortKey="Eschbach Bludau, M" uniqKey="Eschbach Bludau M">M Eschbach-Bludau</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cui, L" uniqKey="Cui L">L Cui</name></author><author><name sortKey="Liu, D" uniqKey="Liu D">D Liu</name></author><author><name sortKey="Shi, W" uniqKey="Shi W">W Shi</name></author><author><name sortKey="Pan, J" uniqKey="Pan J">J Pan</name></author><author><name sortKey="Qi, X" uniqKey="Qi X">X Qi</name></author><author><name sortKey="Li, X" uniqKey="Li X">X Li</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lu, J" uniqKey="Lu J">J Lu</name></author><author><name sortKey="Wu, J" uniqKey="Wu J">J Wu</name></author><author><name sortKey="Guan, D" uniqKey="Guan D">D Guan</name></author><author><name sortKey="Yi, L" uniqKey="Yi L">L Yi</name></author><author><name sortKey="Zeng, X" uniqKey="Zeng X">X Zeng</name></author><author><name sortKey="Zou, L" uniqKey="Zou L">L Zou</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wang, D" uniqKey="Wang D">D Wang</name></author><author><name sortKey="Yang, L" uniqKey="Yang L">L Yang</name></author><author><name sortKey="Gao, R" uniqKey="Gao R">R Gao</name></author><author><name sortKey="Zhang, X" uniqKey="Zhang X">X Zhang</name></author><author><name sortKey="Tan, Y" uniqKey="Tan Y">Y Tan</name></author><author><name sortKey="Wu, A" uniqKey="Wu A">A Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chen, Y" uniqKey="Chen Y">Y Chen</name></author><author><name sortKey="Wang, D" uniqKey="Wang D">D Wang</name></author><author><name sortKey="Zheng, S" uniqKey="Zheng S">S Zheng</name></author><author><name sortKey="Shu, Y" uniqKey="Shu Y">Y Shu</name></author><author><name sortKey="Chen, W" uniqKey="Chen W">W Chen</name></author><author><name sortKey="Cui, D" uniqKey="Cui D">D Cui</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kang, K" uniqKey="Kang K">K Kang</name></author><author><name sortKey="Chen, L" uniqKey="Chen L">L Chen</name></author><author><name sortKey="Zhao, X" uniqKey="Zhao X">X Zhao</name></author><author><name sortKey="Qin, C" uniqKey="Qin C">C Qin</name></author><author><name sortKey="Zhan, Z" uniqKey="Zhan Z">Z Zhan</name></author><author><name sortKey="Wang, J" uniqKey="Wang J">J Wang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Al Soud, Wa" uniqKey="Al Soud W">WA Al-Soud</name></author><author><name sortKey="Radstrom, P" uniqKey="Radstrom P">P Radstrom</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rossen, L" uniqKey="Rossen L">L Rossen</name></author><author><name sortKey="Norskov, P" uniqKey="Norskov P">P Norskov</name></author><author><name sortKey="Holmstrom, K" uniqKey="Holmstrom K">K Holmstrom</name></author><author><name sortKey="Rasmussen, Of" uniqKey="Rasmussen O">OF Rasmussen</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26361351</article-id><article-id pub-id-type="pmc">4567293</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0137862</article-id><article-id pub-id-type="publisher-id">PONE-D-15-08241</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-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</article-title><alt-title alt-title-type="running-head">Evaluation of Commercial H7N9 Molecular Assays, China</alt-title></title-group><contrib-group><contrib contrib-type="author" equal-contrib="yes"><name><surname>Shi</surname><given-names>Dawei</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author" equal-contrib="yes"><name><surname>Shen</surname><given-names>Shu</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author" equal-contrib="yes"><name><surname>Fan</surname><given-names>Xingliang</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Chen</surname><given-names>Suhong</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wang</surname><given-names>Dayan</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>Changgui</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wu</surname><given-names>Xing</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>Lili</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bai</surname><given-names>Dongting</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Zhang</surname><given-names>Chuntao</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref rid="cor001" ref-type="corresp">*</xref></contrib><contrib contrib-type="author"><name><surname>Wang</surname><given-names>Junzhi</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref><xref rid="cor001" ref-type="corresp">*</xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>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</addr-line></aff><aff id="aff002"><label>2</label><addr-line>WHO Collaborating Center for Standardization and Evaluation of Biologicals, Beijing, People’s Republic of China</addr-line></aff><aff id="aff003"><label>3</label><addr-line>Beijing Institute of Radiation Medicine, Beijing, People’s Republic of China</addr-line></aff><aff id="aff004"><label>4</label><addr-line>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</addr-line></aff><aff id="aff005"><label>5</label><addr-line>WHO Collaborating Center for Reference and Research on Influenza, Beijing, People’s Republic of China</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Wang</surname><given-names>Yue</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>National Institute for Viral Disease Control and Prevention, CDC, China, CHINA</addr-line></aff><author-notes><fn fn-type="COI-statement" id="coi001"><p><bold>Competing Interests: </bold>The authors have declared that no competing interests exist. The opinions expressed by the authors contributing to this journal do not necessarily reflect the opinions of the institutions with which the authors are affiliated and the authorities of China.</p></fn><fn fn-type="con" id="contrib001"><p>Conceived and designed the experiments: CTZ JZW DTB. Performed the experiments: DWS XLF SS XW. Analyzed the data: DWS. Contributed reagents/materials/analysis tools: DWS DYW SHC CGL LLL. Wrote the paper: DWS CTZ.</p></fn><corresp id="cor001">* E-mail: <email>zhangct2@126.com</email> (CTZ); <email>wangjunzhi2013@126.com</email> (JZW)</corresp></author-notes><pub-date pub-type="epub"><day>11</day><month>9</month><year>2015</year></pub-date><pub-date pub-type="collection"><year>2015</year></pub-date><volume>10</volume><issue>9</issue><elocation-id>e0137862</elocation-id><history><date date-type="received"><day>24</day><month>2</month><year>2015</year></date><date date-type="accepted"><day>23</day><month>8</month><year>2015</year></date></history><permissions><copyright-statement>© 2015 Shi et al</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>Shi et al</copyright-holder><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="pone.0137862.pdf"></self-uri><abstract><p>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 Log<sub>10</sub> copies/μl [0.7 Log<sub>10</sub>TCID<sub>50</sub>/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.</p></abstract><funding-group><funding-statement>This work is supported by the grant (KJYJ-2013-01-03) from Ministry of Science and Technology of the People´s Republic of China (<ext-link ext-link-type="uri" xlink:href="http://www.most.gov.cn">www.most.gov.cn</ext-link>) to BDT. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</funding-statement></funding-group><counts><fig-count count="2"></fig-count><table-count count="5"></table-count><page-count count="20"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>All relevant data are within the paper and its Supporting Information files.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>All relevant data are within the paper and its Supporting Information files.</p></notes></front></pmc><affiliations><list><country><li>République populaire de Chine</li></country><settlement><li>Pékin</li></settlement></list><tree><country name="République populaire de Chine"><noRegion><name sortKey="Shi, Dawei" sort="Shi, Dawei" uniqKey="Shi D" first="Dawei" last="Shi">Dawei Shi</name></noRegion><name sortKey="Bai, Dongting" sort="Bai, Dongting" uniqKey="Bai D" first="Dongting" last="Bai">Dongting Bai</name><name sortKey="Chen, Suhong" sort="Chen, Suhong" uniqKey="Chen S" first="Suhong" last="Chen">Suhong Chen</name><name sortKey="Fan, Xingliang" sort="Fan, Xingliang" uniqKey="Fan X" first="Xingliang" last="Fan">Xingliang Fan</name><name sortKey="Fan, Xingliang" sort="Fan, Xingliang" uniqKey="Fan X" first="Xingliang" last="Fan">Xingliang Fan</name><name sortKey="Li, Changgui" sort="Li, Changgui" uniqKey="Li C" first="Changgui" last="Li">Changgui Li</name><name sortKey="Li, Changgui" sort="Li, Changgui" uniqKey="Li C" first="Changgui" last="Li">Changgui Li</name><name sortKey="Li, Lili" sort="Li, Lili" uniqKey="Li L" first="Lili" last="Li">Lili Li</name><name sortKey="Shen, Shu" sort="Shen, Shu" uniqKey="Shen S" first="Shu" last="Shen">Shu Shen</name><name sortKey="Wang, Dayan" sort="Wang, Dayan" uniqKey="Wang D" first="Dayan" last="Wang">Dayan Wang</name><name sortKey="Wang, Dayan" sort="Wang, Dayan" uniqKey="Wang D" first="Dayan" last="Wang">Dayan Wang</name><name sortKey="Wang, Junzhi" sort="Wang, Junzhi" uniqKey="Wang J" first="Junzhi" last="Wang">Junzhi Wang</name><name sortKey="Wang, Junzhi" sort="Wang, Junzhi" uniqKey="Wang J" first="Junzhi" last="Wang">Junzhi Wang</name><name sortKey="Wu, Xing" sort="Wu, Xing" uniqKey="Wu X" first="Xing" last="Wu">Xing Wu</name><name sortKey="Wu, Xing" sort="Wu, Xing" uniqKey="Wu X" first="Xing" last="Wu">Xing Wu</name><name sortKey="Zhang, Chuntao" sort="Zhang, Chuntao" uniqKey="Zhang C" first="Chuntao" last="Zhang">Chuntao Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/H2N2V1/Data/Pmc/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000401 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Checkpoint/biblio.hfd -nk 000401 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= H2N2V1
|flux= Pmc
|étape= Checkpoint
|type= RBID
|clé= PMC:4567293
|texte= 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
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Checkpoint/RBID.i -Sk "pubmed:26361351" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Checkpoint/biblio.hfd \
| NlmPubMed2Wicri -a H2N2V1
| This area was generated with Dilib version V0.6.33. |  |