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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
- Source :
- PLoS ONE, Vol 10, Iss 9, p e0137862 (2015), PLOS ONE, PLoS ONE
- Publication Year :
- 2015
- Publisher :
- Public Library of Science (PLoS), 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.
- Subjects :
- Quality Control
Specific detection
lcsh:Medicine
Biology
Influenza A Virus, H7N9 Subtype
Real-Time Polymerase Chain Reaction
medicine.disease_cause
Virus
World health
law.invention
law
Influenza, Human
Pandemic
medicine
Influenza A virus
Humans
lcsh:Science
Polymerase chain reaction
Multidisciplinary
Reverse Transcriptase Polymerase Chain Reaction
lcsh:R
Reproducibility of Results
Correction
RNA
virus diseases
Virology
Influenza A virus subtype H5N1
Molecular Diagnostic Techniques
RNA, Viral
lcsh:Q
Reagent Kits, Diagnostic
Research Article
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Volume :
- 10
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- PLoS ONE
- Accession number :
- edsair.doi.dedup.....73ef1f29db064bb18ea46ce1f859341a