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Editorial

United States FDA’s emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future

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References

  • CDC. Outbreaks chronology: Ebola virus disease. Available from: www.cdc.gov/vhf/ebola/outbreaks/history/chronology.html [Last accessed 13 March 2015]
  • Baize S, Pannetier D, Oestereich L, et al. Emergence of Zaire Ebola virus disease in Guinea - preliminary report. N Engl J Med 2014;371(15):1418-25
  • WHO. Origins of the 2014 Ebola epidemic. Available from: www.who.int/csr/disease/ebola/one-year-report/virus-origin/en/# [Last accessed 13 March 2015]
  • WHO. Ebola situation reports. Available form http://apps.who.int/ebola/en/current-situation/ebola-situation-report [Last accessed 15 April 2015]
  • Hartman AL, Towner JS, Nichol ST. Ebola and Marburg hemorrhagic fever. Clin Lab Med 2010;30(1):161-77
  • Kuhn JH. Laboratory diagnosis of filoviral disease. Filoviruses - A Compendium of 40 Years of Epidemiological, Clinical, and Laboratory Studies. SpringerWien, New York and Vienna, 2008:265-77
  • Wang YP, Zhang XE, Wei HP. Laboratory detection and diagnosis of filoviruses. Virol Sin 2011;26(2):73-80
  • Koehler JW, Hall AT, Rolfe PA, et al. Development and evaluation of a panel of filovirus sequence capture probes for pathogen detection by next-generation sequencing. PLoS One 2014;9(9):e107007
  • WHO. Urgently needed: rapid, sensitive, safe and simple Ebola diagnostic tests. Available from: www.who.int/mediacentre/news/ebola/18-november-2014-diagnostics/en/ [Last accessed 12 March 2015]
  • FDA. Emergency use authorizations. Available from: www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm#ebola [Last accessed 11 March 2015]
  • WHO. Interim guidance on the use of rapid Ebola antigen detection tests. Available from: http://apps.who.int/iris/bitstream/10665/160265/1/WHO_EVD_HIS_EMP_15.1_eng.pdf?ua=1
  • Cnops L, Gerard M, Vandenberg O, et al. Risk of misinterpretation of Ebola virus PCR results after rVSV ZEBOV-GP vaccination. Clin Infect Dis 2015;60(11):1725-6
  • Carroll SA, Towner JS, Sealy TK, et al. Molecular evolution of viruses of the family Filoviridae based on 97 whole-genome sequences. J Virol 2013;87(5):2608-16
  • Kugelman JR, Sanchez-Lockhart M, Andersen KG, et al. Evaluation of the potential impact of Ebola virus genomic drift on the efficacy of sequence-based candidate therapeutics. mBio 2015;6(1):e02227-14
  • Gire SK, Goba A, Andersen KG, et al. Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak. Science 2014;345(6202):1369-72

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