Journal
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Volume 83, Issue 4, Pages 355-358Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.diagmicrobio.2015.07.025
Keywords
Ebola virus; Kits evaluation; Real time RT-PCR; Virus-like particles
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Funding
- National High Technology Research and Development Program of China 863 program [2011AA02A116]
- AIDS and hepatitis, and other major infectious disease control and prevention Program of China [2013ZX10004805]
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Several Chinese commercial real-time PCR kits for Zaire ebolavirus have been developed after the Ebola outbreak and used by Chinese medical teams in West Africa. In order to know the essential performance indicators of these kits, analytical sensitivity and precision were evaluated with virus-like particle (VLP)-encapsulated EBOV RNA. The limit of detection (LOD) and the precision were completed with a series of VLPs. The maximum and minimum of LOD was acquired by ZJ BioTech and Daan gene, respectively. For precision, all of the detection results were <5% except the maximum 5.17%. Among them, Puruikang, Daan gene, Sansure, ZJ BioTech, and Huada demonstrated superior reproducibility. Overall, the requirements of LOD <1000 copies/mL and coefficient of variation <5% could be satisfied by all kits except Kehua. Meanwhile, it is feasible for VLPs as a substitute of positive samples in assay evaluation. (C) 2015 Elsevier Inc. All rights reserved.
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