期刊
VIROLOGY
卷 553, 期 -, 页码 154-156出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.virol.2020.10.010
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资金
- Universidad de Las Americas (Quito, Ecuador)
The Viasure RT-qPCR kit showed a sensitivity of 91.9% and a specificity of 100% for SARS-CoV-2 diagnosis, with a limitation of lacking an RNA quality control probe. Improving an alternative RT-qPCR reaction for RNA extraction quality control, such as RNaseP, is recommended to enhance the diagnostic performance of the Viasure kit.
Background: Several RT-qPCR kits are available for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA, but most of them lacking of proper evaluation studies due to covid19 emergency. Objective: We evaluated Viasure RT-qPCR kit (CerTest Biotec, Spain) for SARS-CoV-2 diagnosis using FDA EUA 2019-nCoV CDC kit (IDT, USA) as a gold standard. Results: Although we found the lack of RNA quality control probe as the main limitation for the Viasure kit, the sensitivity was 91.9% and the specificity was 100%. The limit of detection (LOD) was 2000 copies/mL and 1000 copies/mL for Viasure and IDT kits, respectively. Conclusions: Viasure RT-qPCR kit is a reliable tool for SARS-CoV-2 diagnosis but improvement of an alternative RT-qPCR reaction for RNA extraction quality control as RNaseP is recommended.
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