期刊
VIRUS RESEARCH
卷 297, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.virusres.2021.198398
关键词
SARS-CoV-2; Nucleocapsid gene; Indel mutation; Viral genome sequencing; Different geographical origins
类别
Commercially available reverse transcription-polymerase chain reaction (RT-PCR) kits are widely used for diagnosing SARS-CoV-2 infection, but lack extensive clinical evaluation due to the urgency of the COVID-19 pandemic. A novel insertion/deletion mutation in the nucleocapsid (N) gene of SARS-CoV-2 samples was found to cause negative results in a commonly used assay, highlighting genetic variability and rapid evolution of the virus.
Commercially available reverse transcription-polymerase chain reaction (RT-PCR) kits are being used as an important tool to diagnose SARS-CoV-2 infection in clinical laboratories worldwide. However, some kits lack sufficient clinical evaluation due to the need for emergency use caused by the current COVID-19 pandemic. Here we found that a novel insertion/deletion mutation in the nucleocapsid (N) gene of SARS-CoV-2 samples is a cause of negative results for the N gene in a widely used assay that received emergency use authorization (EUA) from US FDA and Conformite Europeenne-in vitro diagnostics (CE-IVD) from EU. Although SARS-CoV-2 is diagnosed positive by other target probes in the assay, our findings provide an evidence of the genetic variability and rapid evolution of SARS-CoV-2 as well as a reference in designing commercial RT-PCR assays.
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