Abstract
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.
Keywords: Different geographical origins; Indel mutation; Nucleocapsid gene; SARS-CoV-2; Viral genome sequencing.
【저자키워드】 SARS-CoV-2, Different geographical origins, Indel mutation, Nucleocapsid gene, Viral genome sequencing., 【초록키워드】 Mutation, SARS-COV-2 infection, COVID-19 pandemic, RT-PCR, Emergency use authorization, diagnostics, EUA, Laboratory, polymerase chain reaction, Genome sequencing, Viral, clinical evaluation, nucleocapsid, Evolution of SARS-CoV-2, genetic variability, N gene, diagnose, Emergency use, Nucleocapsid gene, Reverse transcription-polymerase chain reaction, Evidence, viral genome, evidence of, Chain Reaction, clinical laboratories, Viral genome sequencing, RT-PCR assays, US FDA, positive, INDEL, insertion/deletion, probe, lack, caused, diagnosed, 【제목키워드】 Mutation, novel, RT-PCR assay, positive, clinical sample, diagnosed,