Health Care : Current Reviews

Novel indel mutation in the N gene of SARS-CoV-2 clinical samples that were diagnosed positive in a commercial RT-PCR assay

5^th International Conference on HEALTHCARE AND HEALTH MANAGEMENT

December 07, 2022 | Dubai, UAE

Yun-tae Kim, Sanghoo Lee, Kyoung-Ryul Lee

Seoul Clinical Laboratories, South Korea

Scientific Tracks Abstracts: Health Care Curr Rev

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.
Recent Publications :
1. Kim, Yun-Tae et al. “Identification of strain harboring both aac(6')-Ib and aac(6')-Ib-cr variant simultaneously in Escherichia coli and Klebsiella pneumoniae.” BMB reports vol. 44,4 (2011): 262-6. doi:10.5483/BMBRep.2011.44.4.262
2. Lee, Sanghoo et al. “Simultaneous determination of cortisol and cortisone from human serum by liquid chromatography-tandem mass spectrometry.” Journal of analytical methods in chemistry vol. 2014 (2014): 787483. doi:10.1155/2014/787483
3. Lee, Sanghoo et al. “Comparative analysis of mutational hotspots in the spike protein of SARS-CoV-2 isolates from different geographic origins.” Gene reports vol. 23 (2021): 101100. doi:10.1016/j.genrep.2021.101100

Biography :

Yun-tae Kim obtained his Ph.D. from Pusan National University at the age of 40. He is currently the Director of the R & D Innovation Center at the Seoul Clinical Research Institute. He is developing several molecular diagnostic products including COVID-19, HIV and STD. He also has over 50 published papers.