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Evaluation of the effects of SARS-CoV-2 genetic mutations on diagnostic RT-PCR assays

Takeru Nakabayashi, Yuki Kawasaki, Koichiro Murashima, Kazuya Omi, Satoshi Yuhara
doi: https://doi.org/10.1101/2021.01.19.426622
Takeru Nakabayashi
H.U. Group Research Institute G.K., 51, Komiya-machi, Hachioji-shi, Tokyo 192-0031, Japan
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Yuki Kawasaki
H.U. Group Research Institute G.K., 51, Komiya-machi, Hachioji-shi, Tokyo 192-0031, Japan
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Koichiro Murashima
H.U. Group Research Institute G.K., 51, Komiya-machi, Hachioji-shi, Tokyo 192-0031, Japan
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Kazuya Omi
H.U. Group Research Institute G.K., 51, Komiya-machi, Hachioji-shi, Tokyo 192-0031, Japan
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Satoshi Yuhara
H.U. Group Research Institute G.K., 51, Komiya-machi, Hachioji-shi, Tokyo 192-0031, Japan
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  • For correspondence: satoshi.yuhara@hugp.com
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Abstract

Several mutant strains of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are emerging. Mismatch(es) in primer/probe binding regions would decrease the detection sensitivity of the PCR test, thereby affecting the results of clinical testing. In this study, we conducted an in silico survey on SARS-CoV-2 sequence variability within the binding regions of primer/probe published by the Japan National Institute of Infectious Diseases (NIID) and Centers for Disease Control and Prevention (CDC). In silico analysis revealed the presence of mutations in the primer/probe binding regions. We performed RT-PCR assays using synthetic RNAs containing the mutations and showed that some mutations significantly decreased the detection sensitivity of the RT-PCR assays.

Our results highlight the importance of genomic monitoring of SARS-CoV-2 and evaluating the effects of mismatches on PCR testing sensitivity.

Competing Interest Statement

The authors have declared no competing interest.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted January 20, 2021.
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Evaluation of the effects of SARS-CoV-2 genetic mutations on diagnostic RT-PCR assays
Takeru Nakabayashi, Yuki Kawasaki, Koichiro Murashima, Kazuya Omi, Satoshi Yuhara
bioRxiv 2021.01.19.426622; doi: https://doi.org/10.1101/2021.01.19.426622
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Evaluation of the effects of SARS-CoV-2 genetic mutations on diagnostic RT-PCR assays
Takeru Nakabayashi, Yuki Kawasaki, Koichiro Murashima, Kazuya Omi, Satoshi Yuhara
bioRxiv 2021.01.19.426622; doi: https://doi.org/10.1101/2021.01.19.426622

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