The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol

<h4>Introduction</h4> GENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples...

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Main Authors: Asami Naito, Yoshihiko Kiyasu, Yusaku Akashi, Akio Sugiyama, Masashi Michibuchi, Yuto Takeuchi, Shigeyuki Notake, Koji Nakamura, Hiroichi Ishikawa, Hiromichi Suzuki
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2021-01-01
Series:PLoS ONE
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719657/?tool=EBI
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author Asami Naito
Yoshihiko Kiyasu
Yusaku Akashi
Akio Sugiyama
Masashi Michibuchi
Yuto Takeuchi
Shigeyuki Notake
Koji Nakamura
Hiroichi Ishikawa
Hiromichi Suzuki
author_facet Asami Naito
Yoshihiko Kiyasu
Yusaku Akashi
Akio Sugiyama
Masashi Michibuchi
Yuto Takeuchi
Shigeyuki Notake
Koji Nakamura
Hiroichi Ishikawa
Hiromichi Suzuki
author_sort Asami Naito
collection DOAJ
description <h4>Introduction</h4> GENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated. <h4>Methods</h4> This prospective comparison between GENECUBE® HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE® HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes. <h4>Results</h4> For 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations. <h4>Conclusion</h4> GENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.
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spelling doaj.art-3429614f13df4d68b83ddf909a3f427f2022-12-22T04:04:16ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-011612The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocolAsami NaitoYoshihiko KiyasuYusaku AkashiAkio SugiyamaMasashi MichibuchiYuto TakeuchiShigeyuki NotakeKoji NakamuraHiroichi IshikawaHiromichi Suzuki<h4>Introduction</h4> GENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated. <h4>Methods</h4> This prospective comparison between GENECUBE® HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE® HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes. <h4>Results</h4> For 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations. <h4>Conclusion</h4> GENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719657/?tool=EBI
spellingShingle Asami Naito
Yoshihiko Kiyasu
Yusaku Akashi
Akio Sugiyama
Masashi Michibuchi
Yuto Takeuchi
Shigeyuki Notake
Koji Nakamura
Hiroichi Ishikawa
Hiromichi Suzuki
The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
PLoS ONE
title The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
title_full The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
title_fullStr The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
title_full_unstemmed The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
title_short The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
title_sort evaluation of the utility of the genecube hq sars cov 2 for anterior nasal samples and saliva samples with a new rapid examination protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719657/?tool=EBI
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