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

Asami Naito; Yoshihiko Kiyasu; Yusaku Akashi; Akio Sugiyama; Masashi Michibuchi; Yuto Takeuchi; Shigeyuki Notake; Koji Nakamura; Hiroichi Ishikawa; Hiromichi Suzuki

doi:10.1371/journal.pone.0262159

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. 2021 Dec 31;16(12):e0262159. doi: 10.1371/journal.pone.0262159. eCollection 2021.

Authors

Asami Naito¹, Yoshihiko Kiyasu^{2

3}, Yusaku Akashi^{2

4}, Akio Sugiyama⁵, Masashi Michibuchi⁵, Yuto Takeuchi^{2

3}, Shigeyuki Notake⁶, Koji Nakamura⁶, Hiroichi Ishikawa⁷, Hiromichi Suzuki^{2

3

8}

Affiliations

¹ Tsukuba i-Laboratory LLP, Tsukuba, Ibaraki, Japan.
² Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
³ Department of Infectious Diseases, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan.
⁴ Akashi Internal Medicine Clinic, Kashiwara, Osaka, Japan.
⁵ Diagnostic System Department, TOYOBO Co., Ltd., Kita-ku, Osaka, Japan.
⁶ Department of Clinical Laboratory, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
⁷ Department of Respiratory Medicine, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan.
⁸ Department of Infectious Diseases, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: GENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.

Publication types

Comparative Study
Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

COVID-19 / diagnosis*
COVID-19 Nucleic Acid Testing / methods*
Diagnostic Tests, Routine / methods*
Humans
Nasopharynx / virology*
Pandemics*
Prospective Studies
Saliva / virology*

Grants and funding

This study was supported financially by TOYOBO Co., Ltd. PSS provided the MagDEA Dx SV and magLEAD Consumable Kit for the evaluation of the rapid protocol with magLEAD. TOYOBO Co., Ltd., provided support in the form of salaries for authors Akio Sugiyama and Masashi Michibuchi, lecture fees for author Hiromichi Suzuki, and advisory fees for author Hiromichi Suzuki. Hiromichi Suzuki also received advisory fees from PSS. The funder did not play any additional role in the study design, data collection or analysis, decision to publish, or preparation of the manuscript.