Diagnostic accuracy of direct reverse transcription-polymerase chain reaction using guanidine-based and guanidine-free inactivators for SARS-CoV-2 detection in saliva samples.

Autor: Katsuno T; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan. Electronic address: katsuno.takashi.jb@mail.hosp.go.jp., Kimura M; Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan., Terada-Hirashima J; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Kazuyama Y; SB Coronavirus Inspection Center Corp., Tokyo, Japan., Ikeda M; SB Coronavirus Inspection Center Corp., Tokyo, Japan., Moriya A; Clinical Laboratory Department, National Center for Global Health and Medicine, Tokyo, Japan., Kurokawa M; Clinical Laboratory Department, National Center for Global Health and Medicine, Tokyo, Japan., Motohashi A; Clinical Laboratory Department, National Center for Global Health and Medicine, Tokyo, Japan., Isaka E; Clinical Laboratory Department, National Center for Global Health and Medicine, Tokyo, Japan., Morishita M; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Kawajiri K; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Hakkaku K; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Saito S; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Terayama Y; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Sugiura Y; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Yamaguchi Y; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Takumida H; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Watanabe H; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Morita C; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Tsukada A; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Kusaba Y; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Tsujimoto Y; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Ishida A; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Sakamoto K; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Hashimoto M; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Suzuki M; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Takasaki J; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Izumi S; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Hojo M; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Sugiyama H; Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan., Sugiura W; Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Journal of virological methods [J Virol Methods] 2024 May; Vol. 326, pp. 114909. Date of Electronic Publication: 2024 Mar 05.
DOI: 10.1016/j.jviromet.2024.114909
Abstrakt: This study aimed to evaluate diagnostic accuracy of SARS-CoV-2 RNA detection in saliva samples treated with a guanidine-based or guanidine-free inactivator, using nasopharyngeal swab samples (NPS) as referents. Based on the NPS reverse transcription-polymerase chain reaction (RT-PCR) results, participants were classified as with or without COVID-19. Fifty sets of samples comprising NPS, self-collected raw saliva, and saliva with a guanidine-based, and guanidine-free inactivator were collected from each group. In patients with COVID-19, the sensitivity of direct RT-PCR using raw saliva and saliva treated with a guanidine-based and guanidine-free inactivator was 100.0%, 65.9%, and 82.9%, respectively, with corresponding concordance rates of 94.3% (κ=88.5), 82.8% (κ=64.8), and 92.0% (κ=83.7). Among patients with a PCR Ct value of <30 in the NPS sample, the positive predictive value for the three samples was 100.0%, 80.0%, and 96.0%, respectively. The sensitivity of SARS-CoV-2 RNA detection was lower in inactivated saliva than in raw saliva and lower in samples treated with a guanidine-based than with a guanidine-free inactivator. However, in individuals contributing to infection spread, inactivated saliva showed adequate accuracy regardless of the inactivator used. Inactivators can be added to saliva samples collected for RT-PCR to reduce viral transmission risk while maintaining adequate diagnostic accuracy.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Takashi Katsuno, Moto Kimura, and Wataru Sugiura received research grants from the SB Coronavirus Inspection Center Corp. Disclosure statement Takashi Katsuno, Moto Kimura, and Wataru Sugiura received research grants from the SB Coronavirus Inspection Center Corp. Yukumasa Kazuyama is the director and Masato Ikeda is the president of SB Coronavirus Inspection Center Corp. All other authors report no conflict of interest.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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