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. 2024 Jan 4;14(1):119.
doi: 10.3390/diagnostics14010119.

Temporal Trend of the SARS-CoV-2 Omicron Variant and RSV in the Nasal Cavity and Accuracy of the Newly Developed Antigen-Detecting Rapid Diagnostic Test

Daisuke Tamura  1 , Yuji Morisawa  2 , Takashi Mato  3 , Shin Nunomiya  4 , Masaki Yoshihiro  5 , Yuta Maehara  5 , Shizuka Ito  5 , Yasushi Ochiai  5 , Hirokazu Yamagishi  1 , Toshihiro Tajima  1 , Takanori Yamagata  1 , Hitoshi Osaka  1
Affiliations

Temporal Trend of the SARS-CoV-2 Omicron Variant and RSV in the Nasal Cavity and Accuracy of the Newly Developed Antigen-Detecting Rapid Diagnostic Test

Daisuke Tamura et al. Diagnostics (Basel). .

Abstract

The aim of this work is to analyze the viral titers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and respiratory syncytial virus (RSV) at the anterior nasal site (ANS) and nasopharyngeal site (NS), evaluate their virological dynamics, and validate the usefulness of a newly developed two-antigen-detecting rapid antigen diagnostic test (Ag-RDT) that simultaneously detects SARS-CoV-2 and RSV using clinical specimens. This study included 195 asymptomatic to severely ill patients. Overall, 668 specimens were collected simultaneously from the ANS and NS. The cycle threshold (Ct) values calculated from real-time polymerase chain reaction were used to analyze temporal changes in viral load and evaluate the sensitivity and specificity of the Ag-RDT. The mean Ct values for SARS-CoV-2-positive, ANS, and NS specimens were 28.8, 28.9, and 28.7, respectively. The mean Ct values for RSV-positive, ANS, and NS specimens were 28.7, 28.8, and 28.6, respectively. SARS-CoV-2 and RSV showed the same trend in viral load, although the viral load of NS was higher than that of ANS. The sensitivity and specificity of the newly developed Ag-RDT were excellent in specimens collected up to 10 days after the onset of SARS-CoV-2 infection and up to 6 days after the onset of RSV infection.

Keywords: RSV; RT-PCR; SARS-CoV-2; omicron; rapid diagnostic test; viral antigens.

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Conflict of interest statement

Author Masaki Yoshihiro, Yuta Maehara, Shizuka Ito and Yasushi Ochiai was employed by the company Sekisui Medical Co., Ltd. The authors declare that this study received funding from Sekisui Medical Co., Ltd. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.

Figures

Figure 1
Figure 1
Flowchart for the selection of the study population.
Figure 2
Figure 2
Comparison of cycle threshold (Ct) values for all specimens, anterior nasal, and nasopharyngeal specimens for coronavirus disease-2019. Mean Ct values are indicated by horizontal bars.
Figure 3
Figure 3
(A) Changes over time in thresholds (Ct) of nasopharyngeal and anterior nasal specimens in all coronavirus disease-2019; (B) changes over time in the cycle threshold (Ct) of nasopharyngeal and anterior nasal specimens in patients with mild and moderate to severe coronavirus disease-2019; (C) comparison of cycle threshold (Ct) values for all specimens, anterior nasal, and nasopharyngeal specimens taken from asymptomatic patients for coronavirus disease-2019. Mean Ct values are indicated by horizontal bars.
Figure 3
Figure 3
(A) Changes over time in thresholds (Ct) of nasopharyngeal and anterior nasal specimens in all coronavirus disease-2019; (B) changes over time in the cycle threshold (Ct) of nasopharyngeal and anterior nasal specimens in patients with mild and moderate to severe coronavirus disease-2019; (C) comparison of cycle threshold (Ct) values for all specimens, anterior nasal, and nasopharyngeal specimens taken from asymptomatic patients for coronavirus disease-2019. Mean Ct values are indicated by horizontal bars.
Figure 4
Figure 4
Comparison of cycle threshold (Ct) values for all specimens, anterior nasal, and nasopharyngeal specimens for the respiratory syncytial virus. Mean Ct values are indicated by horizontal bars.
Figure 5
Figure 5
Changes over time in thresholds (Ct) of nasopharyngeal and anterior nasal specimens in respiratory syncytial virus.
Figure 6
Figure 6
Ct values of respiratory syncytial virus (RSV) specimens by date of onset and determination of RapidTesta RSV and SARS-CoV-2.
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