Objectives: Amid the increasing number of pandemic coronavirus disease 2019 (COVID-19) cases, there is a need for a quick and easy method to obtain a non-invasive sample for the detection of this novel coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2). We aimed to investigate the potential use of saliva samples as a non-invasive tool for the diagnosis of COVID-19. Methods: From 27 March to 4 April 2020, we prospectively collected saliva samples and a standard nasopharyngeal and throat swab in persons seeking care at an acute respiratory infection clinic in a university hospital during the outbreak of COVID-19. Real-time polymerase chain reaction (RT-PCR) was performed, and the results of the two specimens were compared. Results: Two-hundred pairs of samples were collected. Sixty-nine (34.5%) individuals were male, and the median (interquartile) age was 36 (28e48) years. Using nasopharyngeal and throat swab RT-PCR as the reference standard, the prevalence of COVID-19 diagnosed by nasopharyngeal and throat swab RT-PCR was 9.5%. The sensitivity and specificity of the saliva sample RT-PCR were 84.2% (95% CI 60.4%e96.6%), and 98.9% (95% CI 96.1%e99.9%), respectively. An analysis of the agreement between the two specimens demonstrated 97.5% observed agreement (k coefficient 0.851, 95% CI 0.723e0.979; p < 0.001). Conclusions: Saliva might be an alternative specimen for the diagnosis of COVID-19. The collection is non-invasive, and non-aerosol generating. This method could facilitate the diagnosis of the disease, given the simplicity of specimen collection and good diagnostic performance.

26Objectives. Amid the increasing number of global pandemic coronavirus disease 2019 27 cases, there is a need for a quick and easy method to obtain a non-invasive 28 sample for the detection of this novel coronavirus 2019 (SARS-CoV-2). We aimed to 29 investigate the potential use of saliva samples as a non-invasive tool for the diagnosis of 30 Methods. From 27 March to 4 April, 2020, we prospectively collected saliva samples and a 32 standard nasopharyngeal and throat swab in persons seeking care at an acute respiratory 33 infection clinic in a university hospital during the outbreak of COVID-19. Real-time 34 polymerase chain reaction (RT-PCR) was performed, and the results of the two specimens 35 were compared. 36Results. Two-hundred pairs of the samples were collected. Sixty-nine (34.5%) patients were 37 male, and the median (interquartile) age was 36 (28-48) years. Using nasopharyngeal and 38 throat swab RT-PCR as the reference standard, the prevalence of COVID-19 diagnosed by 39 nasopharyngeal and throat swab RT-PCR was 9.5%. The sensitivity and specificity of the 40 saliva sample RT-PCR were 84.2% [95% confidence interval (CI) 79.2%-89.3%], and 98.9% 41 (95% CI 97.5-100.3%), respectively. An analysis of the agreement between the two 42 specimens demonstrated 97.5% observed agreement (kappa coefficient 0.851, 95% CI 0.723-43 0.979; p <0.001). 44Conclusions. Saliva specimens can be used for the diagnosis of COVID-19. The collection 45 method is non-invasive, and non-aerosol generating. Using a saliva sample as a specimen for 46 the detection of SARS-CoV-2 could facilitate the diagnosis of the disease, which is one of the 47

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