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Saliva as a Diagnostic Specimen for SARS-CoV-2 by a PCR-Based Assay: A Diagnostic Validity Study

18 Pages Posted: 28 Feb 2020

See all articles by Shufa Zheng

Shufa Zheng

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Fei Yu

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Jian Fan

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Qianda Zou

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Guoliang Xie

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Xianzhi Yang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Weizhen Chen

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Qi Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Dan Zhang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Ruonan Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Baihuan Feng

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Sa Lin

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Renjie Gong

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Zhaohui Ma

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Siming Lu

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Xiaochen Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

Ling Yu

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

Kaijin Xu

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

Jifang Sheng

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

Yu Chen

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

More...

Abstract

Background: An outbreak of a novel coronavirus (SARS-CoV-2) that began in Wuhan, has spread rapidly to more than 26 countries. False negative diagnosis of respiratory samples, predominantly nasal or throat swabs, has made diagnoses and control difficult.

Methods: To identify the detection rates in different respiratory sample types, we recruited 65 patients with confirmed SARS-CoV-2 infection and sequentially collected throat swabs, nasal swabs and saliva or sputum, followed by a comparative analysis of quantitative RT-PCR and viral loads.

Results: The median age of COVID-19 patients recruited for the study was 52.5 years (IQR 39.3-61). Fever (83.3%), cough (54.2%) and expectoration (25.0%) were the most common clinical manifestations. The detection rates of sputum (95.65%, 22/23) and saliva (88.09%, 37/42) were significantly higher than in throat swabs (41.54%, 27/65) and nasal swabs (72.31%, 47/65) ( P <0.001). Further, the Ct Value from sputum, saliva and nasal swabs were significantly higher than in throat swabs, whereas no significant difference was observed between sputum and saliva samples.

Conclusions: The detection rate of SARS-CoV-2 is higher in saliva than other respiratory samples. Our results show that saliva and sputum are reliable sample types that can be used to detect SARS-CoV-2, and worthy of clinical promotion. The convenience in sampling saliva may also significantly reduce the risk of infection of medical staff.

Funding Statement: This work was supported by the China National Mega-Projects for Infectious Diseases (grant number 2017ZX10103008 and 2018ZX10101001); and the National Natural Science Foundation of China (grant numbers 81672014 and 81702079).

Declaration of Interests: All authors had no reported conflicts.

Ethics Approval Statement: This study conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the Institutional Review Board of the First Affiliated Hospital of Zhejiang University.

Keywords: SARS-CoV-2; COVID-19; Saliva; PCR

Suggested Citation

Zheng, Shufa and Yu, Fei and Fan, Jian and Zou, Qianda and Xie, Guoliang and Yang, Xianzhi and Chen, Weizhen and Wang, Qi and Zhang, Dan and Wang, Ruonan and Feng, Baihuan and Lin, Sa and Gong, Renjie and Ma, Zhaohui and Lu, Siming and Wang, Xiaochen and Yu, Ling and Xu, Kaijin and Sheng, Jifang and Chen, Yu, Saliva as a Diagnostic Specimen for SARS-CoV-2 by a PCR-Based Assay: A Diagnostic Validity Study (February 20, 2020). Available at SSRN: https://ssrn.com/abstract=3543605 or http://dx.doi.org/10.2139/ssrn.3543605

Shufa Zheng

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Fei Yu

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Jian Fan

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Qianda Zou

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Guoliang Xie

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Xianzhi Yang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Weizhen Chen

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Qi Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Dan Zhang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Ruonan Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Baihuan Feng

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Sa Lin

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Renjie Gong

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Zhaohui Ma

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Siming Lu

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Xiaochen Wang

Zhejiang University - Key Laboratory of Clinical In Vitro Diagnostic Techniques

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Ling Yu

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Kaijin Xu

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Jifang Sheng

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases ( email )

38 Zheda Road
Hangzhou, Zhejiang 310058
China

Yu Chen (Contact Author)

Zhejiang University - State Key Laboratory for Diagnosis and Treatment of Infectious Diseases ( email )

38 Zheda Road
Hangzhou, Zhejiang 310058
China

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