Frontiers in Cellular and Infection Microbiology (Jun 2021)
Assessment of the Diagnostic Ability of Four Detection Methods Using Three Sample Types of COVID-19 Patients
- Fei Yu,
- Fei Yu,
- Fei Yu,
- Guoliang Xie,
- Guoliang Xie,
- Guoliang Xie,
- Shufa Zheng,
- Shufa Zheng,
- Shufa Zheng,
- Dongsheng Han,
- Dongsheng Han,
- Dongsheng Han,
- Jiaqi Bao,
- Jiaqi Bao,
- Jiaqi Bao,
- Dan Zhang,
- Dan Zhang,
- Dan Zhang,
- Baihuan Feng,
- Baihuan Feng,
- Baihuan Feng,
- Qi Wang,
- Qi Wang,
- Qi Wang,
- Qianda Zou,
- Qianda Zou,
- Qianda Zou,
- Ruonan Wang,
- Ruonan Wang,
- Ruonan Wang,
- Xianzhi Yang,
- Xianzhi Yang,
- Xianzhi Yang,
- Weizhen Chen,
- Weizhen Chen,
- Weizhen Chen,
- Bin Lou,
- Bin Lou,
- Bin Lou,
- Yu Chen,
- Yu Chen,
- Yu Chen,
- Yu Chen
Affiliations
- Fei Yu
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Fei Yu
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Fei Yu
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Guoliang Xie
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Guoliang Xie
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Guoliang Xie
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Shufa Zheng
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Shufa Zheng
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Shufa Zheng
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Dongsheng Han
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Dongsheng Han
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Dongsheng Han
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Jiaqi Bao
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Jiaqi Bao
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Jiaqi Bao
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Dan Zhang
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Dan Zhang
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Dan Zhang
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Baihuan Feng
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Baihuan Feng
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Baihuan Feng
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Qi Wang
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Qi Wang
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Qi Wang
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Qianda Zou
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Qianda Zou
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Qianda Zou
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Ruonan Wang
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Ruonan Wang
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Ruonan Wang
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Xianzhi Yang
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Xianzhi Yang
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Xianzhi Yang
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Weizhen Chen
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Weizhen Chen
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Weizhen Chen
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Bin Lou
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Bin Lou
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Bin Lou
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Yu Chen
- Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Yu Chen
- Key Laboratory of Clinical In Vitro Diagnostic Techniques of Zhejiang Province, Hangzhou, China
- Yu Chen
- Institute of Laboratory Medicine, Zhejiang University, Hangzhou, China
- Yu Chen
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- DOI
- https://doi.org/10.3389/fcimb.2021.685640
- Journal volume & issue
-
Vol. 11
Abstract
BackgroundViral nucleic acid detection is considered the gold standard for the diagnosis of coronavirus disease 2019 (COVID-19), which is caused by SARS-CoV-2 infection. However, unsuitable sample types and laboratory detection kits/methods lead to misdiagnosis, which delays the prevention and control of the pandemic.MethodsWe compared four nucleic acid detection methods [two kinds of reverse transcription polymerase chain reactions (RT-PCR A: ORF1ab and N testing; RT-PCRB: only ORF1ab testing), reverse transcription recombinase aided amplification (RT-RAA) and droplet digital RT-PCR (dd-RT-PCR)] using 404 samples of 72 hospitalized COVID-19 patients, including oropharyngeal swab (OPS), nasopharyngeal swabs (NPS) and saliva after deep cough, to evaluate the best sample type and method for SARS-CoV-2 detection.ResultsAmong the four methods, dd-RT-PCR exhibited the highest positivity rate (93.0%), followed by RT-PCR B (91.2%) and RT-RAA (91.2%), while the positivity rate of RT-PCR A was only 71.9%. The viral load in OPS [24.90 copies/test (IQR 15.58-129.85)] was significantly lower than that in saliva [292.30 copies/test (IQR 20.20-8628.55)] and NPS [274.40 copies/test (IQR 33.10-2836.45)]. In addition, if OPS samples were tested alone by RT-PCR A, only 21.4% of the COVID-19 patients would be considered positive. The accuracy of all methods reached nearly 100% when saliva and NPS samples from the same patient were tested simultaneously.ConclusionsSARS-CoV-2 nucleic acid detection methods should be fully evaluated before use. High-positivity rate methods such as RT-RAA and dd-RT-PCR should be considered when possible. Furthermore, saliva after deep cough and NPS can greatly improve the accuracy of the diagnosis, and testing OPS alone is not recommended.
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