tetano
Editor, Senior Moderator
J Clin Microbiol. 2020 Apr 27. pii: JCM.00743-20. doi: 10.1128/JCM.00743-20. [Epub ahead of print]
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens.
Zhen W[SUP]1[/SUP], Manji R[SUP]1[/SUP], Smith E[SUP]1[/SUP], Berry GJ[SUP]2,[/SUP][SUP]3[/SUP].
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Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel human coronavirus that causes coronavirus disease 2019 (COVID-19), was first discovered in December 2019 as the cause of an outbreak of pneumonia in the city of Wuhan, Hubei province, China. The clinical presentation of COVID-19 is fairly non-specific, and symptoms overlap with other seasonal respiratory infections concurrently circulating in the population. Furthermore, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-19 positive patients. In the present study, we have evaluated the analytical sensitivity and clinical performance of four SARS-CoV-2 molecular diagnostic assays granted Emergency Use Authorization by the FDA using nasopharyngeal swabs from symptomatic patients: the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Modified CDC), the Simplexa COVID-19 Direct (Diasorin Molecular), GenMark ePlex SARS-CoV-2 assay (GenMark) and the Hologic Panther Fusion? SARS-CoV-2 assay (Hologic). This information is crucial for both laboratories and clinical teams, as decisions on which testing platform to implement are made.
Copyright ? 2020 Zhen et al.
PMID:32341143DOI:10.1128/JCM.00743-20
Free full text
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens.
Zhen W[SUP]1[/SUP], Manji R[SUP]1[/SUP], Smith E[SUP]1[/SUP], Berry GJ[SUP]2,[/SUP][SUP]3[/SUP].
Author information
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel human coronavirus that causes coronavirus disease 2019 (COVID-19), was first discovered in December 2019 as the cause of an outbreak of pneumonia in the city of Wuhan, Hubei province, China. The clinical presentation of COVID-19 is fairly non-specific, and symptoms overlap with other seasonal respiratory infections concurrently circulating in the population. Furthermore, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-19 positive patients. In the present study, we have evaluated the analytical sensitivity and clinical performance of four SARS-CoV-2 molecular diagnostic assays granted Emergency Use Authorization by the FDA using nasopharyngeal swabs from symptomatic patients: the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Modified CDC), the Simplexa COVID-19 Direct (Diasorin Molecular), GenMark ePlex SARS-CoV-2 assay (GenMark) and the Hologic Panther Fusion? SARS-CoV-2 assay (Hologic). This information is crucial for both laboratories and clinical teams, as decisions on which testing platform to implement are made.
Copyright ? 2020 Zhen et al.
PMID:32341143DOI:10.1128/JCM.00743-20
Free full text