Multicenter clinical evaluation of a novel transcription-mediated amplification assay for SARS-CoV-2 molecular testing

Author:

Fernández-Huerta Miguel,Salmerón Paula,Hernández-Hermida Yolanda,Andrés Cristina,Niubó Jordi,Calatayud Laura,Domínguez M. Ángeles,Pumarola Tomàs,Ardanuy Carmen,Antón Andrés,Càmara Jordi

Publisher

Elsevier BV

Subject

General Medicine

Reference12 articles.

1. A novel coronavirus from patients with pneumonia in China, 2019;Zhu;N Engl J Med,2020

2. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries January 2020;Reusken;Euro Surveill,2020

3. Food and Drug Administration (FDA). Individual EUAs for molecular diagnostic tests for SARS-CoV-2. Available from: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 [consulted 22.4.21].

4. Clinical evaluation of the Procleix SARS-CoV-2 assay, a sensitive, high-throughput test that runs on an automated system;Sauleda;Diagn Microbiol Infect Dis,2021

5. High-throughput transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2;Gorzalski;J Clin Virol,2020

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