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

Funder

European Social Fund

European Regional Development Fund

Instituto de Salud Carlos III

Centro de Investigación Biomédica en Red de Cáncer

Publisher

Elsevier BV

Subject

Microbiology (medical)

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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