Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies

Author:

Freire-Paspuel Byron,Vega-Mariño PatricioORCID,Velez Alberto,Castillo Paulina,Cruz Marilyn,Garcia-Bereguiain Miguel AngelORCID

Funder

"Ministerio de Salud Pública"

"Agencia de Regulación y Control de la Bioseguridad y Cuarentena para Galápagos"

"Dirección General de Investigación de la Universidad de Las Américas"

Universidad de Las Américas

Publisher

Elsevier BV

Subject

Infectious Diseases,Virology

Reference6 articles.

1. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19),2019

2. Comparison of Abbott ID now, Diasorin Simplexa, and CDC FDA EUA methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19;Rhoads;J. Clin. Microbiol.,2020

3. Comparative performance of SARS-CoV-2 detection assays using seven different Primer/Probe sets and one assay kit. Comparative performance of SARS-CoV-2 detection assays using seven different Primer/Probe sets and one assay kit;Nallaa;J. Clin. Microbiol.,2020

4. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations (last accession date 05/16/2020).

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