Comparison of SARS‐CoV‐2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS‐CoV‐2 test and a laboratory‐developed real‐time RT‐PCR test

Author:

Pujadas Elisabet1ORCID,Ibeh Nnaemeka1,Hernandez Matthew M.23,Waluszko Aneta4,Sidorenko Tatyana4,Flores Vanessa5,Shiffrin Biana5,Chiu Numthip5,Young‐Francois Alicia5,Nowak Michael D.1,Paniz‐Mondolfi Alberto E.1,Sordillo Emilia M.1,Cordon‐Cardo Carlos1,Houldsworth Jane1,Gitman Melissa R.1ORCID

Affiliation:

1. Department of Pathology, Molecular, and Cell‐Based MedicineIcahn School of Medicine at Mount Sinai New York New York

2. The Graduate School of Biomedical SciencesIcahn School of Medicine at Mount Sinai New York New York

3. Department of MicrobiologyIcahn School of Medicine at Mount Sinai New York New York

4. Molecular Pathology LaboratoryMount Sinai Health System New York New York

5. Clinical Microbiology LaboratoryMount Sinai Health System New York New York

Publisher

Wiley

Subject

Infectious Diseases,Virology

Reference6 articles.

1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Accessed 15 April 2020.

2. The Measurement of Observer Agreement for Categorical Data

3. Guidance for Industry and FDA Staff Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-guidance-reporting-results-studies-evaluating-diagnostic-tests-guidance-industry-and-fda. Accessed 5 January 2020.

4. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

5. Analytical sensitivity and efficiency comparisons of SARS-COV-2 qRT-PCR assays;Vogels C;medRxiv,2020

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