Multisite Clinical Validation of Isothermal Amplification-Based SARS-CoV-2 Detection Assays Using Different Sampling Strategies-Reference-Cited by-同舟云学术

Multisite Clinical Validation of Isothermal Amplification-Based SARS-CoV-2 Detection Assays Using Different Sampling Strategies

Published:2021-10-31 Issue:2 Volume:9 Page:
ISSN:2165-0497
Container-title:Microbiology Spectrum
language:en
Short-container-title:Microbiol Spectr

Author:

Desai Kanan T.¹^ORCID,Alfaro Karla²,Mendoza Laura³,Faron Matthew⁴,Mesich Brian⁴,Maza Mauricio²,Dominguez Rhina⁵,Valenzuela Adriana³,Acosta Chyntia Díaz³,Martínez Magaly³,Felix Juan C.⁴,Masch Rachel²⁶,Smith Jennifer S.⁷,Gabrilovich Sofia⁸,Wu Tracy⁸,Plump Michael⁸,Novetsky Akiva P.⁸⁹,Einstein Mark H.⁸⁹,Douglas Nataki C.⁸,Cremer Miriam²¹⁰,Wentzensen Nicolas¹

Affiliation:

1. Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, Rockville, Maryland, USA

2. Basic Health International, Pittsburgh, Pennsylvania, USA

3. Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asunción, San Lorenzo, Paraguay

4. Medical College of Wisconsin, Milwaukee, Wisconsin, USA

5. Research Unit, El Salvador National Institute of Health (INS), San Salvador, El Salvador

6. The Mount Sinai Hospital, New York, New York, USA

7. Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA

8. Rutgers New Jersey Medical School, Newark, New Jersey, USA

9. Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA

10. Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, USA

Abstract

Numerous SARS-CoV-2 detection assays have been developed and introduced into the market under emergency use authorizations (EUAs). EUAs are granted primarily based on small studies of analytic sensitivity and specificity with limited clinical validations.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Link

https://journals.asm.org/doi/pdf/10.1128/Spectrum.00846-21

Reference39 articles.

1. WHO. 2021. WHO coronavirus (COVID-19) dashboard. WHO Geneva Switzerland. https://covid19.who.int/.

2. UNICEF. 2021. COVID-19 vaccine market dashboard. UNICEF Copenhagen Denmark. https://www.unicef.org/supply/covid-19-vaccine-market-dashboard.

3. Cancino RS Su Z Mesa R Tomlinson GE Wang J. 2020. The impact of COVID-19 on cancer screening: challenges and opportunities. JMIR Cancer 6:e21697. e21697

4. FDA. 2021. In vitro diagnostics EUAs—molecular diagnostic tests for SARS-CoV-2. FDA Silver Spring MD. 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#individual-molecular.

5. Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Carta al editor. Validación clínica de la prueba RT-LAMP para el diagnóstico rápido del SARS-CoV-2. Biomédica. 2022;42(Supl.2):59-72.;Biomédica;2023-03-30

2. Applicability of a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2 detection in high exposure risk setting;International Journal of Infectious Diseases;2023-03

3. Saliva as a sample type for SARS-CoV-2 detection: implementation successes and opportunities around the globe;Expert Review of Molecular Diagnostics;2022-05-04