A Zika Reference Panel for Molecular-Based Diagnostic Devices as a US Food and Drug Administration Response Tool to a Public Health Emergency.

García, Mayra; Fares-Gusmao, Rafaelle; Sapsford, Kim; Chancey, Caren; Grinev, Andriyan; Lovell, Stephen; Scherf, Uwe; Rios, Maria

García, Mayra; Fares-Gusmao, Rafaelle; Sapsford, Kim; Chancey, Caren; Grinev, Andriyan; Lovell, Stephen; Scherf, Uwe; Rios, Maria.

Afiliação

García M; Office of in Vitro Diagnostics and Radiological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland. Electronic address: mayra.garcia@fda.hhs.gov.
Fares-Gusmao R; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Sapsford K; Office of in Vitro Diagnostics and Radiological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Chancey C; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Grinev A; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Lovell S; Office of in Vitro Diagnostics and Radiological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Scherf U; Office of in Vitro Diagnostics and Radiological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Rios M; Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

J Mol Diagn ; 21(6): 1025-1033, 2019 11.

Article em En | MEDLINE | ID: mdl-31628040

Assuntos

RNA Viral/genética; Infecção por Zika virus/diagnóstico; Zika virus/genética; Humanos; Técnicas de Diagnóstico Molecular/normas; Saúde Pública; Kit de Reagentes para Diagnóstico; Padrões de Referência; Estados Unidos; United States Food and Drug Administration; Infecção por Zika virus/virologia

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: RNA Viral / Zika virus / Infecção por Zika virus Tipo de estudo: Diagnostic_studies / Guideline Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: J Mol Diagn Assunto da revista: BIOLOGIA MOLECULAR Ano de publicação: 2019 Tipo de documento: Article

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