es | en | pt | fr
    • Presentación
    • Países
    • Instituciones
    • Participa
        JavaScript is disabled for your browser. Some features of this site may not work without it.
        Ver ítem 
        •   Inicio
        • Colombia
        • Universidades
        • Universidad Jorge Tadeo Lozano (Colombia)
        • Ver ítem
        •   Inicio
        • Colombia
        • Universidades
        • Universidad Jorge Tadeo Lozano (Colombia)
        • Ver ítem

        The 2020 Wild, Wild West of Diagnostics

        Registro en:
        2589-4080
        https://doi.org/10.1016/j.yamp.2020.06.001
        http://hdl.handle.net/20.500.12010/12463
        https://doi.org/10.1016/j.yamp.2020.06.001
        http://repositorioslatinoamericanos.uchile.cl/handle/2250/3495902
        Autor
        Tsongalis, Gregory J.
        Kaul, Karen
        Institución
        • Universidad Jorge Tadeo Lozano (Colombia)
        Resumen
        Regarding regulatory oversight of laboratorydeveloped tests (LDT) for molecular diagnostics, the Q7 Food and Drug Administration (FDA) often refers to the LDT space as the “Wild, Wild West,” making it seem like laboratories are all going rogue with respect to Clinical Laboratory Improvement Amendments Q8 (CLIA)-defined quality assurance practices. Now, with the challenges of the COVID-19 pandemic in 2020, the FDA finds themselves in a self-created Wild, Wild West regarding molecular and serologic testing for SARS-CoV-2. In December 2019, Chinese officials notified the World Health Organization of a cluster of severe pneumonia cases in Wuhan that had a suspicious origin. On January 7, 2020, the cause was identified, the novel severe acute respiratory coronavirus 2 (SARS-CoV-2), and the first death was reported in China several days later. By the end of January, cases were being reported globally, including the first case in Washington State, and travel bans were issued by some countries. The FDA released a guidance document for designing and validating molecular tests for SARSCoV-2 and issued the first Emergency Use Authorization (EUA) for a reverse transcriptase, real-time polymerase chain reaction (RT-PCR) assay to the Centers Q9 for Disease Control and Prevention (CDC) on February 4, 2020. The EUA specified that all diagnostic testing for SARS-CoV-2 be reviewed by the FDA, and in effect removed the option to offer testing as an LDT. This changed the landscape of molecular diagnostics for the virus and thrust the nation into a difficult situation because no assays other than the CDC RT-PCR test, available only to public health laboratories (PHLs), were accessible.
        Materias
        Pandemic
        SARS-CoV-2
        COVID-18
        Laboratory-developed tests
        Regulatory oversight
        Emergency use authorization

        Mostrar el registro completo del ítem


        Red de Repositorios Latinoamericanos
        + de 8.000.000 publicaciones disponibles
        500 instituciones participantes
        Dirección de Servicios de Información y Bibliotecas (SISIB)
        Universidad de Chile
        Ingreso Administradores
        Colecciones destacadas
        • Tesis latinoamericanas
        • Tesis argentinas
        • Tesis chilenas
        • Tesis peruanas
        Nuevas incorporaciones
        • Argentina
        • Brasil
        • Colombia
        • México
        Dirección de Servicios de Información y Bibliotecas (SISIB)
        Universidad de Chile
        Red de Repositorios Latinoamericanos | 2006-2018
         

        EXPLORAR POR

        Instituciones
        Fecha2011 - 20202001 - 20101951 - 20001901 - 19501800 - 1900

        Explorar en Red de Repositorios

        Países >
        Tipo de documento >
        Fecha de publicación >
        Instituciones >

        Red de Repositorios Latinoamericanos
        + de 8.000.000 publicaciones disponibles
        500 instituciones participantes
        Dirección de Servicios de Información y Bibliotecas (SISIB)
        Universidad de Chile
        Ingreso Administradores
        Colecciones destacadas
        • Tesis latinoamericanas
        • Tesis argentinas
        • Tesis chilenas
        • Tesis peruanas
        Nuevas incorporaciones
        • Argentina
        • Brasil
        • Colombia
        • México
        Dirección de Servicios de Información y Bibliotecas (SISIB)
        Universidad de Chile
        Red de Repositorios Latinoamericanos | 2006-2018