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    The Lancet. Microbe. 2023 May 5. doi: 10.1016/S2666-5247(23)00072-1. pii: S2666-5247(23)00072-1
    Design of external quality assessment schemes and definition of the roles of their providers in future epidemics.
    Buchta C1,  Zeichhardt H2,  Aberle SW3,  Camp JV4,  Görzer I5,  Weseslindtner L6,  Puchhammer-Stöckl E7,  Huf W8,  Benka B9,  Allerberger F10,  Mielke M11,  Griesmacher A12,  Müller MM13,  Schellenberg I14,  Kammel M15
    Author information
    1Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests, Vienna, Austria; European Organisation for External Quality Assurance Providers in Laboratory Medicine, Geneva, Switzerland. Electronic address: christoph.buchta@oequasta.at.
    2INSTAND eV Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany; IQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Germany; GBD Gesellschaft für Biotechnologische Diagnostik, Berlin, Germany.
    3Center for Virology, Medical University of Vienna, Vienna, Austria.
    4Center for Virology, Medical University of Vienna, Vienna, Austria.
    5Center for Virology, Medical University of Vienna, Vienna, Austria.
    6Center for Virology, Medical University of Vienna, Vienna, Austria.
    7Center for Virology, Medical University of Vienna, Vienna, Austria.
    8Karl Landsteiner Institute for Clinical Risk Management, Vienna, Austria.
    9Austrian Agency for Health and Food Safety, Vienna, Austria.
    10Austrian Agency for Health and Food Safety, Vienna, Austria.
    11Department for Infectious Diseases, Robert Koch-Institute, Berlin, Germany.
    12Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests, Vienna, Austria.
    13Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests, Vienna, Austria.
    14INSTAND eV Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany.
    15INSTAND eV Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany; IQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Germany; GBD Gesellschaft für Biotechnologische Diagnostik, Berlin, Germany.
    Abstract

    During an epidemic, individual test results form the basis of epidemiological indicators such as case numbers or incidence. Therefore, the accuracy of measures derived from these indicators depends on the reliability of individual results. In the COVID-19 pandemic, monitoring and evaluating the performance of the unprecedented number of testing facilities in operation, and novel testing systems in use, was urgently needed. External quality assessment (EQA) schemes are unique sources of data reporting on testing performance, and their providers are recognised contacts and support for test facilities (for technical-analytical topics) and health authorities (for planning the monitoring of infection diagnostics). To identify information provided by SARS-CoV-2 genome detection EQA schemes that is relevant for public health microbiology, we reviewed the current literature published in PubMed between January, 2020, and July, 2022. We derived recommendations for EQA providers and their schemes for best practices to monitor pathogen-detection performance in future epidemics. We also showed laboratories, test facilities, and health authorities the information and benefits they can derive from EQA data, and from the non-EQA services of their providers.


    Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

    Publikations ID: 37156257
    Quelle: öffnen
     
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