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J Clin Microbiol . Increasing the efficiency of a national laboratory response to COVID-19; a nation-wide multicenter evaluation of 47 commercial SARS-CoV-2 immunoassays by 41 laboratories

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  • J Clin Microbiol . Increasing the efficiency of a national laboratory response to COVID-19; a nation-wide multicenter evaluation of 47 commercial SARS-CoV-2 immunoassays by 41 laboratories


    J Clin Microbiol


    . 2021 Jun 30;JCM0076721.
    doi: 10.1128/JCM.00767-21. Online ahead of print.
    Increasing the efficiency of a national laboratory response to COVID-19; a nation-wide multicenter evaluation of 47 commercial SARS-CoV-2 immunoassays by 41 laboratories


    Maaike J C van den Beld 1 , Jean-Luc Murk 2 , Jan Kluytmans 3 4 , Marion P G Koopmans 5 , Johan Reimerink 1 , Inge H M van Loo 6 , Marjolijn C A Wegdam-Blans 7 , Hans Zaaijer 8 , Serology Workgroup for SARS-CoV-2; Corine GeurtsvanKessel 5 , Chantal Reusken 1



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    Abstract

    In response to the worldwide pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the subsequent overflowing of the market regarding antibody tests, a nationwide collaborative approach in the Netherlands was employed. Forty-one Dutch laboratories joined forces and shared their evaluation data, to allow for the evaluation of a quantity of serological assays for SARS-CoV-2, that exceeds the capacity of each individual laboratory. As of April 2020, these performance data had been aggregated and shared in regularly updated reports with other laboratories, Dutch government, public health organizations and the public. This frequently updated overview of assay performance increased the efficiency of our national laboratory response, supporting laboratories in their choice and implementation of assays. Aggregated performance data for 47 immunoassays for SARS-CoV-2 showed that none of the evaluated immunoassays that detect IgM or IgA only met the diagnostic criteria, indicating that they are not suitable for e diagnosing acute infections. For the detection of IgG, only BIOZEK Corona virus COVID rapid test, EUROIMMUN SARS-CoV-2 IgG and Wantai SARS-CoV-2 Ab ELISA met predefined performance criteria in hospitalized patients where samples were collected 14 days post onset, while for patients with mild or asymptomatic infections only the Wantai SARS-CoV-2 Ab ELISA met the predefined performance criteria if samples were collected 14 days post onset. Here we describe this unique nationwide collaboration during the onset of the COVID-19 pandemic, the collected data and their results are an example of what can be accomplished when forces are joined during a public health crisis.


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