• J. Clin. Virol. · Jul 2020

    Multicenter Study

    Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic.

    • Femke Wolters, Jeroen van de Bovenkamp, Bart van den Bosch, Sharon van den Brink, Maaike Broeders, Ngoc Hoa Chung, Barbara Favié, Gabriel Goderski, Judith Kuijpers, Ilse Overdevest, Janette Rahamat-Langedoen, Lisa Wijsman, Willem Jg Melchers, and Adam Meijer.
    • Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands. Electronic address: femke.wolters@radboudumc.nl.
    • J. Clin. Virol. 2020 Jul 1; 128: 104426.

    BackgroundWith the outbreak of SARS-CoV-2, rapid diagnostics are paramount to contain the current pandemic. The routinely used realtime RT-PCR is sensitive, specific and able to process large batches of samples. However, turnaround time is long and in cases where fast obtained results are critical, molecular point of care tests (POCT) can be an alternative. Here we report on a multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 point-of-care test.Study DesignThe Xpert Xpress SARS-CoV-2 assay was evaluated against the routine in-house real-time RT-PCR assays in three medical microbiology laboratories in The Netherlands. A sensitivity and specificity panel was tested consisting of a dilution series of SARS-CoV-2 and ten samples containing SARS-CoV-2 and a range of other seasonal respiratory viruses. Additionally, 58 samples of patients positive for SARS-CoV-2 with different viral loads and 30 tested negative samples in all three Dutch laboratories using an in-house RT-PCR, were evaluated using Cepheids Xpert Xpress SARS-CoV-2 cartridges.ResultsXpert Xpress SARS-CoV-2 point of care test showed equal performance compared to routine in-house testing with a limit of detection (LOD) of 8.26 copies/mL. Other seasonal respiratory viruses were not detected. In clinical samples Xpert Xpress SARS-CoV-2 reaches an agreement of 100 % compared to all in-house RT-PCRs CONCLUSION: Cepheids GeneXpert Xpert Xpress SARS-CoV-2 is a valuable addition for laboratories in situations where rapid and accurate diagnostics are of the essence.Copyright © 2020 Elsevier B.V. All rights reserved.

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