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J Clin Virol Plus . Analytical and clinical performances of seven direct detection assays for SARS-CoV-2

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  • J Clin Virol Plus . Analytical and clinical performances of seven direct detection assays for SARS-CoV-2


    J Clin Virol Plus


    . 2023 Feb;3(1):100138.
    doi: 10.1016/j.jcvp.2023.100138. Epub 2023 Jan 13.
    Analytical and clinical performances of seven direct detection assays for SARS-CoV-2


    Yasufumi Matsumura 1 , Wataru Yamazaki 2 , Taro Noguchi 1 , Masaki Yamamoto 1 , Miki Nagao 1



    Affiliations

    Abstract

    Background: Direct detection tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that bypass complicated nucleic acid/antigen purification steps are promising tools for the rapid diagnosis of coronavirus disease 2019 (COVID-19).
    Methods: To determine the analytical and clinical diagnostic performances of the direct detection assays, we compared 6 direct molecular detection assays, including two loop-mediated isothermal amplification (LAMP) assays and one lateral flow antigen assay, against the reference extraction-based RT-PCR assay using 183 respiratory samples (87 nasopharyngeal swabs, 51 saliva samples, and 45 sputum samples).
    Results: Analytical sensitivity analysis showed that the direct RT-PCR assay of Toyobo exhibited the lowest LOD of 1,000 copies/mL. Compared with the 80 positive and 103 negative samples based on the reference assay, the Toyobo assay had the highest positive percent agreement (PPA) of 96.3%, followed by the two direct RT-PCR assays of Takara and Shimadzu and one LAMP assay of Eiken (86.3-87.5%). The Fujirebio antigen assay had the lowest PPA of 44.7% among the assays tested. The negative percent agreement of these direct detection assays was 100%, except for the Eiken assay (96.3%).
    Conclusions: Large differences in PPA existed among the direct detection tests. Laboratories need to take these characteristics into consideration before implementing these assays.

    Keywords: Direct detection; Lateral flow antigen assay; RT-PCR; SARS-CoV-2.

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