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タイトル: | Analytical and clinical performances of seven direct detection assays for SARS-CoV-2 |
著者: | Matsumura, Yasufumi https://orcid.org/0000-0001-8595-8944 (unconfirmed) Yamazaki, Wataru https://orcid.org/0000-0002-7874-8014 (unconfirmed) Noguchi, Taro https://orcid.org/0000-0002-6601-6799 (unconfirmed) Yamamoto, Masaki Nagao, Miki https://orcid.org/0000-0002-8886-6145 (unconfirmed) |
著者名の別形: | 松村, 康史 山崎, 渉 野口, 太郎 山本, 正樹 長尾, 美紀 |
キーワード: | SARS-CoV-2 RT-PCR Lateral flow antigen assay Direct detection |
発行日: | Feb-2023 |
出版者: | Elsevier BV |
誌名: | Journal of Clinical Virology Plus |
巻: | 3 |
号: | 1 |
論文番号: | 100138 |
抄録: | 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. |
著作権等: | © 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license. |
URI: | http://hdl.handle.net/2433/286143 |
DOI(出版社版): | 10.1016/j.jcvp.2023.100138 |
PubMed ID: | 36683610 |
出現コレクション: | 学術雑誌掲載論文等 |
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