Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19

Autor: Kaori Saito, Tomohiko Ai, Akinori Kawai, Jun Matsui, Yoshiyuki Fukushima, Norihiro Kikukawa, Takuya Kyoutou, Masayoshi Chonan, Takeaki Kawakami, Yoshie Hosaka, Shigeki Misawa, Haruhi Takagi, Yasushi Matsushita, Makoto Hiki, Atsushi Okuzawa, Satoshi Hori, Toshio Naito, Takashi Miida, Kazuhisa Takahashi, Yoko Tabe
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Scientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
Druh dokumentu: article
ISSN: 2045-2322
DOI: 10.1038/s41598-021-02636-x
Popis: Abstract Here, we aimed to evaluate the clinical performance of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit designed to detect the nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This kit comprises automated chemiluminescence detection systems. Western blot analysis confirmed that anti-SARS-CoV antibodies detected SARS-CoV-2N proteins. The best cut-off index was determined, and clinical performance was tested using 115 serum samples obtained from 46 patients with coronavirus disease 2019 (COVID-19) and 69 individuals who tested negative for COVID-19 through reverse transcription quantitative polymerase chain reaction (RT-qPCR). The HISCL Antigen assay kit showed a sensitivity of 95.4% and 16.6% in samples with copy numbers > 100 and
Databáze: Directory of Open Access Journals
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