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

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 s...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7c8565b2fcd543a4ae0dcc01191fae6f
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spelling	oai:doaj.org-article:7c8565b2fcd543a4ae0dcc01191fae6f2021-12-05T12:13:08ZPerformance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-1910.1038/s41598-021-02636-x2045-2322https://doaj.org/article/7c8565b2fcd543a4ae0dcc01191fae6f2021-12-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-02636-xhttps://doaj.org/toc/2045-2322Abstract 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 < 99, respectively. The kit did not cross-react with human coronaviruses causing seasonal common cold and influenza, and none of the 69 individuals without COVID-19 were diagnosed with positive results. Importantly, 81.8% of the samples with low virus load (< 50 copy numbers) were diagnosed as negative. Thus, using HISCL antigen assay kits may reduce overdiagnosis compared with RT-qPCR tests. The rapid and high-throughput HISCL SARS-CoV-2 Antigen assay kit developed here proved suitable for screening infectious COVID-19 and may help control the pandemic.Kaori SaitoTomohiko AiAkinori KawaiJun MatsuiYoshiyuki FukushimaNorihiro KikukawaTakuya KyoutouMasayoshi ChonanTakeaki KawakamiYoshie HosakaShigeki MisawaHaruhi TakagiYasushi MatsushitaMakoto HikiAtsushi OkuzawaSatoshi HoriToshio NaitoTakashi MiidaKazuhisa TakahashiYoko TabeNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q 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 Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
description	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 < 99, respectively. The kit did not cross-react with human coronaviruses causing seasonal common cold and influenza, and none of the 69 individuals without COVID-19 were diagnosed with positive results. Importantly, 81.8% of the samples with low virus load (< 50 copy numbers) were diagnosed as negative. Thus, using HISCL antigen assay kits may reduce overdiagnosis compared with RT-qPCR tests. The rapid and high-throughput HISCL SARS-CoV-2 Antigen assay kit developed here proved suitable for screening infectious COVID-19 and may help control the pandemic.
format	article
author	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
author_facet	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
author_sort	Kaori Saito
title	Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
title_short	Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
title_full	Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
title_fullStr	Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
title_full_unstemmed	Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
title_sort	performance and usefulness of a novel automated immunoassay hiscl sars-cov-2 antigen assay kit for the diagnosis of covid-19
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/7c8565b2fcd543a4ae0dcc01191fae6f
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Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19

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