tetano
Editor, Senior Moderator
Sci Rep
. 2021 Dec 1;11(1):23196.
doi: 10.1038/s41598-021-02636-x.
Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
Kaori Saito[SUP] #[/SUP][SUP] 1 [/SUP], Tomohiko Ai[SUP] #[/SUP][SUP] 1 [/SUP], Akinori Kawai[SUP] 2 [/SUP], Jun Matsui[SUP] 3 [/SUP], Yoshiyuki Fukushima[SUP] 3 [/SUP], Norihiro Kikukawa[SUP] 2 [/SUP], Takuya Kyoutou[SUP] 4 [/SUP], Masayoshi Chonan[SUP] 5 [/SUP], Takeaki Kawakami[SUP] 5 [/SUP], Yoshie Hosaka[SUP] 5 [/SUP], Shigeki Misawa[SUP] 5 [/SUP], Haruhi Takagi[SUP] 6 [/SUP], Yasushi Matsushita[SUP] 7 [/SUP], Makoto Hiki[SUP] 8 9 [/SUP], Atsushi Okuzawa[SUP] 10 [/SUP], Satoshi Hori[SUP] 11 [/SUP], Toshio Naito[SUP] 12 [/SUP], Takashi Miida[SUP] 1 [/SUP], Kazuhisa Takahashi[SUP] 6 [/SUP], Yoko Tabe[SUP] 13 14 [/SUP]
Affiliations
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.
. 2021 Dec 1;11(1):23196.
doi: 10.1038/s41598-021-02636-x.
Performance and usefulness of a novel automated immunoassay HISCL SARS-CoV-2 Antigen assay kit for the diagnosis of COVID-19
Kaori Saito[SUP] #[/SUP][SUP] 1 [/SUP], Tomohiko Ai[SUP] #[/SUP][SUP] 1 [/SUP], Akinori Kawai[SUP] 2 [/SUP], Jun Matsui[SUP] 3 [/SUP], Yoshiyuki Fukushima[SUP] 3 [/SUP], Norihiro Kikukawa[SUP] 2 [/SUP], Takuya Kyoutou[SUP] 4 [/SUP], Masayoshi Chonan[SUP] 5 [/SUP], Takeaki Kawakami[SUP] 5 [/SUP], Yoshie Hosaka[SUP] 5 [/SUP], Shigeki Misawa[SUP] 5 [/SUP], Haruhi Takagi[SUP] 6 [/SUP], Yasushi Matsushita[SUP] 7 [/SUP], Makoto Hiki[SUP] 8 9 [/SUP], Atsushi Okuzawa[SUP] 10 [/SUP], Satoshi Hori[SUP] 11 [/SUP], Toshio Naito[SUP] 12 [/SUP], Takashi Miida[SUP] 1 [/SUP], Kazuhisa Takahashi[SUP] 6 [/SUP], Yoko Tabe[SUP] 13 14 [/SUP]
Affiliations
- PMID: 34853366
- DOI: 10.1038/s41598-021-02636-x
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.