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A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag.
Takeuchi, Yuto; Akashi, Yusaku; Kiyasu, Yoshihiko; Terada, Norihiko; Kurihara, Yoko; Kato, Daisuke; Miyazawa, Takashi; Muramatsu, Shino; Shinohara, Yuki; Ueda, Atsuo; Notake, Shigeyuki; Nakamura, Koji; Suzuki, Hiromichi.
  • Takeuchi Y; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: yuto-takeuchi@umin.ac.jp
  • Akashi Y; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan; Department of Infectious Diseases, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan; Akashi Internal Medicine Clinic
  • Kiyasu Y; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: kiyasu-tuk@umin.ac.jp.
  • Terada N; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: terada.norihiko.ck@ms.ho
  • Kurihara Y; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan. Electronic address: kurihara.yoko.sk@ms.hosp.tsukuba.ac.jp.
  • Kato D; Denka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D Department, 1-2-2 Minami-hon-cho, Gosen-shi, Niigata, 959-1695, Japan. Electronic address: daisuke-kato@denka.co.jp.
  • Miyazawa T; Denka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D Department, 1-2-2 Minami-hon-cho, Gosen-shi, Niigata, 959-1695, Japan. Electronic address: takashi-miyazawa@denka.co.jp.
  • Muramatsu S; Denka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D Department, 1-2-2 Minami-hon-cho, Gosen-shi, Niigata, 959-1695, Japan. Electronic address: shino-muramatsu@denka.co.jp.
  • Shinohara Y; Denka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D Department, 1-2-2 Minami-hon-cho, Gosen-shi, Niigata, 959-1695, Japan. Electronic address: yuki-shinohara@denka.co.jp.
  • Ueda A; Department of Clinical Laboratory, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: atsuo.ueda06090727@outlook.jp.
  • Notake S; Department of Clinical Laboratory, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: notake@tmch.or.jp.
  • Nakamura K; Department of Clinical Laboratory, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan. Electronic address: koji-nakamura@tmch.or.jp.
  • Suzuki H; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan; Department of Infectious Diseases, Faculty o
J Infect Chemother ; 28(6): 840-843, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1828872
ABSTRACT

INTRODUCTION:

Since respiratory sample collection is an uncomfortable experience, simultaneous detection of pathogens with a single swab is preferable. We prospectively evaluated the clinical performance of a newly developed antigen test QuickNavi-Flu+COVID19 Ag (Denka Co., Ltd., Tokyo, Japan) which can detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses at the same time with a single testing device.

METHODS:

We included those who were suspected of contracting coronavirus disease 2019 (COVID-19) and were referred to a PCR center at Ibaraki prefecture in Japan, between August 2, 2021 to September 13, 2021, when the variant carrying L452R spike mutation of SARS-CoV-2 were prevalent. Additional nasopharyngeal samples and anterior nasal samples were obtained for the antigen test and were compared with a reference real-time reverse transcription PCR (RT-PCR) using nasopharyngeal samples.

RESULTS:

In total, 1510 nasopharyngeal samples and 862 anterior nasal samples were evaluated. During the study period, influenza viruses were not detected by QuickNavi-Flu+COVID19 Ag and reference real-time RT-PCR. For SARS-CoV-2 detection in nasopharyngeal samples, the sensitivity and specificity of the antigen test were 80.9% and 99.8%, respectively. The sensitivity and specificity using anterior nasal samples were 67.8% and 100%, respectively. In symptomatic cases, the sensitivities increased to 88.3% with nasopharyngeal samples and 73.7% with anterior nasal samples. There were three cases of discrepant results between the antigen test and the real-time RT-PCR. All of them were positive with the antigen test but negative with the real-time RT-PCR in SARS-CoV-2 detection.

CONCLUSION:

A combo kit, QuickNavi-Flu+COVID19 Ag, showed an acceptable sensitivity and sufficient specificity for SARS-CoV-2 detection, especially using nasopharyngeal sample collected from symptomatic patients.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: J Infect Chemother Journal subject: Microbiology / Drug Therapy Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: J Infect Chemother Journal subject: Microbiology / Drug Therapy Year: 2022 Document Type: Article