tetano
Editor, Senior Moderator
J Infect Chemother
. 2022 Mar 7;S1341-321X(22)00075-7.
doi: 10.1016/j.jiac.2022.02.027. Online ahead of print.
A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag
Yuto Takeuchi[SUP] 1 [/SUP], Yusaku Akashi[SUP] 2 [/SUP], Yoshihiko Kiyasu[SUP] 3 [/SUP], Norihiko Terada[SUP] 4 [/SUP], Yoko Kurihara[SUP] 5 [/SUP], Daisuke Kato[SUP] 6 [/SUP], Takashi Miyazawa[SUP] 7 [/SUP], Shino Muramatsu[SUP] 8 [/SUP], Yuki Shinohara[SUP] 9 [/SUP], Atsuo Ueda[SUP] 10 [/SUP], Shigeyuki Notake[SUP] 11 [/SUP], Koji Nakamura[SUP] 12 [/SUP], Hiromichi Suzuki[SUP] 13 [/SUP]
Affiliations
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.
Keywords: Antigen test; COVID-19; Immunochromatography; Influenza; QuickNavi-Flu+COVID19 Ag; SARS-CoV-2.
. 2022 Mar 7;S1341-321X(22)00075-7.
doi: 10.1016/j.jiac.2022.02.027. Online ahead of print.
A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag
Yuto Takeuchi[SUP] 1 [/SUP], Yusaku Akashi[SUP] 2 [/SUP], Yoshihiko Kiyasu[SUP] 3 [/SUP], Norihiko Terada[SUP] 4 [/SUP], Yoko Kurihara[SUP] 5 [/SUP], Daisuke Kato[SUP] 6 [/SUP], Takashi Miyazawa[SUP] 7 [/SUP], Shino Muramatsu[SUP] 8 [/SUP], Yuki Shinohara[SUP] 9 [/SUP], Atsuo Ueda[SUP] 10 [/SUP], Shigeyuki Notake[SUP] 11 [/SUP], Koji Nakamura[SUP] 12 [/SUP], Hiromichi Suzuki[SUP] 13 [/SUP]
Affiliations
- PMID: 35277343
- DOI: 10.1016/j.jiac.2022.02.027
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.
Keywords: Antigen test; COVID-19; Immunochromatography; Influenza; QuickNavi-Flu+COVID19 Ag; SARS-CoV-2.