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.
【저자키워드】 COVID-19, immunochromatography, Influenza, SARS-CoV-2., antigen test, QuickNavi-Flu+COVID19 Ag, 【초록키워드】 coronavirus disease, immunochromatography, SARS-CoV-2, Coronavirus disease 2019, coronavirus, Influenza, variant, severe acute respiratory syndrome Coronavirus, RT-PCR, Antigen, SARS-CoV-2 detection, sensitivity, specificity, PCR, Symptomatic patients, pathogen, Sensitivity and specificity, L452R, spike mutation, Japan, influenza viruses, Pathogens, Swab, real-time RT-PCR, reverse transcription PCR, Nasal sample, Tokyo, referred to, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, study period, Nasopharyngeal samples, symptomatic cases, sensitivities, positive, nasal samples, discrepant results, nasopharyngeal sample, prevalent, respiratory sample, detect, collected, evaluated, influenza virus, Denka, discrepant result, 【제목키워드】 diagnostic, Antigen,