tetano
Editor, Senior Moderator
J Infect Chemother
. 2021 Mar 4;S1341-321X(21)00069-6.
doi: 10.1016/j.jiac.2021.02.029. Online ahead of print.
The evaluation of a newly developed antigen test (QuickNavi?-COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan
Yuto Takeuchi[SUP] 1 [/SUP], Yusaku Akashi[SUP] 2 [/SUP], Daisuke Kato[SUP] 3 [/SUP], Miwa Kuwahara[SUP] 4 [/SUP], Shino Muramatsu[SUP] 5 [/SUP], Atsuo Ueda[SUP] 6 [/SUP], Shigeyuki Notake[SUP] 7 [/SUP], Koji Nakamura[SUP] 8 [/SUP], Hiroichi Ishikawa[SUP] 9 [/SUP], Hiromichi Suzuki[SUP] 10 [/SUP]
Affiliations
Abstract
Introduction: Several antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed worldwide, but their clinical utility has not been well established. In this study, we evaluated the analytical and clinical performance of QuickNavi?-COVID19 Ag, a newly developed antigen test in Japan.
Methods: This prospective observational study was conducted at a PCR center between October 7 and December 5, 2020. The included patients were referred from a local public health center and 89 primary care facilities. We simultaneously obtained two nasopharyngeal samples with flocked swabs; one was used for the antigen test and the other for real-time reverse transcription PCR (RT-PCR). Using the results of real-time RT-PCR as a reference, the performance of the antigen test was evaluated.
Results: A total of 1186 patients were included in this study, and the real-time RT-PCR detected SARS-CoV-2 in 105 (8.9%). Of these 105 patients, 33 (31.4%) were asymptomatic. The antigen test provided a 98.8% (95% confidence interval [CI]: 98.0%-99.4%) concordance rate with real-time RT-PCR, along with a sensitivity of 86.7% (95% CI: 78.6%-92.5%) and a specificity of 100% (95% CI: 99.7%-100%). False-negatives were observed in 14 patients, 8 of whom were asymptomatic and had a low viral load (cycle threshold (Ct) > 30). In symptomatic patients, the sensitivity was 91.7% (95% CI: 82.7%-96.9%).
Conclusion: QuickNavi?-COVID19 Ag showed high specificity and sufficient sensitivity for the detection of SARS-CoV-2. This test is a promising potential diagnostic modality especially in symptomatic patients.
Keywords: Antigen test; COVID-19; Immunochromatography; QuickNavi?-COVID19 Ag; SARS-CoV-2.
. 2021 Mar 4;S1341-321X(21)00069-6.
doi: 10.1016/j.jiac.2021.02.029. Online ahead of print.
The evaluation of a newly developed antigen test (QuickNavi?-COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan
Yuto Takeuchi[SUP] 1 [/SUP], Yusaku Akashi[SUP] 2 [/SUP], Daisuke Kato[SUP] 3 [/SUP], Miwa Kuwahara[SUP] 4 [/SUP], Shino Muramatsu[SUP] 5 [/SUP], Atsuo Ueda[SUP] 6 [/SUP], Shigeyuki Notake[SUP] 7 [/SUP], Koji Nakamura[SUP] 8 [/SUP], Hiroichi Ishikawa[SUP] 9 [/SUP], Hiromichi Suzuki[SUP] 10 [/SUP]
Affiliations
- PMID: 33727026
- DOI: 10.1016/j.jiac.2021.02.029
Abstract
Introduction: Several antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed worldwide, but their clinical utility has not been well established. In this study, we evaluated the analytical and clinical performance of QuickNavi?-COVID19 Ag, a newly developed antigen test in Japan.
Methods: This prospective observational study was conducted at a PCR center between October 7 and December 5, 2020. The included patients were referred from a local public health center and 89 primary care facilities. We simultaneously obtained two nasopharyngeal samples with flocked swabs; one was used for the antigen test and the other for real-time reverse transcription PCR (RT-PCR). Using the results of real-time RT-PCR as a reference, the performance of the antigen test was evaluated.
Results: A total of 1186 patients were included in this study, and the real-time RT-PCR detected SARS-CoV-2 in 105 (8.9%). Of these 105 patients, 33 (31.4%) were asymptomatic. The antigen test provided a 98.8% (95% confidence interval [CI]: 98.0%-99.4%) concordance rate with real-time RT-PCR, along with a sensitivity of 86.7% (95% CI: 78.6%-92.5%) and a specificity of 100% (95% CI: 99.7%-100%). False-negatives were observed in 14 patients, 8 of whom were asymptomatic and had a low viral load (cycle threshold (Ct) > 30). In symptomatic patients, the sensitivity was 91.7% (95% CI: 82.7%-96.9%).
Conclusion: QuickNavi?-COVID19 Ag showed high specificity and sufficient sensitivity for the detection of SARS-CoV-2. This test is a promising potential diagnostic modality especially in symptomatic patients.
Keywords: Antigen test; COVID-19; Immunochromatography; QuickNavi?-COVID19 Ag; SARS-CoV-2.