Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals
| Autor: | Shino Muramatsu, Kato Daisuke, Yoshihiko Kiyasu, Atsuo Ueda, Hiroichi Ishikawa, Hiromichi Suzuki, Shigeyuki Notake, Miwa Kuwahara, Yusaku Akashi, Koji Nakamura, Yuto Takeuchi |
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| Rok vydání: | 2021 |
| Předmět: |
Microbiology (medical)
2019-20 coronavirus outbreak medicine.medical_specialty Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Asymptomatic Gastroenterology Sensitivity and Specificity COVID-19 Serological Testing Antigen Internal medicine False positive paradox medicine Humans Pharmacology (medical) Prospective Studies Antigen testing Prospective cohort study Antigens Viral Asymptomatic Infections business.industry SARS-CoV-2 Clinical performance COVID-19 Antigen test Infectious Diseases Asymptomatic patient Original Article medicine.symptom business QuickNavi™-COVID19 Ag Nasopharyngeal sample |
| Zdroj: | Journal of Infection and Chemotherapy |
| ISSN: | 1437-7780 |
| Popis: | IntroductionAntigen testing may help screen for and detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in asymptomatic individuals. However, limited data regarding the diagnostic performance of antigen tests for this group are available.MethodsWe used clinical samples to prospectively evaluate the analytical and clinical performance of the antigen test QuickNavi™-COVID19 Ag. This study was conducted at a PCR center between October 7, 2020 and January 9, 2021. Two nasopharyngeal samples per patient were obtained with flocked swabs; one was used for the antigen test, and the other for real-time reverse transcription PCR (RT-PCR). The diagnostic performance of the antigen test was compared between asymptomatic and symptomatic patients, and the RT-PCR results were used as a reference.ResultsAmong the 1,934 collected samples, SARS-CoV-2 was detected by real-time RT-PCR in 188 (9.7%); 76 (40.4%) of these samples were from asymptomatic individuals. Over half of the total samples (1,073; 55.5%) were obtained from asymptomatic volunteers. The sensitivity of the antigen test was significantly lower for asymptomatic group than for symptomatic patients (67.1% vs 89.3%, p < 0.001). The specificity was 100% for both groups, and no false positives were observed among all 1,934 samples. The median Ct value for the asymptomatic group was significantly higher than that of the symptomatic group (24 vs 20, p < 0.001).ConclusionsThe QuickNavi™-COVID19 Ag showed a lower sensitivity for asymptomatic group than for symptomatic patients. However, its specificity was consistently high, and no false positives were found in this study. |
| Databáze: | OpenAIRE |
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