2022年冬に検体採取し、3月に解析、5月に投稿していた論文が無事にアクセプトされました。
概要：
1. PCRセンターに来院の方に対して、追加で1本鼻咽頭スワブを採取し、基準検査法（感染研法PCR)と比較
2. 1073名が参加（417名陽性）919名は有症状
3. 感度：94.2% (95% CI: 91.6%–96.3%)
特異度：99.5% (95% CI: 98.7%–99.9%)
＊検体の87％がCt25未満
鼻咽頭検体で採取した場合、オミクロン株（BA.1, BA.2）での有症状者に対して抗原検査は高い感度を認めた。
Introduction
Rapid qualitative antigen testing is essential in the clinical management of COVID-19. However, most evaluations of antigen tests have been performed before the emergence of the Omicron variant.
Methods
This prospective observational study evaluated QuickNavi-COVID19 Ag, a rapid antigen detection test between December 2021 and February 2022 in Japan, using real-time reverse transcription (RT)-PCR as a reference. Two nasopharyngeal samples were simultaneously collected for antigen testing and for RT-PCR. Variant analysis of the SARS-CoV-2 genomic sequencing was also performed.
Results
In total, nasopharyngeal samples were collected from 1073 participants (417 positive; 919 symptomatic; 154 asymptomatic) for analysis. Compared with those of RT-PCR, the sensitivity, specificity, positive predictive value, and negative predictive value were 94.2% (95% CI: 91.6%–96.3%), 99.5% (95% CI: 98.7%–99.9%), 99.2% (95% CI: 97.8%–99.8%), and 96.5% (95% CI: 94.8%–97.7%), respectively. The sensitivity among symptomatic individuals was 94.3% (95% CI: 91.5%–96.4%). Overall, 85.9% of sequences were classified as Omicron sublineage BA.1, 12.4% were Omicron sublineage BA.2, and 1.6% were Delta B.1.617.2. (Delta variant). Most of the samples (87.1%) had Ct values of
Conclusions
The QuickNavi-COVID19 Ag test showed sufficient diagnostic performance for the detection of the SARS-CoV-2 Omicron sublineages BA.1 and BA.2 from nasopharyngeal samples. However, the current study was mainly performed in symptomatic patients and the results are not sufficiently applicable for asymptomatic patients.
