ラピッドテスタ SARS-CoV-2

Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): A prospective observational study with nasopharyngeal samples

Hiromichi Suzuki , Yusaku Akashi , Atsuo Ueda , Yoshihiko Kiyasu , Yuto Takeuchi , Yuta Maehara , Yasushi Ochiai , Shinya Okuyama , Shigeyuki Notake , Koji Nakamura , Hiroichi Ishikawa, JIC, 2021 

前向き臨床性能試験（1127検体）

全体感度（目視）：71.6% (95% CI: 59.9%–81.5%) 

全体特異度（目視）：99.2% (95% CI: 98.5%–99.7%)

全体感度（機器）：78.3% (95% CI: 67.3%–87.1%)

全体特異度（機器）：97.6% (95% CI: 96.5%–98.5%)

有症状感度: 89.4% (機器）, 85.1%(目視）

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549190/