Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): A prospective observational study with nasopharyngeal samples. Issue 1 (January 2022)

• Record Type: Journal Article
• Authors: Suzuki, Hiromichi; Akashi, Yusaku; Ueda, Atsuo; Kiyasu, Yoshihiko; Takeuchi, Yuto; Maehara, Yuta; Ochiai, Yasushi; Okuyama, Shinya; Notake, Shigeyuki; Nakamura, Koji; Ishikawa, Hiroichi
• Is Part Of: Journal of infection and chemotherapy. Volume 28:Issue 1(2022)
• Page Start: 78
• Page End: 81
• Publication Date: 2022-01
• Subjects: RapidTesta SARS-CoV-2 -- Digital immunoassay -- Nasopharyngeal sample -- SARS-CoV-2 -- COVID-19 -- Asymptomatic patients; Chemotherapy -- Periodicals; Infection -- Periodicals; Communicable diseases -- Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1016/j.jiac.2021.10.024
• Languages: English
• ISSNs: 1341-321X

Abstract

Abstract: Introduction: Digital immunoassays are generally regarded as superior tests for the detection of infectious disease pathogens, but there have been insufficient data concerning SARS-CoV-2 immunoassays. Methods: We prospectively evaluated a novel digital immunoassay (RapidTesta SARS-CoV-2). Two nasopharyngeal samples were simultaneously collected for antigen tests and Real-time RT-PCR. Results: During the study period, 1127 nasopharyngeal samples (symptomatic patients: 802, asymptomatic patients: 325) were evaluated. For digital immunoassay antigen tests, the sensitivity was 78.3% (95% CI: 67.3%–87.1%) and the specificity was 97.6% (95% CI: 96.5%–98.5%). When technicians visually analyzed the antigen test results, the sensitivity was 71.6% (95% CI: 59.9%–81.5%) and the specificity was 99.2% (95% CI: 98.5%–99.7%). Among symptomatic patients, the sensitivity was 89.4% (95% CI; 76.9%–96.5%) with digital immunoassay antigen tests, and 85.1% (95% CI; 71.7%–93.8%) with visually analyzed the antigen test, respectively. Conclusions: The sensitivity of digital immunoassay antigen tests was superior to that of visually analyzed antigen tests, but the rate of false-positive results increased with the introduction of a digital immunoassay device.