A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples. Issue 6 (June 2022)

• Record Type: Journal Article
• Authors: Akashi, Yusaku; Horie, Michiko; Takeuchi, Yuto; Togashi, Kenichi; Adachi, Yuki; Ueda, Atsuo; Notake, Shigeyuki; Nakamura, Koji; Terada, Norihiko; Kurihara, Yoko; Kiyasu, Yoshihiko; Suzuki, Hiromichi
• Is Part Of: Journal of infection and chemotherapy. Volume 28:Issue 6(2022)
• Page Start: 780
• Page End: 785
• Publication Date: 2022-06
• Subjects: SARS-CoV-2 -- COVID-19 -- Rapid antigen test -- Anterior nasal sample -- Diagnostic performance study; Chemotherapy -- Periodicals; Infection -- Periodicals; Communicable diseases -- Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1016/j.jiac.2022.02.016
• Languages: English
• ISSNs: 1341-321X

Abstract

Abstract: Introduction: The diagnostic accuracy of antigen testing of anterior nasal (AN) samples for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has not been evaluated in the Japanese population. This study assessed the diagnostic accuracy of the Roche SARS-CoV-2 rapid antigen test (rapid antigen test) using AN samples. Methods: Two AN samples and one nasopharyngeal (NP) sample were collected from individuals undergoing screening for SARS-CoV-2 infection. The results of the rapid antigen test and the reverse-transcription polymerase chain reaction (RT-PCR) test using AN samples were compared to those of RT-PCR tests using NP samples. Results: Samples were collected from 800 participants, 95 and 110 of whom tested positive for SARS-CoV-2 on RT-PCR tests of AN and NP samples, respectively. The overall sensitivity/specificity of the AN rapid antigen test and AN RT-PCR were 72.7%/100% and 86.4%/100%, respectively. In symptomatic cases, the sensitivities of the AN rapid antigen test and AN RT-PCR were 84.7% and 94.9%, respectively. In asymptomatic cases, the sensitivities of the AN rapid antigen test and AN RT-PCR were 58.8% and 76.5%, respectively. The sensitivity of the AN rapid antigen test was over 80% in cases with cycle threshold (Ct) values < 25; it significantly decreased with an increase in the Ct values (p < 0.001). Conclusion: The rapid antigen test with AN samples had a favorable sensitivity, especially in symptomatic cases or in cases with Ct values < 25. It gave no false-positive results. Compared with AN-RT PCR, the AN rapid antigen test had a modestly lower sensitivity in asymptomatic cases.