tetano
Editor, Senior Moderator
J Infect Chemother
. 2022 Feb 24;S1341-321X(22)00064-2.
doi: 10.1016/j.jiac.2022.02.016. Online ahead of print.
A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples
Yusaku Akashi[SUP] 1 [/SUP], Michiko Horie[SUP] 2 [/SUP], Yuto Takeuchi[SUP] 3 [/SUP], Kenichi Togashi[SUP] 4 [/SUP], Yuki Adachi[SUP] 5 [/SUP], Atsuo Ueda[SUP] 6 [/SUP], Shigeyuki Notake[SUP] 7 [/SUP], Koji Nakamura[SUP] 8 [/SUP], Norihiko Terada[SUP] 9 [/SUP], Yoko Kurihara[SUP] 10 [/SUP], Yoshihiko Kiyasu[SUP] 11 [/SUP], Hiromichi Suzuki[SUP] 12 [/SUP]
Affiliations
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.
Keywords: Anterior nasal sample; COVID-19; Diagnostic performance study; Rapid antigen test; SARS-CoV-2.
. 2022 Feb 24;S1341-321X(22)00064-2.
doi: 10.1016/j.jiac.2022.02.016. Online ahead of print.
A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples
Yusaku Akashi[SUP] 1 [/SUP], Michiko Horie[SUP] 2 [/SUP], Yuto Takeuchi[SUP] 3 [/SUP], Kenichi Togashi[SUP] 4 [/SUP], Yuki Adachi[SUP] 5 [/SUP], Atsuo Ueda[SUP] 6 [/SUP], Shigeyuki Notake[SUP] 7 [/SUP], Koji Nakamura[SUP] 8 [/SUP], Norihiko Terada[SUP] 9 [/SUP], Yoko Kurihara[SUP] 10 [/SUP], Yoshihiko Kiyasu[SUP] 11 [/SUP], Hiromichi Suzuki[SUP] 12 [/SUP]
Affiliations
- PMID: 35256268
- DOI: 10.1016/j.jiac.2022.02.016
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.
Keywords: Anterior nasal sample; COVID-19; Diagnostic performance study; Rapid antigen test; SARS-CoV-2.