Merino-Amador, PalomaGonzález-Donapetry, PatriciaDomínguez Fernández, MercedesGonzález-Romo, FernandoSánchez-Castellano, Miguel ÁngelSeoane-Estévez, AlejandroDelgado-Iribarren, AlbertoGarcía, JulioBou, GermánCuenca-Estrella, ManuelOteo, Jesús2025-10-302025-10-302021-08-23Merino-Amador P, González-Donapetry P, Domínguez-Fernández M, González-Romo F, Sánchez-Castellano MÁ, Seoane-Estevez A, Delgado-Iribarren A, García J, Bou G, Cuenca-Estrella M, Oteo-Iglesias J. Clinitest rapid COVID-19 antigen test for the diagnosis of SARS-CoV-2 infection: a multicenter evaluation study. J Clin Virol. 2021 Oct;143:104961.1386-6532https://hdl.handle.net/2183/46184Multicenter study[Abstract] Objectives: RT-PCR assay is the reference method for diagnosis of COVID-19, but it is also a laborious and time-consuming technic, limiting the availability of testing. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the Clinitest Rapid COVID-19 Antigen Test (ClinitestRT) (SIEMENS) for SARS-CoV-2 in nasopharyngeal swab specimens. Methods: This prospective multicenter study was carried out in three Spanish university hospitals including individuals with clinical symptoms or epidemiological criteria for COVID-19. Only individuals with ≤7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the ClinitestRT, as a point-of-care test, and a diagnostic RT-PCR test. Results: Overall sensitivity and specificity for the ClinitestRT among the 450 patients studied were 93.3% (CI 95%: 89.7-96.8) and 99.2% (CI 95%: 97.2-99.8), respectively. Sensitivity in participants with ≤5 days of the clinical course was 93.6% (CI 95%: 89.2-96.3), and in participants who had a CT < 25 for the RT-PCR test was 98.4% (CI 95%: 94.5-99.6). Agreement between techniques was 96.7% (kappa score: 0.93; CI 95%: 0.90-0.97). Conclusions: The ClinitestRT provides good clinical performance, with more reliable results for patients with a higher viral load. The results must be interpreted based on the local epidemiological context.engAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/COVID-19Rapid antigen-detection testSARS-CoV-2journal articleopen access10.1016/j.jcv.2021.104961