Clinitest rapid COVID-19 antigen test for the diagnosis of SARS-CoV-2 infection: A multicenter evaluation study

• Published in: Journal of clinical virology Vol. 143; p. 104961
• Main Authors: Merino-Amador, Paloma, González-Donapetry, Patricia, Domínguez-Fernández, Mercedes, González-Romo, Fernando, Sánchez-Castellano, Miguel Ángel, Seoane-Estevez, Alejandro, Delgado-Iribarren, Alberto, García, Julio, Bou, Germán, Cuenca-Estrella, Manuel, Oteo-Iglesias, Jesús
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.10.2021
• Subjects: Antigens, Viral; Citric Acid; Copper Sulfate; COVID-19; Humans; Prospective Studies; Rapid antigen-detection test; Reproducibility of Results; SARS-CoV-2; Sensitivity and Specificity; Sodium Bicarbonate; COVID-19; Rapid antigen-detection test; SARS-CoV-2
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2021.104961

•Overall sensitivity and specificity for the Clinitest Rapid COVID-19 Antigen Test for SARS-CoV-2 in nasopharyngeal swab specimens among the 450 patients studied were 93.3% and 99.2%, respectively.•Sensitivity in participants who had a CT < 25 for the RT-PCR test was 98.4%.•The Clinitest Rapid COVID-19 Antigen Test provided good clinical performance, with more reliable results for patients with a higher viral load. 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. 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. 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). 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.