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

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

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 C(T) < 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.