Multicenter evaluation of the Panbioâ„¢ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection

Merino, Paloma; Guinea, Jesús; Muñoz-Gallego, Irene; González-Donapetry, Patricia; Galán, Juan Carlos; Antona, Nerea; Cilla, Gustavo; Hernáez-Crespo, Silvia; Díaz-de Tuesta, José Luis; Torrella, Ana Gual-de; González-Romo, Fernando; Escribano, Pilar; Sánchez-Castellano, Miguel Ángel; Sota-Busselo, Mercedes; Delgado-Iribarren, Alberto; García, Julio; Cantón, Rafael; Muñoz, Patricia; Folgueira, María Dolores; Cuenca-Estrella, Manuel; Oteo-Iglesias, Jesús; Medrano, Sara; Pérez, Alba; Galar, Alicia; Martínez-Expósito, Oscar; Alejo-Cancho, Izaskun; Martín-Higuera, M. Carmen; Rolo, Marta; Estévez, Ma Jesús; Bravo, Tania; Vicente, Diego; Montes, Mila

OBJECTIVES: The standard RT-PCR assay for COVID-19 is laborious and time-consuming, 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 Panbio(TM) COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens. METHODS: This prospective multicenter study was carried out in ten 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 PanbioRT, as a point-of-care test, and a diagnostic RT-PCR test. RESULTS: Among the 958 patients studied, 325 (90.5%) had true-positives results. The overall sensitivity and specificity for the PanbioRT were 90.5% (CI 95%: 87.5-93.6) and 98.8% (CI 95%: 98-99.7), respectively. Sensitivity in participants who had a C(T) <25 for the RT-PCR test was 99.5% (CI 95%: 98.4-100), and in participants with ≤5 days of the clinical course was 91.8% (CI 95%: 88.8-94.8). Agreement between techniques was 95.7% (kappa score: 0.90; CI 95%: 0.88–0.93). CONCLUSIONS: The PanbioRT provides good clinical performance, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. The results must be interpreted based on the local epidemiological context.