1. Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection
- Author
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Rafael Cantón, Patricia González-Donapetry, María Dolores Folgueira, Alba Pérez, Marta Rolo, Silvia Hernáez-Crespo, José Luis Díaz-de Tuesta, Alicia Galar, Pilar Escribano, Mercedes Sota-Busselo, M. Carmen Martín-Higuera, Tania Bravo, Gustavo Cilla, M. Montes, Ana Gual-de Torrella, Izaskun Alejo-Cancho, Miguel Ángel Sánchez-Castellano, Alberto Delgado-Iribarren, Manuel Cuenca-Estrella, Julio García, Paloma Merino, Irene Muñoz-Gallego, Diego Vicente, Fernando González-Romo, Jesús Guinea, Jesús Oteo-Iglesias, Sara Medrano, Juan Carlos Galán, M. Jesús Estévez, Oscar Martínez-Expósito, Nerea Antona, and Patricia Muñoz
- Subjects
0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,Context (language use) ,Disease ,Multicentre evaluation ,Antigen diagnosis ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,Internal medicine ,Epidemiology ,Medicine ,030212 general & internal medicine ,Pandemic ,business.industry ,COVID-19 ,General Medicine ,Test (assessment) ,Infectious Diseases ,SARS-CoV2 ,Original Article ,Control of cases ,business ,Quick diagnosis ,Viral load - Abstract
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 reliability of the PanbioTM COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens. This was a prospective multicenter study in ten Spanish university hospitals of patients from hospital units with clinical symptoms or epidemiological criteria for COVID-19. Patients whose onset of symptoms or exposure was more than 7 days earlier were excluded. Two nasopharyngeal exudate samples were taken to perform the PanbioRT and a diagnostic RT-PCR test. Among the 958 patients studied, 359 (37.5%) were positive by RT-PCR and 325 (33.9%) were also positive by the PanbioRT. Agreement was 95.7% (kappa score: 0.90). All 34 false-negative PanbioRT results were in symptomatic patients, with 23.5% of them at 6–7 days since the onset of symptoms and 58.8% presenting CT >30 values for RT-PCR, indicating a low viral load. Overall sensitivity and specificity for the PanbioRT were 90.5% and 98.8%, respectively. The PanbioRT provides good clinical performance as a point-of-care test, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. While this study has had a direct impact on the national diagnostic strategy for COVID-19 in Spain, the results must be interpreted based on the local epidemiological context.
- Published
- 2021
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