Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection

Paloma Merino et al. Clin Microbiol Infect. .

Free PMC article


Objectives: The standard RT-PCR assay for coronavirus disease 2019 (COVID-19) is laborious and time-consuming, limiting testing availability. 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™ COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swab specimens.

Methods: This prospective multicentre study was carried out in ten Spanish university hospitals and included individuals with clinical symptoms or epidemiological criteria of 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-positive results. The overall sensitivity and specificity for the PanbioRT were 90.5% (95%CI 87.5-93.6) and 98.8% (95%CI 98-99.7), respectively. Sensitivity in participants who had a threshold cycle (CT) < 25 for the RT-PCR test was 99.5% (95%CI 98.4-100), and in participants with ≤5 days of the clinical course it was 91.8% (95%CI 88.8-94.8). Agreement between techniques was 95.7% (κ score 0.90; 95%CI 0.88-0.93).

Conclusions: The PanbioRT performs well clinically, 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.

Keywords: Antigen diagnosis; COVID-19; Control of cases; Multicentre evaluation; Pandemic; Quick diagnosis; SARS-CoV2.

Similar articles

Cited by 18 articles


    1. World Health Organization Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays. Interim Guidance. 2020 September 11th. Available from:
    1. Foundation for Innovative New Diagnostics SARSCoV-2 diagnostic pipeline 2020. Available from:
    1. Rodríguez Domínguez M., Franco Álvarez de Luna F., Goyanes Galán M.J., García Rodríguez J. Diagnóstico microbiológico en el lugar de asistencia al paciente. Procedimientos en Microbiología Clínica. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) 2019. Available from:
    1. Nguyen T., Duong Bang D., Wolff A. 2019 Novel coronavirus disease (COVID-19): paving the road for rapid detection and point-of-care diagnostics. Micromachines (Basel) 2020;11:306. doi: 10.3390/mi11030306. - DOI - PMC - PubMed
    1. McHugh M.L. Interrater reliability: the kappa statistic. Biochem Med (Zagreb) 2012;22:276–282. - PMC - PubMed

LinkOut - more resources

Reach out

Find us at the office

Mcevilly- Liposky street no. 40, 55778 Tórshavn, Faroe Islands

Give us a ring

Maliek Elvis
+23 188 845 957
Mon - Fri, 7:00-15:00

Say hello