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Updated: Jul 25, 2026
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care
Oana Bulilete1, Patricia Lorente2, Alfonso Leiva1
1Primary Health Care Research Unit, Balearic Public Health Service (Ib-Salut), Escola Graduada n9, 07002 Palma, Illes Balears, Spain; Balearic Islands Health Research Institute (IdISBa), Carretera de Valldemossa, 79, 07120 Palma, Illes Balears, Spain.
Objectives:
We aimed to evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.
Methods:
The study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.
Findings:
A total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.
Interpretation:
Ag-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our data do not support the sole use of Panbio™ Ag-RDT in asymptomatic individuals.
Funding:
None.
